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PATIENT INFORMATION LEAFLET ON GB726-6174LF-AM01

AMDIPHARM

ERYTHROMYCIN ETHYLSUCCINATE sugar free (sf) suspensions

(Erythromycin ethylsuccinate)

This leaflet contains information nbout Erythromycin Ethylsuccinate SF Suspension 125 mg/5 ml.

Erythromycin Ethylsuccinnte SF Suspension 250 mg/5ml and Erythromycin Ethylsuccinnte SF Suspension 500 mg/S ml.

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

In this leaflet:

1.    What Erythromycin Ethylsuccinate SF Suspensions are and what they are used for

2.    Before you take Erythromycin Ethylsuccinate SF Suspensions

3.    How to take Erythromycin Ethylsuccinnte SF Suspensions

4.    Possible side effects

5.    How to store Erythromycin Ethylsuccinate SF Suspensions

6.    Further informotion

1.    WHAT ERYTHROMYCIN ETHYLSUCCINATE SF SUSPENSIONS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Erythromycin Ethylsuccinate SF Suspension. Erythromycin Ethylsuccinate SF Suspension contains the active ingredient erythromycinwhich belongs to a group of medicines called macrolide antibiotics.

Erythromycin Ethylsuccinate SF Suspensions 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 bums, operations or dental procedures.

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

2.    BEFORE YOU TAKE ERYTHROMYCIN ETHYLSUCCINATE SF SUSPENSIONS

Do not take Erythromycin Ethylsuccinate SF Suspensions if you:

*    have been told you that you are allergic to erythromycin or other macrolide antibiotics such as clarithromycin or azithromycin or any of the other ingredients of Erythromycin Ethylsuccinate SF Suspensions.

*    are currently taking a medicine called

-    ergatamine or dihydroergatamine (used to treat migraines) as this may cause serious side effects while taking erythromycin.

-    terfenadine or astemizole (widely taken lor hayfever and allergies), cisapride (for stomach disorders) or pimozide (for psychiatric conditions) while receiving erythromycin, as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice an alternative medicines you con take instead.

Take special care with Erythromycin Ethylsuccinate SF Suspensions if you:

*    are taking colchicine (used for treatment of gout and arthritis) as this may cause serious side effects while taking erythromycin;

*    have any liver problems or have been told that any drugs you are taking con cause liver problems;

*    have previously experienced diarrhoea following the use of antibiotics;

*    are pregnant and have been told that you have a sexually transmitted disease called syphilis. In this case erythromycin may not be effective for preventing the transfer of this infection to your baby. Consult your doctor before receiving erythromycin. Alternatively if you were treated for early stages of syphilis during your pregnancy, and your child is under 1 year and is prescribed

erthyromycin, consult your doctor before giving erythromycin to your child;

*    are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately;

*    suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your doctor before receiving erythromycin;

*    are taking erythromycin with 'statins' sudi as simvastatin or lovastatin (used to lower cholesterol) as serious side effects can occur.

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 from the following families:

*    astemizole, terfenadine or mizolastine (used to treat allergies such as hayfover);

*    pimozide (used to treat mental problems);

*    ergatamine or dihydroergotamine (used to relieve migraine);

*    cisapride (used to treat stomach disorders);

*    statins (used to help lower cholesterol levels e.g. lovastatin and simvastatin);

*    protease inhibitors (used to treat viral infections e.g. saquinavir);

*    oral contraceptives.

This is also important if you are taking medicines called:

*    colchicine (used to treat gout and arthritis);

*    cimetidine and omeprazole (used to treat acid reflux and other related conditions);

*    clarithromycin, rifabutin, or rifampicin (medicines used to treat different types of bacterial infection);

*    fluconazole, ketoconazole and itraconazole (medicines used to treat fungal infections);

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

*    ciloslazol (a medicine used to treat peripheral circulation problems);

*    hexobarbitone, phenabarbital or midazolam (used as sedatives);

*    warfarin and acenocoumarol (used to help thin the blood);

*    valproate, carbamazepine or phenytoin (used to control epilepsy);

*    theophylline (used to treat asthma and other breathing problems);

*    cidosporin or tacrolimus (used following organ transplants);

*    bromocriptine (used to treat Parkinson's disease);

*    zopidone or triazolam/alprazolam (used to help you sleep or relieve states of anxiety);

*    alfentanil (a medicine used to provide pain relief);

*    methylprednisolone (used to help suppress the body's immune system - this is useful in treating a wide range of conditions);

*    St John's Wart (a herbal medicine used to treat depression);

*    verapamil (used to treat high blood pressure and chest pain);

*    vinblastine (used to treat certain types of cancer);

*    sildenafil (used to treat erectile dysfunction).

If you or your child goes for any medical tests, tell your doctor that you are taking Erythromycin Ethylsuccinate SF Suspensions, 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 breast-feeding please consult your doctor before taking this medicine.

Important information about some of the ingredients of Erythromycin Ethylsuccinate SF Suspensions

Each 5 ml teaspoon of this product contains approximately 12 g of sorbitol. Hence this product may be unsuitable if you or your child have been told you have hereditary fructose intolerance (a carbohydrate metabolism disorder), and therefore you should contact your doctor.

Sorbitol can cause stomach upset or diarrhoea.

3. HOW TO TAKE ERYTHROMYCIN ETHYLSUCCINATE SF SUSPENSIONS

Always take Erythromycin Ethylsuccinate SF suspensions exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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 Erythromycin Ethylsuccinate SF Suspensions 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 your doctor or go to your nearest hospital emergency department immediately. An overdose of Erythromycin Ethylsuccinate SF Suspension could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythromycin Ethylsuccinate SF Suspensions

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, Erythromycin Ethylsuccinate SF Suspension can cause side effects, although not everybody gets them.

If you notice any of the following, 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.

Other side effects of Erythromycin Ethylsuccinate SF Suspensions include:

•    diarrhoea which may be severe or prolonged and may contain blood or mucus;

•    feeling sick or being sick;

•    increase in a particular type of white blood cells (eosinophilia);

•    stomach pains; these may be a symptom of an inflamed pancreas (pancreatitis);

•    ringing in the ears (tinnitus);

•    reversible loss of hearing (usually associated with high doses or in patients with kidney problems);

•    various liver or gall-bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine;

•    chest pains;

•    abnormal heart rhythms (including palpitations);

•    fever;

•    anorexia;

o

AMDIPHARM