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ZITHROMAX 200 MG/5 ML SUSPENSION

Active substance(s): AZITHROMYCIN

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Package leaflet: Information for the patient

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 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

Zithromax 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 Zithromax. If you are diabetic, you may need to take this into account in your
diet.
3. How to take Zithromax
Always take or give Zithromax 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 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. 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.

1. What Zithromax is and what it is used for

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.

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:

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





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.

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.

You must talk to a doctor if you do not feel better or if you feel worse.

A. Instructions for the syringe

2. What you need to know before you take Zithromax

Filling the syringe with medicine

Do not take Zithromax:

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.



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

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
 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.

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.

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.

8. Hold the syringe and bottle firmly. Turn the bottle upright, with
the syringe still in place.

Other medicines and Zithromax

9. Remove syringe from bottle.

Tell your doctor or pharmacist if you/your child are taking, have recently taken or might
take any other medicines, including medicines obtained without a prescription.

Giving the medicine using the syringe
1. Make sure your child is supported in an upright position.

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)

4. Allow your child some time to swallow the medicine.

Zithromax with food and drink

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

Zithromax is not affected by food or drink.

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.

Pregnancy, breast-feeding and fertility

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.

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.

Cleaning and storing the syringe

Driving and using machines

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.

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

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 2½ and 4 stones)

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.

26-35kg bodyweight (8-11 years):
(Between 4 and 5½ stones)
36-45kg bodyweight (12-14 years):
(Between 5½ and 7 stones)

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

5ml

2.
3.
4.
5.

(100mg)

(200mg)

Small end
to graduation
Small end
brimful

7.5ml

(300mg)

Large end
to graduation

10ml

(400mg)

Large end
brimful

Shake the bottle well and then remove the child-proof cap.
Gently pour the medicine into the spoon as required to give the correct dose.
Allow the patient to swallow the medicine slowly.
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.
4. Possible side effects
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 (may affect more than 1 in 10 people):


stomach cramps, feeling sick, diarrhoea, wind

Common side effects (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 (type of white blood cells), higher number of
eosinophils (type of white blood cells)
low blood bicarbonate
tiredness or weakness

Uncommon side effects (may affect up to 1 in 100 people):
 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 (may affect up to 1 in 1,000 people):




agitation
vertigo
changes in liver function

Other side effects that have been reported, but 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 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.
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.

6. Contents of the pack and other information
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.
POM

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.): 20.05.2015.
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.

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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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