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ZITHROMAX 200MG IN 5ML SUSPENSION

Active substance(s): AZITHROMYCIN / AZITHROMYCIN DIHYDRATE

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Package leaflet: Information for the patient
UNITED KINGDOM

ZITHROMAX

®

200 mg in 5 ml
Suspension
azithromycin

1. W
 hat 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. W
 hat you need to know before you
take Zithromax



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

Do not take Zithromax:
• if you/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.
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
• myasthenia gravis (a condition that causes certain muscles
to become weak)
• or 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.

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
Please refer to section 3.
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 suspension contains sucrose, a type of sugar (3.87 g in
5 ml). If you have been told by your doctor that you have an intolerance
to some sugars contact your doctor before taking this medicine. If you
are diabetic, you may need to take this into account in your diet. May
be harmful to the teeth.

3. How to take Zithromax
Always take or give this medicine exactly as your doctor has told you.
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
(15 ml pack only).
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.
Zithromax suspension is not affected by food or drink.
Children under 45 kg
The recommended 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 recommended 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 recommended dose is 1 g 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 the recommended
dose. 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 15 kg in
bodyweight, you should measure the dose as clearly as possible using
the 10 ml oral dosing syringe provided. The syringe is graduated in
0.25 ml divisions, providing 10 mg 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.

You will find more about ZITHROMAX
on the back of this leaflet

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
15-25 kg bodyweight (3-7 years): 5 ml (200 mg), given as 1 x 5 ml
(Between 2½ and 4 stones)
spoonful, once daily for 3 days.
26-35 kg bodyweight (8-11 years): 7.5 ml (300 mg), given as
(Between 4 and 5½ stones)
1 x 7.5 ml spoonful, once daily
for 3 days.
36-45 kg bodyweight
10 ml (400 mg), given as
(12-14 years): (Between 5½ and 1 x 10 ml spoonful, once daily
7 stones)
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 2½ 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:
2.5 ml (100 mg)
Small end

to graduation
5 ml (200 mg)


Small end
brimful

7.5 ml (300 mg)


Large end
to graduation

10 ml (400 mg)


Large end
brimful

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 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.
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: may affect more than 1 in 10 people
• stomach cramps, feeling sick, diarrhoea, wind.
Common: 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 (a type of white blood cell), higher
number of eosinophils (type of white blood cells)
• low blood bicarbonate
• tiredness or weakness.
Uncommon: may affect up to 1 in 100 people
• yeast infections of the mouth and vagina (thrush)
• low numbers of leukocytes (a type of white blood cell), low number
of neutrophils (a type of white blood cell)
• 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: may affect up to 1 in 1,000 people
• agitation
• vertigo
• changes in liver function
Very rare: may affect up to 1 in 10,000 people
• skin rash accompanied by other symptoms such as fever, swollen
glands and an increase of eosinophils (a type of white blood cell). A
rash appears as small, itchy red bumps.
Not known: 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 (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.

United Kingdom
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

5. How to store Zithromax
Keep this medicine 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 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 5 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 protect the environment.

6. C
 ontents of the pack and other
information
What Zithromax contains
The active substance is azithromycin (200 mg in 5 ml).
Other ingredients are sucrose (3.87 g per 5 ml) (see section 2, Zithromax
contains sucrose) hydroxypropylcellulose, sodium phosphate tribasic
anhydrous, xanthan gum and flavourings: artificial banana, artificial cherry
and artificial creme de vanilla.
What Zithromax looks like and contents of the pack
Zithromax Suspension is a dry powder which reconstitutes with water to
give a cherry/banana flavoured suspension with a slight vanilla odour and
comes in the following sizes: 15 ml (600 mg), 22.5 ml (900 mg), 30 ml
(1200 mg) and 37.5 ml (1500 mg) bottles.
Each pack contains a multi-dosing spoon and the 15 ml size contains an
oral dosing syringe.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Ltd.
Ramsgate Rd.
Sandwich
Kent
CT13 9NJ
United Kingdom.
Manufacturer
Haupt Pharma Latina S.r.l.
SS 156 Km 47,600
04100, Borgo San Michele
Latina
Italy
Company Contact Address
For further information on this medicine, please contact Medical
Information at Pfizer Limited, Walton Oaks, Tadworth, Surrey,
Tel: 01304 616161
This leaflet was last revised in: 11/2015
ZX POS 15_2 UK
51730931new

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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