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ZITHROMAX SUSPENSION

Active substance(s): AZITHROMYCIN / AZITHROMYCIN DIHYDRATE

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Package leaflet: Information for the patient

®

Zithromax Suspension
(azithromycin)
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.
The name of your medicine is Zithromax
Suspension but will be referred to as Zithromax
throughout this leaflet.
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 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 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 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 (15ml pack only).
Zithromax is generally used for children under 7
stones (45Kg). 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 45Kg
The recommended 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 recommended 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 recommended dose is 1g daily
taken as a single dose. For gonorrhoea the
recommended dose is 1g or 2g of azithromycin in
combination with 250 or 500mg 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 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 in children between 3
and 14 years of age
Bodyweight and
age
15-25Kg bodyweight
(3-7 years):
(Between 2½ and 4
stones)
26-35Kg bodyweight
(8-11 years):
(Between 4 and 5½
stones)
36-45Kg bodyweight
(12-14 years):
(Between 5½ and 7
stones)

Dose and duration
5ml (200mg), given as
1 x 5ml spoonful,
once daily for 3 days.
7.5ml (300mg), given
as 1 x 7.5ml spoonful,
once daily for 3 days.
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 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:

(100mg)

Small end
to
graduation

5ml

(200mg)

Small end
brimful

7.5ml

(300mg)

Large end
to
graduation

2.5ml

10ml

(400mg)

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,
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 out of the sight and reach of children.
Zithromax should not be stored in a refrigerator.
Do not store above 30°C.
Do not use after the expiry date which is stated on
the carton and bottle label after ‘Exp’. The expiry
date refers to the last day of that month.
If the suspension becomes discoloured or show
any signs of deterioration, seek the advice of your
pharmacist.
If your doctor tells you to stop taking this medicine,
return any remaining suspension to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
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
The active ingredient in Zithromax is azithromycin
(as azithromycin dihydrate). Each 5ml of off-white,
suspension contains 200mg of azithromycin.
The other ingredients are sucrose, hydroxypropyl
cellulose, sodium phosphate tribasic anhydrous,
xanthan gum and cherry, banana and crème de
vanilla artificial flavouring.
What Zithromax looks like and contents of the
pack
Zithromax is an off-white suspension with a cherry
and banana flavour and a slight vanilla odour.
Zithromax is available as a powder for
reconstitution as 15ml, 30ml and 37.5ml of
suspension, in an amber glass bottle.
The 15ml pack also contains an oral dosing syringe
and bottle neck adaptor.
Manufactured by: Farmasierra S.A., 28700 San
Sebastián de los Reyes, Madrid, Spain.
Procured from within the EU and repackaged
by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
POM
Zithromax® Suspension PL 18799/2544
Leaflet date: 22.09.2016

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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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