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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Azithromycin 500 mg Tablets

Azithromycin

Read all of this 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 or pharmacist.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet:

1.    WhatAzithromycin Tablets are and what they are used for

2.    What you need to know before you takeAzithromycin Tablets

3.    How to take Azithromycin Tablets

4.    Possible side effects

5.    Howto storeAzithromycin Tablets

6.    Contents of the pack and other information

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

Azithromycin Tablets is an antibiotic. It belongs to a group of antibiotics called macrolides. It is used to treat infections caused by bacteria.

This medicine is usually prescribed to treat:

•    chest infections such as chronic bronchitis, pneumonia

•    infections of the tonsils, throat (pharyngitis) and sinuses

•    ear infections (acute otitis media)

•    skin and soft tissue infections, with exception of infected burn wounds

•    urethra and cervix infections caused by chlamydia.

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

Do not take this medicine if you are allergic (hypersensitive) to:

•    azithromycin

•    erythromycin

•    any other macrolide or ketolide antibiotic

•    any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin Tablets:

•    Liver problems: your doctor may need to monitor your liver function or stop the treatment.

•    Kidney problems: if you have severe kidney problems, the dose may have to be adjusted.

•    Nervous (neurological) or mental (psychiatric) problems.

•    A certain type of muscle weakness called myasthenia gravis.

Since azithromycin may increase the risk of abnormal heart rhythm please tell your doctor if you have any of the following problems before taking this medicine:

•    Heart problems such as a weak heart (heart failure), very slow heart rate, irregular heart beat, or something called “long QT syndrome” (found by an electro-cardiogram)

•    Low potassium or magnesium in your blood.

Other medicines and Azithromycin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines obtained without a prescription. It is especially important to mention before taking this medicine:

•    Theophylline (used to treat asthma): the effect of theophylline may be increased

•    Warfarin or any similar medicine to prevent blood clots: concomitant use can increase the risk of bleeding

•    Ergotamine, dihydroergotamine (used to treat migraine): ergotism (ie. itching in the limbs, muscle cramps and gangrene of hands and feet due to poor blood circulation) may occur. Concomitant use is therefore not recommended

•    Cyclosporin (used to suppress the immune system to prevent and treat rejection of an organ or bone marrow transplant): if concomitant use is required, your doctor will check your blood levels regularly and may adapt the dose

•    Digoxin (for heart failure): digoxin levels may increase. Your doctor will check your blood levels

•    Antacids (for indigestion): see section 3

•    Cisapride (for stomach problems), terfenadine (used to treat hay fever): concomitant use with azithromycin may cause heart disorders

•    Medicines for irregular heart beat (called anti-arrythmics)

•    Nelfinavir (used to treat HIV infections): concomitant use can increase the side effects of azithromycin

•    Alfentanil (used for narcosis) or astemizol (used to treat hay fever): concomitant use with azithromycin may increase the effect of these medicinal products.

Azithromycin Tablets with food and drink The tablets may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not use this medicine during pregnancy and when you are breast-feeding unless your doctor has specifically recommended it.

This medicine goes into human milk. So, you should stop breast-feeding until 2 days after you have finished taking this medicine.

Driving and using machines

This medicine may cause side effects such as dizziness or convulsions. This may make you less able to do certain things, such as driving or using machines.

Azithromycin Tablets contain soya lecithin

If you are allergic to peanut or soya, do not use this medicine.

3. HOW TO TAKE AZITHROMYCIN TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. These doses are for adults and children weighing more than 45 kg. Children weighing less than this should not take these tablets.

The recommended dose is:

Azithromycin Tablets is taken as a 3 or 5 day course

•    3 day course: Take 500 mg (two 250 mg or one 500 mg tablet) once each day

•    5 day course:

-    Take 500 mg on Day 1 (two 250 mg tablets)

-    Take 250 mg (one 250 mg tablet) on Days 2, 3, 4 and 5.

For urethra & cervix infections caused by chlamydia, it is taken asa 1 day course:

•    1 day course: 1,000 mg (four 250 mg tablets or two 500 mg tablets).

Take the tablets together on one day only.

Patients with kidney or liver problems

You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose. Swallow these tablets whole with a drink of water.

•    You can take these tablets with or without food.

Taking Azithromycin Tablets with medicines for indigestion

•    If you need to take a medicine for indigestion, such as an antacid, take your tablets at least one hour before or two hours after the antacid.

If you forget to take Azithromycin Tablets:

•    If you forgot to take a dose, take it as soon as possible. Then go on as before. Do not take more than one dose in a single day.

If you take more of Azithromycin Tablets than you should:

If you take too many tablets you may feel unwell. You also may experience other side effects such as deafness and

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diarrhoea. Tell your doctor or talk to your nearest hospital casualty department immediately. If possible, take your tablets or the box with you to show the doctor what you have taken.

If you stop taking Azithromycin Tablets:

Always keep taking the tablets until the course is finished, even if you feel better. If you stop taking the tablets too soon, the infection may come back. Also, the bacteria may become resistant to the medicine and will then be more difficult to treat. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

If you have any of the following symptoms of a severe allergic reaction stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    sudden difficulty in breathing, speaking and swallowing

•    swelling of the lips, tongue, face and neck

•    extreme dizziness or collapse

•    severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs

If you experience any of the following side effects contact your doctor as soon as possible:

•    diarrhoea that is serious, lasts a long time or has blood in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation. This is something that can rarely happen after taking antibiotics.

•    yellowing of the skin or whites of the eyes caused by liver problems

•    inflammation of the pancreas, which causes severe pain in the abdomen and back.

•    increased or reduced urine output, or traces of blood in your urine caused by kidney problems

•    skin rash caused by sensitivity to sunlight

•    unusual bruising or bleeding

•    irregular or rapid heart beat

These are all serious side effects. You may need urgent medical attention. Serious side effects are uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people) or the frequency cannot be estimated from the available data.

Other possible side effects:

Very common side effects (may affect more than 1 in 10 people):

•    diarrhoea.

Common side effects (may affect up to 1 in 10 people):

•    headache

•    vomiting, stomach upset, stomach cramps, feeling sick

•    low numbers of lymphocytes (type of white blood cells), higher number of eosinophils (type of white blood cells), low blood bicarbonate, higher number of basophils, monocytes and neutrophils (types of white blood cells).

Uncommon side-effects (may affect up to 1 in 100 people):

•    yeast and bacterial infections especially of the mouth, throat, nose, lung, bowel and vagina

•    low numbers of leukocytes (type of white blood cells), low number of neutrophils (type of white blood cells), higher number of eosinophils (type of white blood cells)

•    swelling, allergic reactions of various severity

•    loss of appetite

•    nervousness, sleeplessness

•    dizziness, drowsiness, taste disturbance, tingling or numbness of the hands or feet

•    visual disturbances

•    impaired hearing, spinning sensation

•    pounding heart beat

•    skin rash, sweating (hot flush)

•    difficulty breathing, nose bleeds

•    constipation, wind, indigestion, inflammation of the stomach, difficulty in swallowing, bloating, dry mouth, eructation, mouth sores, increased salivary flow

•    inflammation of the liver

•    itchy rash, inflammation of the skin, dry skin, sweating

•    joint inflammation, muscle, back and neck pains

•    difficulty and pain when passing urine, kidney pain

•    uterine bleeding, testis disorder

•    skin swelling, weakness, generally feeling unwell, tiredness, swelling of the face, chest pain, fever, pain

•    abnormal laboratory test values (e.g. blood, liver and kidney function test results)

•    problems after treatment.

Rare side-effects (may affect up to 1 in 1,000 people):

•    agitation, a feeling of loss of identity

•    abnormal liver function

•    being sensitive to sunlight.

Side effects of not known frequency (frequency cannot be estimated from the available data):

•    reduction in blood platelets, which increases risk of bleeding or bruising

•    reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness

•    feelings of aggression, anxiety, severe confusion, hallucination

•    fits, fainting, decreased skin sensitivity, feeling hyperactive, disturbed sense of smell, loss of sense of smell or taste, muscle weakness (myasthenia gravis)

•    poor hearing, deafness or ringing in the ears

•    abnormal electrocardiogram (ECG)

•    low blood pressure

•    staining of the tongue

•    joint pain.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE AZITHROMYCIN TABLETS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP: The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

WhatAzithromycin Tablets contains

•    The active substance is azithromycin monohydrate equivalent to 500 mg azithromycin.

•    The other ingredients are in the:

-    Core: microcrystalline cellulose, pregelatinised maize starch, sodium starch glycolate Type A, colloidal anhydrous silica, sodium laurilsulfate, magnesium stearate,

-    Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, soya lecithin, xanthan gum.

What Azithromycin Tablets looks like and contents of the pack

Azithromycin 500 mg Tablets are white to off-white, oblong, film-coated, deep break line on one side and score line on other side. The tablet can be divided into equal halves.

Azithromycin 500 mg Tablets are packed in a PVC/PVdC//Aluminium-blister.

The 500 mg tablets are packed in the following pack sizes:

Carton box with blister(s) containing: 2, 3, 6,12,24, 30,50, or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder: Sandoz Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Manufacturer: Sandoz GmbH, BiochemiestrBe 10, 6250 Kundl, Austria or Lek d.d., Pharmaceuticals, Verovskova 57, 1526 Ljubljana, Slovenia or Sandoz S.R.L., Livenzeni Street no 7A, Targu Mures, RO - 540472, Romania.

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This leafletwas last revised in 06/2013.