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Project : Azithromycin 250mg & 500mg film coated tablets PIL ID: ROW (Jubilant) - Version 15

Version created: 21/10/10, 09/11/10, 02/12/10, 07/12/10, 08/12/10,

20/02/12(new text), 29/3/12, 11/04/12, 8/08/12, 18/3/13, 21/08/13,

11/12/13(created from scratch), 12/12/13, 19/12/13, 23/12/13,

18/03/14, 14/10/14

Size: 240 x 420 mm PORTRAIT

Text area : 230 x 350 mm (Front-Back) PORTRAIT

Client : Jubilant Life Sciences Ltd.

Company contact: Johanna Soenens

Artwork No.: -

Colour: Black

Media: pdf version

Font used: 9 pt.Times New Roman

Main Title: 14 pt. Times New Roman

Section Headings: 9 pt. Times New Roman

Leading (space between lines of body copy 3.5mm)

Barcode / Pharma code and information boxes 60 x 32mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Azithromycin 250 mg Film-coated tablets Azithromycin 500 mg Film-coated tablets

(azithromycin)

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.

-    Ifyouhave any further questions, askyour doctor orpharmacist.

-    This medicine has been prescribed for you only. Do not pass it onto 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.    WhatAzithromycinis and what it is used for

2.    What you need to know before you useAzithromycin

3.    How to take Azithromycin

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 infections such as acute exacerbation of chronic bronchitis (adequately diagnosed) and pneumonia

-    infections in your sinus, throat, tonsil 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 bacteria called 'Chlamydia trachomatis'. They can cause inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix)

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)

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

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 taking Azithromycin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin 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-apainkillerusede.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

This medicine can 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.

Azithromycin is not recommended if you 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.

Azithromycin contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to takeAzithromycin

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

Taking this medicine

-    Swallow the tablets whole with a glass of water.

-    Do not crush or chew the tablets.

-    The 500 mg tablet can be divided into equal halves.

How much to take

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

The usual total dose is 1500 mg. This can be taken in two ways. Your doctor will tell you which way to take it:

-    Over three days: one 500 mg tablet each day. or

-    Over five days: one 500 mg tablet on day 1 and then one 250 mg tablet on days 2,3,4 and 5.

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.

Children and adolescents under 45 kg:

The tablets are not recommended. 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 if you have kidney or liver problems as your doctor may need to alter the normal dose.

If you 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

If you forget to takeAzithromycin

-    If you 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

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

If you stop takingAzithromycin

Do not stop taking Azithromycin without talking to your doctor.

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, althoughnot everybody gets them.

Stop taking Azithromycin and see a doctor straight away if you 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 'erythemamultiforme'.

Other side effects include:

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

-    diarrhoea

Common (may affect up to 1 in 10people)

-    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 (may affect up to 1 in 100people)

- 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)

-    runnynose, sneezing (rhinitis)

- reduction in the number of white blood cells

-    hypersensitivity

-    anorexia

-    nervousness

-    having difficulty sleeping (insomnia)

-    feeling dizzy

-    feeling drowsy (somnolence)

- sensation of pins andneedles ornumbness (paraesthesia)

-    changes in your sense oftaste and smell (dysgeusia)

-    visual impairment

-    ear disorder

-    palpitations

-    hot flush

- shortness of breath

-    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

-    chestpain

-    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 (may affect up to 1 in 1,000people)

-    feeling agitated

-    abnormal hepatic function

-    jaundice cholestatic

-    allergic skinreactions

-    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 in your sense oftaste (ageusia)

- exacerbation or aggravation of myasthenia gravis

-    hearinglossorringinginyourears

-    rapid or irregular heart beat, sometimes being life-threatening, changes of the heart rhythm found by an electro-cardiogram

-    lowbloodpressure

- inflammation of the pancreas (pancreatitis)

- your tongue changes colour

- inflammation of the liver

-    allergic skinreactions

-    joint pain

-    kidneyproblems

- disturbances in heart rhythm called QT prolongation

The following side effects have been reported in prophylactic treatment against Mycobacterium Avium 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 of appetite (anorexia)

-    feeling dizzy

-    headache

-    sensation of pins andneedles ornumbness (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)

-    hearinglossorringinginyourears

-    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.    How to storeAzithromycin

-    Keep this medicine out ofthe sight andreach of children.

-    This medicinal product does not require any special storage conditions.

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 Film-coated tablets contain azithromycin dihydrate equivalent to 250 mg of azithromycin.

Azithromycin 500 mg Film-coated tablets contain azithromycin dihydrate equivalent to 500 mg of azithromycin.

The other ingredients are:

Tablet core:

calcium hydrogen phosphate anhydrous, hypromellose (E464), croscarmellose sodium, magnesium stearate (E470b), pregelatinised maize starch, sodium laurilsulfate.

Tablet coat:

hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin. WhatAzithromycin looks like and contents ofthe pack

Azithromycin 250 mg Film-coated tablets are white to off-white, capsule shaped, film-coated tablets debossed with 'AZ' and '250' on one side and plain on other side ofthe tablets.

The film-coated tablets are available in blister packages of 3, 4 or 6 tablets. Not all pack sizes may be marketed.

Azithromycin 500 mg Film-coated tablets are white to off-white, capsule shaped, film-coated tablets, debossed with 'AZ' and '500' on either side of scoreline on one side and plain on other side ofthe tablets.

The film-coated tablets are available in blister packages of 2, 3,6 or 30 tablets. Not all pack sizes may be marketed.

MarketingAuthorisation Holder and Manufacturer

Azithromycin 250 mg

Marketing Authorisation Holder: Jubilant Pharmaceuticals nv Axxes Businesspark Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

Azithromycin 500 mg

Marketing Authorisation Holder: Jubilant Pharmaceuticals nv Axxes Businesspark Guldensporenpark 22 - Block C 9820 Merelbeke Belgium

This medicinal product is authorised in the Member States of the EEA under the following names:

Azithromycin 250 mg

The Netherlands: Azitromycine Jubilant 250 mg filmomhulde tabletten Belgium:    Azithromed 250 mg filmomhulde tabletten

Germany:    Azithromycin    Jubilant 250 mg Filmtabletten

United Kingdom: Azithromycin 250 mg film-coated tablets Sweden:    Azithromycin    Jubilant, 250mg, FilmdrageradeTabletter

Denmark:    Azithromycin    Jubilant

Lithuania:    Azithromycin    Jubilant, 250 mg, plevele dengtos tabletes

Latvia:    Azithromycin    Jubilant 250 mg apvalkotas tabletes

Azithromycin 500 mg

The Netherlands: Azitromycine Jubilant 500 mg filmomhulde tabletten Belgium:    Azithromed 500 mg filmomhulde tabletten

Germany:    Azithromycin Jubilant 500 mg Filmtabletten

Slovakia:    Zigilex 500 mg Filmom obalenatableta

Spain:    AzitromicinaApotex500mgcomprimidosrecubiertosconpeliculaEFG

United Kingdom: Azithromycin 500 mg film-coated tablets Sweden:    Azithromycin Jubilant, 500mg, FilmdrageradeTabletter

Denmark:    Azithromycin Jubilant

Lithuania:    Azithromycin Jubilant, 500 mg, plevele dengtos tabletes

Latvia:    Azithromycin Jubilant 500 mg apvalkotas tabletes

This leaflet was last revised in 10/2014