PACKAGE LEAFLET: INFORMATION FOR THE USER

Erythromycin Ethylsuccinate 500mg film-coated tablets

Erythromycin Ethylsuccinate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects or if you notice any side effects not listed in this leaflet, please talk to your doctor or pharmacist.

In this leaflet:

1. What Erythromycin Ethylsuccinate tablets are and what they are used for

2. What you need to know before you take Erythromycin Ethylsuccinate tablets

3. How to take Erythromycin Ethylsuccinate tablets

4. Possible side effects

5. How to store Erythromycin Ethylsuccinate tablets

6. Contents of the pack and other information

1.    WHAT ERYTHROMYCIN ETHYLSUCCINATE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Erythromycin Ethylsuccinate film-coated tablets. Erythromycin Ethylsuccinate tablets contain a medicine called Erythromycin Ethylsuccinate. This medicine belongs to a group of medicines called antibiotics. Erythromycin Ethylsuccinate is a macrolide antibiotic. Erythromycin Ethylsuccinate works by impeding the growth of bacteria in your body.

Erythromycin Ethylsuccinate tablets are used to prevent and treat infections such as:

-    Throat and sinus infections.

-    Chest infections. such as bronchitis and pneumonia.

-    Ear infections.

-    Mouth infections.

-    Eye infections.

-    Skin and tissue infections, such as acne.

-    Stomach and intestinal infections.

-    Prevention of infection following burns or operations other infections, such as sexually transmitted diseases, bone infections or scarlet fever.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERYTHROMYCIN ETHYLSUCCINATE TABLETS

Do not take Erythromycin Ethylsuccinate tablets if you:

-    Are allergic to erythromycin ethylsuccinate, any other macrolide antibiotic or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problem, swelling of your lips, face, throat or tongue.

-    Are currently taking a medicine called astemizole or terfenadine (used to treat allergies such as hay fever)

-    Are currently taking a medicine called pimozide (used to treat mental problems)

-    Are currently taking a medicine called ergotamine or dihydroergotamine (used to relieve migraine)

-    Are currently taking a medicine called cisapride (used to treat acid reflux)

Take Special Care with Erythromycin Ethylsuccinate tablets if you:

-    Ever 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 been diagnosed with an ECG abnormality called long QT syndrome or have an abnormal heartbeat or are taking medicines for treatment of heart conditions

-    have low blood levels of potassium or magnesium.

-    take drugs that lower cholesterol levels (also called “statins”)

-    take colchicine (for the treatment of gout)

If any of these apply to you, or if you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Erythromycin Ethylsuccinate tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines, including any medicines obtained without a prescription. This is because Erythromycin Ethylsuccinate tablets can affect the way some other medicines work.

In particular, tell your doctor if you are taking any of the following medicines. This is because it can increase the chances of you getting side effects, when taken with Erythromycin Ethylsuccinate tablets:

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

-    Pimozide (used to treat mental problems),

-    Cisapride (used to treat acid reflux),

-    Ergotamine or dihydroergotamine (used to relieve migraine),

-    Digoxin or disopyramide or 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 or aminophylline (used to treat asthma and other breathing problems).

-    Cyclosporine or tacrolimus (used following organ transplants),

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

-    Alfentanil (used for pain relief),

-    Zopiclone or triazolam (used to help you sleep),

-    Rifabutin or rifampicin (used to treat tuberculosis (TB).

-    Lovastatin or simvastatin (used to control cholesterol levels).

-    Citalopram or escitalopram (used to treat mental problems)

-    Ritonavir or indinavir (used to treat HIV)

-    Sildenafil (used to treat erectile dysfunction)

-    Cilostazol (used to prevent platelet aggregation)

-    Methylprednisolone (used to treat inflammation and allergies)

-    Omeprazole or cimetidine (used to treat heartburn)

-    Vinblastine (used for treatment of certain types of cancer)

-    Ketoconazole, itraconazole, voriconazole, posaconazole or fluconazole (used to treat fungal infections)

-    Colchicine (used to treat or prevent gout)

-    Verapamil (used to treat high blood pressure)

-    Phenobarbital (used to control seizures)

-    St. John's Wort (used to treat depression)

If your doctor has prescribed a medical test, tell your doctor that you are taking Erythromycin Ethylsuccinate tablets, as this may interfere with some test results.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may get side effects after taking this medicine, including feeling dizzy. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention.

3. HOW TO TAKE ERYTHROMYCIN ETHYLSUCCINATE TABLETS?

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

-    Take this medicine by mouth

-    Swallow the tablets whole with a drink of water

-    The tablets may be taken just before or with meals or food

How much to take

-    Your doctor will decide on how many Erythromycin Ethylsuccinate tablets you should take

-    The dose will depend on the type of infection you have and where the infection is in your body.

-    The length of your treatment will depend on how serious your infection is.

-    If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.

Adults and the elderly

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

2 g daily in divided doses 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.

Children and adolescents

This medicine must not be given to children 8 years of age and below.

If you take more Erythromycin Ethylsuccinate tablets than you should

If you accidentally take more tablets than you should, or if a child has taken some of the medicine by mistake, tell a doctor or get other medical advice straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: temporary hearing loss, nausea, vomiting and diarrhoea.

If you forget to take Erythromycin Ethylsuccinate tablets

If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose.

Do not double-up the next dose to make up for the missed dose.

If you stop taking Erythromycin Ethylsuccinate tablets

Do not stop taking Erythromycin Ethylsuccinate tablets just because you feel better. It is important that you complete the course of tablets that your doctor has prescribed for you. If you stop taking the tablets too soon, the infection may return, your condition may get worse or the bacteria may become resistant to the medicine.

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 tablets can cause side effects, although not everybody gets them.

Stop taking Erythromycin Ethylsuccinate tablets and see a doctor or go to a hospital straight away if you notice the following side effects:

-    Difficulty breathing

-    Fainting

-    Swelling of the face, lips or throat

-    Skin rashes

As these may be signs of an allergic reaction.

-    Severe skin reactions which may include blisters and bleeding in the lips, eyes, mouth, nose and genitals or skin reactions with peeling of the skin, accompanied by fever and chills, aching muscles and generally feeling unwell (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)

If you develop severe or prolonged diarrhoea, or diarrhoea containing blood or mucus during or after taking Erythromycin ethylsuccinate tablets, tell your doctor immediately.

Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:

Common

-    Feeling sick or being sick (vomiting, diarrhoea, anorexia)

-    Stomach pains

-    Loss of appetite

-    Increase in the level of some liver enzymes in your blood

-    Heartburn

Uncommon

-    Inflammation of the kidneys

-    Abnormal counts of some blood cells (eosinophilia)

-    Dizziness, vertigo and confusion

-    Abnormal heart rhythm

-    Allergic reactions of various severity

-    Chest pain and palpitations

Rare

-    Pancreatitis

-    Unusual fatigue

-    Dark urine

-    Inflammation of the liver (hepatitis), enlarged liver, liver failure

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

-    Chest pain

-    Muscle weakness

-    Impaired hearing

-    tinnitus

-    Malaise and fever

Very rare

-    Reversible loss of hearing (usually with high doses)

-    Convulsions and hallucinations

-    Infantile hypertrophic pyloric stenosis (a severe stomach condition affecting newborn babies)

The following side effects occur with unknown frequency:

-    Hives, rash, itching

-    Low blood pressure

-    Swelling of the face, lips, mouth , tongue or throat which may cause difficulty in swallowing or breathing (angioedema)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    HOW TO STORE ERYTHROMYCIN ETHYLSUCCINATE TABLETS

Keep this medicine out of the sight and reach of children

This medicine does not require any special storage conditions but it is best to keep Erythromycin Ethylsuccinate tablets in the original blisters and box in a dry place.

Do not use this medicine after the expiry date which is stated on the carton and foil after EXP. The expiry date refers to the last day of the month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Erythromycin Ethylsuccinate tablets contain

The active ingredient is Erythromycin Ethylsuccinate

Each 500mg film-coated tablet contains 500mg of erythromycin equivalent

to approximately 587.3 mg Erythromycin Ethylsuccinate

The other ingredients are:

For the tablet core: Pregelatinised starch, Anhydrous calcium hydrogen phosphate, Sodium starch glycolate Type A, Povidone K 30, Magnesium stearate

For the tablet coating: Opadry Yellow 03G520008 (Hypromellose, Titanium dioxide, Macrogol, Quinoline Yellow Aluminium Lake, Iron Oxide Yellow)

What Erythromycin Ethylsuccinate tablets look like and the contents of the pack

Erythromycin Ethylsuccinate tablets are presented as yellow coloured oval shaped film-coated tablets, debossed “K” on one side and plain on other side.

Erythromycin Ethylsuccinate film-coated tablets are available in blister packs of 10, 12, 14, 24, 28, 30, 56 and 84 tablets.

Not all pack sizes may be marketed

Marketing Authorization Holder

DAWA LIMITED 5, Sandridge Close,

Harrow, Middlesex HA11XD United Kingdom

Manufacturer

DRUGSRUS LIMITED 5, Sandridge Close,

Harrow, Middlesex HA11XD United Kingdom

This leaflet was last revised in 09/2014