PATIENT INFORMATION LEAFLET

ON

ERYTHROPED A

(Erythromycin ethylsuccinate)

Please read this leaflet carefully before you start taking Erythroped A. It gives a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What's in your medicine?

The name of your medicine is Erythroped A. Erythroped A is available as tablets or in sachets.

Erythroped A tablets are yellow and contain 500 mg of erythromycin ethylsuccinate as the active ingredient. Other ingredients in the tablet include: hydroxypropyl methylcellulose, calcium hydrogen phosphate, sodium starch glycollate, maize starch, povidone, magnesium stearate, titanium dioxide, sorbic acid, polyethylene glycol and non-azo yellow colour E104.

Each Erythroped A sachet contains: 1 g of orange-coloured erythromycin ethylsuccinate granules as the active ingredient. Other ingredients in the sachet include: sucrose, azo yellow colour E110, sodium citrate, saccharin sodium, aluminium magnesium silicate, orange bramble flavour, silicon dioxide, surfactant and carmellose sodium.

Erythroped A tablets are available in blister packs of 28 tablets.

Erythroped A sachets are available in cartons of 14 sachets.

Erythroped A is an antibiotic. Its use is described below.

Product Licence Holder and Manufacturer's Name and Address

Abbott Laboratories Ltd., Queenborough, Kent, ME11 5EL

What is Erythroped A used for?

Erythroped A is used to prevent and treat infections such as:

1. Ear, throat and sinus infections

2. Chest infections such as bronchitis and pneumonia

3. Skin and tissue infections such as acne

4. Bone infections

5. Sexually transmitted diseases

6. Mouth and dental infections

7. Eye infections

8. Stomach infections

Before taking Erythroped A

Do not take Erythroped A if you have been told that you are allergic to erythromycin or other macrolide antibiotics such as clarithromycin or azithromycin.

Do not take ergotamine tablets or use ergotamine inhalers for migraine while taking Erythroped A tablets or sachets as this can cause serious side effects.

Do not take terfenadine or astemizole tablets for hay fever or allergies whilst you are taking Erythroped A as these drugs can interact. Consult your doctor or pharmacist who can advise you on other allergy products which you can take instead.

If you have any liver problems or have been told that any drugs you are taking can cause liver problems, tell your doctor before taking Erythroped A.

Erythroped A has not been shown to be harmful during pregnancy but can pass into breast milk, so ask your doctor's advice before breast-feeding while taking Erythroped A.

continued

Tell your doctor if you are taking any other medicine: particularly any of the following drugs: digoxin (heart drug), warfarin (blood thinner), carbamazepine and phenytoin (drugs for epilepsy), theophylline (helps breathing), cyclosporin (used following organ transplants), ergotamine or dihydroergotamine (used for severe migraine), bromocriptine (used to suppress breast milk production), disopyramide (a heart drug), triazolam (a sleeping tablet), or alfentanil (pain killer used in hospitals). The doctor may need to change your dosage.

Taking Erythroped A

The usual dose of Erythroped A sachets or tablets for adults and children over 8 years is 2 g daily in divided doses i.e. a 1 g sachet twice a day or two 500 mg tablets twice a day. If you have a bad infection you may be told to take up to 4 g daily. The contents of the sachet should be dissolved in a small glass of water before swallowing.

Erythroped A is normally given for 5-14 days. However, the treatment may need to be longer in certain cases. To prevent infections prior to dental work or surgical procedures, treatment is usually given one and a half to two hours before the treatment and continued every 6 hours for eight doses.

If you are not sure about the dose you should be taking or if your dose is different to that recommended in this leaflet, speak to your doctor if you have not already done so.

Take the sachets or tablets until your doctor tells you to stop; do not stop taking Erythroped A just because you feel better. If you stop the treatment too early your problem could come back.

If you forget to take a sachet or tablet, take as soon as you remember. Do not take more sachets or tablets in one day than your doctor tells you to.

If you accidentally take more sachets or tablets in one day than your doctor has told you to, or if a child has taken some of the sachets or tablets, seek medical advice urgently. An overdose could cause temporary hearing loss, nausea, vomiting and diarrhoea.

What problems can Erythroped A cause?

Erythroped A can sometimes cause stomach problems such as feeling sick, vomiting, stomach pain or diarrhoea. It can sometimes cause allergic reactions such as rashes which are usually mild, but very rarely allergic reactions can cause difficulty in breathing, fainting and swelling of the face and throat which may need emergency treatment.

Erythroped A can rarely cause jaundice, so if you feel unwell and develop yellow skin and/or eyes, see your doctor immediately.

Reversible loss of hearing can occur rarely with high doses.

There are no reports of Erythroped A causing problems with growing teeth and only rare reports of damage to the blood, kidneys, liver or nervous system.

Changes in normal heartbeat causing dizziness, palpitations and fainting have been reported rarely in patients taking Erythroped A. Chest pain has also been reported very rarely.

Tell your doctor if you develop any of these problems or if you have any other unexpected or unusual symptoms while taking Erythroped A.

How should Erythroped A tablets and sachets be stored?

Do not use these tablets/sachets after their use-by (exp) date which is printed on the blister/carton. If the sachets or tablets are out of date, return them to your pharmacist and, if necessary, get a new prescription from your doctor.

Store these tablets/sachets in a cool, dry place. Keep them safely out of reach of children. Your medicine could harm them.

If your doctor decides to stop your treatment with Erythroped A, return any remaining tablets or sachets to a pharmacist. Only keep them if your doctor tells you to.

REMEMBER these tablets/sachets are for you. NEVER give them to someone else. This medicine may harm them, even if their symptoms are the same as yours.

If you have any questions about your treatment which are not answered by this leaflet, ask your doctor or pharmacist.

This leaflet applies only to Erythroped A tablets and sachets and was prepared in June 1995.

001-650-201