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Co-Fluampicil Oral Suspension 125 Mg/125 Mg In 5 Ml

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| PATIENT INFORMATION LEAFLET

Co-Fluampicil Oral Suspension i25/mg/i25mg/5mi

Please read this leaflet carefully before you start to take your oral suspension.

■    It contains important information.

■    If you are not sure about anything or you want to know more, ask your doctor or a pharmacist.

■    Keep this leaflet safe, as you may want to read it again.

In this leaflet:

Q About your oral suspension

^ How to take your oral suspension

What is in your oral suspension

J What to do if you take too much oral suspension

Who makes your oral suspension

^ After taking your oral suspension

What your oral suspension does Before you take your oral suspension

^ Looking after your oral suspension

1.    About your oral suspension

Your oral suspension is called Co-Fluampicil Oral Suspension. Each pack contains 100ml when reconstituted. It is part of a group of drugs known as penicillin antibiotics.

2.    What is in your oral suspension

Each 5ml spoonful contains:

•    Flucloxacillin Sodium BP equivalent to Flucloxacillin BP 125 milligrams (mg) and Ampicillin Trihydrate BP equivalent to Ampicillin BP 125 milligrams (mg) (active ingredients)

•    Sodium benzoate, disodium edetate, saccharin sodium, mono-ammonium glycyrrhizinate, sodium citrate, apricot flavour, menthol flavour, Yellow FD&C (E110) and sucrose (inactive ingredients)

Co-Fluampicil Oral Suspension is free-flowing powder in two layers, the top being White, the bottom layer being off white.

3.    Who makes your oral suspension Manufacturer:

1.    Athlone laboratories limited

Unit 7 & 8, monksland industrial estate, Athlone, Republic of Ireland

2.    Regent laboratories limited Cunard road, north acton, London,

Nw10 6pn, United kingdom

Marketting Authorisation Holder

ZeCare Ltd.

Unit 5 Blenheim Court, Brownfields,

Welwyn Garden City, Hertfordshire,

AL7 1AN, UK

4.    What your oral suspension does

Co-Fluampicil Oral Suspension is used to treat a variety of severe infections where the bacterium causing the infection is not known or where more than one bacterium are involved. These include chest infections, ear, nose and throat and soft tissue infections. In hospitals, Co-Fluampicil Capsules may be used to treat respiratory tract infections, post-operative chest and wound infections and septicaemia (blood poisoning).

They may also be given after childbirth or abortion (as you may have a condition known as puerperal fever), before major surgery or to patients who are having drugs which reduce the body's resistance to infection.

5. Before you take your oral suspension Do not take if:

•    you have a history of allergy (hypersensitivity) to antibiotics e.g. penicillins, cephalosporins or to any of the ingredients listed in the section "What is in your oral suspension"

•    you have a history of yellowing of the skin or whites of the eyes (jaundice) or liver problems associated with taking flucloxacillin

Take special care

•    if you have infectious mononucleosis (glandular fever) and/or acute (short-lived) or chronic (long term) leukaemia (blood cancer) of lymphoid origin

•    if you have liver problems

•    if this medicine is given to a newborn baby

•    if you need to take this medicine for a long time as your liver and kidney function should be monitored

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor if you are taking any of the following:

•    Medicines that inhibit the growth of bacteria (bacteriostatic medicines) e.g. co-trimoxazole (sulfomamides), doxycycline (tetracyclines), chloramphenicols

•    Oral contraception ('the pill') as it may not be as effective. Other contraceptive precautions should be used e.g. condoms

•    Probenecid and allopurinol, used to treat gout

Glucose urine test

If you need to be tested for the presence of glucose in your urine, tell your doctor or nurse that you are taking Co-Fluampicil. A certain method of testing may need to be used to avoid false positive readings.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or breast-feeding, you should not use Co-Fluampicil, unless told to do so by your doctor.

Driving or operating machinery

Co-Fluampicil should not affect your ability to drive or operate machinery.

continued....

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Important information about some of the ingredients of this medicine

This oral suspension contains the azo dye sunset yellow (E110) as a colouring agent. It can cause allergic reactions.

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Each 5ml spoonful contains 3.03g of sucrose. If you are taking the usual dose prescribed for this product, each dose will contain up to 24.24g of sucrose (48.48g if you are taking this medicine for severe infections). This should be taken into account if you have diabetes mellitus.

This medicine contains 12.3mg of sodium per 5ml of oral suspension. This is to taken into consideration by patients on a controlled sodium diet.

This medicine also contains sodium benzoate. It may increase the risk of jaundice in new born babies.

6.    How to take your oral suspension

You must take your oral suspension as your doctor has told you to. The label will tell you how much to take and how often to take it. The amount of oral suspension you take is called the ‘dose'. The most common dose for this oral suspension is 10 ml four times a day (20 ml four times a day for severe infections).

This medicine must only be taken orally.

This medicine should not be used on the eyes. Children should take 5 ml four times a day (10 ml four times a day for severe infections).

Swallow the oral suspension, half an hour to one hour before a meal.

It can be dangerous to stop taking your oral suspension without your doctor's advice.

If you forget to take a dose at the right time, take it as soon as you remember. Do not take two doses together. If it is almost time to take the next dose, wait until then and then carry on as before.

7.    What to do if you take too much oral suspension

It is important not to take too much oral suspension.

Contact your nearest hospital casualty department or a doctor for advice if you have swallowed too much oral suspension or if you think a child has accidentally swallowed any.

Take this leaflet and any oral suspension that you still have to show the doctor.

Symptoms of an overdose include: feeling or being sick and diarrhoea.

8.    After taking your oral suspension

Like all medicines, Co-Fluampicil can cause unwanted side effects although they are uncommon. Any side effects are usually mild and do not last very long.

Stop taking Co-Fluampicil and see your doctor immediately if you experience any of the following:

Allergic reaction

• skin rash, itching, itchy rash, skin rash resulting from bleeding into the skin, fever, wheezing, breathlessness or swelling of the throat

•    red patches on the skin, blistering of the skin (toxic epidermal necrolysis), blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome), difficulty in breathing or dizziness (anaphylaxis)

•    joint or muscle pain

Other rare side effects

•    kidney inflammation, which can cause swollen ankles or high blood pressure

•    reduction in blood platelets, which increases the risk of bleeding or bruising

•    reduction in white blood cells, which may make infections more likely

•    reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness

(The side effects above are usually reversible when treatment is stopped)

•    feeling or being sick, diarrhoea

•    infection of the colon which can cause diarrhoea, fever and abdominal pain

•    inflammation of the liver (hepatitis) or yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice). These side effects may develop two months after finishing treatment

Other side effect reported

•    transient increase in transaminases (detected through blood test)

If you feel unwell in any other way, tell your doctor as soon as you can.

9. Looking after your oral suspension

Keep your oral suspension in a safe place where children cannot see or reach it. It may be dangerous to children.

You should keep this oral suspension in a cool dry place, below 25°C.

Keep it in the pack it came in. Do not put it into another container.

Do not take the oral suspension after the ‘use by' date.

You should take any oral suspension that is out of date or which you no longer need back to your pharmacist.

This oral suspension is only for you. ‘Only a doctor can prescribe it for you' should be added here if appropriate. Never give it to anyone else.

This information only applies to Co-Fluampicil Oral Suspension 125mg/125mg/5ml.

Product Licence Number 24581/0034

This leaflet was updated in July 2012

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