PACKAGE LEAFLET: INFORMATION FOR THE USER

ERYTHROMYCIN TABLETS BP 250 mg

[Erythromycin]

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, health care provider 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take Erythromycin Tablets

3.    Howto take Erythromycin Tablets

4.    Possible side effects

5.    HowtostoreErythromycinTablets

6.    Furtherinformation

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

Erythromycin belongs to the group of medicines known as antibiotics.

Erythromycin is used to treat bacterial infections causing infections of the ear, nose, mouth, throat, gut and chest. It can be used to treat skin infections including burns and to treat urinary infections and sexually transmitted infections. It may be used before or after operations to prevent infection.

2.    Beforeyou take Erythromycin Tablets

Do not take Erythromycin tablets and tell your doctor if you:

•    Are hypersensitive (allergic) to erythromycin or any of the other ingredients in this medicine (See section 6. Further information)

•    Are pregnant or breast feeding

•    Are taking Astemizole, Terfenadine or Mizolastine which are antihistamines and are used to treat allergies. (See section 2; Taking other medicines)

•    Are taking Cisapride for stomach problems

•    Are taking Pimozide or Sertindole which are used to treat mental problems. (See section 2:Taking other medicines)

•    Are taking Amisulpride which is used to treat depression and mood disorders

•    Are taking Simvastatin which is used to lower cholesterol (fat) levels

•    Are taking medicines known as ergot derivatives which are used to treat migraine and speed up labour (e.g. ergotamine, Di-hydroergotamine and Methysergide)

•    Tolterodine which is used to treat bladder disorders.

Take special care with Erythromycin Tablets

Tell your doctor ifyou:

•    Suffer from liver disease; your doctor may want to monitor your liver during treatment

•    Have myasthenia gravis (muscle condition causing weakness) as erythromycin may aggravateyour condition

•    Are already taking medication for a heart complaint as these may interfere with the heartbeat (See section 2; Taking other medicines

•    Are treating a young child with antibiotics and they are irritable or vomit when fed.

•    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 erythromycin, consult your doctor before giving erythromycin to your child.

Taking other medicines

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

Especially:

•    Chloramphenicol, Clindamycin or Lincomycin used to treat infections Theophylline used to treat asthma Carbamazepine, Valproate, Phenytoin or Hexobarbital which are used to treat epilepsy Digoxin, Quinidine or Disopyramide used in heart conditions

Warfarin and Acenocoumarol used to prevent blood clots

Cimetidine used to treat stomach ulcers. Cisapride used to treat stomach disorders Lovastatin, Atorvastatin, Simvastatin used to reducecholesterol (fat) levels Buspirone used to treat anxiety disorders Clozapine or Quetiapine used to treat mental health problems.

Zopiclone, Alfentanil, Midazolam or Triazolam used to treat insomnia (inability to sleep) Cabergoline or Bromocriptine used in Parkinson’s disease

Cilostazol is used to treat intermittent claudication (circulation disorder)

Eletriptan used to treat migraine Felodipine used to treat high blood pressure Rifabutin used to treat Tuberculosis (TB) Sildenafil or Tadalafil used to treat erection problems

Tacrolimus or Ciclosporin which suppress the immune system after an organ transplant Astemizole, Terfenedine or Mizolastine, Amisulpride, Pimozide and Sertindole as these medicines may cause a change in heart rhythm.

Whilst you are taking Erythromycin tablets your doctor may occasionally check your liver function.

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

Pregnancy and breast-feeding

Ifyou are pregnant, think you might be pregnant or are breast feeding, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Erythromycin tablets may cause dizziness, if you are affected do not drive or operate machines.

Important information about some of the ingredients of Erythromycin tablets

Erythromycin tablets contain the colouring dispersed red lake which also contains sunset yellow (E124 and E110), these can cause hypersensitivity (allergic) reactions including asthma; this is more common in people allergic to aspirin. Do not take Erythromycin tablets ifyou are allergic to sunset yellow or dispersed red lake.

3.    How to take Erythromycin Tablets

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

The tablets should be swallowed whole by mouth.

Adults and the Elderly:

The usual dose is 250mg every 6 hours one hour before meals. However, your doctor may suggest a different dose. The dose may increase to 4000mg per day according to the severity of the condition.

Children:

Your doctor will determine the correct dose to use which depends on the age and weight of your child and severity of the infection. The dose should be given 1 hour before meals. The usual dose is 30 - 50mg/kg/day in divided doses given twice daily or every 6 hours. For more severe infections, this dosage may be doubled.

If you take more Erythromycin Tablets than you should

Ifyou accidentlytaketoo many Erythromycin Tablets tell your doctor at once. Ifyou can’t do this, go to the nearest hospital casualty department. The symptoms of an overdose are nausea, vomiting (being sick) and diarrhoea. Take along any tablets that are left, the container and the label so that the hospital staff can easily tell what you have taken.

If you forget to take Erythromycin Tablets

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Erythromycin Tablets

Even if your condition has improved it is important to complete the prescribed course of Erythromycin. If you stop taking this medicine too soon your infection may come back and could be more difficult to treat.

4.    Possible Side Effects

Like all medicines, Erythromycin tablets can cause side effects, although not everybody gets them.

Stop taking this medicine and tell your doctor immediately if you have sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) as these may be signs of an allergic reaction.

Serious side effects

If you develop any of the following side effects, contact your doctor immediately:

•    Chest pain or a fluttering heart beat

•    Severe stomach pain and diarrhoea which may be watery or bloody and high temperature (fever), as these may be symptoms of a serious disorder (inflammation of the colon or pancreatitis)

•    Yellowing of the skin and eyes which may indicate a liver disorder

•    Severe skin disorders, which is blistering and painful.

The following side effects have also been reported:

Less common:

•    Nausea (feeling sick), vomiting (being sick), stomach pain and discomfort which may occur at higher dose levels

•    Liver problems which may have symptoms of jaundice (yellowing of the eyes and skin)

Rarely

•    Rash which may be red or itchy

Other side effects

•    ringing in the ears (tinnitus)

•    Superinfections including colitis (with symptoms of severe diarrhoea) and stomach pain

•    Confusion, hallucinations (seeing or hearing things that aren’t there) fits, vertigo (feeling that the room is spinning) these may stop when the medication ceases

•    Feeling generally unwell (malaise)

•    Fever

•    Inflammation of the kidneys (a condition known as interstitial nephritis)

•    Low blood pressure

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

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

•    Anorexia.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety ofthis medicine.

5.    How to store Erythromycin Tablets

Keep out of the sight and reach of children.

Keep the tablets in a cool, dry place away from direct light and heat, store below 25°C.

Do not use Erythromycin tablets after the expiry date which is stated on the label. The expiry refers to the last day of that month.

Do not use Erythromycin tablets if you notice visible signs of deterioration.

Medicines should not be disposed of via waste water 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 tablets contain 250mg of the active substance Erythromycin BP/Ph.Eur

The other ingredients are Maize starch, Croscarmellose sodium, Povidone, Purified Talc and Magnesium Stearate.

Ingredients for Coating:

Hypromellose, Dispersed red lake 18152 (E110 and E124), polyethylene glycol 6000, Purified Talc, Polysorbate 80 and methacrylic acid - ethyl acrylate Copolymer.

What Erythromycin Tablets look like and contents of the pack

Description: Reddish orange coloured, opaque enteric coated round tablet.

Contents of pack: Blister pack with 14 tablets in a blister and 2 blisters in a carton; or pot with 500 tablets.

Marketing Authorisation Holder and Manufacturer

Co-Pharma Limited Unit 4, Metro Centre,

Tolpits Lane, Watford, Herts,

WD18 9SS, UK

This leaflet was last revised in February 2015 S

150 x 300 mm

150 x 300 mm

ARTWORK DETAIL LABEL

Ver.: 05 - Rev. 01 - Dt: 16.02.15

F-10-R0/PDC-001