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Package leaflet: Information for the patient

Co-Fluampicil 250/250 mg capsules, hard

(ampicillin trihydrate and fludoxacillin sodium)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Co-Fluampicil is and what it is used for.

2.    What you need to know before you take Co-Fluampicil.

3.    How to take Co-Fluampicil.

4.    Possible side effects.

5.    How to store Co-Fluampicil.

6.    Contents of the pack and other information.

1.    What Co-Fluampicil is and what it is used for

Co-Fluampicil contains flucloxacillin and ampicillin, which belong to the group of antibiotics called 'Penicillins' Antibiotics are used to kill the bacteria that cause infections.

Your doctor will have prescribed Co-Fluampicil for treating an infection. Co-Fluampicil can be used for treating a wide range of infections, for example infections of the chest (bronchitis or pneumonia), sinuses (sinusitis), ears (otitis media), nose, throat, skin and soft tissues.

It can also be used to treat chest and wound infections following surgery or for the treatment of septicaemia (infections in the blood), treatment of infection following childbirth or termination of pregnancy. It can also be used to treat patients who are prone to infection (e.g. following a bone marrow transplant) or given before major surgery to prevent infection.

2.    What you need to know before you take Co-Fluampicil

Do not take Co-Fluampicil if:

•    you are allergic to ampicillin, flucloxacillin or any of the other ingredients of this medicine (listed in section 6)

•    you are allergic to penicillin or any other antibiotic

•    you have experienced liver problems when taking

an antibiotic.

Warnings and precautions

Talk to your doctor before taking Co-Fluampicil if:

•    you suffer from kidney or liver disease including jaundice (the skin and whites of the eyes turn yellow)

•    you have a history of allergies

•    you have any conditions affecting your white blood cells (e.g. infectious mononucleosis or lymphoid leukaemia)

•    you are having a urine test (ampicillin can affect tests for glucose in urine).

Other medicines and Co-Fluampicil

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, especially any of the following:

•    allopurinol or probenecid (used to treat gout)

•    oral contraceptives ('the pill'); you should take additional contraceptive precautions as advised by your doctor

•    anti-coagulation therapy (such as warfarin); the tendency to bleed may increase

•    methotrexate (used to treat some types of cancer, severe psoriasis or severe arthritis

•    other antibiotics.

Pregnancy and breast-feeding

Co-Fluampicil should only be given to pregnant or breast-feeding mothers if the benefits to the mother outweigh the risks to the baby. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

3. How to take Co-Fluampicil

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The medicine should be taken half an hour to one hour before a meal.

Adults and the Elderly

The recommended dose is one capsule four times a day. This dose may be doubled in severe infections.

Use in children

The recommended dose for children over 10 years old is the same as for adults. These capsules are not suitable for children under 10 years.

Patients with kidney disease

If you suffer from severe kidney disease, your doctor may prescribe a lower dose for you than that stated above.

Date: 09 APR 2015

If you take more Co-Fluampicil than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining capsules with you. Symptoms of overdose include feeling sick, being sick, and diarrhoea.

If you forget to take Co-Fluampicil

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Co-Fluampicil

Keep taking Co-Fluampicil until the course is finished. Do not stop taking this medicine just because you feel better. If you stop too soon, the infection may come back again. When you have finished the medicine, if your symptoms persist, tell your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you get any of the following, contact your doctor straight away or seek emergency help immediately:

•    swelling of the eyelids, lips or face

•    sudden wheeziness or tightness of chest or breathing problems

•    severe diarrhoea with or without bleeding

•    skin problems such as 'hives' (nettle rash), itching or rash which may include blistering or peeling of the skin

•    liver problems including jaundice (the colour of your skin or the whites of your eyes turn yellow). This may happen several weeks after stopping treatment

•    changes in the colour of urine or faeces

inflammation of the kidneys that can cause blood in the urine, swollen ankles or high blood pressure

•    tiredness, headaches, being short of breath when exercising, dizziness, looking pale and yellowing of the skin and/or eyes - signs of destruction of red blood cells (haemolytic anaemia).

Other possible side effects:

•    red or purple discolourations on the skin

•    fever

•    changes in blood may occur. You may experience bleeding for longer than usual or tiredness and generally feeling poorly. If you have a blood test while taking this medicine, tell your doctor that you are taking Co-Fluampicil

•    stomach problems such as diarrhoea, feeling sick (nausea) and being sick (vomiting)

•    increase in certain enzymes in the blood (seen in a blood test)

•    Changes in the colour of urine or faeces

•    joint pain, muscle pain.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. 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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the carton or label after 'EXP'. The expiry date refers to the last day of that month.

Store below 25°C.

Store in the original package and keep the container tightly closed in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Co-Fluampicil contains

The active substances are ampicillin trihydrate (equivalent to 250 mg of ampicillin) and flucloxacillin sodium (equivalent to 250 mg of flucloxacillin).

This combination of active substances is also known as Co-Fluampicil.

The other ingredients are magnesium stearate, gelatin, quinoline yellow (E104), patent blue (E131), titanium dioxide (E171) and iron oxides (E172).

What Co-Fluampicil looks like and contents of the pack

Your medicine comes as a hard gelatin capsule. The capsules are blue with a dark grey cap, marked with "G CS 500", containing a white powder.

This medicine is available in blisters and plastic or glass containers of 5, 7, 10, 14, 15, 20, 21,25, 28, 30,

50, 56, 60, 84, 90, 100, 250, 500 and 1000 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

Manufacturer

Generics [UK] Limited,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

This leaflet was last revised in

April 2015    605473

Date: 09 APR 2015