Skip to Content

ZITHROMAX SUSPENSION

Active substance(s): AZITHROMYCIN / AZITHROMYCIN DIHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript





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 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.
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
• Once reconstituted with water, Zithromax has a
shelf-life of 5 days.
• Do not use this medicine after the expiry date
shown on the carton label or bottle label. 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.
• If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Zithromax contains
Each 5ml of suspension contains 200mg
azithromycin as azithromycin dihydrate.
Zithromax contains 3.87g of sucrose per 5ml.
Your medicine also contains the following inactive
ingredients: Hydroxypropylcellulose, sodium
phosphate, sucrose, xanthan gum, banana flavour,
cherry flavour and vanilla flavour.
What Zithromax looks like and contents of the
pack
Zithromax is light coloured, dry powder which
reconstitutes with water to give a cherry/banana
flavoured suspension with a slight vanilla odour.
Zithromax are available in bottles of 15ml or 30ml.
Manufacturer and Licence Holder
Zithromax is manufactured by Haupt Pharma Latina
S.r.I, Strada Statale,156 Km 47,600, 04100 Borgo
San Michele (Latina), Italy, and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

PATIENT INFORMATION LEAFLET

Ref: 0627/081015/1/F

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.

Your medicine is called Zithromax Suspension and
will be referred to as Zithromax throughout the rest
of 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. Contnets 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.

• 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.
Other medicines and Zithromax
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.
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
Zithromax is not affected by food or drink.

POM

PL 15184/0627 - Zithromax Suspension

Zithromax is a registered trademark of Pfizer
Products Inc.
Leaflet revision date: 08/10/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

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

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.

Do not take Zithromax:
• 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

Driving and using machines
Zithromax is not expected to affect your ability to
drive or use machines.
Zithromax contains sucrose, a type of sugar
(3.87 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 (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.
Children under 45 kg
The usual 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 usual 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 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
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.

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.

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

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

This multi-dosing spoon delivers doses as follows:

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

How to give Zithromax Suspension in children
less than 3 years of age

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.

15-25 kg bodyweight
(3-7 years):
(Between 2½ and 4
stones)

9. Remove syringe from bottle.

3. Slowly push down the plunger of the syringe:
Do not squirt it out quickly. The medicine will
trickle into your child’s mouth.

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

Dose and duration

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

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.

A. Instructions for the syringe:
- Filling the syringe with
medicine

Bodyweight and age

- 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.

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.

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.

How to give Zithromax Suspension in children
between 3 and 14 years of age

2.5ml (100mg)

Small end
to graduation

5ml

Small end
brimful

(200mg)

7.5ml (300mg)

10ml (400mg)

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.

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 about the use of
this product, ask your doctor or pharmacist for
advice.
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)
Ref: 0627/081015/1/B

Expand view ⇕

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.

Hide