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Erythroped A 500mg Tablets

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Variation No: 0003. Reason: Add/amend - Labels and leaflet have been amended to include the salt form (erythromycin ethylsuccinate) in the common name and

statement °f active content.

Variation No: 0003. Reason: Add/amend - Labels and leaflet have been amended to include the salt form (erythromycin ethylsuccinate) in the common name and

statement °f active content.

®    2073


19.08.13[6]


APPROVED

By Bushra Hussain at 11:16am, Aug 20, 2013

^_J


Erythroped® A 500mg Tablets

(erythromycin ethylsuccinate)

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine.

-    Please 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Erythroped A 500mg Tablets but will be referred to Erythroped A Tablets as throughout the leaflet.

In this leaflet:

1.    What Erythroped A Tablets are and what they are used for.

2.    Before you take Erythroped A Tablets.

3.    How to take Erythroped A Tablets.

4.    Possible side effects.

5.    How to store Erythroped A Tablets.

6.    Further information.

1.    WHAT ERYTHROPED A TABLETS ARE AND WHAT THEY ARE USED FOR.

Erythroped A Tablets contain the active ingredient erythromycin ethylsuccinate, which belongs to a group of medicines called macrolide antibiotics.

Erythroped A Tablets are used to prevent and treat infections such as:

-    Throat and sinus infections.

-    Chest infections, such as bronchitis and pneumonia.

-    Ear infections.

-    Mouth and dental infections.

-    Eye infections.

-    Skin and tissue infections, such as acne.

-    Stomach and intestinal infections.

-    Prevention of infection following burns, operations or dental procedures.

-    Other infections, such as sexually transmitted diseases, bone infections or scarlet fever.

2.    BEFORE YOU TAKE ERYTHROPED A TABLETS Do not take Erythroped A Tablets if you:

-    have been told that you are allergic to erythromycin or any of the other ingredients of Erythroped A Tablets.

-    are currently taking a medicine called

-    astemizole or terfenadine (used to treat allergies such as hay fever)

-    pimozide (used to treat mental problems)

-    ergotamine or dihydroergotamine (used to relieve migraine)

-    cisapride (used to treat acid reflux)

Take special care with Erythroped A tablets if you:

-    have any liver problems or are taking any medicines which can cause liver problems.

-    suffer from a condition called myasthenia gravis which causes muscle weakness.

If any of these apply to you, or if you are not sure, tell your doctor.

Taking other medicines

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

This is especially important if you are taking medicines called:

-    astemizole, terfenadine or mizolastine (used to treat allergies such as hay fever),

-    pimozide (used to treat mental problems),

-    clarithromycin (an antibiotic),

-    cisapride (used to treat acid reflux),

-    ergotamine or dihydroergotamine (used to relieve migraine),

-    digoxin or disopyramide quinidine (used to treat heart problems),

-    hexobarbitone or midazolam (used as sedatives),

-    warfarin or acenocoumarol (used to thin the blood),

-    valproate, carbamazepine or phenytoin (used to control epilepsy),

-    theophylline (used to treat asthma and other breathing problems),

-    ciclosporin or tacrolimus (used following organ transplants),

-    bromocriptine (used to treat Parkinson's disease),

-    alfentanil, zopiclone or triazolam (used to help you sleep),

-    rifabutin (used to treat tuberculosis (TB),

-    lovastatin (used to control cholesterol levels).

If you or your child goes for any medical tests, tell your doctor that you are taking Erythroped A Tablets, as this may interfere with some test results.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, or if you are breastfeeding please consult your doctor before taking this medicine.

3.    HOW TO TAKE ERYTHROPED A TABLETS

Always take Erythroped A Tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.

The usual dose for adults and children over 8 years is:

2 g daily in divided doses i.e. two tablets twice a day, taken just before or with meals or food.

If you have a bad infection you may be told to take up to 4 g (8 tablets) daily.

Continue to take this medicine until the course is completed or until your doctor tells you to stop; do not stop taking your medicine, even if you feel better. If you stop the treatment too early your problem could come back.

If you take more Erythroped A Tablets than you should

If you accidentally take more medicine in one day than your doctor has told you to, or if a child has taken some of the medicine by mistake, contact you doctor or go to your nearest hospital emergency department immediately. An overdose of Erythroped A Tablets could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythroped A Tablets

If you forget to take a dose of your medicine, take it as soon as you remember. Do not take more medicine in one day than your doctor tells you to.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Erythroped A Tablets can cause side effects, although not everybody gets them.

If you notice any of the following, stop taking Erythroped A Tablets and contact your doctor immediately:

-    difficulty breathing

-    fainting

-    swelling of the face, lips or throat

-    skin rashes

-    severe skin reactions including large fluid-filled blisters, sores and ulcers

-    ulcers in the mouth and throat

As these may be signs of an allergic reaction.

If you develop severe or prolonged diarrhoea during or after taking Erythroped A Tablets, tell your doctor immediately.

Other side effects of Erythroped A Tablets include:

-    Feeling sick or being sick

-    Stomach pains

-    Reversible loss of hearing (usually with high doses)

-    Damage to the blood, kidneys or nervous systems.

-    Yellowing of the skin and/or eyes, which are signs of liver problems including jaundice

-    Chest pain

-    Dizziness

-    Abnormal heart rhythm

If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE ERYTHROPED A TABLETS

Do not store above 25°C. Store in the original package.

Do not use these tablets after the expiry date shown on the blister/label. The expiry date refers to the last day of that month.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

If the medicines become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

6. FURTHER INFORMATION.

What Erythroped A Tablets contain

Each film-coated tablet contains 500mg of erythromycin as erythromycin ethylsuccinate.

The other ingredients are: hypromellose, calcium hydrogen phosphate, sodium starch glycollate, maize starch, povidone, magnesium stearate, titanium dioxide (E171), sorbic acid, macrogol 400, macrogol 8000 and quinoline yellow (E104).

What Erythroped A Tablets look like and the contents of the pack Erythroped A Tablets are yellow capsule shaped film-coated tablets with the abbott logo on one side and plain on the other side and are available in a bottle of 100 tablets, or blister packs of 30, 40 or 100 tablets.

Manufacturer and Product Licence Holder

Manufactured by: Aesica Queenborough Ltd, Queenborough, Kent,

England and procured from within the EU by Product Licence holder Tenolol Ltd., 5, Sandridge Close, Harrow, HA1 1XD. Repackaged by Servipharm Ltd.

POM


Erythroped A 500mg Tablets - PL 30900/2073


Leaflet revision and issue date (Ref) 19.08.13[6]

Erythroped is a trademark of Amdipharm International Limited.