PATIENT INFORMATION LEAFLET ON 752-9225

AMDIPHARM

ERYTHROPED SUGAR FREE (SF) SUSPENSIONS (Erythromycin ethylsuccinate)

This leaflet contains information about Erythroped SF, Erythroped PI SF and Erythroped Forte SF.

Read all of this leaflet carefully before you start taking this medicine. Please keep this leaflet. You may used to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do net pass it cn to others. It may harm them, even if their symptoms are the some 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.

In this leaflet:

1.    What Erythroped Sugar Free (SF) Suspensions are and what they are used for

2.    Before you take Erythroped Sugar Free (SF) Suspensions

3.    How to take Erythroped Sugar Free (SF) Suspensions

4.    Possible side effects

5.    How to store Erythroped Sugar Free (SF) Suspensions

6.    Further information

1.    WHAT ERYTHROPED SUGAR FREE (SF) SUSPENSIONS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Erythroped SF suspension. Erythroped SF suspension contains the active ingredient erythromycin which belongs to a group of medicines called macrolide antibiotics.

Erythroped 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 burns,    operations or dental procedures.

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

2.    BEFORE YOU TAKE ERYTHROPED SUGAR FREE (SE)

SUSPENSIONS

Do not take Erythroped SF Suspensions if you:

•    have been told that you are allergic to erythromycin or any of the other ingredients of Erythroped Sugar Free Suspensions.

•    are currently taking a medicine called

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

-    pimozide (used to treat mental problems)

-    ergotamine or dihydroergotamine (used to relieve migraine)

-    cisapride (used to treat aid reflux)

Take special care with Erythroped SF Suspensions 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.

•    have previously experienced diarrhoea following the use of antibiotics;

•    are treating a young child with antibiotics and they are sick or irritable when fed you should contact your physician immediately.

If any of these apply to you, of 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:

■    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:

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

■    pimozide (used to treat mental problems);

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

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

■    ergotamine or dihydroergotamine (used to relieve migraine);

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

■    cilostazol (a medicine used to treat peripheral circulation problems);

■    hexobarbitone, phenobarbital 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);

■    ciclosporin or tacrolimus (used following organ transplants);

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

■    zopiclone or triazolam/alprazolam (used to help you sleep or relief states of anxiety);

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

■    cisapride, cimetidine and omeprazole (used to treat acid reflux and other related conditions);

■    colchicine (used to treat gout and arthritis);

■    methylprednisolone (used to help suppress the bodies immune system - this is useful in treating a wide range of conditions);

■    St John's Wort (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 Erythroped 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 Erythroped SF Suspensions

Each 5 ml teaspoon of this medicine contains approximately 1.2 g of sorbitol, a typed sugar. If you have been told that you have an intolerance to some sugars you should contact your doctor before taking Erythroped SF Suspensions.

3. HOW TO TAKE ERYTHROPED SUGAR FREE (SF) SUSPENSIONS

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

The usual doses are

For adults and children over 8 years of age:

2 g per day in divided doses, In severe infections, this can increase up to 4 g per day in divided doses (see table);

For children aged 2-8 years:

30 mg per kg of bodyweight per day in divided doses. In severe infections, this can increase up to 50 mg per kg of bodyweight per day in divided doses (see table);

For infants under 2 years of age:

30 mg per kg of bodyweight per day in divided doses. In severe infections, this can increase up to 50 mg per kg of bodyweight per day in divided doses (see table);

Normal doses

Continue so 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 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 could cause temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythroped 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, Erythroped SF Suspensions can cause side effects, although not everybody gels them.

If you notice any of the following, stop taking Erythroped SF Suspensions 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 SF Suspensions, tell your doctor immediately.

Other side effects of Erythroped SF Suspensions include:

■    feeling sick or being sick;

■    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);

■    yellowing of the skin and/or eyes (jaundice), which are signs of various liver problems;

■    chest pains;

■    abnormal heart rhythms (including palpitations);

■    fever;

■    anorexia;

■    confusion;

■    fits (seizures);

■    vertigo (problems with balance that can result in feelings of dizziness or sickness - particularly on standing);

■    hallucinations (seeing or hearing things that aren't there);

■    feeling generally unwell (malaise);;

■    inflammation of the kidneys (a condition known as interstitial nephritis);

■    low blood pressure

■    serious skin rashes that may involve blistering and can cover large areas of the torso, face and limbs (conditions known as Stevens Johnson syndrome, toxic epidermal necrolysis and erythema multiforme);

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 SUGAR FREE (SF) SUSPENSIONS

Your medicine will be stored by the pharmacist and reconstituted to a suspension before giving it to you. It should be used wthin 7 days of reconstitution.

Do not use these suspensions after the expiry date shown on the bottle.

KEEP OUT OF THE REACH AND SIGHT 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.

6. FURTHER INFORMATION

What Erythroped SF Suspensions contain

There are three different strengths of Erythroped SF Suspensions available.

They all contain the active ingredient erythromycin.

Erythroped PI SF contains 125 mg of erythromycin as erythromycin ethylsuccinate in every 5 ml.

Erythroped SF contains 250 mg of erythromycin as erythromycin ethylsuccinate in every 5 ml.

Erythroped Forte SF contains 500 mg of erythromycin as erythromycin ethylsuccinate in every 5 ml.

The other ingredients are: sodium citrate, saccharin sodium, xanthan gum, poloxamer, sodium methlyhydroxybenzoate, sodium propylhydroxybenzoate, purified water, colloidal silica, imitation banana No. 2 flavour and imitation cream flavour, sorbitol and acesulfame (K).

What Erythroped SF looks like and the contents of the pack

Erythroped SF Suspensions are granules which are made up to a white, opaque suspension by the pharmacist.

Erythroped SF Suspensions are available in bottles of 100 ml or 140 ml.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Arndipharm Plc, fegency House,

Miles Gray tod,

Basildon,

Essex SS14 3AF UK

Manufacturer:

Aesica Queensborough Limited,

Queensborough,

Kent ME11 5EL UK

This leaflet was prepared in June 1998. Revised in February 2010