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ZITHROMAX 200MG/5ML SUSPENSION

Active substance(s): AZITHROMYCIN / AZITHROMYCIN DIHYDRATE

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Package leaflet: Information for the
patient

Zithromax® 200mg/5ml
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
200mg/5ml 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 microorganisms 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 childproof 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

Dose and duration

15-25kg bodyweight
(3-7 years):
(Between 2½ 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
5½ stones)

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

36-45kg bodyweight
(12-14 years):
(Between 5½ 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 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:
2.5ml

(100mg)

5ml

(200mg)

7.5ml

(300mg)

10ml

(400mg)

Small end
to
graduation
Small end
brimful
Large end
to
graduation
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.
• Serious skin reactions:
• blistering of the skin, mouth, eyes and
genitals (Stevens-Johnson Syndrome
(SJS))
• blistering of the skin, severe skin
reaction (Toxic Epidermal Necrosis
(TEN))
• 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
(Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS))
• skin eruption that is characterised by
the rapid appearance of areas of red
skin studded with small pustules
(small blisters filled with white/yellow
fluid) (Acute Generalized
Exanthematous Pustulosis (AGEP)).
Stop taking azithromycin if you develop these
skin symptoms and contact your doctor or
seek medical attention immediately.
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
• 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
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
• 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 or search
for MHRA Yellow Card in the Google Play or
Apple App Store. 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.
Do not store above 30°C.
Do not refrigerate.
Store in the original package.
Any remaining suspension should be
discarded after 5 days.
Do not take the suspension 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 discolored or
shows any sign of deterioration, seek the
advice of your pharmacist.
Remember if your doctor tells you to stop
taking this medicine, return any unused
medicine 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 is azithromycin.
15ml bottle: Each 5ml of suspension
contains 200mg azithromycin (as dihydrate).
30ml bottle: Each 10ml of suspension
contains 400mg azithromycin (as dihydrate).
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 a dry powder which
reconstitutes with water to give a
cherry/banana flavoured suspension with a
slight vanilla odour and comes in
15ml (600mg) and 30ml (1200mg) amber
glass bottles.
Each pack contains a multi-dosing spoon and
the 15ml pack contains an oral dosing
syringe with a bottle neck adaptor
Manufactured by: 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 the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Zithromax® 200mg/5ml Suspension;
PL 18799/2544
POM
Leaflet date: 14.12.2017
Zithromax is a registered trademark of Pfizer
lnc.

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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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