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ZITHROMAX 250MG CAPSULES

Active substance(s): AZITHROMYCIN / AZITHROMYCIN DIHYDRATE

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Package leaflet: Information for the patient


UNITED KINGDOM

ZITHROMAX®

250 mg Capsules
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.

What is in this leaflet
1. What Zithromax is and what it is used for
2. W
 hat 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 and
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 are allergic to azithromycin or any other
macrolide antibiotic such as erythromycin or
clarithromycin or any of the ingredients of this
medicine (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 have or have had any of the
following conditions:
• kidney problems
• heart conditions
• 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 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
You should take Zithromax either 1 hour before
a meal or 2 hours after a meal.
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 capsules contain lactose, a type of
sugar. If you have been told by your doctor that you
have an intolerance to some sugars contact your
doctor before taking this medicine.

Zithromax capsules contain sulfur dioxide,
which may rarely cause severe allergic
(hypersensitivity) reactions and wheezing
(bronchospasm).

3. How to take Zithromax
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure. The capsules should be
swallowed whole.
The recommended dose in adults and children
over 7 stones (45 kg) is 500 mg (2 capsules) taken
together, once a day, for 3 days. For some diseases
such as Chlamydia the recommended dose is 1 g
(4 capsules) taken all together on one day only. For
gonorrhoea the recommended dose is 1 g or 2 g of
azithromycin in combination with 250 or 500 mg of
ceftriaxone.
Zithromax capsules should not be taken by children
weighing less than 45 kg.
You should tell your doctor if you 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 should take. If you are still not
sure, ask your doctor or pharmacist.
Always continue with the course even if you 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 you take more Zithromax than you should
If you take too much Zithromax you may feel unwell.
Tell your doctor or contact your nearest hospital
casualty department immediately.
If you forget to take 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.
You will find more about ZITHROMAX
on the back of this leaflet

If you stop taking Zithromax
If you stop taking Zithromax too soon, the infection
may return. Take the capsules for the full time of
treatment, even when you begin to feel better.
If you have any further questions about 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 (a type
of white blood cell)
• 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side
effects you can help provide more information on the
safety of this medicine.
United Kingdom
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting at:
www.medicinesauthority.gov.mt/adrportal

5. How to store Zithromax
Keep this medicine out of the sight and reach of
children.
This medicine does not require any special storage
conditions.
Do not take this medicine after the expiry date which
is stated on the blister and carton after EXP. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

Marketing Authorisation Holder
Pfizer Limited
Ramgate Rd
Sandwich
Kent
CT13 9NJ
United Kingdom.
Manufacturer
Haupt Pharma Latina S.r.l.
S.S 156 Km 47,600
04100 Borgo San Michele
Latina
Italy.
Company Contact Address
For further information on this medicine, please
contact Medical Information at Pfizer Limited, Walton
Oaks, Tadworth, Surrey, Tel: 01304 616161
This leaflet was last revised in: 11/2015
Ref: ZX Caps 18_2 UK

6. Contents of the pack and other
information
What Zithromax contains
The active substance is azithromycin (250 mg).
The other ingredients are lactose anhydrous (see
section 2, Zithromax capsules contain lactose),
magnesium stearate, maize starch, sodium lauryl
sulfate, gelatin, iron oxide (black) E172, shellac,
propylene glycol, sulfur dioxide (see section 2
Zithromax capsules contain sulfur dioxide) and
titanium dioxide.
What Zithromax looks like and contents of
the pack
Zithromax capsules are white hard gelatin capsules
marked Pfizer and ZTM 250. They come in blister
packs of 4 or 6.
Not all pack sizes may be marketed.

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FPO

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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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