Skip to Content

AZITHROMYCIN 250MG CAPSULES

Active substance(s): AZITHROMYCIN

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Add/amend for the generic leaflet (Section 4 Uncommon) to remove "blistering of the skin,
mouth, eyes and genitals"

By Aneela Mahmood at

Mock-up

Previously assessed against UK PIL dated September 2017
Package leaflet: Information for the patient

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. 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 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).

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.

Zithromax with food and drink
You should take Zithromax either 1 hour
before a meal or 2 hours after a meal.

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.

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.

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.

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

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.

Zithromax 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 contain sulphur 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.

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.
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
• 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 (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
• 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 all medicines out of the sight and reach
of children.
Do not store above 30°C.
Do not refrigerate.
Store in the original package.
Do not take this medicine after the expiry date
stamped on the pack after EXP. The expiry
date refers to the last day of that month.
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.
If your medicine gets discoloured or shows any
other signs of deterioration, seek the advice of
your pharmacist.

6. Contents of the pack and other
information
What Zithromax contains
Each capsule contains 250mg azithromycin as
azithromycin dihydrate.
The other ingredients are anhydrous lactose,
magnesium stearate, sodium lauryl sulphate,
corn starch (gluten). The capsule shell
contains gelatin, titanium dioxide (E171) and
black ink which consists of shellac, iron oxide
(black) E172, propylene glycol, ammonium
hydroxide or shellac,
iron oxide (black) E172, propylene glycol,
strong ammonia solution and potassium
hydroxide.
What Zithromax looks like and contents of
the pack
Zithromax capsules are white marked Pfizer
and ZTM 250. They come in blister packs
of 6.
Manufactured by:
Farmasierra Manufacturing S.L. Ctra. N-1, Km
26,200. 28700 San Sebastian de los Reyes,
Madrid.
Procured from within the EU & repackaged
by Product Licence holder: Kosei Pharma
UK Limited, 956 Buckingham Avenue, Slough
Trading Estate, Slough, SL1 4NL, UK

Zithromax® 250 mg Capsules
PL 39352/0070
Zithromax® is a registered trademark of Pfizer
limited.
POM
Leaflet date: 11/12/2017

To listen to or
request a copy of this
leaflet in Braille, large
print or audio please
call: 01753515054
(UK only)

Package leaflet: Information for the patient

Azithromycin
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 Azithromycin is and what it is used
for
2. What you need to know before you take
Azithromycin
3. How to take Azithromycin
4. Possible side effects
5. How to store Azithromycin
6. Contents of the pack and other
information

1. What Azithromycin 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 Azithromycin
Do not take Azithromycin:
• 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
Azithromycin 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 Azithromycin.
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
Azithromycin.
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 Azithromycin
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
In particular, Azithromycin 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).
Azithromycin with food and drink
You should take Azithromycin 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
Azithromycin is not expected to affect your
ability to drive or use machines.
Azithromycin 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.
Azithromycin contain sulphur dioxide,
which may rarely cause severe allergic
(hypersensitivity) reactions and wheezing
(bronchospasm).

3. How to take Azithromycin
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 1g (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.
Azithromycin 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 Azithromycin than you
should
If you take too much Azithromycin you may
feel unwell. Tell your doctor or contact your
nearest hospital casualty department
immediately.
If you forget to take Azithromycin
If you forget to take Azithromycin 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 Azithromycin
If you stop taking Azithromycin 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 Azithromycin 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 Azithromycin 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
• 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 Azithromycin
Keep all medicines out of the sight and reach
of children.
Do not store above 30°C.
Do not refrigerate.
Store in the original package.
Do not take this medicine after the expiry date
stamped on the pack after EXP. The expiry
date refers to the last day of that month.
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.
If your medicine gets discoloured or shows any
other signs of deterioration, seek the advice of
your pharmacist

6. Contents of the pack and other
information
What Azithromycin contains
Each capsule contains 250mg azithromycin as
azithromycin dihydrate.
The other ingredients are anhydrous lactose,
magnesium stearate, sodium lauryl sulphate,
corn starch (gluten). The capsule shell
contains gelatin, titanium dioxide (E171) and
black ink which consists of shellac, iron oxide
(black) E172, propylene glycol, ammonium
hydroxide or shellac, iron oxide (black) E172,
propylene glycol, strong ammonia solution and
potassium hydroxide.
What Azithromycin looks like and contents
of the pack
Azithromycin capsules are white marked Pfizer
and ZTM 250. They come in blister packs of 6.
Manufactured by:
Farmasierra Manufacturing S.L. Ctra. N-1, Km
26,200. 28700 San Sebastian de los Reyes,
Madrid.
Procured from within the EU & repackaged
by Product Licence holder: Kosei Pharma
UK Limited, 956 Buckingham Avenue, Slough
Trading Estate, Slough, SL1 4NL, UK

Azithromycin 250mg Capsules
PL 39352/0070
Leaflet date: 11/12/2017

POM

To listen to or
request a copy of this
leaflet in Braille, large
print or audio please
call: 01753515054
(UK only)

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide