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2. Co-Fluampicil Capsules

Document: leaflet MAH GENERIC_PL 20416-0051 change

• label-leaflet MAH GENERIC_PL 20416-0051
• leaflet MAH GENERIC_PL 00530-0178
• leaflet MAH GENERIC_PL 20416-0051

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If you forget to take Co-Fluampicil Capsules: If you forget to take a dose of this medicine, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. DO NOT TAKE TWO DOSES AT THE SAME TIME.

4. possible side effects

Like all medicines, Co-Fluampicil Capsules may cause side-effects in some patients. Some side-effects may be delayed and may occur after you have stopped taking your capsules.

If any of the following occur STOP TAKING the capsules IMMEDIATELY and contact your doctor:

•    difficulty breathing, sudden wheezing or shortness of breath, swelling of the face, tongue, mouth or throat, itching skin or raised itchy red lumps (hives) - these may be signs of an allergy or a severe allergic reaction

•    other effects on the skin such as rashes, red patches, peeling, swelling or blistering

•    severe bloody diarrhoea with fever and abdominal pain.

The following other side-effects have been reported:

•    feeling or being sick, mild diarrhoea

•    inflammation of the kidney (symptoms include swollen ankles)

•    rarely, inflammation of the liver and a type of jaundice (symptoms include yellowing of the skin or whites of the eyes, loss of appetite, pale stools and dark urine). These effects may be delayed and may not occur until up to 2 months after you have stopped taking this medicine

•    rarely, changes in blood which can cause unexplained bleeding, bruising, pale skin, weakness, tiredness and also problems with blood clotting

•    fever or joint or muscle pains (which may develop 2 days or more after you have started taking this medicine)

•    dark or discoloured tongue

•    high doses, particularly in infants and the elderly may cause convulsions or symptoms such as

dizziness, drowsiness, numbness or tingling, eyesight or hearing disturbances.

If you do notice any side effects, including any not mentioned in this leaflet, please inform your doctor or pharmacist.

5.    how to store co-fluampicil capsules

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN. Keep the capsules in the pack provided. Protect from heat, light and moisture.

Do not take the capsules if the expiry date on the pack has passed.

If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    further information

Ingredients: Each Co-Fluampicil capsule contains 250 mg of ampicillin (as trihydrate) and 250 mg of flucloxacillin (as flucloxacillin sodium). The other ingredients are sodium starch glycolate and magnesium stearate. The capsule shell contains gelatin and the colours titanium dioxide (E171), erythrosine (E127), black iron oxide (E172) and patent blue V (E131).

What Co-Fluampicil Capsules look like: The capsules are powder blue and black and are printed with “co-fluam” and “RL”. They are available in pack sizes containing 9, 10, 14, 15, 20, 21, 28, 30, 50, 56, 84, 100, 250, 500 and 1000 capsules. (Not all pack sizes may be marketed).

Product Licence Holder and Manufacturer is Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.

Date leaflet revised: August 2010.

If you would like this leaflet in a different format, please contact the licence holder at the above address.

PATIENT INFORMATION LEAFLET

CO-FLUAMPICIL Capsules

(Ampicillin 250 mg & Flucloxacillin 250 mg)

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

Keep the leaflet, you may need to read it again.

If you have any questions or are not sure about anything, 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.

IN THIS LEAFLET:

1.    What Co-Fluampicil Capsules are and what they are used for

2.    Before you take Co-Fluampicil Capsules

3.    How to take Co-Fluampicil Capsules

4.    Possible side effects

5.    How to store Co-Fluampicil Capsules

6.    Further information

1. WHAT CO-FLUAMPICIL CAPSULES ARE AND WHAT THEY ARE USED FOR

These capsules contain two active ingredients, ampicillin (as trihydrate) and flucloxacillin (as flucloxacillin sodium). Ampicillin and flucloxacillin belong to a group of antibiotics called penicillins. They are used to kill bacteria which cause infections in your body.

Co-Fluampicil Capsules are used:-

•    to treat a wide range of bacterial infections. These include infections of the respiratory tract (e.g. chest and lungs), ear, nose, throat, skin and soft tissues

•    to treat infections and prevent blood poisoning following surgery

•    in patients receiving treatment which affects the body’s immune system (e.g. following organ or bone marrow transplant)

•    to treat infections associated with difficulties in childbirth.

2. BEFORE YOU TAKE CO-FLUAMPICIL CAPSULES

Do not take these capsules if:

•    you are allergic to ampicillin, flucloxacillin, any other penicillin antibiotic or any of the other ingredients in the capsules which are listed in Section 6. (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips)

•    you have ever had liver problems after taking flucloxacillin

Check with your doctor before taking these capsules if:

•    you have liver or kidney problems

•    you have a history of allergy

•    you have glandular fever

•    you are suffering from leukaemia or any other serious illness

•    you are pregnant or breast feeding

•    you are 50 years old or over.

Taking other medicines:

Co-Fluampicil Capsules and other medicines you may be taking may affect

how each other work. Make sure your doctor or pharmacist knows if you

are taking any other medicines, especially:

•    oral contraceptives (as it may not work properly and you will need to use other means of contraception e.g. a condom)

•    other medicines to treat infections such as chloramphenicol, erythromycin, tetracycline, sulphonamides (e.g.trimethoprim) or cephalosporin antibiotics (e.g. minocycline, cefotaxime)

•    probenecid or allopurinol (used to treat gout)

•    methotrexate (a cancer drug which can also be used to treat psoriasis or arthritis)

Other special warnings

Pregnancy and breast feeding: If you are pregnant or breast feeding, check with your doctor before taking this medicine.

Tests: If you need to have any urine or liver function tests, tell the doctor or nurse you are taking this medicine as it may affect the result.

Sodium content: Each capsule contains 13 mg of sodium. This may need to be taken into consideration in patients on a controlled sodium diet.

Driving and using machines: There are no reports of this medicine affecting your ability to perform skilled tasks such as driving or operating machinery.

3. HOW TO TAKE CO-FLUAMPICIL CAPSULES

Swallow the capsules with a drink of water, half an hour to one hour before meals.

Your doctor has decided the dose which is best for you. The pharmacist’s label will tell you how many capsules to take and how often to take them. If you are not sure, ask your doctor or pharmacist.

The usual doses are as follows:

Adults including the elderly and children over 10 years: Take one capsule four times a day.

Children under 10 years: Half the usual adult dose, using a Co-fluampicil syrup. For more severe infections your doctor may have prescribed a higher dose.

Space the doses out as evenly as possible throughout the day. DO NOT stop taking this medicine until you have finished the course. If you stop too early your condition may reoccur or get worse.

If you take too many Co-Fluampicil Capsules: If you think you have taken too many capsules, contact your doctor straightaway or go to the nearest hospital casualty department. Take with you any remaining capsules and the pack so that the medicine can be identified.