Fucidin H Ointment

Fucidin H Ointment

sodium fusidate and hydrocortisone acetate

Please read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

In this leaflet:

• 1. What Fucidin H Ointment is and what it is used for


• 2. Before you use Fucidin H Ointment


• 3. How to use Fucidin H Ointment


• 4. Possible side effects


• 5. How to store Fucidin H Ointment


• 6. Further information

What Fucidin H Ointment Is And What It Is Used For

Fucidin H Ointment contains two different types of medicine. One medicine is called sodium fusidate. It is a type of antibiotic. The other medicine is called hydrocortisone acetate. It is a type of corticosteroid (steroid). These two medicines work at the same time in different ways.

Fucidin H Ointment works by:

• The antibiotic killing germs (bacteria) that cause infections.


• The corticosteroid reducing any swelling, redness or itchiness of your skin.

Fucidin H Ointment is used to treat:

• Conditions where the skin is inflamed (eczema or dermatitis) and also infected by germs (bacteria).

Before You Use Fucidin H Ointment

Do not use Fucidin H Ointment

• If you are allergic (hypersensitive) to fusidic acid, sodium fusidate or hydrocortisone acetate.


• If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.


• To treat a skin condition called acne rosacea. This is redness and inflammation over your nose and cheeks. Ask your doctor if you are unsure.


• To treat a skin condition called perioral dermatitis. This is a red spotty rash around your mouth or chin.


• To treat skin conditions caused by tuberculosis or syphilis.


• To treat skin conditions caused only by bacteria, such as boils or spots.


• To treat a skin condition caused by a virus, such as cold sores or chickenpox.


• To treat a skin condition caused by a fungus, such as athlete’s foot.

Take special care with Fucidin H Ointment

• Take special care if you are going to use this medicine near your eyes or the eyes of a child.


• If you use the ointment over a long time or in large amounts it may make the chance of getting any side effects higher. Also your skin may get more sensitive to this medicine.


• You must not use the medicine for a long time on your face.


• Unless your doctor has told you to, you must not use Fucidin H Ointment on open wounds or sensitive areas such as the nostrils, ears, lips or genitals.


• Unless your doctor has told you to, you must not use Fucidin H Ointment on thin skin, skin ulcers, broken veins or acne.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before using Fucidin H Ointment:

• If you are pregnant, or think you are pregnant.
  You must not use your medicine for a long time or in large amounts. You must ask your doctor for advice.

• If you are breast-feeding.

Tell your doctor if you become pregnant while using this medicine.

Driving and using machines

Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Fucidin H Ointment

Fucidin H Ointment contains:

• Lanolin (wool fat). This may give you an itchy rash and inflammation on your skin where your medicine is used.


• Cetyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

How To Use Fucidin H Ointment

Always use Fucidin H Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to put on Fucidin H Ointment

This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body.

Remove the cap. Check the seal is not broken before you first use the ointment. Then push the spike in the cap through the seal on the tube.

Always wash your hands before using Fucidin H Ointment. Rub the medicine gently on the skin. If you use it on your face be careful to avoid your eyes.

Unless you are using the ointment to treat your hands, always wash your hands after using Fucidin H Ointment.

If you accidentally get any medicine in your eye, wash it out with cold water straight away. Then bathe your eye with eyewash if possible. Your eye may sting. If you start to have any problems with your sight or your eye is sore, contact your doctor immediately.

How much Fucidin H Ointment to use

Your doctor will tell you how much Fucidin H Ointment to use.

The usual treatment time is up to two weeks. Ask your doctor before using this medicine for any longer.

You should notice your skin improve after just a few days of using the ointment. If there is no improvement after 7 days you should stop using the ointment and go back to your doctor.

Usually, you should use this medicine twice each day. Use it in the morning and evening. To remind you to use the medicine it may help to use it when you do another regular action, such as brushing your teeth.

If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.

Adults and children:

Your doctor should tell you the dose that is right for you or the child. If your doctor has told you the amount of ointment to use then keep to this advice. If not, the following guide will help you to use the correct amount.

You can use your first (index) finger to measure how much Fucidin H Ointment to use. Squeeze the ointment along your finger from the tip to the first joint as shown in the diagram. This is called a fingertip unit.

The usual number of finger tip units you need to cover different parts of the body is shown in the diagrams. If you need to use a little more or a little less do not worry. If you are using the ointment on a child still use an adult finger to measure out the fingertip unit.

For an adult:

For application to the face and neck- 2 and a half fingertip units of cream.

For application to the back of the trunk- 7 fingertip units of cream.

For application to the front of the trunk- 7 fingertip units of cream.

For application to one arm (not including the hand)- 3 fingertip units of cream.

For application to both sides of one hand- 1 fingertip unit of cream.

For application to one leg (not including the foot)- 6 fingertip units of cream.

For application to one foot- 2 fingertip units of cream.

For a child under 11 years:

For a child aged three to six months:



For application to the face and neck- 1 fingertip unit of cream.

For application to one arm and hand- 1 fingertip unit of cream.

For application to one leg and foot- 1 and a half fingertip units of cream.

For application to the front of the trunk- 1 fingertip unit of cream.

For application to the back of the trunk, including the buttocks- 1 and a half fingertip units.

For a child aged one to two years:



For application to the face and neck- 1 and a half fingertip units of cream.

For application to one arm and hand- 1 and a half fingertip units of cream.

For application to one leg and foot- 2 fingertip units of cream.

For application to the front of the trunk- 2 fingertip units of cream.

For application to the back of the trunk, including the buttocks- 3 fingertip units.

For a child aged three to five years:



For application to the face and neck- 1 and a half fingertip units of cream.

For application to one arm and hand- 2 fingertip units of cream.

For application to one leg and foot- 3 fingertip units of cream.

For application to the front of the trunk- 3 fingertip units of cream.

For application to the back of the trunk, including the buttocks- 3 and a half fingertip units.

For a child aged six to ten years:



For application to the face and neck- 2 fingertip units of cream.

For application to one arm and hand- 2 and a half fingertip units of cream.

For application to one leg and foot- 4 and a half fingertip units of cream.

For application to the front of the trunk- 3 and a half fingertip units of cream.

For application to the back of the trunk, including the buttocks- 5 fingertip units.

If you forget to use Fucidin H Ointment

If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual time.

If you have any further questions about using this medicine, please ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Fucidin H Ointment can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

• 
  You have difficulty breathing
  


• 
  Your face or throat swell
  


• 
  Your skin develops a severe rash.
  

Other possible side effects:

Any of the problems listed below are more likely if the medicine is used for a long time, in large amounts or on skin folds (such as armpits or under breasts).

These problems are more likely in babies and children. They are also more likely if the skin is covered with a dressing or bandage or nappy.

Skin problems

• Rash.


• Burning and stinging feeling.


• Skin irritation.


• Itching skin.


• Worsening of your eczema.


• Thinning of the skin.


• Small veins near the surface of the skin become visible.


• Stretch marks.


• Itchy rash and skin inflammation in the area where the medicine is used.


• Inflammation or swelling of the hair root (folliculitis).


• Changes in growth of your body hair.


• Red spotty rash around the mouth or chin.


• Lightening of your skin colour.


• Skin of the face may become puffy.

If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How To Store Fucidin H Ointment

• Keep out of the reach and the sight of children.


• Do not use Fucidin H Ointment after the expiry date on the carton. The expiry date is the last day of that month.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need any more. If you do this you will help
protect the environment.

Further Information

What Fucidin H Ointment contains

• There are two active ingredients, sodium fusidate and hydrocortisone acetate.
  
  Fucidin H Ointment contains 2% sodium fusidate and 1% hydrocortisone.
  

• The other ingredients are cetyl alcohol, lanolin (wool fat), liquid paraffin and white soft paraffin.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

What Fucidin H Ointment looks like and contents of the pack

Fucidin H Ointment is an off-white ointment.

Fucidin H Ointment comes in tubes of 30 g and 60 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited

Princes Risborough

Bucks.

HP27 9RR

UK

Manufacturer:

LEO Laboratories Limited

Dublin 12

Ireland

This leaflet was last revised in March 2008.

Registered Trade Mark

LEO

017565 - 05

MicRhogam Ultra-Filtered

Generic Name: rho(d) immune globulin (Injection route, Intramuscular route, Intravenous route)

roe-dee i-MUNE GLOB-ue-lin

Intravenous route(Powder for Solution;Solution)

Intravascular hemolysis (IVH) leading to death has been reported in patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) immune globulin. IVH can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC). Alert patients and closely monitor for the signs and symptoms of IVH in a health care setting for at least eight hours after administration for ITP. Perform a dipstick urinalysis at baseline, 2 hours, 4 hours after administration, and prior to the end of the monitoring period. If signs and/or symptoms of IVH are present or suspected, post-treatment laboratory tests should be performed, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect) .

Commonly used brand name(s)

In the U.S.

• BayRho-D


• HyperRHO S/D


• MicRhogam Ultra-Filtered


• Rhogam


• RhoGAM Ultra-Filtered Plus


• Rhophylac


• WinRho SDF

In Canada

• Winrho SDF

Available Dosage Forms:

• Powder for Solution


• Solution


• Injectable

Therapeutic Class: Immune Serum

Uses For MicRhogam Ultra-Filtered

Rho(D) immune globulin is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. ITP is a type of blood disorder where the person has a very low number of platelets. Platelets help to clot the blood. Rho(D) immune globulin is also used to prevent antibodies from forming after a person with Rh-negative blood receives a transfusion with Rh-positive blood, or during pregnancy when a mother has Rh-negative blood and the baby is Rh-positive. It belongs to a group of medicines called immunizing agents. Rho(D) immune globulin works to boost the immune system and prevent excessive bleeding.

The Rh factor is one part of the red blood cell. A person has either Rh-positive or Rh-negative blood. If you receive the opposite type of blood, your body will create antibodies that can destroy the red blood cells. When a pregnant woman is Rh-negative and her baby is Rh-positive, the baby's blood can get into her system and cause her to make antibodies. When the same woman has a second baby with Rh-positive blood, the antibodies will destroy the red blood cells in the baby. Rho(D) immune globulin is given to these women during pregnancy or after delivery to prevent them from making antibodies.

This medicine is to be administered only by or under the supervision of your doctor.

Before Using MicRhogam Ultra-Filtered

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Rho(D) immune globulin in children. It is not recommended for an infant with Rh-positive blood whose mother is Rh-negative.

Geriatric

Although appropriate studies on the relationship of age to the effects of Rho(D) immune globulin have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of Rho(D) immune globulin in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, and might have conditions that require an adjustment in the dose for patients receiving Rho(D) immune globulin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Varicella Virus Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia, severe or


• Blood clotting problems, history of or


• Breathing problems, severe or


• Disseminated intravascular coagulation (blood clotting problem) or


• Kidney problems or


• Pulmonary edema (fluid in the lungs), history of—Use with caution. May make these conditions worse.

• Atherosclerosis (hardening of the arteries), history of or


• Heart or blood vessel problems or


• Hyperviscosity (thick blood), history of or


• Stroke—Use with caution. May cause side effects to become worse.

• Autoimmune hemolytic anemia (bleeding problem) or


• Hemolysis, active (red blood cells are being destroyed) or


• Immunoglobulin A (IgA) deficiency with antibodies against IgA—Should not be used in patients with these conditions.

• Diabetes—The liquid form of WinRho® contains maltose. Some glucose testing systems will not work properly if maltose is in the blood. Discuss this with your doctor.

Proper Use of rho(d) immune globulin

This section provides information on the proper use of a number of products that contain rho(d) immune globulin. It may not be specific to MicRhogam Ultra-Filtered. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins or as a shot into one of your muscles.

Precautions While Using MicRhogam Ultra-Filtered

It is very important that your doctor check the progress of you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you or your child have back pain; shaking chills; a fever; dark urine; a decreased amount of urine; a sudden weight gain; swelling of the hands or feet; or shortness of breath after receiving this medicine. These may be symptoms of a serious blood problem called intravascular hemolysis (IVH).

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have itching, a rash, hives, chest pain, dizziness or lightheadedness, trouble breathing, or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may cause blood clots, especially in patients with a history of blood clotting problems, heart disease, and atherosclerosis (hardening of the arteries) or circulation problems. Patients who stay in bed for a long time because of surgery or illness may also have blood clots. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.

This medicine may cause a rare and serious lung problem a few hours after it is given. Tell your doctor right away if you or your child have any breathing problems with or without a fever after you receive the medicine.

While you are being treated with Rho(D) immune globulin, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving Rho(D) immune globulin.

MicRhogam Ultra-Filtered Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

• Bloody urine


• decreased frequency of urination or amount of urine


• fever


• increased blood pressure


• increased thirst


• loss of appetite


• lower back pain


• nausea or vomiting


• pale skin


• swelling of the face, fingers, or lower legs


• troubled breathing


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Soreness at the place of injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: MicRhogam Ultra-Filtered side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More MicRhogam Ultra-Filtered resources

• MicRhogam Ultra-Filtered Side Effects (in more detail)
• MicRhogam Ultra-Filtered Use in Pregnancy & Breastfeeding
• MicRhogam Ultra-Filtered Drug Interactions
• MicRhogam Ultra-Filtered Support Group
• 2 Reviews for MicRhogam Ultra-Filtered - Add your own review/rating

Compare MicRhogam Ultra-Filtered with other medications

• Idiopathic Thrombocytopenic Purpura
• Rh-Isoimmunization

Glucophage 500 mg and 850 mg film coated tablets

1. Name Of The Medicinal Product

Glucophage 500 mg film-coated tablet

Glucophage 850 mg film-coated tablet

2. Qualitative And Quantitative Composition

Glucophage 500 mg: One film-coated tablet contains 500mg metformin hydrochloride corresponding to 390 mg metformin base.

Glucophage 850 mg: One film-coated tablet contains 850mg metformin hydrochloride corresponding to 662.9 mg metformin base.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White, circular, convex film-coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.

• In adults, Glucophage may be used as monotherapy or in combination with other oral antidiabetic agents or with insulin.

• In children from 10 years of age and adolescents, Glucophage may be used as monotherapy or in combination with insulin.

A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure (see section 5.1).

4.2 Posology And Method Of Administration

Adults:

Monotherapy and combination with other oral antidiabetic agents:

The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2 or 3 times daily given during or after meals. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.

If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above.

Combination with insulin:

Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin hydrochloride is given at the usual starting dose of 500 mg or 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.

Elderly:

Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary (see section 4.4).

Children and adolescents:

Monotherapy and combination with insulin

• Glucophage can be used in children from 10 years of age and adolescents.

• The usual starting dose is 500 mg or 850 mg metformin hydrochloride once daily, given during or after meals.

After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability. The maximum recommended dose of metformin hydrochloride is 2 g daily, taken as 2 or 3 divided doses.

4.3 Contraindications

• Hypersensitivity to metformin or to any of the excipients.

• Diabetic ketoacidosis, diabetic pre-coma.

• Renal failure or renal dysfunction (creatinine clearance < 60 ml/min).

• Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock.

• Acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock.

• Hepatic insufficiency, acute alcohol intoxication, alcoholism.

4.4 Special Warnings And Precautions For Use

Lactic acidosis: Lactic acidosis is a rare, but serious (high mortality in the absence of prompt treatment), metabolic complication that can occur due to metformin accumulation. Reported cases of lactic acidosis in patients on metformin have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and should be reduced by assessing also other associated risk factors such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia. Diagnosis: The risk of lactic acidosis must be considered in the event of non-specific signs such as muscle cramps with digestive disorders as abdominal pain and severe asthenia. This can be followed by acidotic dyspnea, abdominal pain, hypothermia and coma. Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, metformin should be discontinued and the patient should be hospitalised immediately (see section 4.9).

Renal function:

As metformin is excreted by the kidney, creatinine clearance (this can be estimated from serum creatinine levels by using the Cockcroft-Gault formula) should be determined before initiating treatment and regularly thereafter:

• at least annually in patients with normal renal function,

• at least two to four times a year in patients with creatinine clearance at the lower limit of normal and in elderly subjects.

Decreased renal function in elderly subjects is frequent and asymptomatic. Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive therapy or diuretic therapy and when starting therapy with a non-steroidal anti-inflammatory drug (NSAID).

Administration of iodinated contrast media:

The intravascular administration of iodinated contrast media in radiologic studies can lead to renal failure. This may induce metformin accumulation and may expose to lactic acidosis. Metformin must be discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).

Surgery:

Metformin must be discontinued 48 hours before elective surgery under general, spinal or peridural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and only if normal renal function has been established.

Children and adolescents:

The diagnosis of type 2 diabetes mellitus should be confirmed before treatment with metformin is initiated.

No effect of metformin on growth and puberty has been detected during controlled clinical studies of one-year duration but no long-term data on these specific points are available. Therefore, a careful follow-up of the effect of metformin on these parameters in metformin-treated children, especially prepubescent children, is recommended.

Children aged between 10 and 12 years:

Only 15 subjects aged between 10 and 12 years were included in the controlled clinical studies conducted in children and adolescents. Although efficacy and safety of metformin in these children did not differ from efficacy and safety in older children and adolescents, particular caution is recommended when prescribing to children aged between 10 and 12 years.

Other precautions:

All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet.

The usual laboratory tests for diabetes monitoring should be performed regularly.

Metformin alone does not cause hypoglycaemia, but caution is advised when it is used in combination with insulin or other oral antidiabetics (e.g. sulfonylureas or meglitinides).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use not recommended:

Alcohol:

Acute alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in case of:

fasting or malnutrition, hepatic insufficiency.

Avoid consumption of alcohol and alcohol-containing medicinal product.

Iodinated contrast media :

Intravascular administration of iodinated contrast media may lead to renal failure, resulting in metformin accumulation and an increased risk of lactic acidosis.

Metformin must be discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).

Combinations requiring precautions for use:

Medicinal products with intrinsic hyperglycaemic activity (e.g. glucocorticoids (systemic and local routes) and sympathomimetics):

More frequent blood glucose monitoring may be required, especially at the beginning of treatment. If necessary, adjust the metformin dosage during therapy with the respective medicinal product and upon its discontinuation.

Diuretics, especially loop diuretics:

They may increase the risk of lactic acidosis due to their potential to decrease renal function.

4.6 Pregnancy And Lactation

Pregnancy

Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased risk of congenital abnormalities and perinatal mortality.

A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital abnormalities. Animal studies do not indicate harmful effects with respect to pregnancy, embryonic or fetal development, parturition or postnatal development (see section 5.3).

When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus.

Lactation

Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants. However, as only limited data are available, breast-feeding is not recommended during metformin treatment.A decision on whether to discontinue breast-feeding should be made, taking into account the benefit of breast-feeding and the potential risk to adverse effects on the child. .

Fertility

Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.

4.7 Effects On Ability To Drive And Use Machines

Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or to use machines.

However, patients should be alerted to the risk of hypoglycaemia when metformin is used in combination with other antidiabetic agents (e.g. sulfonylureas, insulin or meglitinides).

4.8 Undesirable Effects

During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended to take metformin in 2 or 3 daily doses and to increase slowly the doses.

The following adverse reactions may occur under treatment with metformin. Frequencies are defined as follows: very common: >1/100, <1/10; uncommon >1/1,000, <1/100; rare >1/10,000, <1/1,000; very rare <1/10,000.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Metabolism and nutrition disorders:

very rare:

Lactic acidosis (see section 4.4).

Decrease of vitamin B12 absorption with decrease of serum levels during long-term use of metformin. Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia.

Nervous system disorders:

Common: Taste disturbance

Gastrointestinal disorders:

very common: Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases. To prevent them, it is recommended that metformin be taken in 2 or 3 daily doses during or after meals. A slow increase of the dose may also improve gastrointestinal tolerability.

Hepatobiliary disorders:

very rare: Isolated reports of liver function tests abnormalities or hepatitis resolving upon metformin discontinuation.

Skin and subcutaneous tissue disorders:

very rare: Skin reactions such as erythema, pruritus, urticaria

Paediatric population

In published and post marketing data and in controlled clinical studies in a limited paediatric population aged 10-16 years treated during 1 year, adverse event reporting was similar in nature and severity to that reported in adults.

4.9 Overdose

Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Blood glucose lowering drugs. Biguanides; ATC code: A10BA02

Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.

Metformin may act via 3 mechanisms:

(1) reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis.

(2) in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization.

(3) and delay of intestinal glucose absorption.

Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.

Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.

In clinical studies, use of metformin was associated with either a stable body weight or modest weight loss.

In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.

Clinical efficacy:

The prospective randomised study (UKPDS) has established the long-term benefit of intensive blood glucose control in adult patients with type 2 diabetes.

Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:

- a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1000 patient-years) versus diet alone (43.3 events/1000 patient-years), p=0.0023, and versus the combined sulfonylurea and insulin monotherapy groups (40.1 events/1000 patient-years), p=0.0034;

- a significant reduction of the absolute risk of diabetes-related mortality: metformin 7.5 events/1000 patient-years, diet alone 12.7 events/1000 patient-years, p=0.017;

- a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1000 patient-years versus diet alone 20.6 events/1000 patient-years (p=0.011), and versus the combined sulfonylurea and insulin monotherapy groups 18.9 events/1000 patient-years (p=0.021);

- a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1000 patient-years, diet alone 18 events/1000 patient-years (p=0.01).

Benefit regarding clinical outcome has not been shown for metformin used as second-line therapy, in combination with a sulfonylurea.

In type 1 diabetes, the combination of metformin and insulin has been used in selected patients, but the clinical benefit of this combination has not been formally established.

Paediatric population

Controlled clinical studies in a limited paediatric population aged 10-16 years treated during 1 year demonstrated a similar response in glycaemic control to that seen in adults.

5.2 Pharmacokinetic Properties

Absorption:

After an oral dose of metformin hydrochloride tablet, maximum plasma concentration (C_max) is reached in approximately 2.5 hours (t_max). Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects. After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.

After oral administration, metformin absorption is saturable and incomplete. It is assumed that the pharmacokinetics of metformin absorption is non-linear.

At the recommended metformin doses and dosing schedules, steady state plasma concentrations are reached within 24 to 48 hours and are generally less than 1 microgram/ml. In controlled clinical trials, maximum metformin plasma levels (C_max) did not exceed 5 microgram/ml, even at maximum doses.

Food decreases the extent and slightly delays the absorption of metformin. Following oral administration of a 850 mg tablet, a 40% lower plasma peak concentration, a 25% decrease in AUC (area under the curve) and a 35 minute prolongation of the time to peak plasma concentration were observed. The clinical relevance of these findings is unknown.

Distribution:

Plasma protein binding is negligible. Metformin partitions into erythrocytes. The blood peak is lower than the plasma peak and appears at approximately the same time. The red blood cells most likely represent a secondary compartment of distribution. The mean volume of distribution (Vd) ranged between 63-276 l.

Metabolism:

Metformin is excreted unchanged in the urine. No metabolites have been identified in humans.

Elimination:

Renal clearance of metformin is> 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.

When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.

Paediatric population

Single dose study: After single doses of metformin hydrochloride 500 mg paediatric patients have shown similar pharmacokinetic profile to that observed in healthy adults.

Multiple dose study: Data are restricted to one study. After repeated doses of 500 mg twice daily for 7 days in paediatric patients the peak plasma concentration (C_max) and systemic exposure (AUC0-t) were reduced by approximately 33% and 40%, respectively compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days. As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies on safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core

Povidone K 30

Magnesium stearate

Film-coating

Hypromellose.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions

6.5 Nature And Contents Of Container

500mg tablets

1 (x 100), 9, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 200, 500, 600 or 1000 tablets in blister packs (PVC-aluminium)

21, 30, 40, 50, 60, 100, 120, 300, 400, 500, 600 or 1000 tablets in plastic bottles (high-density polyethylene) with caps (polypropylene),

Not all pack sizes may be marketed.

850mg tablets:

1 (x 100), 8, 9, 10,14, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 300, 600 or 1000 tablets in blister packs (PVC-aluminium)

30, 60, 200, 300 or 600 tablets in plastic bottles (high-density polyethylene) with caps (polypropylene),

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Merck Serono Limited

Bedfont Cross, Stanwell Road

Feltham, Middlesex

TW14 8NX

United Kingdom

8. Marketing Authorisation Number(S)

PL 11648/0085-0086

9. Date Of First Authorisation/Renewal Of The Authorisation

1st October 2007

10. Date Of Revision Of The Text

10/2010

Combivent Metered Aerosol

1. Name Of The Medicinal Product

Combivent^® Metered Aerosol.

2. Qualitative And Quantitative Composition

COMBIVENT Metered Aerosol is a combination of ipratropium bromide monohydrate and salbutamol sulphate. Each valve activation delivers 21 mcg of ipratropium bromide monohydrate (corresponds to 20 mcg ipratropium bromide anhydrous) and 120 mcg of salbutamol sulphate.

For excipients, see 6.1

3. Pharmaceutical Form

Pressurised inhalation, suspension.

Pressurised aluminium container closed with a metering valve containing a creamy-white suspension inserted into a grey plastic actuator (mouthpiece).

4. Clinical Particulars

4.1 Therapeutic Indications

COMBIVENT is indicated as a bronchodilator for the treatment of bronchospasm associated with chronic obstructive pulmonary disease in patients who require regular treatment with both ipratropium and salbutamol.

4.2 Posology And Method Of Administration

Adults (including elderly patients):

Two inhalations four times a day.

Children:

There is no experience of the use of COMBIVENT in children below the age of 12 years.

Administration

The correct operation of the metered aerosol apparatus is essential for successful therapy.

The aerosol should be shaken and the valve depressed once or twice before the apparatus is initially used.

Before each use the following rules should be observed:

1. Remove protective cap.

2. Shake the metered aerosol well before each use.

3. Breathe out deeply.

4. Hold the metered aerosol and close lips over the mouthpiece. The arrow and the base of the container should be pointing upwards.

5. Breathe in as deeply as possible, pressing the base of the container firmly at the same time, this releases one metered dose. Hold the breath for a few seconds, then remove the mouthpiece from the mouth and breathe out.

6. Replace the protective cap after use.

As the container is not transparent it is not possible to see when the contents are used up, but shaking the container will show if there is any remaining fluid.

The mouthpiece should always be kept clean and can be washed with warm water. If soap or detergent is used, the mouthpiece should be thoroughly rinsed in clear water.

4.3 Contraindications

COMBIVENT Metered Aerosol is contraindicated in patients with hypertrophic obstructive cardiomyopathy or tachyarrhythmia, and in patients with a history of hypersensitivity to any of its components, or to atropine or its derivatives.

COMBIVENT Metered Aerosol is also contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soya bean and peanut. For such patients COMBIVENT Unit Dose Vials without soya lecithin can be used.

4.4 Special Warnings And Precautions For Use

Immediate hypersensitivity reactions may occur after administration of COMBIVENT Metered Aerosol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal oedema.

There have been rare reports of ocular complications (i.e. mydriasis, blurring of vision, narrow-angle glaucoma, eye pain) when the contents of metered aerosols containing ipratropium bromide have been sprayed inadvertently into the eye. Care must be taken to prevent COMBIVENT from entering the eye, particularly in patients who may be pre-disposed to glaucoma. Such patients should be specifically warned to protect their eyes.

Eye pain or discomfort, blurred vision, visual halos or coloured images, in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.

Patients must be instructed in the correct administration of COMBIVENT Metered Aerosol.

In the following conditions COMBIVENT should only be used after careful risk/benefit assessment: Insufficiently controlled diabetes mellitus, recent myocardial infarction and/or severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma, risk of narrow-angle glaucoma. prostatic hypertrophy or bladder-neck obstruction.

There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with salbutamol. Patients with underlying severe heart disease (e.g. ischaemic heart disease, tachyarrhythmia or severe heart failure) who are receiving salbutamol for respiratory disease, should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease.

The patient should be instructed to consult a doctor immediately in the event of acute, rapidly worsening dyspnoea. In addition, the patient should be warned to seek medical advice should a reduced response become apparent.

Potentially serious hypokalemia may result from beta₂-agonist therapy. Particular caution is advised in severe asthma, as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics. Additionally, hypoxia may aggravate the effects of hypokalemia on cardiac rhythm, especially in patients receiving digoxin. It is recommended that serum potassium levels are monitored in such situations.

Patients with cystic fibrosis may be more prone to gastro-intestinal motility disturbances.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Beta-adrenergics, xanthine derivatives and corticosteroids may enhance the effect of COMBIVENT. The concurrent administration of other beta-mimetics, systemically absorbed anticholinergics and xanthine derivatives may increase the side effects.

A potentially serious reduction in effect may occur during concurrent administration of beta-blockers.

Beta-adrenergic agonists should be administered with caution in patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta-adrenergic agonists may be enhanced.

Inhalation of halogenated hydrocarbon anaesthetics such as halothane, trichloroethylene and enflurane may increase the susceptibility to the cardiovascular effects of beta-agonists.

Anticholinergic effects of other drugs can be enhanced.

4.6 Pregnancy And Lactation

Ipratropium bromide has been in general use for several years and there is no definite evidence of ill-consequence during pregnancy; animal studies have shown no hazard.

Salbutamol has been in widespread use for many years without apparent ill-consequence during pregnancy. There is inadequate published evidence of safety in the early stages of human pregnancy but in animal studies there has been evidence of some harmful effects on the foetus at very high dose levels.

As with all medicines, COMBIVENT should not be used in pregnancy, especially the first trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus. Similarly, COMBIVENT should not be administered to breast-feeding mothers unless the expected benefit is thought to outweigh any possible risk to the neonate.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

The following side effects have been reported based on clinical trials involving 821 patients.

Frequencies

Very common
Common
Uncommon
Rare
Very Rare	< 1/10,000
Not known	cannot be estimated from the available data

Immune system disorders:

Anaphylactic reaction	Not known
Hypersensitivity	Not known

Metabolism and nutrition disorders:

Hypokalaemia

Not known

Psychiatric disorders:

Nervousness	Uncommon
Mental disorder	Not known

Nervous system disorders:

Dizziness	Uncommon
Headache	Uncommon
Tremor	Uncommon

Eye disorders:

Angle closure glaucoma	Not known
Eye pain	Not known
Intraocular pressure increased	Not known
Mydriasis	Not known
Vision blurred	Not known

There have been isolated reports of ocular complications with symptoms mentioned above when aerosolised ipratropium bromide either alone or in combination with an adrenergic beta₂-agonist, has escaped into the eyes

Cardiac disorders:

Palpitations	Uncommon
Tachycardia	Uncommon
Arrhythmia	Very rare
Atrial fibrillation	Very rare
Myocardial ischaemia	Very rare
Blood pressure diastolic decreased	Not known
Blood pressure systolic increased	Not known

Respiratory, thoracic and mediastinal disorders:

Cough	Uncommon
Dysphonia	Uncommon
Bronchospasm	Not known
Laryngospasm	Not known
Pharyngeal oedema	Not known
Throat irritation	Not known

Gastrointestinal disorders:

Dry mouth	Common
Nausea	Uncommon
Oedema mouth	Not known
Gastrointestinal motility disorder	Not known
Vomiting	Not known

Skin and subcutaneous tissue disorders:

Angioedema	Not known
Hyperhidrosis	Not known
Rash	Not known
Skin reaction	Not known
Urticaria	Not known

Musculoskeletal and connective tissue disorders

Muscle spasms	Not known
Muscular weakness	Not known
Myalgia	Not known

Renal and urinary disorders:

Urinary retention

Uncommon

General disorders and administration site conditions:

Asthenia

Uncommon

As with all beta₂-agonists hyperactivity in children is possible.

4.9 Overdose

The effects of overdosage are expected to be primarily related to salbutamol because acute overdosage with ipratropium bromide is unlikely as it is not well absorbed systemically after inhalation or oral administration. Hypokalaemia may occur following overdose. Serum potassium levels should be monitored.

Manifestations of overdosage with salbutamol may include anginal pain, hypertension, hypokalaemia and tachycardia. The preferred antidote for overdosage with salbutamol is a cardioselective beta-blocking agent but due care and attention should be used in administering these drugs in patients with a history of bronchospasm.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ipratropium bromide is an anticholinergic agent which inhibits vagally mediated reflexes by antagonising the action of acetylcholine, the transmitter agent released from the vagus nerve. The bronchodilation following inhalation of ipratropium bromide is primarily local and site specific to the lung and not systemic in nature.

Salbutamol sulphate is a beta₂-adrenergic agent which acts on airway smooth muscle resulting in relaxation. Salbutamol relaxes all smooth muscle from the trachea to the terminal bronchioles and protects against all bronchoconstrictor challenges.

COMBIVENT Metered Aerosol provides the simultaneous release of ipratropium bromide and salbutamol sulphate allowing the synergistic efficacy on the muscarinic and beta₂-adrenergic receptors in the lung to cause bronchodilation.

5.2 Pharmacokinetic Properties

Ipratropium bromide is not readily absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract as compared by blood level and renal excretion studies. The half-life elimination of drug and metabolites is about 3 - 4 hours after inhalation or intravenous administration. Ipratropium bromide does not penetrate the blood brain barrier.

Salbutamol sulphate is rapidly and completely absorbed following oral administration either by the inhaled or gastric route. Peak plasma salbutamol concentrations are seen within three hours of administration and the drug is excreted unchanged in the urine after 24 hours. Intravenous salbutamol will cross the blood brain barrier reaching concentrations amounting to about five percent of the plasma concentrations. From a pharmacokinetic perspective, the additive activity of COMBIVENT is due to the local effect of the fixed dose of the active components (ipratropium bromide and salbutamol sulphate) on the muscarinic and beta₂-adrenergic receptors in the lung.

5.3 Preclinical Safety Data

The individual active ingredients ipratropium bromide and salbutamol sulphate have been extensively investigated in animal models and the safety concerns are not clinically significant when COMBIVENT is used as metered aerosol at the recommended dosage levels to patients.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dichlorodifluoromethane

Dichlorotetrafluoroethane

Trichloromonofluoromethane

Soya lecithin

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store below 25°C.

Protect from direct sunlight and frost.

The canister contains a pressurised liquid. Do not expose to temperatures higher than 50ºC. Do not try to open, puncture or burn the canister even when apparently empty.

6.5 Nature And Contents Of Container

COMBIVENT Metered Aerosol is a creamy - white suspension of micronised substances in halogenated propellants filled in metal canisters with a metering valve, delivering 50 µl per actuation.

Pack size: 10 ml

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell,

Berkshire,

RG12 8YS,

United Kingdom.

8. Marketing Authorisation Number(S)

PL 00015/0191

9. Date Of First Authorisation/Renewal Of The Authorisation

22.03.94

10. Date Of Revision Of The Text

February 2009

Legal category

POM

Infumorph Solution

Pronunciation: MORE-feen
Generic Name: Morphine
Brand Name: Infumorph

Infumorph Solution is usually administered through special infusion equipment. Because Infumorph Solution is concentrated, it is not intended for single-dose intravenous, intramuscular, or subcutaneous administration. Do not use Infumorph Solution in place of other forms of morphine. Doing any of these things could result in accidental overdose, which can cause seizures, severe breathing problems, and possibly death.

Administration of the first dose of Infumorph Solution, as well as any refilling or maintenance of infusion equipment, should be performed in a health care facility where naloxone injection and resuscitative equipment are available. Patients should be observed in such a health care setting for at least 24 hours after receiving the initial dose of Infumorph Solution and for the first several days after intrathecal catheter implantation, as appropriate.

If you accidentally get Infumorph Solution on your skin or clothing, remove the contaminated clothing and rinse your skin well with water.

Infumorph Solution is used for:

Treating chronic pain, usually after other treatments have not been adequate.

Infumorph Solution is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, breathing and circulatory systems) at higher doses.

Do NOT use Infumorph Solution if:

• you are allergic to any ingredient in Infumorph Solution


• you are taking cimetidine, sodium oxybate (GHB), or a tricyclic antidepressant (eg, amitriptyline), or you drink alcohol


• you have known or suspected paralysis of the intestines or antibiotic-associated colitis


• you have diarrhea due to poisoning


• you have an upper airway (breathing) obstruction or low blood volume, or you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Infumorph Solution:

Some medical conditions may interact with Infumorph Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems, or you have a history of drug abuse or dependence


• if you have increased pressure in the head, a recent head injury, or lesions in the head


• if you have heart, liver, or thyroid disease; curvature of the spine; seizures; or a history of suicidal thoughts or behaviors


• if you have a stomach blockage or inflammatory bowel disease, or you recently had stomach tract surgery

Some MEDICINES MAY INTERACT with Infumorph Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluoxetine, naltrexone, rifampin, or risperidone because they may decrease Infumorph Solution's effectiveness


• Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, ketorolac, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects (eg, disorientation, respiratory depression, seizures) may occur


• Barbiturate anesthetics (eg, thiopental) or sodium oxybate (GHB) because the risk of their side effects may be increased by Infumorph Solution


• Mexiletine or trovafloxacin because their effectiveness may be decreased by Infumorph Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Infumorph Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Infumorph Solution:

Use Infumorph Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Infumorph Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Infumorph Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Infumorph Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Infumorph Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• If you miss a dose of Infumorph Solution and you are using it regularly, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Infumorph Solution.

Important safety information:

• Infumorph Solution may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Infumorph Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Infumorph Solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• The risk of Infumorph Solution becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Tell your doctor or dentist that you take Infumorph Solution before you receive any medical or dental care, emergency care, or surgery.


• Do not use Infumorph Solution if you have had a severe allergic reaction to morphine or hydromorphone (eg, MS Contin, Roxanol, Dilaudid). If you have a question about whether you are allergic to Infumorph Solution or if a certain medicine contains morphine or hydromorphone, contact your doctor or pharmacist.


• Lab tests, including liver function, kidney function, lung function, and complete blood cell counts, may be performed while you use Infumorph Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Infumorph Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• Infumorph Solution should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Infumorph Solution while you are pregnant. Infumorph Solution is found in breast milk. Do not breast-feed while taking Infumorph Solution.

When used for long periods of time or at high doses, Infumorph Solution may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Infumorph Solution stops working well. Do not take more than prescribed.

Some people who use Infumorph Solution for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Infumorph Solution suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Infumorph Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Agitation; anxiety; changes in vision; confusion; constipation; decreased sex drive; dizziness; drowsiness; dry mouth; exaggerated sense of well-being; fear; frequent urination; headache; incoordination; lack of energy; lightheadedness; loss of appetite; mental clouding; mood swings; nausea; pinpoint pupils; restless mood; sleeplessness; sweating; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); delirium; difficulty urinating; disorientation; fainting; fast or slow heartbeat; flushing of the face; hallucinations; pounding in the chest; seizures; slowed breathing; tremor; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Infumorph side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold and clammy skin; convulsions; deep sleep; dizziness; drowsiness; lightheadedness; loss of consciousness; slowed breathing; slowed heartbeat.

Proper storage of Infumorph Solution:

Infumorph Solution is usually handled and stored by a health care provider. If you are using Infumorph Solution at home, store Infumorph Solution as directed by your pharmacist or health care provider. Keep Infumorph Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Infumorph Solution, please talk with your doctor, pharmacist, or other health care provider.


• Infumorph Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Infumorph Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Infumorph resources

• Infumorph Side Effects (in more detail)
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