PACKAGE LEAFLET: INFORMATION FORTHE USER

Erythromycin Tablets 250mg

[Erythromycin]

Read all ofthis 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, pharmacist or nurse.

•    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, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2.    What you need to know before you take Erythromycin Tablets

3.    How to take Erythromycin Tablets

4.    Possible side effects

5.    How to store Erythromycin Tablets

6.    Contents of the pack and other information

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

Erythromycin Tablets are from the group of

medicines called antibiotics and are useful in the

treatment of and prevention of bacterial infections

including:

•    Infections of the upper respiratory tract i.e. tonsillitis, pharyngitis, laryngitis, sinusitis and secondary infections in colds and flu

•    Infections of the lower respiratory tract i.e. tracheitis, bronchitis and pneumonia

•    Mouth infections i.e. gingivitis (inflamed gums)

•    Eye infections i.e. blepharitis (inflammation of the eyelids)

•    Ear infections i.e. otitis media, otitis externa and mastoiditis

•    Skin and soft tissue infections

•    Genito-urinary infections i.e. urethritis, gonorrhoea, prostatitis

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

•    Other infections such as scarlet fever, diptheria and infections of the bones (osteomyelitis).

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

Do not take Erythromycin Tablets ifyou:

•    Are hypersensitive (allergic) to erythromycin or any of the other ingredients of Erythromycin Tablets (See section 6)

•    Are taking antihistamines for allergies such as astemizole, terfenadine and mizolastine

•    Are taking pimozide or amisulpride - medicines to treat mental illness

•    Are taking ergotamine or dihydroergotamine for migraine

•    Are taking tolterodine to treat urinary incontinence

•    Are taking cisapride for stomach disorders

•    Are taking simvastatin to lower your cholesterol.

nogen Pharma

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Erythromycin Tablets ifyou:

•    Have liver problems

•    A muscle disorder called myasthenia gravis

•    Have previously experienced diarrhoea following the use of antibiotics

•    Have an irregular heart rhythm

•    Are breastfeeding (see section Pregnancy and breastfeeding).

Other medicines and Erythromycin Tablets

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

In particular, tell your doctor if you are taking any of the following:

•    Anticoagulants to thin your blood e.g. Warfarin, acenocoumarol

•    The antibiotic clarithromycin, used to treat certain bacterial infections

•    Zopiclone, a medicine used to help you sleep

•    Theophylline, a medicine used to treat breathing disorders such as asthma

•    Alfantanil, hexobarbitone used as anaesthetics

•    Bromocriptine used in the treatment of parkinsons disease, neuroleptic malignant syndrome

•    Carbamazepine, phenytoin, phenobarbital, valproate used to treat epilepsy

•    Cyclosporin, tacrolimus used after organ transplants

•    Digoxin, disopyramide, quinidine, verapamil used to treat heart disorders

•    Midazolam, triazolam, alprazolam used to treat insomnia

•    Cilostazol used to treat muscle pain

•    Methylprednisolone used to treat arthritis, bronchitis

•    Omeprazole used to treat dyspepsia

•    Rifabutin used to treat tuberculosis

•    Sildenafil used to treat erectile dysfunction

•    Vinblastine used to treat certain cancers

•    Fluconazole, ketoconazole, itraconazole used to treat fungal infections

•    Rifampicin, penicillin, cephalosporins, clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines, colistin used to treat bacterial infections

•    Herbal remedies e.g. St John's wort used to treat depression

•    Contraceptive pill

•    Colchicine used to treat gout

•    Cimetidine used to treat stomach disorders.

DO NOT TAKE Erythromycin Tablets ifyou are also taking astemizole, terfenadine, mizolastine, pimozide, amisulpride, ergotamine,

dihydroergotamine, tolterodine, cisapride or simvastatin.

Pregnancy and breastfeeding

Ask your doctor or pharmacistfor advice if you are pregnant, planning on becoming pregnant or are breastfeeding.

If you are pregnant and treated with Erythromycin Tablets for early syphilis, you should talk to your doctor as erythromycin may not be effective in preventing the infection affecting the baby. Erythromycin passes into breast milk. Talk to your

doctor before breastfeeding if you are taking these tablets.

Driving and using machines

Do not drive or use machinery if you think you may be affected by these tablets.

3. HOW TO TAKE ERYTHROMYCIN TABLETS

Always take Erythromycin Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Adults: The usual dose is 250mg (1 tablet) every 4 to 6 hours. This may be increased to 4a (16x 250mg tablets) per day depending on tne severity ofthe infection.

Children: Follow your doctors instructions. The age and weight of the child, and the severity of the infection are all important factors when deciding on the correct dose to be given.

The usual dose is 30-50mg/kg a day, given in divided doses.

If dosage is reguired twice daily in adults and children, one half of the total daily dose may be given every 12 hours, one hour before meals.

•    Hearing disorders including deafness and a ringing in the ears (tinnitus)

•    Feeling sick, being sick, abdominal pain, loss ofappetite

•    Fever, feeling tired (malaise)

•    Confusion, seizures and vertigo (feeling that everything around you is spinning)

•    Seeing or hearing things that are not there (hallucinations)

•    Kidney disorders such as interstitial nephritis (a disorderwhere spaces between the kidney tubules become swollen or inflamed).

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. HOWTOSTOREERYTHROMYCIN TABLETS

Ifyou take more Erythromycin Tablets than you should

This medicine is to be taken at regular intervals, as determined by the physician. Ifyou take too many tablets by mistake contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

You may experience loss of hearing, feeling sick, being sick and diarrhoea.

Ifyou stop taking Erythromycin Tablets

You may feel better after a few days, but you should keep taking your tablets until the prescribed course is finished. Your symptoms may come back if you stop your treatment too soon.

Ifyou forget to take Erythromycin Tablets

If you have forgotten to take a dose, take the missed dose as soon as you remember, unless it is almost time for your next dose, and carry on as before. Do not take a double dose.

Do not take this medicine after the expiry date stated on the label.

Store in a cool dry place below 20°C.

In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer reguired. These measures help to protect the environment.

Keep out of the sight and reach of children

6. CONTENTS OF THE PACK AND OTHER INFORMATION

4. POSSIBLESIDEEFFECTS

Like all medicines, Erythromycin Tablets can cause

side effects, although not everyone gets them.

If any of the following occur, STOP taking the

medicine and contact a doctor immediately:

•    Allergic reactions may occur with symptoms such as rash, itching, swelling ofthe face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy when standing up

•    Severe skin reactions such as erythema multiforme (a red rash caused by hypersensitivity to a drug, disease or allergen), Steven's Johnson syndrome (a severe inflammatory eruption of the skin and mucous membranes) and Toxic Epidermal Necrolysis (large areas of the skin become intensely red and begin to peel)

•    Liver problems, a yellow discolouration of the eyes and skin (jaundice) and abnormal liver function tests. These will be picked up by the doctor

•    Diarrhoea which may be severe or prolonged and may contain blood or mucus

•    Severe abdominal pain (pancreatitis)

•    Abnormal heart rhythms including palpitations (Torsade de pointes).

Other reported reactions include:

•    Changes in the blood (eosinophilia). Symptoms include rashes, itching

•    Changes in your heart beat and rhythm, chest pains, dizziness, palpitations, low blood pressure

What Erythromycin Tablets contain:

Erythromycin Tablets 250mg contain the active substance erythromycin BP 250mg in each tablet.

The other ingredients are: maize starch, croscarmellose sodium type A, povidone, (Kollidone K90), talc, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, dispersed red 18152 (E110and E124), methacrylic acid copolymer, polysorbate 80.

What Erythromycin Tablets look like and contents of the pack

Erythromycin Tablets 250mg are reddish orange coloured, opaque film-coated round tablets with no markings on eitherside.

Erythromycin Tablets 250mg are supplied in pots and bulk pots of21, 100, 250, 500 and 1000 tablets.

These tablets are also supplied in blister packs of 28, 56, 84 and 100.

However, the amount dispensed will be changed according to your prescription.

Marketing Authorisation Holder

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

The manufacturer and batch release site

Regent-gm Laboratories Limited Cunard Road, North Acton, London NW10 6PN, United Kingdom

This leaflet was last revised in October 2014.

SIZE :160X 270 (mm) Back