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Azithromycin 250mg Capsules

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Azithromycin 250mg Capsules

(azithromycin)

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


Patient Information Leaflet

In this leaflet:

1)    What Azithromycin 250mg Capsules are and what they are used for

2)    Before you take Azithromycin 250mg Capsules

3)    How to take Azithromycin 250mg Capsules

4)    Possible side effects

5)    How to store Azithromycin 250mg Capsules

6)    Further information

1)    What Azithromycin 250mg Capsules are and what they are used for

Azithromycin is one of the group of macrolide antibiotics. It is used to treat a number of infections including:

•    Upper and lower respiratory tract infections (e.g. tonsillitis, pharyngitis, sinusitis, bronchitis and pneumonia)

•    Skin and soft tissue infections (e.g. abscesses and other infections)

•    Ear infections

•    Sexually transmitted diseases caused by an organism called Chlamydia.

2)    Before you take Azithromycin 250mg Capsules Do not take Azithromycin 250mg Capsules if:

•    If you are allergic (hypersensitive) to azithromycin or to any other macrolide antibiotic (e.g. erythromycin, clarithromycin), or to any of the other ingredients of Azithromycin 250mg Capsules

•    If you are taking any of the medicines listed under ‘Taking other medicines; Do not take'

•    If you suffer from liver problems

Take special care with Azithromycin 250mg Capsules

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

•    have severe kidney problems

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

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.

Do not take Azithromycin 250mg Capsules if you are taking:

•    Medicines known as ergot derivatives e.g. ergotamine or dihydroergotamine (medicines used for migraines or reducing blood flow).

It is especially important to tell your doctor or pharmacist if you are taking:

•    Cyclosporin (a medicine used for skin conditions, rheumatoid arthritis, or following organ transplants)

•    Theophylline (for breathing problems)

•    Warfarin or other medicines to thin your blood

•    Digoxin (for heart problems)

•    Zidovudine (for HIV). Azithromycin may reduce the blood levels of zidovudine and should therefore be taken at least 1-2 hours before or after zidovudine

•    Rifabutin (for HIV or tuberculosis)

•    Antacids. Your Azithromycin 250mg Capsules should be taken at least one hour before or two hours after you take your antacids.

Taking Azithromycin 250mg Capsules with food and drink

Your medicine should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, may be pregnant or are breast-feeding. Azithromycin 250mg Capsules should not be used during pregnancy or breast-feeding unless this has been discussed with your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Azithromycin 250mg Capsules may make you feel dizzy. If affected, do not drive or operate machinery.

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

This medicine contains sulphur dioxide (E220) which may rarely cause severe allergic reactions and cause difficulty in breathing

3) How to take Azithromycin 250mg Capsules

Always take Azithromycin 250mg Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

Respiratory tract and skin or soft tissue infections: 500 mg (two capsules) once daily for three days. Sexually transmitted diseases: 1000 mg (four capsules) as a single dose.

Elderly

The usual adult doses may be used.

Children

Azithromycin 250mg Capsules are not recommended for use in children weighing less than 45 kg. For children weighing more than 45 kg the usual adult dose 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.

It is very important that you follow your doctor's instructions as to the dosage of Azithromycin 250mg Capsules and for how long you should continue to take your capsules. Keep taking then for as long as your doctor tells you.

If you take more Azithromycin 250mg Capsules than you should

It is important to stick to the dose on the label of your medicine. If you or someone else swallows several of these capsules all together, or you think a child has swallowed any of these capsules, contact your doctor, pharmacist or hospital emergency department immediately. Always take any capsules left over with you and also the box, as this will allow easier identification of the capsules.

Symptoms of overdose may include severe nausea, vomiting and diarrhoea and reversible loss of hearing.

If you forget to take your Azithromycin 250mg Capsules

Do not take a double dose to make up for a forgotten dose. If a dose is forgotten, it should be taken as soon as it is remembered. However, if it is nearly time for the next dose, miss the forgotten dose altogether and continue with the rest of the medicine as normal.

If you stop taking your Azithromycin 250mg Capsules

Even when you start to feel better it is important for you to keep on taking your capsules for as long as your doctor tells you.

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

4) Possible side effects

Like all medicines, Azithromycin 250mg Capsules can cause side effects, although not everybody gets them. These are usually mild to moderate, and stop when treatment is stopped.

If you suffer from any of the following side effects, stop taking your Azithromycin 250mg Capsules and either tell your doctor IMMEDIATELY or go to your nearest hospital emergency department. You may be experiencing a rare severe allergic reaction to the capsules:

•    Swelling of the hands, feet, ankles, face, lips, mouth or throat

•    Problems with swallowing or breathing

•    Serious skin reactions including Stevens- Johnson Syndrome (a severe skin rash) and other severe skin rashes which may involve blistering or peeling (these may be severe allergic reactions)

•    Severe, persistent diarrhoea especially if it has blood or mucus in it (this may be Pseudomembranous colitis).

Common side effects (affecting less than 1 in 10 people)

•    Feeling or being sick, stomach ache and diarrhoea.

Uncommon side effects that (affecting less than 1 to 100 people):

•    Headache, dizziness or fits

•    Allergic reactions with rashes or itching

•    Taste disturbances, indigestion, inflammation of the gut, loss of appetite or wind

•    Joint pain

•    Vaginal infections.

Rare side effects (affecting less than 1 to 1000 people):

•    Changes to the number of certain types of blood cells

•    Aggressive reaction, anxiety, restlessness or nervousness

•    Hyperactivity or inability to sleep

•    Strange skin sensations (numbness, tingling, pins and needles or ‘burning')

•    Feeling tired or weak

•    Hearing problems, hearing loss or tinnitus (ringing in the ears)

•    Heart palpitations (a strong or forceful heart beat), change in the speed of your heart beat

•    Constipation, tongue discolouration

•    Liver problems, hepatitis (an inflammation of the liver), jaundice (yellowing of the skin or the whites of the eyes), liver failure and liver damage

•    Increased sensitivity to sunlight and sun beds, or other serious skin reactions

•    Kidney damage and kidney failure

•    Thrush.

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.

5)    How to store Azithromycin 250mg Capsules

•    Keep all medicines out of the sight and reach of children.

•    Do not store above 25°C. Store in the original package.

•    Do not take this medicine after the expiry date stamped on the pack after EXP. 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.

6)    Further Information

What Azithromycin 250mg Capsules contains

The active substance is azithromycin. Each capsule contains 250mg azithromycin (as dihydrate).

The other ingredients are microcrystalline cellulose, magnesium stearate and sodium lauryl sulphate.

The capsule is made of gelatin, sulphur dioxide (E220) and the colouring agents titanium dioxide (E171), FD & C Blue 2 (E132) and indigo carmine (E132).

What Azithromycin 250mg Capsules looks like and contents of the pack

Hard gelatin capsule with opaque, dark blue cap and opaque, light blue body containing white to pale yellow, odourless crystalline powder. There are no markings on the capsule.

They are available in blister packs of 6 capsules.

PL 10383/1968    Azithromycin 250mg Capsules    |POM|

Who makes and repackages your medicine?

Your medicine is manufactured by Teva Operations Poland Sp. z.o.o. ul. Mogilska 80, 31-546 krakko, Poland. and is procured from within the EU and repackaged by the Product Licence holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 03.07.2014