PATIENT INFORMATION LEAFLET 3. How to take Zithromax

Zithromax® 200 mg/5 ml Suspension Azithromycin 200 mg/5 ml Suspension

(azithromycin)

This product is available using any of the above names but will be referred to as Zithromax throughout the following leaflet.

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.

In this leaflet:

1.    What Zithromax is and what it is used for

2.    Before you take Zithromax

3.    How to take Zithromax

4.    Possible side effects

5.    How to store Zithromax

6.    Further information

1. What Zithromax is and what it is used fo

Zithromax 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 an organism called chlamydia.

2. 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

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

Take special care with Zithromax

Your doctor needs to know before you take 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.

Taking other medicines

Tell your doctor before taking or giving Zithromax if you/your child are taking any of the medicines listed below:

■    ergot or ergotamine, see ‘Take special care' 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)

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

Taking Zithromax with food and drink

Zithromax is not affected by food or drink.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or are breast-feeding you should not take Zithromax without discussing it with your doctor first.

Driving and using machines

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

Important information about some of the ingredients of Zithromax

This medicine 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.

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

The pharmacist should have advised you whether to measure the medicine using the multi-dosing spoon or the oral dosing syringe (15ml pack only).

Zithromax 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 3 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 3 days. For some diseases such as Chlamydia the dose is 1g daily taken as a single dose.

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 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.

How to give Zithromax Suspension in children between 3 and 14 years of age

Bodyweight and age Dose and duration

■    15-25kg bodyweight (3-7 years):

(Between 2¹/2 and 4 stones)

-    5ml (200mg), given as 1 x 5ml spoonful, once daily for 3 days.

■    26-35kg bodyweight (8-11 years):

(Between 4 and 5¹/2 stones)

-    7.5ml (300mg), given as 1 x 7.5ml spoonful, once daily for 3 days.

■    36-45kg bodyweight (12-14 years):

(Between 5¹/2 and 7 stones)

-    10ml (400mg), given as 1 x 10ml spoonful, once daily for 3 days.

B. Instructions for the plastic spoon

The spoon should not be used for children less than 3 years of age (less than 2^ stones).

- Giving the medicine using the spoon

1. A plastic double-ended spoon is provided with the medicine. Check which end of the spoon and to which level gives you your required dose. If you are unsure, check with your doctor or pharmacist.

This multi-dosing spoon delivers doses as follows:

2.5ml	(100mg)	Small end to graduation	I2| ^
5ml	(200mg)	Small end brimful
7.5ml	(300mg)	Large end to graduation
10ml	(400mg)	Large end brimful	J?1

2.    Shake the bottle well and then remove the child-proof cap.

3.    Gently pour the medicine into the spoon as required to give the correct dose.

4.    Allow the patient to swallow the medicine slowly.

5.    Wash the spoon under warm, running water. Dry and store it with the medicine in a safe place.

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

■    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 taking Zithromax 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 taking Zithromax 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 (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, pharmacist or nurse. 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.

■    Do not store above 30°C. Do not refrigerate. Store in the original container.

■    Any unused medicine should be discarded after 5 days.

■    If your medicine become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.

■    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.

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 (occurring in at least 1 in 10 people taking Zithromax)

■    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

What Zithromax contains

Each 5ml of suspension contains 200mg azithromycin (as dihydrate).

Other ingredients are sucrose, sodium phosphate tribasic anhydrous, hydroxypropylcellulose, xanthan gum, cherry flavour artificial, banana flavour artificial and vanilla flavour artificial.

What Zithromax looks like and contents of the pack

Zithromax is available as a cherry and banana flavour white powder in an amber glass bottle with a tamper evident metal screw cap. Pack also contains 10 ml oral dosing syringe with detachable adaptor and double-ended multi-dosing plastic spoon.

Zithromax suspension is available as a powder for reconstitution as 15ml and 30ml of suspension.

PL No: 15814/1094

This product is manufactured by Farmasierra Manufacturing S.L., Madrid, Spain. Procured from within the EU and repackaged by the PL holder: O.P.D. Laboratories Ltd., Watford, Herts WD24 4PR.

Leaflet revision and issue date (Ref.): 23.07.2014.

Zithromax and Zitromax are registered trademarks of Pfizer Products Inc., USA.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.