Document: document 1 change

• document 0
• document 1

---

S0387-30-SP-PIL-08.06.2015

PATIENT INFORMATION LEAFLET

Zithromax™ 200mg in 5ml Suspension (Azithromycin)

Your medicine is available by the above name, but will be referred to as Zithromax throughout the remainder of this leaflet.

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 possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Zithromax is and what it is used for

2.    What you need to know before you take Zithromax

3.    How to take Zithromax

4.    Possible side effects

5.    How to store Zithromax

6.    Contents of the pack and other information

1.    What Zithromax is and what it is used for

This medicine contains azithromycin, which 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)

•    sexually-transmitted diseases caused by organisms called Chlamydia trachomatis or Neisseria gonorrhoea.

You must talk to a doctor if you do not feel better or if you feel worse.

2.    What you need to know before you take Zithromax Do not take Zithromax:

•    if you/your child are allergic to Zithromax 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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Zithromax if you/your child have or have had any of the following:

•    kidney problems

•    heart conditions

•    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 Zithromax.

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 Zithromax.

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 Zithromax

Tell your doctor or pharmacist if you/your child are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

In particular, Zithromax may interact with the medicines listed below:

•    ergot or ergotamine, see ‘Warnings and precautions' section

•    warfarin or any similar medicine to prevent blood clots

•    ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow)

•    antacids (for indigestion)

•    digoxin (used to treat heart failure)

•    terfenadine (for hay fever or a skin allergy)

Zithromax with food and drink

Zithromax is not affected by food or drink.

Pregnancy, breast-feeding and fertility

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

Zithromax is not expected to affect your ability to drive or use machines.

Zithromax contains sucrose, a type of sugar (3.87g in 5ml). If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking Zithromax. If you are diabetic, you may need to take this into account in your diet.

3. How to take Zithromax

Always take or give Zithromax exactly as your doctor has told you.

Check with your doctor or pharmacist if you are not sure.

The pharmacist should have advised you to measure the medicine using the oral dosing syringe.

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

Children under 45 kg

The usual dose in children is 10 mg for each kg of bodyweight, given as a single daily dose for 3 days.

Adults and children over 45 kg

The usual dose in adults and in children over 7 stones (45 kg) is 500 mg taken as a single dose, for 3 days. For some diseases such as Chlamydia the dose is 1g daily taken as a single dose. For gonorrhoea the recommended dose is 1 g or 2 g of azithromycin in combination with 250 or 500 mg of ceftriaxone.

You should tell your doctor if you/your child have kidney or liver problems as your doctor may need to alter the normal dose.

Doctors sometimes prescribe different doses to these. The label on the pack will tell you which dose you/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/your child 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.

How to give Zithromax Suspension in children less than 3 years of age

If your child is under three years of age or weighs up to 15kg in bodyweight, 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.

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

3.    Check the dispensing label attached by your pharmacist to see how much medicine needs to be taken.

4.    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.

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

6.    Slowly pull back the plunger of the syringe so that the top edge is level with the graduation mark corresponding to the quantity in the millilitres (ml) prescribed by your doctor.

7.    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 6 again.

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

9.    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 5 ml 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/your child takes more Zithromax than they should

If you/your child take too much Zithromax 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 or give Zithromax

If you forget to take Zithromax 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 Zithromax

If you/your child stop taking Zithromax too soon, the infection may return. Take Zithromax for the full time of treatment, even when you/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, Zithromax 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 Zithromax 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 Zithromax 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 (may affect more than 1 in 10 people):

•    stomach cramps, feeling sick, diarrhoea, wind

Common side effects (may affect up to 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

•    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 (may affect up to 1 in 1,000 people):

•    agitation

•    vertigo

•    changes in liver function

Other side effects that have been reported, but frequency cannot be estimated from the available data:

•    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 (ECG)

•    reduction in red blood cells which can make the skin pale and cause weakness or breathlessness.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Zithromax

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

•    Do not take or give this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

•    Any unused medicine should be discarded after 5 days.

•    Do not store above 30°C.

•    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.    Contents of the pack and other information What Zithromax contains

•    Each 10ml of suspension contains 400mg azithromycin as azithromycin dihydrate.

•    Other ingredients are sucrose, hydroxypropylcellulose, xanthum gum, tribasic sodium phosphate anhydrous, banana flavour artificial, cherry flavour artificial and creme de vanilla flavour.

What Zithromax looks like and contents of the pack

•    Zithromax is a white to off white powder (for the preparation of 30ml suspension) with a cherry/ banana flavour with a slight vanilla odour.

•    Each pack contains an amber glass bottle with a white metal screw cap with tamper evident seal. The carton also contains 10ml oral plastic syringe with detachable adaptor.

•    Zithromax comes in 30ml (1200mg) suspension.

Manufacturer:

Farmasierra Manufacturing S.L., Ctra. N-1, Km 26,200. 28700 San

Sebastian de los Reyes, Madrid, Spain.

Procured from within the EU and repackaged by: Amimed Direct Ltd, Hendon, London, NW9 6AQ.

Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.

PL No: 33902/0387

This leaflet was last approved: 08/06/2015

Uncommon side effects (may affect up to 1 in 100 people):    ^Zithr°^max™ ^{is a re}g^{istered trademark} °^{f Pfizer products} he.

•    yeast infections of the mouth and vagina (thrush)    S0387-30-SP-PIL-08 06 2015

•    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