ZITHROMAX 200MG/5ML ORAL SUSPENSION

Active substance: AZITHROMYCIN

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S0087 LEAFLET Zithromax Suspension 20121220

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZITHROMAX 200mg/5ml ORAL SUSPENSION
AZITHROMYCIN 200mg/5ml ORAL SUSPENSION
(azithromycin)
Your medicine is known by one 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 FOR
Zithromax is one of a group of antibiotics called macrolides. It is used
to treat infections caused by certain bacteria and other microorganisms which include:

3. HOW TO TAKE ZITHROMAX
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:



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.

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

Filling the syringe with medicine



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

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.



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

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

2. BEFORE YOU TAKE ZITHROMAX
Do not take Zithromax if you/your child:

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:

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 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.



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)

4. The medicine will trickle into your child’s mouth.



antacids (for indigestion)



digoxin (used to treat heart failure)

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



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.

3. Slowly push down the plunger of the syringe: Do not squirt it out
quickly.
5. Allow your child some time to swallow the medicine.

7. 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):

Important information about some of the ingredients of Zithromax

(Between 2½ and 4 stones)

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

-

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



26-35kg bodyweight (8-11 years):
(Between 4 and 5½ stones)

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)

(Between 5½ and 7 stones)



allergic reactions of various severity

-



blistering of the skin, mouth, eyes and genitals



skin more sensitive to sunlight than normal

B. Instructions for the plastic spoon



feeling nervous

The spoon should not be used for children less than 3 years of age
(less than 2½ stones).



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





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

36-45kg bodyweight (12-14 years):
10ml (400mg), given as 1 x 10ml spoonful, once daily for 3
days.

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

5ml

(100mg)

(200mg)

swelling

Small end to graduation



general discomfort

Small end brimful

 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:


7.5ml

(300mg)

Large end to graduation

10ml

(400mg)

Large end brimful

agitation



vertigo

 changes in liver function
Other side effects that have been reported, but it is not known
how frequently they occur:

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



fits or fainting

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



aggression or anxiety



feeling hyperactive

4. Allow the patient to swallow the medicine slowly.



localised muscle weakness

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.



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

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.

yellowing of the skin or eyes (jaundice) or liver failure (rarely lifethreatening)



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.

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 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 ZITHROMAX

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store below 30°C. Discard unused suspension after 5 days.

4. POSSIBLE SIDE EFFECTS



Do not use after the expiry date printed on the carton label or
bottle.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the medicine if
your doctor tells you to.



If the medicine becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.

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

6. FURTHER INFORMATION



severe skin rash causing redness and flaking





rapid or irregular heartbeat



low blood pressure

When prepared correctly, the medicine contains 200mg of the
active ingredient, azithromycin (as the dihydrate), per 5ml of
suspension and 3.87g of sucrose per 5ml of suspension.



Zithromax Oral Suspension also contains the following inactive
ingredients: hydroxypropylcellulose, sodium phosphate tribasic
anhydrous, sucrose, xanthan gum and flavourings: artificial
banana, artificial cherry and artificial creme de vanilla.

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)

What Zithromax contains

What Zithromax looks like and contents of the pack
It is available as a powder which is prepared as a suspension by a
pharmacist.
Zithromax Oral Suspension are available in 2 pack sizes containing
600mg and 900mg of azithromycin (as the dihydrate) which are
reconstituted as 15ml and 22.5ml of oral suspension respectively. The
packs contain a plastic bottle containing the powder, a measuring cup,
a plastic oral syringe with adapter and a plastic spoon.



dizziness, headache



numbness or pins and needles



being sick, indigestion



loss of appetite, taste disturbance



visual disturbances, deafness



Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Wembley, HA0 1DX.

skin rash and /or itching



Manufacturer

joint pain



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

This product is manufactured by Pfizer Italiana SpA, Strada Statale
No.156 km50, 04100 Latina, Italy.



low blood bicarbonate

Leaflet revision date: 20 December 2012



tiredness or weakness

Zithromax is a registered trade mark of Pfizer Inc, USA.

Product Licence holder

POM

PL No: 19488/0087

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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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