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PACKAGE LEAFLET: INFORMATION FOR THE USER Azithromycin 200mg/5ml Powder for Oral Suspension

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 side effects not listed in this leaflet.

The name of your medicine is Azithromycin 200mg/5ml Powder for Oral Suspension. In the rest of this leaflet it is called Azithromycin Suspension.

In this leaflet:

1.    What Azithromycin Suspension is and what it is used for

2.    What you need to know before you take Azithromycin Suspension

3.    How to take Azithromycin Suspension

4.    Possible side effects

5.    How to store Azithromycin Suspension

6.    Contents of the pack and other information

1. WHAT AZITHROMYCIN SUSPENSION IS AND WHAT IT IS USED FOR

Azithromycin is one of a group of antibiotics called macrolides. It is used to treat infections caused by certain bacteria and other micro-organisms which 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)

•    urethritis and cervicitis (sexually-transmitted diseases caused by an organism called chlamydia).

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

Do not take Azithromycin Suspension if you or your child:

•    are allergic to azithromycin or any other macrolide antibiotic such as erythromycin or clarithromycin or any of the ingredients listed in section 6. An allergic reaction may cause skin rash or wheezing

•    are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with azithromycin.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Azithromycin Suspension. Tell your doctor if you or your child have or have had any of the following:

•    kidney problems

•    heart conditions, in particular problems with heart beat such as long QT syndrome (shown on an electro-cardiogram or ECG trace)

•    your blood levels of potassium or magnesium are too low

•    diabetes

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

•    and if you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with azithromycin.

Tell your doctor immediately if you feel your heart beating in your chest or have an abnormal heartbeat, or get dizzy or faint or suffer from any muscle weakness when taking Azithromycin Suspension.

If you develop diarrhoea or loose stools during or after treatment, tell your doctor at once. Do not take any medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues, please inform your doctor.

Other medicines and Azithromycin Suspension

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

Tell your doctor or pharmacist if you or your child 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 asthis 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

•    astemizol - used to treat hay fever

•    pimozide - used to treat mental health problems.

You should always tell your doctor if you or your child are taking or have recently taken any other medicines including those obtained without a prescription.

Azithromycin Suspension with food and drink

Azithromycin Suspension it not affected by food or drink.

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.

Driving and using machines

Side effects such as dizziness, which can affect the ability to drive or use machines can occur with Azithromycin Suspension.

Azithromycin Suspension contains sucrose, ethanol and aspartame (E951)

This medicine contains sucrose, a type of sugar (3.82g in 5ml). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. If you are diabetic, you may need to take this into account in your diet.

This medicine contains small amounts of ethanol (alcohol), less than 100mg per dose.

This medicine contains a source of phenylalanine (aspartame, E951). May be harmful to people with phenylketonuria.

3. HOW TO TAKE AZITHROMYCIN SUSPENSION

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

Azithromycin Suspension is generally used for children under 7 stones (45kg). It may also be used in adults and older children who have difficulty swallowing capsules.

Children under 45kg

The usual dose in children is 10mg for each kg of bodyweight, given as a single daily dose for three days.

Adults and children over 45kg

The usual dose in adults and in children over 7 stones (45kg) is 500mg taken as a single dose, for three days. For some diseases such as Chlamydia the dose is 1g daily taken as a single dose.

Children less than three years of age or weighs up to 15kg

Doctors sometimes prescribe different doses to these. The label on the pack will tell you which dose you or your child should take. If you are still not sure, ask your doctor or pharmacist.

Always continue with the course of treatment even if you or your child feels 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.

You should measure the dose as clearly as possible using the 10ml oral dosing syringe provided. The syringe is graduated in 0.25ml divisions, providing 10mg of azithromycin (the active ingredient) in every graduation.

- Instructions for the syringe

Filling the syringe with medicine

1.    Shake the bottle before use and remove the child-proof cap.

2.    An adaptor for the syringe should have been fitted into the neck of the bottle of medicine by the pharmacist. If this has not been done, take off the adaptor from the syringe and fit

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to the neck of the bottle as shown. The adaptor is so that you can fill the syringe with medicine from the bottle.

3.    While the bottle is sitting on a firm, flat surface, hold it steady with one hand. With the other hand insert the tip of the syringe into the adaptor.

4.    Turn the bottle upside down while holding the syringe in place.

5.    Slowly pull back the plunger of the syringe so that the top edge is level with the line on the syringe, for the required dose.

6.    if large bubbles can be seen in the syringe, slowly push the plunger back into the syringe. This will force the medicine back into the bottle. Repeat step 5 again.

7.    Hold the syringe and bottle firmly. Turn the bottle upright, with the syringe still in place.

8.    Remove syringe from bottle.

Giving the medicine using the syringe

1.    Make sure your child is supported in an upright position.

2.    Put the tip of the syringe carefully into your child's mouth. Point the tip of the syringe towards the inside of your child's cheek.

3.    Slowly push down the plunger of the syringe: Do not squirt it out quickly. The medicine will trickle into your child's mouth.

4.    Allow your child some time to swallow the medicine.

5.    Replace the child-proof cap on the bottle. Wash the syringe as instructed below.

6.    Where daily doses of less than 5ml have been given for three days, some suspension will remain in the bottle. This remaining suspension should be discarded.

Cleaning and storing the syringe

1.    Pull the plunger out of the syringe and wash both parts by holding under warm running water or by immersing in sterilising solution used for baby's feeding bottles, etc.

2.    Dry the two parts. Push the plunger back into the syringe. Keep it in a clean safe place with the medicine. After you have given your child the final dose of medicine, wrap the syringe in a sheet of newspaper and put it in the rubbish bin.

Warning: if giving this medicine to a child, ensure that while receiving the medicine he/she is supported in an upright position to avoid the risk of choking.

If you take more Azithromycin Suspension than you should

If you or your child take too much Azithromycin Suspension they may feel unwell. Tell your doctor or contact your nearest hospital casualty department immediately. Take any remaining medicine with you.

If you forget to take Azithromycin Suspension

If you forget to take Azithromycin Suspension take it as soon as you can. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Azithromycin Suspension

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

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

4. POSSIBLE SIDE EFFECTS

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

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine as the symptoms can be severe:

•    sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)

•    severe or prolonged diarrhoea, which may have blood or mucus in it, during or after treatment with Azithromycin Suspension as this may be a sign of serious bowel inflammation

•    severe skin rash causing redness and flaking

•    rapid or irregular heartbeat

•    low blood pressure

The most common side effects that occur when taking Azithromycin Suspension are listed below. These may go away during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue to bother you:

Very common side effects (occurring in at least 1 in 10 people):

•    stomach cramps, feeling sick, diarrhoea, wind.

Common side effects (likely to occur in less than 1 in 10 people):

•    dizziness, headache

•    numbness or pins and needles

•    being sick, indigestion

•    loss of appetite, taste disturbance

•    visual disturbances, deafness

•    skin rash and /or itching

•    joint pain

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

•    low blood bicarbonate

•    tiredness or weakness.

Uncommon side effects that occur in less than 1 in 100 people are:

•    yeast infections of the mouth and vagina (thrush)

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

•    allergic reactions of various severity

•    blistering of the skin, mouth, eyes and genitals

•    skin more sensitive to sunlight than normal

•    feeling nervous

•    reduced sense of touch or sensation (hypoesthesia)

•    sleepiness or sleeplessness (insomnia)

•    poor hearing or ringing in the ears

•    heart palpitations, chest pain

•    constipation, stomach pain associated with diarrhoea and fever

•    inflammation of the liver (hepatitis), changes in liver enzymes

•    general loss of strength

•    swelling

•    general discomfort

•    abnormal laboratory test values (e.g. blood or liver tests).

Rare side effects that occur in less than 1 in 1,000 people are:

•    agitation

•    vertigo

•    changes in liver function.

Other side effects that have been reported, but it is not known how frequently they occur:

•    fits or fainting

•    aggression or anxiety

•    feeling hyperactive

•    localised muscle weakness

•    loss of smell or altered sense of smell, loss of taste

•    tongue discolouration

•    inflammation of the pancreas (pancreatitis)

•    inflammation of the kidney or kidney failure

•    yellowing of the skin or eyes (jaundice) or liver failure (rarely life-threatening)

•    bruising or prolonged bleeding after injury

•    blistering of the skin, severe skin reaction

•    abnormal electrocardiogram (EEG).

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 SUSPENSION

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 bottle and outer packaging after {EXP}. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Any unused medicine should be discarded after 10 days.

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

What Azithromycin Suspension contains

The active substance is azithromycin (200mg in 5ml).

The other ingredients are sucrose, hydroxypropylcellulose (E463), trisodium phosphate anhydrous (E339), xanthan gum (E415), sucralose (E955), colloidal anhydrous silica (E551), cherry flavour 501027 AP0551, banana flavour 501013 AP0551, masking flavour 501482 TP0424, banana durarome flavour 501392 TDI0991.

What Azithromycin Suspension looks like and contents of the pack

Azithromycin Suspension comes in a 60ml bottle in three sizes: 15ml (600mg), 22.5ml (900mg) and 30ml (1200mg). Each pack contains contains an oral dosing syringe. Azithromycin Suspension is a white to yellowish off-white mottled powder, which after reconstitution forms an off-white to buff coloured cherry flavoured suspension.

Marketing Authorisation Holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Manufacturer

CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only).

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

UK and Ireland: Azithromycin 200mg/5ml Powder for Oral Suspension

Leaflet Revised: 03/2013.

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