Patient Information Leaflet

Please read this leaflet before this medicine is started.

'Floxapen' Syrup is prescribed mainly for children, but may also be prescribed for adults. This leaflet is written with child patients and their parents in mind, but the information enclosed is just as important if you are taking the medicine yourself as an adult, or are helping another adult to take it.

• Please read this leaflet before the treatment begins.

• Keep this leaflet until you have finished giving the medicine to your child. You may want to read it again.

• If you are helping someone else to take 'Floxapen', read this leaflet before giving the first dose.

• Remember this medicine is for the person named by the doctor. Never give it to others.

• Follow the doctor's advice, give the medicine as instructed. If there is anything you do not understand, please ask the doctor or pharmacist.

• Before taking any medicines, you should tell your doctor if you are pregnant or think you may be.

• Like all medicines, 'Floxapen' can sometimes cause unwanted effects. (You will find more information about this later in the leaflet).

• For more information about 'Floxapen', please read the rest of this leaflet .

This leaflet should contain all the information you need, however, if you are unsure about anything ask your doctor or pharmacist.

The name of this medicine is 'Floxapen' Syrup. It contains a penicillin called flucloxacillin (present as Flucloxacillin Magnesium).

'Floxapen' Syrup is available in 125 mg and 250 mg strengths. Each bottle contains 100 ml of syrup and each 5 ml contains 125 mg or 250 mg of the flucloxacillin.

'Floxapen' Syrup also contains inactive ingredients to make the medicine acceptable. These inactive ingredients include sucrose as a sweetener and sodium benzoate as a preservative.

'Floxapen' Syrup does not contain tartrazine or any other azo dyes.

'Floxapen' is supplied to you as an opaque liquid for swallowing. This medicine belongs to the penicillin group of antibiotics.

Manufacturer and Product Licence Holder: Beecham Group plc, Brentford trading as Beecham Research, Welwyn Garden City, Hertfordshire AL7 1EY.

Floxapen may be used for the treatment of a wide range of bacterial infections, including chest infections, ear infections, skin infections, wound and burn infections, bone infections, urinary tract infections and septicaemia.

This medicine must not be given to children or adults who are allergic to penicillin. If your child has an allergic reaction (such as a rash) to an antibiotic, you should talk to your doctor before you give the first dose.

If your child develops a skin rash while taking ‘Floxapen' do not give any more medicine and tell your doctor at once.

If your child has had liver problems do not give this medicine tell your doctor.

If your child has kidney problems, tell your doctor, who may decide to change the dosage.

If you are taking the medicine yourself tell your doctor if you are pregnant or think you may be pregnant or breast feeding your baby.

Follow your doctor's instructions about how and when to give the syrup. Your doctor will decide how much medicine you need to give to your child each day.

The usual dosages are:

children under 2 years - 2.5 ml of 125 mg syrup four times a day

children 2-10 years - 5 ml of 125 mg syrup four times a day

children over 10 and adults - 5 ml of 250 mg syrup four times a day.

However, your doctor may wish to double this dose. Space the doses as evenly as possible through the day and give each dose half to one hour before meals.

Please read the label carefully. If you have any questions about the medicine, please ask your doctor or pharmacist.

Use the 5 ml spoon/dropper provided with the medicine. If you are unsure on how to use the spoon/dropper, ask your pharmacist for advice.

Make sure the whole dose is swallowed each time.

Give the medicine until the full course of syrup is finished. Do not stop when your child feels better.

Problems of overdosage with this medicine are unlikely. If a large amount is taken contact your doctor or local casualty department at once. Show the doctor the bottle of medicine.

If you forget to give a dose at the night time, give it as soon as you remember. Then carry on as before, but do not give two doses within an hour of each other.

Side effects with 'Floxapen' are usually mild and infrequent. A few people may find that this medicine gives them diarrhoea (several loose bowel movements a day). It may sometimes cause indigestion or make your child feel sick or occasionally be sick. If this happens, these symptoms are usually mild. If these symptoms continue or become severe, you should take your child to see the doctor.

Allergic reactions can occur occasionally. Tell your doctor immediately if your child starts to itch or develops a rash.

Very rarely 'Floxapen' may be associated with more serious effects relating to the liver and the digestive system (e.g. severe diarrhoea). Extremely rarely severe reactions including symptoms such as itchy rash, swollen face and difficulty in breathing can occur. If these symptoms continue seek immediate treatment .

If your child develops any unusual discomfort while taking this medicine, tell your doctor as soon as possible.

The expiry date of this medicine is printed on the label. Do not use the medicine after this date.

Keep the syrup in the original pack. Store in a refrigerator.

Keep all medicines out of the reach of children.

Please return any left-over medicine to the pharmacist. Leaflet prepared in December 1993.

'Floxapen' is a trade mark

© 1994 Beecham Research