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Erythromycin Tablets 250mg

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ERYTHROMYCIN 250 mg TABLETS

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 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS

1.    What Erythromycin is for

2.    Before you take Erythromycin

3.    How to take Erythromycin

4.    Possible side effects

5.    How to store Erythromycin

6.    Further information

1. WHAT ERYTHROMYCIN IS FOR

Erythromycin belongs to a group of medicines called macrolide antibiotics. It can be used for the treatment and prevention of infections caused by erythromycin-sensitive organisms, these include:

•    respiratory tract infections such as tonsillitis, bronchitis, pneumonia or diphtheria

•    eye or ear infections

•    mouth / dental infections such as Vincent's angina or gingivitis

•    skin and soft tissue infections such as acne or cellulitis

•    bone infections

•    gastrointestinal infections

•    sexually transmitted infections such as gonorrhoea or syphilis

•    other infections such as urethritis, prostatitis or scarlet fever

•    infections in patients allergic to penicillin

•    infections which may occur before or after some dental or surgical procedures.

If you are not sure why you have been prescribed this medicine then please ask your doctor.

2. BEFORE YOU TAKE ERYTHROMYCIN

Do not take Erythromycin and tell your doctor if

you:

•    are allergic to Erythromycin or any of the other ingredients in the tablets (listed in section 6 of this leaflet)

•    are taking Terfenadine or Astemizole (for the treatment of hayfever and other allergies)

•    are taking Cisapride (for stomach problems)

•    are taking Pimozide (for mental health problems)

•    are taking Ergotamine or Dihydroergotamine (for migraines)

•    are taking Simvastatin (to lower your cholesterol).

Take special care with Erythromycin

Tell your doctor before you take this medicine if you:

•    have liver problems

•    are taking medicines which can harm your liver (check with your doctor to see if this applies to any medicines you are taking)

•    have muscle weakness (myasthenia gravis)

•    are pregnant, planning to become pregnant or are breast-feeding.

If you are not sure if any of the above apply to you, talk to

your doctor or pharmacist before taking this medicine.

Having tests

Your doctor will monitor you closely, especially if you are taking Erythromycin for long-term treatment, as you may be more likely to get another infection.

If you are having urine tests or liver function tests, tell the doctor that you are taking Erythromycin, as it may interfere with the results.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.

This is because Erythromycin can affect the way some other medicines work. Also, some medicines can affect the way Erythromycin works.

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

•    Warfarin (thins the blood)

•    Clarithromycin (antibiotic used to treat certain infections)

•    Digoxin, Disopyramide or Quinidine (for heart problems)

•    Zopiclone (to help you sleep)

•    Midazolam or Triazolam (to calm you down or to help you sleep)

•    Alfentanil (anaesthetic to relieve pain)

•    Theophylline (helps breathing)

•    Carbamazepine, Phenytoin, Hexobarbitone or Valproate (used to treat epilepsy)

•    Bromocriptine (used to treat Parkinson's disease)

•    Ciclosporin or Tacrolimus (used to stop the rejection of organs after transplants).

Your doctor will monitor you appropriately and may adjust your dose of Erythromycin as necessary.

DO NOT TAKE Terfenadine, Astemizole, Cisapride, Pimozide, Ergotamine, Dihydroergotamine or Simvastatin if you have been prescribed Erythromycin.

Taking Erythromycin with food and drink

Erythromycin tablets should be taken without food or immediately before food.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.

Driving and using machines

Erythromycin should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Erythromycin

This medicine contains lactose (a type of sugar). If you know you have an intolerance to some sugars contact your doctor before taking Erythromycin.

This medicine also contains the colour red (E124), which may cause allergic reactions, including asthma.


3. HOW TO TAKE ERYTHROMYCIN

Always take Erythromycin tablets exactly as your doctor has told you. Take the tablets by mouth, either without food or immediately before food.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition.

Adults, Elderly and Children over 8 years old:

The usual dose is 4-8 tablets (1000-2000 mg) per day in divided doses.

For severe infections your doctor may increase your dose up to 16 tablets (4000 mg) per day in divided doses.

Children under 8 years old:

A suspension form of this medicine is recommended.

If you take more Erythromycin than you should

If you or a child accidentally takes too many tablets, contact your doctor or go to a hospital immediately. Take this leaflet and any remaining tablets with you, if possible. Symptoms of an overdose include loss of hearing or severe nausea, vomiting and diarrhoea.

If you forget to take Erythromycin

Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

If you stop taking Erythromycin

It is important that you complete your full course of antibiotics; do not stop taking the tablets early if you feel better.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Erythromycin can cause side effects,

although not everybody gets them.

If you get any of the following side effects, STOP

TAKING this medicine and seek urgent medical

help:

•    an allergic reaction, which may cause skin rash, itching, skin reactions including red patches or raised lumps, skin peeling, blistering of the skin, mouth, eyes or genitals, swelling of the face or throat, difficulty in breathing or swallowing, sudden wheezing or collapse

•    liver problems including inflammation of the liver (hepatitis), which may cause yellowing of the skin or whites of the eyes (jaundice), aches and pains in the stomach area or loss of appetite. Abnormal liver function test results may also occur

•    damage to the kidneys, which may cause a change in the amount of urine passed, blood in the urine, swollen ankles, nausea, vomiting, confusion, fever or rash

•    damage to the nervous system, which may cause psychotic reactions or nightmares

•    effects on the blood. If you notice increased bruising, nosebleeds, sore throat, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.

Tell your doctor if you get any of these

side effects:

•    feeling sick (nausea)

•    being sick (vomiting)

•    aches and pains in the stomach area

•    diarrhoea

•    infection of the intestine causing watery diarrhoea, fever and cramps (pseudomembranous colitis)

•    irregular heartbeats, which may cause dizziness, breathlessness or fainting

•    temporary loss of hearing, particularly if you are taking a high dose of Erythromycin.

In addition, there have been isolated reports of dizziness, chest pain and palpitations (abnormal awareness of your heartbeat).

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

5. HOW TO STORE ERYTHROMYCIN

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package or container. Keep the container tightly closed or keep the blister strips in the outer carton.

Do not use the tablets after the expiry date, which is stated on the package or container. The expiry date refers to the day, month and year.

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 contains

The active ingredient in Erythromycin 250 mg tablets is erythromycin. The other ingredients are lactose, maize starch, potato starch, sodium starch glycollate, magnesium stearate, cellulose acetate phthalate, diethyl phthalate, colour red (E124), macrogol 6000.

What Erythromycin looks like and contents of the pack

Erythromycin 250 mg tablets are round, red, enteric film-coated gastro-resistant tablets, available in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Metwest Pharmaceuticals Limited 15 Runnelfield, Harrow on the Hill,

Middlesex HA1 3NY

Manufacturer

DDSA Pharmaceuticals Limited 310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 07/2013

M0007/O/PIL/M1