PACKAGE LEAFLET: INFORMATION FOR THE USER

Azithromycin 250 mg Capsules

(azithromycin dihydrate)

Read all of this leaflet carefully before you start using 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.

What is in this leaflet:

1.    WhatAzithromycin is and what it is used for

2.    What you need to know before you useAzithromycin

3.    HowtotakeAzithromycin

4.    Possible side effects

5.    Howto storeAzithromycin

6.    Contents of the pack and other information

1.    WhatAzithromycin is and what it is used for

Azithromycin is an antibiotic. It belongs to a group of antibiotics called 'macrolides'.

Azithromycin is used to treat bacterial infections caused by 'micro-organisms' such as bacteria. These infections include:

-    Chest, throat or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis) and sinusitis)

-    ear infections

-    skin and soft tissue infections (such as an abscess or boil)

-    sexually transmitted diseases caused by an organism called chlamydia

2.    What you need to know before you useAzithromycin Do not takeAzithromycin if

-    you are allergic (hypersensitive) to azithromycin dihydrate, erythromycin or any of the other ingredients in this medicine (listed in section 6). An allergic reaction may cause skin rash or wheezing

-    you are allergic (hypersensitive) to any macrolide or ketolide antibiotic

-    you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together withAzithromycin

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before takingAzithromycin.

Warnings and precautions

Talk to your doctor or pharmacist before takingAzithromycin if:

-    you have liver problems: your doctor may need to monitor your liver function or stop the treatment

-    you have severe kidney problems

-    you have severe heart problems or problems with your heart beat such as long QT syndrome (shown on an electro-cardiogram or ECG machine)

-    your blood levels of potassium or magnesium are too low

-    you develop signs of another infection

-    you have nervous (neurological) or mental health (psychiatric) problems

Stop taking Azithromycin and see a doctor straight away if you notice any of the following serious side effects while taking this medicine:

-    swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, rash which may range from itchy skin rash to serious blistering of the skin or ulcers on your lips, eyes, nose, mouth and genitals. These could be signs of a severe allergic reaction, angioedema or anaphylaxis.

-    severe diarrhoea that lasts a long time or has blood and mucous in it. These could be signs of a serious gut (intestine) problem called 'pseudomembranous colitis'.

Other medicines andAzithromycin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor or pharmacist if you are taking any of the following medicines:

-    antacids - used for heartburn and indigestion. Azithromycin should be taken at least 1 hour before or 2 hours after the antacid

-    ergotamine - (used for migraine) should not be taken at the same time as serious side effects may develop (with numbness or tingling sensations in the limbs, muscle cramps, headaches, convulsions, abdominal or chest pain)

-    warfarin or similar medicines - used to thin the blood. Azithromycin can thin the blood even more

-    cisapride - (used to treat stomach problems) should not be taken at the same time as this may cause severe heart problems (shown on an electro-cardiogram or ECG machine)

-    terfenadine - (used to treat hay fever) should not be taken at the same time as this may cause severe heart problems (shown on an electro-cardiogram or ECG machine)

-    zidovudine or nelfinavir - used to treat HIV infections. Taking nelfinavir with Azithromycin may mean that you get more of the side effects listed in this leaflet

-    rifabutin - used to treat tuberculosis (TB)

-    quinidine - used to treat heart rhythm problems

-    cyclosporin - used to stop your body rejecting an organ transplant. Your doctor will regularly check your blood levels of cyclosporin and may change your dose

Tell your doctor or pharmacist if you are taking any of the following medicines. Azithromycin can make the effects of these other medicines stronger. Your doctor may change your dose:

-    triazolam, midazolam (sedatives)

-    alfentanil-a painkiller used e.g. during operations

-    theophylline - used for breathing problems such as asthma and chronic obstructive

pulmonary disease (COPD)

-    digoxin - used to treat heart problems

-    astemizole-used to treat hay fever

-    pimozide - used to treat mental health problems

Azithromycin with food and drink

You should takeAzithromycin either 1 hour before a meal or 2 hours after a meal. 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.

Azithromycin is not recommended ifyou are pregnant or planning to become pregnant or if you are breast-feeding. Azithromycin should only be used during pregnancy when clearly necessary.

This medicine goes into human milk. So, you should stop breast-feeding until 2 days after you have finished taking this medicine. You may discuss with your doctor to pump and discard milk during this time or alternatively to use another antibiotic.

Driving and using machines

If your medicine makes you feel dizzy or you have other side effects that reduce your ability to concentrate, do not drive or operate machinery.

3.    HowtotakeAzithromycin

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist ifyou are not sure.

Taking this medicine

Swallow the capsules whole with a glass of water.

How much to take

Adults and young people with a body weight of45 kg and above:

The usual dose is 500 mg (2 capsules) taken together, once a day, for 3 days.

The dose is different if you have inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix). Your doctor will ask you to take a single dose of 1000 mg (4 capsules) taken all together on one day only.

Children and adolescents under 45 kg:

The Azithromycin capsules should not be taken by children weighing less than 45 kg. Young people with a body weight of less than 45 kg should use other forms of this medicine such as azithromycin suspension.

Patients with kidney or liver problems

You should tell your doctor ifyou have kidney or liver problems as your doctor may need to alter the normal dose.

Always continue with the course even if you feel better. If your infection gets worse or you do not start to feel better within a few days or a new infection develops, go back and see your doctor.

Ifyou take moreAzithromycin than you should

If you take more Azithromycin than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen:

-    temporary loss of hearing

-    feeling very sick (severe nausea), being sick (vomiting) and diarrhoea

Ifyou forget to takeAzithromycin

-    Ifyou forget a dose, take it as soon as you remember it

-    However, if it is nearly time for the next dose, skip the missed dose

-    Do not take a double dose to make up for a forgotten dose

-    Ifyou have to skip a dose, still take all of your capsules. This means that you will finish your course a day later

Ifyou stop takingAzithromycin

Do not stop takingAzithromycin without talking to your doctor.

If you stop taking Azithromycin too soon, the infection may return. Take the capsules for the full time of treatment, even when you begin to feel better.

Ifyou 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.

Stop taking Azithromycin and see a doctor straight away ifyou notice any of the following serious side effects - you may need urgent medical treatment:

-    swelling of your face, lips, tongue, face or throat, difficulty breathing or swallowing, rash which may range from itchy skin rash to serious blistering of the skin or ulcers on your lips, eyes, nose, mouth and genitals. These could be signs of a severe allergic reaction, angioedema or anaphylaxis.

-    severe diarrhoea that lasts a long time or has blood or mucus in it. These could be signs of a serious gut (intestine) problem called 'pseudomembranous colitis'.

-    fever, red spotted skin, blistering or peeling skin, joint pain, swollen eyes. These could be signs of a serious reaction such as 'Steven-Johnson syndrome', 'toxic epidermal necrolysis' or 'erythema multiforme'.

Other side effects include:

Very common (affects more than 1 user in 10)

-    diarrhoea

Common (affects 1 to 10 users in 100)

-    headache

-    being sick (vomiting), abdominal pain, feeling sick (nausea)

-    change in the quantity of the white blood cells and the concentration of bicarbonate in the blood

Uncommon (affects 1 to 10 users in 1,000)

-    thrush (candidiasis) - yeast infections especially of the mouth

-    infections of the vagina

-    lung infection (pneumonia)

-    fungal infection

-    bacterial infection

-    inflammed throat(pharyngitis)

-    inflammation of the stomach and intestines (gastroenteritis)

-    runny nose, sneezing (rhinitis)

-    reduction in the number ofwhite blood cells

-    hypersensitivity

-    anorexia

-    nervousness

-    having difficulty sleeping (insomnia)

-    feeling dizzy

-    feeling drowsy (somnolence)

-    sensation of pins and needles or numbness (paraesthesia)

-    changes inyour sense oftaste and smell (dysgeusia)

-    visual impairment

-    ear disorder

-    palpitations

-    hot flush

-    shortness ofbreath

-    nosebleeds

-    gastritits

-    constipation

-    loose wind (flatulence)

-    problems with digesting your food (dyspepsia)

-    difficulty swallowing (dysphagia)

-    abdominal distension

-    dry mouth

-    belching (eructation)

-    excess production of saliva

-    liver problems such as hepatitis or jaundice

-    urticaria

-    skin inflammation

-    dry skin

-    increased sweating

-    swelling, creaking and stiffness of one or more joints

-    muscle pain

-    back pain

-    neck pain

-    pain when passing urine

-    pain in kidneys

-    mild menstrual bleeding at irregual intervals

-    testicular pain and swelling

-    swelling (oedema)

-    malaise

-    weakness

-    fatigue

-    chest pain

-    pain

-    skinswelling

-    change in liver enzyme levels and blood levels

-    abnormal kidney function test results, abnormal blood potassium, abnormal sugar levels in blood

-    post-procedural complication

Rare (affects 1 to 10 users in 10,000)

-    feeling agitated

-    abnormal hepatic function

-    jaundice cholestatic

-    allergic skin reactions

-    being sensitive to sunlight

Notknown (frequency cannot be estimated from the available data)

-    reduced number of red blood cells due to destruction (haemolytic anaemia); reduction in number of platelets (thrombocytopenia)

-    anaphylactic reaction

-    feeling angry, aggressive

-    anxiety

-    delirium

-    seeing, feeling or hearing things that are not there (hallucination)

-    fainting (syncope)

-    fits (convulsions)

-    reduced sense of touch (hypoaesthesia)

-    feeling hyperactive

-    change in your sense of smell (anosmia, parosmia)

-    change inyour sense oftaste (ageusia)

-    exacerbation or aggravation of myasthenia gravis

-    hearing loss or ringing in your ears

-    low blood pressure

-    inflammation of the pancreas (pancreatitis)

-    your tongue changes colour

-    inflammation of the liver

-    allergic skin reactions

-    joint pain

-    kidney problems

-    rapid (ventricular tachycardia) or irregular heart beat, sometimes being life-threatening, changes of the heart rhythm found by an electro-cardiogram (QT prolongation and torsade de pointes)

The following side effects have been reported in prophylactic treatment against MycobacteriumAvium complex (MAC):

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

-    diarrhoea

-    abdominal pain

-    feeling sick (nausea)

-    loose wind (flatulence)

-    abdominal discomfort

-    loose stools

Common (may affect up to 1 in 10people)

-    lack ofappetite (anorexia)

-    feeling dizzy

-    headache

-    sensation ofpins and needles or numbness (paraesthesia)

-    changes in your sense oftaste

-    visual impairment

-    deafness

-    skin rashes and itching

-    joint pain (arthralgia)

-    fatigue

Uncommon (may affect up to 1 in 100people)

-    reduced sense of touch (hypoaesthesia)

-    hearing loss or ringing in your ears

-    palpitations

-    liver problems such as hepatitis

-    severe form of skin flushing

-    allergic skin reactions such as being sensitive to sunlight, red, flaking and swollen skin

-    general feeling ofbeing unwell (malaise)

-    weakness (asthenia)

If any of the side effects gets serious, or if you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.Your doctor may then decide to reduce your dose or stop treatment.

You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    Howto storeAzithromycin

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

-    Store below 25°C. Store in the original package.

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

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 contains

The active substance is azithromycin (as dihydrate).

Azithromycin 250 mg capsules contain azithromycin dihydrate equivalent to 250 mg of azithromycin.

The other ingredients are:

Cellulose microcrystalline (E460), Pregelatinised starch (maize), Magnesium stearate (E470b), Sodium laurilsulfate, gelatin, black ink (shellac, propylene glycol, black iron oxide, potassium hydroxide).

WhatAzithromycin looks like and contents of the pack

Azithromycin 250 mg Capsules consist of a white cap and white body, size “0” hard gelatin opaque capsuls, imprinted in black ink with “250” on cap and body, containing white to off white granular powder.

The capsules are available in blister packages of 2,4 or 6 capsules. Not all pack sizes may be marketed.

MarketingAuthorisation Holder and Manufacturer

Marketing Authorisation Holder:

Jubilant Pharmaceuticals nv Axxes Businesspark Guldensporenpark 22 - Block C 9820Merelbeke Belgium

Manufacturer:

PSI supply nv Axxes Businesspark Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

Marketing authorisation number: PL 19156/0138 This leaflet was last revised in 02/2015.