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Hicyn 250mg Capsules

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PATIENT INFORMATION LEAFLET

Patient Information Leaflet ERYTHROMYCIN 250mg CAPSULES

Please read this leaflet carefully before you start taking your medicine.

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

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

•    Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.

IN THIS LEAFLET

1.

What your medicine is and what it is used for

2.

Before you take your medicine

3.

How to take your medicine

4.

Possible side effects

5.

How to store your medicine

6.

Further information

1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR


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

Erythromycin is prescribed to treat infections caused by bacteria, including:

■    upper and lower respiratory tract infections

■    skin and other soft tissue infections including acne

■    ear, mouth or eye infections

■    gastrointestinal infections (e.g. gall bladder or intestinal infections)

■    other infections such as syphilis or gonorrhoea

Erythromycin is prescribed for the prevention of infections when patients:

■    are going to have or have recently had dental or surgical procedures

■    have suffered from burns

■    have had rheumatic fever

■    are allergic to penicillin and have heart disease

2.    BEFORE YOU TAKE YOUR MEDICINE


DO NOT take Erythromycin and tell your doctor if you:

■    are allergic (hypersensitive) to erythromycin, to any other medicine containing erythromycin or to any of the ingredients in the capsule

■    are taking any of the following medication:

-    dihydroergotamine, ergotamine (for migraine)

-    cisapride (for stomach disorders)

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

-    pimozide and sertindole (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 disease

■    suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing and swallowing and slurred speech

Long term use of erythromycin has been associated with overgrowth of bacteria or fungi not sensitive to this antibiotic, causing a serious bowel infection (see section 4. Possible Side Effects)

Taking other medicines:

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

Erythromycin is known to interact with the following medicines:

■    eletriptan (for migraine)

■    clozapine, , quetiapine (for psychiatric disorders)

■    acenocoumarol and warfarin (for preventing blood clots)

■    alfentanil, midazolam and triazolam (sedatives which may be given before an operation)

■    atorvastatin, lovastatin (for reducing blood cholesterol)

■    bromocriptine and cabergoline (for Parkinson’s disease)

■    buspirone (for anxiety)

■    carbamazepine, hexobarbital, phenytoin and valproate (for epilepsy)

■    chloramphenicol, clindamycin and lincomycin (for infections)

■    ciclosporin and tacrolimus (for prevention of rejection after graft or organ transplant)

■    cilostazol (for circulatory problems)

■    cimetidine (for stomach ulcers)

■    digoxin, disopyramide and quinidine (for heart conditions)

■    felodipine (for high blood pressure)

■    rifabutin (for tuberculosis)

■    sildenafil and tadalafil (for erectile dysfunction in men)

■    theophylline (for breathing problems)

■    zopiclone (for insomnia).

Pregnancy and Breast-feeding

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

Tests

If you are asked to provide urine for any tests, tell your doctor that you are taking Erythromycin 250mg Capsules, as erythromycin can interfere with certain tests.

Important information about some of the ingredients of Erythromycin 250 mg Capsules

This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.


HOW TO TAKE YOUR MEDICINE


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

Swallow the capsules whole either before or with meals. DO NOT chew the capsules.

Do not give to children who cannot swallow the capsules whole.

Adults (including the elderly)

The usual dose is 2 capsules (500 mg) twice daily or 1 capsule (250 mg) four times daily, taken either before or with meals.

Your doctor may prescribe a different dose for you depending on the condition you are being treated for. If the total daily dose to be taken is greater than 4 capsules (1000 mg) you should take Erythromycin 250 mg Capsules 3 or 4 times a day.

Children

The dosage for children will depend upon the child’s weight.

DO NOT give to children who cannot swallow the capsule whole

The usual dosage is between 30mg to 50 mg of Erythromycin 250 mg Capsules for each kg of weight. Your doctor will work out the exact dose. The prescribed course should always be completed.

If you take more of the medicine than you should

If you (or someone else) take too many capsules, contact your nearest hospital casualty department or tell your doctor IMMEDIATELY. Symptoms of an overdose include nausea, vomiting and diarrhoea.

Take any remaining capsules and the pack they were in with you to the hospital.

If you forget to take your medicine

If you forget to take a dose, take it as soon as you remember it and then take the next dose at the correct time. DO NOT take a double dose to make up for a forgotten dose.

If you stop taking your medicine:

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.

4. POSSIBLE SIDE EFFECTS


Like all medicines, Erythromycin 250 mg Capsules can cause side effects although not everybody gets them.

STOP taking your 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 and they worry you.

Stevens-Johnson syndrome (A severe inflammatory eruption of the skin and mucous membranes).

Most common side effects:

■    nausea

■    diarrhoea

■    abdominal discomfort

■    vomiting

Occasional side effects:

■    confusion

■    hallucinations

■    a feeling that you or your surroundings are spinning (vertigo)

■    irregularities of the heartbeat (palpitations)

■    seizure (fits)

■    hearing problems (associated with very high doses)

Less frequent side effects:

■    jaundice (yellowing of the skin and eyes)

■    abnormal blood tests of liver function

Rare side effects:

■    itching and skin rashes

■    inflammation of the pancreas, leading to abdominal pain

■    long-term use of Erythromycin 250 mg Capsules has been associated with the growth of bacteria or fungi not sensitive to this antibiotic- this can include serious infection involving the large bowel (pseudomembranous colitis)

Very rare side effects:

■    severe skin reactions, with soreness, blistering and ulceration or peeling of the skin

If you notice any of these side effects or if you notice any side effects not listed please tell your doctor or pharmacist.

5. HOW TO STORE YOUR MEDICINE


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

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Store in the original package. Do not transfer your medicine to another container.

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 250mg Capsules contain

The active substance is: erythromycin (250 mg)

The other ingredients are: neutral microgranules (containing sucrose and corn starch), hydroxypropyl methylcellulose, triacetin, methacrylic acid and ethyl acrylate copolymer, and talc. The capsule shell contains gelatine.

What Erythromycin 250mg Capsules look like and contents of the pack Erythromycin Capsules are gastro-resistant, hard capsules.

These capsules are available in packs of 28 and 30. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

PL 30464/0061

This leaflet was last revised September 2012