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2. Co-Fluampicil Capsules

Document: label-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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CRESCENT PHARMA

DRAFT VERSION    PROOF FOR APPROVAL - 6th June, 2015

SIZES & TEXT crctd.(ml.17-06-15) - 30th June, 2015 TEXT corrected (ml.15-07-15) - 16th July, 2015

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.

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, this medicine can cause side effects, although not everybody gets them. 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.

Reporting of side effects:

If you get any side effects, talk to your doctor,

pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CO-FLUAMPICIL CAPSULES

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH 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 : June 2015.

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

•* 110mm >■