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AZITHROMYCIN 250 mg AND 500 mg FILM-COATED TABLETS

Azithromycin dihydrate

PACKAGE LEAFLET: INFORMATION FORTHE USER

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

INTHIS LEAFLET:

1.    What Azithromycin is and what it is used for

2.    Before you take Azithromycin

3.    How to take Azithromycin

4.    Possible side effects

5.    How to store Azithromycin

6.    Further information

O WHAT AZITHROMYCIN IS AND WHAT IT IS USED FOR

Azithromycin is one of a group of antibiotics called macrolides. It is used to treat bacterial infections caused by micro organisms such as bacteria.These infections include:

• Chest infections such as acute bronchitis and pneumonia

• infections in your sinuses, throat, tonsils or ears • Mild to moderate skin and soft tissue infections, e.g. infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas)

• Infections caused by a bacterium called Chlamydia trachomatis.They can cause inflammations of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix).

BEFORE YOU TAKE AZITHROMYCIN

Do NOT take Azithromycin:

• if you are allergic (hypersensitive) to azithromycin or any of the other ingredients of this medicine or any other macrolide or ketolide antibiotic, e.g. erythromycin or telithromycin.

Take special care with Azithromycin

Talk to your doctor before you start to take this medicine if you:

• have ever had a serious allergic reaction causing swelling of the face and throat, possibly with breathing problems

• have severe kidney problems: your doctor may alter the dose

• have liver problems: your doctor may need to monitor your liver function or stop the treatment • are aware of ever being diagnosed with prolonged QT interval (a heart condition): azithromycin is not recommended

• are aware that you have a slow or irregular heart beat or reduced heart function: azithromycin is not recommended

• know that you have low levels of potassium or magnesium in your blood: azithromycin is not recommended

• are taking medicines known as antiarrhythmics (used to treat abnormal heart rhythms), cisapride (used to treat stomach problems) or terfenadine (an antihistamine that is used to treat allergies): azithromycin is not recommended • are taking medicines known as ergot alkaloids (such as ergotamine), which are used to treat migraine: azithromycin is not recommended (see 'Taking other medicines' below)

• have been diagnosed with a neurological disease, which is a disease of the brain or nervous system • have mental, emotional or behavioural problems • have a condition known as myasthenia gravis, with fatigue and exhaustion of the muscles: azithromycin may worsen or cause symptoms of myasthenia.

If you develop severe and persistent diarrhoea during or after treatment, especially if you notice blood or mucus, tell your doctor immediately.

If your symptoms persist after the end of your treatment with azithromycin or if you notice any new and persistent symptoms, contact your doctor.

Taking other medicines

Check with your doctor if you are taking any of the following:

•    Antacids e.g. aluminium hydroxide: take Azithromycin at least 1 hour before or 2 hours after taking an antacid

•    Ergot derivatives e.g. ergotamine, (used to treat migraine): Azithromycin should not be taken at the same time, as ergotism may develop (a potentially serious side effect with numbness or tingling sensations in the limbs, muscle cramps, headaches, convulsions, abdominal or chest pain)

•    Coumarin derivatives, e.g. warfarin (used to stop the blood clotting): the risk of bleeding may be increased

•    Digoxin (used to treat heart failure): the levels of digoxin in your blood may increase

•    Zidovudine nelfinavir (used in the treatment of HIV): the levels of zidovudine or azithromycin might be increased

•    Rifabutin (used in the treatment of HIV and bacterial infections including tuberculosis): decreases in your number of white blood cells could occur

•    Ciclosporin (an immunosuppressant used following organ transplant): your doctor will need to monitor your ciclosporin blood levels

•    Cisapride (used to treat stomach problems): heart problems may occur

•    Astemizole, terfenadine (antihistamines used to treat allergic reactions): their effect might be increased

•    Alfentanil (a painkiller): the effect of alfentanil might be increased

•    Fluconazole (for fungal infections): the levels of azithromycin might be reduced.

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosine, efavirenz, indinavir (for HIV infection); atorvastatin (for cholesterol and heart problems); carbamazepine (for epilepsy); cimetidine (an antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for impotence) and trimethoprim/sulphamethoxazole (an antibiotic combination).

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

Pregnancy and breast-feeding

There is insufficient information regarding the safety of azithromycin during pregnancy. Consequently, Azithromycin is not recommended if you are pregnant or planning to become pregnant. However, your doctor may prescribe it under serious circumstances.

You should not breast-feed whilst you are taking Azithromycin, because it may cause side effects including diarrhoea and infection in your baby.You may resume nursing two days after stopping your treatment with Azithromycin.

Ask your doctor for advice before taking any medicine.

Driving and using machines

Azithromycin may cause dizziness and fits. If affected, do not drive or operate machinery.

HOWTO TAKE AZITHROMYCIN

Always take Azithromycin 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 preferably with a drink of water, and can be taken with or without food.

The usual dose is:

Adults (including the elderly) and children with a body weight of over 45 kg:

The usual dose is 1500 mg divided over either 3 or 5 days as follows:

•    When taken over 3 days, 500 mg a day.

•    When taken over 5 days, 500 mg on the first day and then 250 mg on days 2 through to 5.

•    Inflammation of the urethra or cervix caused by Chlamydia'. 1000 mg taken as a single dose, for one day only.

Children and Adolescents under 45 kg:

Tablets are not indicated for these patients. Other pharmaceutical forms of azithromycin-containing products (e.g. suspensions) may be used.

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.

If you take more Azithromycin than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your doctor or pharmacist immediately. An overdose is likely to cause reversible hearing loss, severe nausea (feeling sick), vomiting and diarrhoea.

Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Azithromycin

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

If you stop taking Azithromycin

Do not stop taking your medicine without talking to your doctor first even if you feel better. It is very important that you keep taking Azithromycin for as long as your doctor has told you to, otherwise the infection may come back.

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

POSSIBLE SIDE EFFECTS

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

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

•    blisters/bleeding of the lips, eyes, nose, mouth and genitals, which may be caused by Stevens-Johnson syndrome or toxic epidermal necrosis, which are serious illnesses

•    an irregular heart beat.

•    prolonged diarrhoea with blood and mucus.

These are very serious but rare side effects.You may need urgent medical attention or hospitalisation.

The following other side effects have been reported:

Very common (affecting more than 1 user in 10):

•    Diarrhoea, stomach pain, feeling sick, wind.

Common (affecting 1 to 10 users in 100):

•    Changes in the numbers of some white blood cells and blood bicarbonate

•    Dizziness, headache, pins and needles or numbness

•    Taste disorders

•    Sight disorders

•    Deafness

•    Vomiting, indigestion, loss of appetite

•    Rash, itching

•    Joint pain

•    Tiredness.

Uncommon (affecting 1 to 10 users in 1,000):

•    Yeast infection e.g. of the mouth (thrush), vaginal infection

•    Blood disorders characterised by fever or chills, sore throat, ulcers in your mouth or throat

•    Allergic reactions

•    Loss of sensation, sleepiness, difficulty sleeping

•    Hearing disturbances including ringing in the ears

•    Abnormality of the rhythm or rate and awareness of the heart beat (palpitations)

•    Inflammation of the stomach, constipation, loose stools

•    Hepatitis (inflammation of the liver)

•    Reddening and blistering of the skin when exposed to sunlight, hives (nettle rash)

•    Inflammation of the vagina

•    Chest pain, swelling, feeling unwell, lethargy

•    Changes in liver enzymes and laboratory blood values.

Rare (affecting 1 to 10 users in 10,000):

•    Agitation

•    A feeling of things being unreal

•    Confusion, especially in the elderly

•    Spinning sensation

•    Teeth discolouration

•    Abnormal liver function.

The frequency of the following side effects is not

known:

•    Blood disorders characterised by unusual bleeding or unexplained bruising, low blood count causing unusual tiredness or weakness

•    Aggression, anxiety

•    Fainting, fits, hyperactivity, alteration or loss of the sense of smell, loss of the sense of taste, myasthenia gravis (fatigue and exhaustion of the muscle, see 'Take special care with Azithromycin' above)

•    Change in heart rate

•    Low blood pressure (which may be associated with weakness, lightheadedness and fainting)

•    Discolouration of the tongue, inflammation of the pancreas causing nausea, vomiting, abdominal pain, back pain

•    Liver failure (rarely life-threatening)

•    Rash with spots and blisters

•    Kidney problems

•    Pain.

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

HOWTO STORE AZITHROMYCIN

Keep out of the reach and sight of children.

Do not use Azithromycin after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month. 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.

FURTHER INFORMATION

What Azithromycin tablets contain:

•    Each tablet contains either 250 or 500 mg of the active ingredient azithromycin as dihydrate.

•    The other ingredients are calcium hydrogen phosphate anhydrous, hypromellose, maize starch, starch pregelatinised, cellulose microcrystalline, magnesium stearate, sodium lauryl sulfate, colour indigotin lake (E 132) (500 mg tablets only), titanium dioxide (E171), polysorbate 80 and talc.

What Azithromycin tablets look like and contents of

the pack:

•    Azithromycin 250 mg tablets are white, oblong, biconvex, film-coated tablets, with imprint A1 250 on one side

•    Azithromycin 500 mg tablets are pale blue, oblong, biconvex film-coated tablets, with imprint A1 500 and break line on one side.The tablet can be divided into equal doses.

•    The 250 mg tablets are available in pack sizes of 2, 4, 6 or 10 tablets

•    The 500 mg tablets are available in pack sizes of 1, 2, 3, 6 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised: September 2011

PL 00289/0584-0585

™

TEVA UK LIMITED 83969-Z