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•    damage to the blood, kidneys or central nervous system

•    chest pain

•    fever

•    dizziness

Very rare Side effects:

•    severe skin reaction , with soreness, blistering, ulceration

•    cardiac arrhythmia (an abnormal rate of muscle contractions in the heart)

If any of the experience any of the side effects or if you notice any side effects not listed in this leaflet or if they get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

You can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or filling a paper form available from your local pharmacy.

5.    HOW TO STORE ERYTHROMYCIN TABLETS

Do not use this medicine after the expiry date shown on the label.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25°C.

Store in the original package and keep container tightly closed.

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 Erythromycin Tablets contain

The active substance is: erythromycin, 250mg per tablet.

The other ingredients are: maize starch, croscarmellose sodium, Type A povidone, talc, magnesium stearate (E572), hypromellose (E464), macrogol 6000, erythrosine (E127), methacrylic acid copolymer and polysorbate 80(E433)

What Erythromycin Tablets look like and contents of the pack

The tablets are reddish orange colored, biconvex enteric/film-coated and round in shape. They are available in containers of 21, 100, 250, 500 and 1000 tablets, as well as in blister packs of 28, 56, 84, 100 tablets.

In addition bags of 5,000 and 10,000 tablets are also available (Not all pack sizes may be marketed).

MA Holder:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham, TW13 7HF, UK E-mail: info@medreich .co.uk

This leaflet was last approved in December 2013

PL No.: 21880/0069

II

PACKAGE LEAFLET: INFORMATION FOR THE USER

Erythromycin

250mg Gastro-resistant tablets

In this leaflet:

f. What Erythromycin Tablets are and what they are used for

2.    Before you take Erythromycin Tablets

3.    How to take Erythromycin Tablets

4.    Possible side effects

5.    How to store Erythromycin Tablets

6.    Further information

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

Erythromycin belongs to a group of medicines called antibiotics which act by preventing the growth and multiplication of bacteria.

Erythromycin is used for the treatment and prevention of infections caused by erythromycin-sensitive organisms, such as:

•    Upper and lower respiratory tract infections

•    Eye and ear infections

•    Oral infections

•    Skin and soft tissue infections

•    Gastrointestinal infections

•    Prophylaxis pre- and post- operative trauma, burns, rheumatic fever

•    Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever.

2.    BEFORE YOU TAKE ERYTHROMYCIN TABLETS DO NOT TAKE Erythromycin Tablets if you are:

•    Allergic (hypersensitive) to erythromycin or any of the other ingredients in the product (see Section 6 What Erythromycin Tablets contain')

Warnings and Precautions

Talk to your doctor or pharmacist before taking these tablets:

If you are taking any of the following medication: dihydroergotamine, ergotamine (for migraine) cisapride (for stomach disorders)

astemizole, mizolastine and terfenadine (antihistamines, for treating allergies)

pimozide (for psychiatric disorders)

simvastatin (for reducing blood cholesterol)

tolterodine (for urinary incontinence)

amisulpride (for schizophrenia)

Take special care with your medicine if you:

suffer from liver or kidney problems.

suffer from myasthenia gravis (a condition characterized by muscle disorder, difficulty chewing and swallowing and slurred speech).

If any of these points apply to you, do not take this medicine until you have talked to your doctor. You may need to be given a different medicine or the dose may need to be changed.

Taking other medicines

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

Erythomycin is known to interact with the following medicines:

•    Warfarin and acenocoumarol (for preventing blood clots)

•    Clarithromycin and other macrolide antibiotics/ (antibiotics used to treat certain infections)

•    Zopiclone (induces sleep)

•    Theophylline (helps breathing).

•    Lovastatin (blood cholesterol lowering drugs)

•    Chloramphenicol, clindamycin and lincomycin, streptomycin, tetracyclines, colistin (for infections)

•    Midazolam, alfentanil, alprazolam and triazolam or related benzodiazepines (sedatives which may be given before an operation)

•    Cisapride and omeprazole(gastric reflux)

•    Carbamazepine, phenytoin, rifampicin and phenobarbital (for epilepsy)

•    Colchicine (for gout)

•    Cimetidine (for stomach ulcers)

•    Bromocriptine (for Parkinson’s disease)

•    Carbamazepine, hexobarbitone, phenytoin, valproate (for epilepsy)

•    Cilostazol (for circulatory problems)

•    Cyclosporin and tacrolimus (for prevention of rejection after graft or organ transplant)

•    Digoxin, disopyramide, quinidine (for heart conditions)

•    Rifabutin (for tuberculosis)

•    Sildenafil (for erectile dysfunction in men)

•    Theophylline (for breathing problems)

•    Methylprednisolone (steriods)

Tests

If you are asked to provide a urine test, tell your doctor that you are taking Erythromycin as it may interfere with certain tests.

Pregnancy and breast-feeding

If you are taking contraceptives, pregnant, planning to become pregnant or are breast-feeding ask your doctor for advice before taking this medicine. Erythromycin could harm the baby.

Driving and using machines

Erythromycin Tablets are not expected to affect your ability to drive or operate machinery.

3. HOW TO TAKE ERYTHROMYCIN TABLETS

Always take Erythromycin Tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Oral use. Swallow whole with a glass of water. Do not crush or chew.

Adults and older children: The usual dosage is one 250mg tablet every four to six hours. This can be increased to 4g per day if your infection is very severe. It is important that you complete your full course of antibiotics; do not stop taking the tablets early even if you feel better.

If you take more Erythromycin Tablets than you should

If you (or someone else) take too much medicine, contact your doctor or nearest hospital emergency department immediately. Symptoms of overdose include nausea, vomiting and diarrhoea and loss of hearing.

Take this leaflet, the box and any remaining tablets with you, if possible.

If you forget to take Erythromycin Tablets

If you miss a dose, take the tablets as soon as you remember and carry on as before. If it is almost time for your next dose, skip the missed dose and continue as usual. DO NOT take a double dose to make up for the forgotten dose.

If you stop taking your medicines

Keep taking this medicine until your doctor tells you to stop, DO NOT stop taking it just because you feel better. If you stop taking the medicine, your condition may re-occur or get worse.

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 Tablets can cause side effects, although not everyone gets them.

Serious Allergic Reactions

STOP taking the medicine and tell your doctor immediately, or go to accident and emergency if you have:

•    allergic reactions (which can be serious. Symptoms include: skin rashes which may be itchy, swelling of the face and tongue, fever, chest pain and anaphylaxis (breathing difficulties).

Tell your doctor or pharmacist if you notice any of the following effects and if they worry you:

Common side effects:

•    nausea,

•    vomiting

•    diarrhoea

•    abdominal discomfort

Occasional side effects:

•    hallucinations

•    hearing loss (associated with very high doses)

•    irregularities of the heart (palpitations)

Less frequent side effects:

•    jaundice (yellowing of the skin and whites of eyes)

•    liver dysfunction

•    abnormal blood liver function tests

Rare side effects:

•    itching and skin rashes

•    inflammation of the colon

•    inflammation of the pancreas leading to abdominal pain

•    toxic epidermal necrolysis and (severe skin reaction where a large portion of the skin becomes intensely red and peels off)

•    erythema multiforme (mild skin disorder)

•    stevens-johnson syndrome (a severe inflammatory eruption of the skin)

•    hypotension (low blood pressure)

•    confusion

•    seizures (fits)

•    vertigo

•    inflammation of the lower stomach

•    break down of muscle fibers