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AZITHROMYCIN 500 MG FILM COATED TABLETS

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Azithromycin dihydrate

Template

BLACK

PANTONE® GREEN C

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. This
includes any possible side effects not listed in this
leaflet. See section 4.

WHAT IS IN THIS LEAFLET:
1.
2.
3.
4.
5.
6.

Version:

1

20 January 2017

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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

1

Colours Used:

Pharma code 966 (Main)

Azithromycin is one of a group of antibiotics called
macrolides. It is used to treat bacterial infections caused
by micro-organisms such as bacteria. These infections
include:
• Chest infections such as acute bronchitis and
pneumonia
• Infections in your sinuses, throat, tonsils or ears
• Mild to moderate skin and soft tissue infections, e.g.
infection of the hair follicles (folliculitis), bacterial
infection of the skin and its deeper layers (cellulitis),
skin infection with shiny red swelling (erysipelas)
• Infections caused by a bacterium called Chlamydia
trachomatis. They can cause inflammation of the tube
that carries urine from your bladder (urethra) or
where your womb joins your vagina (cervix).

2

WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AZITHROMYCIN

Do NOT take Azithromycin

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A



TEVA UK Ref:

231-30-83969-ZB LEA AZITHROMYCIN A/S TAB TUK

WHAT AZITHROMYCIN IS AND WHAT IT IS
USED FOR

REG0073354

If you are allergic (hypersensitive) to azithromycin or
any of the other ingredients of this medicine (listed in
section 6) or any other macrolide or ketolide
antibiotic, e.g. erythromycin or telithromycin
• If you are taking a product containing ergotamine, for
example, some migraine treatments (see “Other
medicines and Azithromycin”).
Warnings and precautions
Talk to your doctor before taking azithromycin if you:
• have ever had a serious allergic reaction causing
swelling of the face and throat, possibly with
breathing problems
• have severe kidney problems: your doctor may alter
the dose
• have liver problems: your doctor may need to
monitor your liver function or stop the treatment
• are aware of ever being diagnosed to have prolonged
QT interval (a heart condition): azithromycin is not
recommended
• are aware that you have a slow or irregular heart
beat, or reduced heart function: azithromycin is not
recommended
• know that you have low levels of potassium or
magnesium in your blood: azithromycin is not
recommended
• are taking medicines known as antiarrhythmics (used
to treat abnormal heart rhythms), cisapride (used to
treat stomach problems) or terfenadine (an
antihistamine that is used to treat allergies):
azithromycin is not recommended
• are taking medicines known as ergot alkaloids (such
as ergotamine), which are used to treat migraine:
azithromycin is not recommended (see “Other
medicines and Azithromycin” below)
• have been diagnosed with a neurological disease,
which is a disease of the brain or nervous system
• have mental, emotional or behavioural problems
• have a condition known as myasthenia gravis, with
fatigue and exhaustion of the muscles: azithromycin
may worsen or cause symptoms of myasthenia.
If you develop severe and persistent diarrhoea during or
after treatment, especially if you notice blood or mucus,
tell your doctor immediately.
If your symptoms persist after the end of your treatment
with azithromycin, or if you notice any new and
persistent symptoms, contact your doctor.
Other medicines and Azithromycin
Tell your doctor if you are taking, have recently taken or
might take any other medicines:
• Antacids e.g. aluminium hydroxide: take
Azithromycin at least 1 hour before or 2 hours after
taking an antacid

Version 4.4

Approved



Ergot derivatives, e.g. ergotamine (used to treat
migraine): Azithromycin should not be taken at the
same time as ergotism may develop (a potentially
serious side effect with numbness or tingling
sensations in the limbs, muscle cramps, headaches,
convulsions, abdominal or chest pain)
• Coumarin-type oral anticoagulants , e.g. warfarin
(used to stop the blood clotting): the risk of bleeding
may be increased
• Digoxin (used to treat heart failure): the levels of
digoxin in your blood may increase
• Zidovudine, nelfinavir (used in the treatment of HIV):
the levels of zidovudine or azithromycin might be
increased
• Rifabutin (used in the treatment of HIV and bacterial
infections including tuberculosis): decreases in your
number of white blood cells could occur
• Ciclosporin (an immunosuppressant used following
organ transplant): ciclosporin levels may be elevated.
Your doctor will need to monitor your ciclosporin
blood levels
• Cisapride (used to treat stomach problems): heart
problems may occur
• Astemizole, terfenadine (antihistamines used to treat
allergic reactions): their effect might be increased
• Alfentanil (a painkiller): the effect of alfentanil might
be increased.
• Fluconazole (for fungal infections): the levels of
azithromycin might be reduced.
No interactions have been observed between
azithromycin and cetirizine (an antihistamine);
didanosine, efavirenz, indinavir (for HIV infection);
atorvastatin (for cholesterol and heart problems);
carbamazepine (for epilepsy); cimetidine (an antacid);
methylprednisolone (to suppress the immune system);
midazolam, triazolam (sedatives); sildenafil (for
impotence), theophylline (for asthma) and
trimethoprim/sulphamethoxazole (an antibiotic
combination).
Azithromycin with food and drink:
Tablets can be taken with or without food and drink.
Pregnancy and breast-feeding
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.
There is insufficient information regarding the safety of
azithromycin during pregnancy.
Consequently, Azithromycin is not recommended if you
are pregnant or planning to become pregnant. However,
your doctor may prescribe it under serious
circumstances.
Azithromycin has been reported to be secreted into
human breast milk, but there are no adequate and
well-controlled clinical studies in nursing women that
have characterized the pharmacokinetics of azithromycin
excretion into human breast milk.
You should not use this medicine during pregnancy and
when you are breastfeeding unless your doctor has
specifically recommended it. This medicines goes into
human milk. So, you should stop breastfeeding until
2 days after you have finished taking this medicine.
Driving and using machines
There is no evidence to suggest that azithromycin may
have an effect on a patient’s ability to drive or operate
machinery. However, Azithromycin may cause dizziness
and fits. If affected, do not drive or operate machinery.

3

HOW TO TAKE AZITHROMYCIN

Always take Azithromycin exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
The tablets should be swallowed preferably with a drink
of water, and can be taken with or without food.
The usual dose is:
Adults (including the older people) and children with a
body weight of over 45 kg:
The usual dose is 1500 mg divided over either 3 or 5 days
as follows:
• When taken over 3 days, 500 mg a day.
• When taken over 5 days, 500 mg on the first day and
then 250 mg on days 2 through to 5.
• Inflammation of the urethra or cervix caused by
Chlamydia: 1000 mg taken as a single dose, for one
day only.
Children and adolescents under 45 kg:
Tablets are not indicated for these patients. Other
pharmaceutical forms of azithromycin-containing
products (e.g. suspensions) may be used.
Patients with kidney or liver problems:
You should tell your doctor if you have kidney or liver
problems as your doctor may need to alter the normal
dose.
If you take more Azithromycin than you should
If you (or someone else) swallow a lot of the tablets all
together, or if you think a child has swallowed any of the
tablets, contact your doctor or pharmacist immediately.
An overdose is likely to cause reversible hearing loss,
severe nausea (feeling sick), vomiting and diarrhoea.
Please take this leaflet, any remaining tablets and the
container with you to the hospital or doctor so that they
know which tablets were consumed.
If you forget to take Azithromycin
If you forget to take a tablet, take one as soon as you

Page 1 of 3

Top of page cut-off to middle of registration mark: 44 mm.

Azithromycin
250 mg and 500 mg Film-Coated
Tablets

remember, unless it is nearly time to take the next one.
Do not take a double dose to make up for a forgotten
dose.
If you stop taking Azithromycin
Do not stop taking your medicine without talking to your
doctor first even if you feel better. It is very important
that you keep taking Azithromycin for as long as your
doctor has told you to, otherwise the infection may come
back.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

Template

BLACK

PANTONE® GREEN C

POSSIBLE SIDE EFFECTS

These are very serious but rare side effects. You may
need urgent medical attention or hospitalisation.

Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Colours Used:

The following other side effects have been reported:

TEVA UK Ref:

231-30-83969-ZB LEA AZITHROMYCIN A/S TAB TUK

Version:

1

20 January 2017

4

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If the following happens, stop taking the tablets and tell
your doctor immediately or go to the casualty
department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck
leading to severe difficulty in breathing; skin rash or
hives)
• blisters/bleeding of the lips, eyes, nose, mouth and
genitals, which may be caused by Stevens-Johnson
syndrome, erythema multiforme or toxic epidermal
necrosis, which are serious illnesses
• an irregular heart beat
• prolonged diarrhoea with blood and mucus.

REG0073354

Very common (may affect more than 1 in 10 people):
• Diarrhoea
Common (may affect up to1 in 10 people):
• Changes in the numbers of some white blood cells
and blood bicarbonate
• Headache
• Vomiting, stomach pain, feeling sick
Uncommon (may affect up to 1 in 100 people):
• Yeast infection e.g. of the mouth (thrush), vaginal
infection, pneumonia, bacterial infection
• Sore throat, inflammation of the lining of the
stomach and the bowel
• Breathlessness, chest pain, wheeze and cough
(respiratory disorders),stuffy nose
• Blood disorders characterised by fever or chills, sore
throat, ulcers in your mouth or throat
• Allergic reactions
• Loss of appetite
• Nervousness, difficulty sleeping
• Dizziness, sleepiness, taste disorders, pins and
needles or numbness,
• Sight disorders
• Ear disorders
• Vertigo (spinning sensation)
• Abnormality of the rhythm or rate and awareness of
the heart beat (palpitations)
• Hot flush
• Difficulty breathing
• Nose bleed
• Inflammation of the stomach, constipation, wind,
indigestion, difficulty swallowing
• Feeling bloated, dry mouth
• Belching, ulcers in the mouth, increased salivation,
loose stools
• Liver problems (such as hepatitis)
• Rash, itching, hives (nettle rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of the joint, muscle pain, back pain,
neck pain
• Painful and difficult urination pain in the upper back
(kidney pain)
• Inflammation of the vagina, irregular menstrual
bleeding, testicle disorders
• Chest pain, swelling, feeling unwell, weakness,
tiredness
• Swelling of the face, fever, pain
• Changes in liver enzymes and laboratory blood
values.
Rare (may affect up to 1 in 1000 people):
• Agitation
• Feeling of unreality to the self and own feeling
• Teeth discolouration
• Abnormal liver function, jaundice (yellowish
pigmentation of the skin)
• Reddening and blistering of the skin when exposed
to sunlight
Not known (frequency cannot be estimated from the
available data):
• Gut (colon) infection (pseudomembranous colitis)
• Blood disorders characterised by unusual bleeding or
unexplained bruising, low red blood cell count
causing unusual tiredness or weakness
• Anaphylactic reaction
• Feeling angry, anxiety, confusion, seeing or hearing
things not really there
• Fainting, fits, reduced sense of touch, hyperactivity,
alteration or loss of the sense of smell, loss of the
sense of taste, myasthenia gravis (fatigue and
exhaustion of the muscle, see 'Warnings and
precautions above)
• Hearing disturbances including deafness and/or
ringing in the ears
• Change in heart rate, changes of the heart rhythm
found by an electro-cardiogram (QT prolongation and
torsade de pointes)

Version 4.4



Low blood pressure (which may be associated with
weakness, lightheadedness and fainting)
Discolouration of the tongue, inflammation of the
pancreas causing nausea, vomiting, abdominal pain,
back pain
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
• Joint pain
• Kidney problems
The following side effects have been reported in patients
taking azithromycin for prevention of Mycobacterium
Avium Complex (MAC) infections):
Very common (may affect more than 1 in 10 people)
• Diarrhea
• Abdominal pain
• Feeling sick (nausea)
• Loose wind (flatulence)
• Abdominal discomfort
• Loose stools
Common (may affect up to1 in 10 people):
• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness
(paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue
Uncommon (may affect up to 1 in 100 people):
• Reduced sense of touch (hypoesthesia)
• Hearing loss or ringing in your ears
• Abnormality of the rhythm or rate and awareness of
the heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth and
genitals, which may be caused by Stevens-Johnson
syndrome
• Allergic skin reactions such as being sensitive to
sunlight, red, flaking and swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise)
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 AZITHROMYCIN

Keep this medicine out of the sight and reach of
children. Do not use Azithromycin after the expiry date
that is stated on the outer packaging. 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.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Azithromycin contain
• Each tablet contains either 250 or 500 mg of the active
ingredient azithromycin as dihydrate.
• The other ingredients are calcium hydrogen
phosphate anhydrous, hypromellose, maize starch,
starch pregelatinised, cellulose microcrystalline,
magnesium stearate, sodium lauryl sulfate, colour
indigotin lake (E 132) (500 mg tablets only), titanium
dioxide (E171), polysorbate 80 and talc.
What Azithromycin look like and contents of the pack
• Azithromycin 250 mg tablets are white, oblong,
biconvex, film-coated tablets, with imprint Al 250 on
one side
• Azithromycin 500 mg tablets are pale blue, oblong,
biconvex film-coated tablets, with imprint AI 500 and
break line on one side. The tablet can be divided into
equal doses.
• The 250 mg tablets are available in pack sizes of 2, 4,
6 or 10 tablets
• The 500 mg tablets are available in pack sizes of 1, 2,
3, 6 or 30 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG
This leaflet was last approved in January 2017
PL 00289/0584-0585

Approved

83969-ZB
323 x 160

Page 2 of 3

Azithromycin 250 mg and
500 mg Film-Coated Tablets
Azithromycin dihydrate
PACKAGE LEAFLET: INFORMATION FOR THE USER

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. 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

Template

BLACK

PANTONE® GREEN C

Version:

1

23 January 2017

1

Azithromycin is one of a group of
antibiotics called macrolides. It is used
to treat bacterial infections caused by
micro-organisms such as bacteria. These
infections include:
• Chest infections such as acute
bronchitis and pneumonia
• Infections in your sinuses, throat,
tonsils or ears
• Mild to moderate skin and soft tissue
infections, e.g. infection of the hair
follicles (folliculitis), bacterial infection
of the skin and its deeper layers
(cellulitis), skin infection with shiny
red swelling (erysipelas)
• Infections caused by a bacterium
called Chlamydia trachomatis. They
can cause inflammation of the tube
that carries urine from your bladder
(urethra) or where your womb joins
your vagina (cervix).

Colours Used:
No
500 mm
145 mm
N/A
N/A
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

231-30-88321-E LEA AZITHROMYCIN A/S TAB TUK
2

TEVA UK Ref:

WHAT AZITHROMYCIN IS AND
WHAT IT IS USED FOR

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
AZITHROMYCIN

Do NOT take Azithromycin
• If you are allergic (hypersensitive) to
azithromycin or any of the other
ingredients of this medicine (listed in
section 6) or any other macrolide or
ketolide antibiotic, e.g. erythromycin
or telithromycin
• If you are taking a product containing
ergotamine, for example, some
migraine treatments (see “Other
medicines and Azithromycin”).
Warnings and precautions
Talk to your doctor before taking
azithromycin if you:
• have ever had a serious allergic
reaction causing swelling of the face
and throat, possibly with breathing
problems
• have severe kidney problems: your
doctor may alter the dose
• have liver problems: your doctor may
need to monitor your liver function or
stop the treatment
• are aware of ever being diagnosed to
have prolonged QT interval (a heart
condition): azithromycin is not
recommended
• are aware that you have a slow or
irregular heart beat, or reduced heart
function: azithromycin is not
recommended
• know that you have low levels of
potassium or magnesium in your blood:
azithromycin is not recommended
• are taking medicines known as
antiarrhythmics (used to treat
abnormal heart rhythms), cisapride
(used to treat stomach problems) or
terfenadine (an antihistamine that is
used to treat allergies): azithromycin
is not recommended
• are taking medicines known as ergot
alkaloids (such as ergotamine), which
are used to treat migraine:
azithromycin is not recommended
(see “Other medicines and
Azithromycin” below)
• have been diagnosed with a
neurological disease, which is a
disease of the brain or nervous system
• have mental, emotional or
behavioural problems
• have a condition known as
myasthenia gravis, with fatigue and
exhaustion of the muscles:
azithromycin may worsen or cause
symptoms of myasthenia.
If you develop severe and persistent
diarrhoea during or after treatment,
especially if you notice blood or mucus,
tell your doctor immediately.







potentially serious side effect with
numbness or tingling sensations in
the limbs, muscle cramps, headaches,
convulsions, abdominal or chest pain)
Coumarin-type oral anticoagulants ,
e.g. warfarin (used to stop the blood
clotting): the risk of bleeding may be
increased
Digoxin (used to treat heart failure):
the levels of digoxin in your blood
may increase
Zidovudine, nelfinavir (used in the
treatment of HIV): the levels of
zidovudine or azithromycin might be
increased
Rifabutin (used in the treatment of
HIV and bacterial infections including
tuberculosis): decreases in your
number of white blood cells could
occur
Ciclosporin (an immunosuppressant
used following organ transplant):
ciclosporin levels may be elevated.
Your doctor will need to monitor your
ciclosporin blood levels
Cisapride (used to treat stomach
problems): heart problems may occur
Astemizole, terfenadine
(antihistamines used to treat allergic
reactions): their effect might be
increased
Alfentanil (a painkiller): the effect of
alfentanil might be increased.
Fluconazole (for fungal infections):
the levels of azithromycin might be
reduced.

No interactions have been observed
between azithromycin and cetirizine (an
antihistamine); didanosine, efavirenz,
indinavir (for HIV infection); atorvastatin
(for cholesterol and heart problems);
carbamazepine (for epilepsy); cimetidine
(an antacid); methylprednisolone (to
suppress the immune system);
midazolam, triazolam (sedatives);
sildenafil (for impotence), theophylline
(for asthma) and
trimethoprim/sulphamethoxazole (an
antibiotic combination).
Azithromycin with food and drink:
Tablets can be taken with or without
food and drink.
Pregnancy and breast-feeding
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.
There is insufficient information
regarding the safety of azithromycin
during pregnancy. Consequently,
Azithromycin is not recommended if you
are pregnant or planning to become
pregnant. However, your doctor may
prescribe it under serious circumstances.
Azithromycin has been reported to be
secreted into human breast milk, but
there are no adequate and
well-controlled clinical studies in nursing
women that have characterized the
pharmacokinetics of azithromycin
excretion into human breast milk.
You should not use this medicine during
pregnancy and when you are
breastfeeding unless your doctor has
specifically recommended it. This
medicines goes into human milk. So,
you should stop breastfeeding until
2 days after you have finished taking this
medicine.
Driving and using machines
There is no evidence to suggest that
azithromycin may have an effect on a
patient’s ability to drive or operate
machinery. However, Azithromycin may
cause dizziness and fits. If affected, do
not drive or operate machinery.

3

HOW TO TAKE AZITHROMYCIN

Always take Azithromycin exactly as
your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure.
The tablets should be swallowed
preferably with a drink of water, and can
be taken with or without food.
The usual dose is:
Adults (including the older people) and
children with a body weight of over 45 kg:
The usual dose is 1500 mg divided over
either 3 or 5 days as follows:
• When taken over 3 days, 500 mg a
day.
• When taken over 5 days, 500 mg on
the first day and then 250 mg on days
2 through to 5.
• Inflammation of the urethra or cervix
caused by Chlamydia: 1000 mg taken
as a single dose, for one day only.
Children and adolescents under 45 kg:
Tablets are not indicated for these
patients. Other pharmaceutical forms of
azithromycin-containing products (e.g.
suspensions) may be used.

Patients with kidney or liver problems:
You should tell your doctor if you have
kidney or liver problems as your doctor
If your symptoms persist after the end of may need to alter the normal dose.
your treatment with azithromycin, or if
If you take more Azithromycin than you
you notice any new and persistent
should
symptoms, contact your doctor.
If you (or someone else) swallow a lot of
Other medicines and Azithromycin
the tablets all together, or if you think a
Tell your doctor if you are taking, have
child has swallowed any of the tablets,
recently taken or might take any other
contact your doctor or pharmacist
medicines:
immediately. An overdose is likely to
• Antacids e.g. aluminium hydroxide:
cause reversible hearing loss, severe
take Azithromycin at least 1 hour
nausea (feeling sick), vomiting and
before or 2 hours after taking an
diarrhoea.
antacid
Please take this leaflet, any remaining
• Ergot derivatives, e.g. ergotamine
(used to treat migraine): Azithromycin tablets and the container with you to the
should not be taken at the same time hospital or doctor so that they know
which tablets were consumed.
as ergotism may develop (a

REG0073428

Version 5.4

Approved

Page 1 of 3

If you forget to take Azithromycin

• Low blood pressure (which may be
associated with weakness,
lightheadedness and fainting)
• Discolouration of the tongue,
inflammation of the pancreas causing
nausea, vomiting, abdominal pain,
back pain
If you stop taking Azithromycin
• Liver failure (rarely life-threatening)
• Rash with spots and blisters
Do not stop taking your medicine
without talking to your doctor first even • Joint pain
if you feel better. It is very important that • Kidney problems
you keep taking Azithromycin for as long The following side effects have been
as your doctor has told you to,
reported in patients taking azithromycin
otherwise the infection may come back. for prevention of Mycobacterium Avium
If you have any further questions on the Complex (MAC) infections):
use of this medicine, ask your doctor or Very common (may affect more than 1 in
10 people)
pharmacist.
• Diarrhea
4 POSSIBLE SIDE EFFECTS
• Abdominal pain
• Feeling sick (nausea)
Like all medicines, this medicine can
• Loose wind (flatulence)
cause side effects, although not
• Abdominal discomfort
everybody gets them.
• Loose stools
If the following happens, stop taking the
tablets and tell your doctor immediately Common (may affect up to1 in 10
or go to the casualty department at your people):
nearest hospital:
• Lack of appetite (anorexia)
• an allergic reaction (swelling of the
• Feeling dizzy (dizziness)
lips, face or neck leading to severe
• Headache
difficulty in breathing; skin rash or
• Sensations of pins and needles or
hives)
numbness (paraesthesia)
• blisters/bleeding of the lips, eyes,
• Changes in your sense of taste
nose, mouth and genitals, which may
(dysgeusia)
be caused by Stevens-Johnson
• Visual impairment
syndrome, erythema multiforme or
• Deafness
toxic epidermal necrosis, which are
• Skin rashes
serious illnesses
• Itching (pruritus)
• an irregular heart beat
• Joint pain (arthralgia)
• prolonged diarrhoea with blood and
• Fatigue
mucus.
Uncommon (may affect up to 1 in 100
These are very serious but rare side
people):
effects. You may need urgent medical
• Reduced sense of touch
attention or hospitalisation.
(hypoesthesia)
The following other side effects have
• Hearing loss or ringing in your ears
been reported:
• Abnormality of the rhythm or rate and
awareness of the heart beat
Very common (may affect more than 1 in
(palpitations)
10 people):
• Liver problems such as hepatitis
• Diarrhoea
• Blisters/bleeding of the lips, eyes,
Common (may affect up to1 in 10 people):
nose, mouth and genitals, which may
• Changes in the numbers of some
be caused by Stevens-Johnson
white blood cells and blood
syndrome
bicarbonate
• Allergic skin reactions such as being
• Headache
sensitive to sunlight, red, flaking and
• Vomiting, stomach pain, feeling sick
swollen skin
• Weakness (asthenia)
Uncommon (may affect up to 1 in 100
• General feeling of being unwell
people):
(malaise)
• Yeast infection e.g. of the mouth
(thrush), vaginal infection,
Reporting of side effects
pneumonia, bacterial infection
If you get any side effects, talk to your
• Sore throat, inflammation of the
doctor or pharmacist. This includes any
lining of the stomach and the bowel
possible side effects not listed in this
• Breathlessness, chest pain, wheeze
leaflet.
and cough (respiratory disorders),
You can also report side effects directly
stuffy nose
via the Yellow Card Scheme at:
• Blood disorders characterised by
www.mhra.gov.uk/yellowcard
fever or chills, sore throat, ulcers in
your mouth or throat
By reporting side effects you can help
• Allergic reactions
provide more information on the safety
• Loss of appetite
of this medicine.
• Nervousness, difficulty sleeping
• Dizziness, sleepiness, taste disorders,
5 HOW TO STORE AZITHROMYCIN
pins and needles or numbness,
Keep this medicine out of the sight and
• Sight disorders
reach of children. Do not use
• Ear disorders
Azithromycin after the expiry date that is
• Vertigo (spinning sensation)
• Abnormality of the rhythm or rate and stated on the outer packaging. The
expiry date refers to the last day of that
awareness of the heart beat
month. Medicines should not be
(palpitations)
disposed of via wastewater or household
• Hot flush
waste. Ask your pharmacist how to
• Difficulty breathing
dispose of medicines no longer
• Nose bleed
required. These measures will help to
• Inflammation of the stomach,
protect the environment.
constipation, wind, indigestion,

Template

BLACK

PANTONE® GREEN C

Colours Used:
No
500 mm
145 mm
N/A
N/A
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

TEVA UK Ref:

231-30-88321-E LEA AZITHROMYCIN A/S TAB TUK
Version:

1

23 January 2017

If you forget to take a tablet, take one as
soon as you remember, unless it is
nearly time to take the next one. Do not
take a double dose to make up for a
forgotten dose.

difficulty swallowing
• Feeling bloated, dry mouth
• Belching, ulcers in the mouth,
increased salivation, loose stools
• Liver problems (such as hepatitis)
• Rash, itching, hives (nettle rash)
• Skin inflammation, dry skin, increased
sweating
• Inflammation of the joint, muscle
pain, back pain, neck pain
• Painful and difficult urination pain in
the upper back (kidney pain)
• Inflammation of the vagina, irregular
menstrual bleeding, testicle disorders
• Chest pain, swelling, feeling unwell,
weakness, tiredness
• Swelling of the face, fever, pain
• Changes in liver enzymes and
laboratory blood values.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Azithromycin contain
• Each tablet contains either 250 or
500 mg of the active ingredient
azithromycin as dihydrate.
• The other ingredients are calcium
hydrogen phosphate anhydrous,
hypromellose, maize starch, starch
pregelatinised, cellulose
microcrystalline, magnesium stearate,
sodium lauryl sulfate, colour indigotin
lake (E 132) (500 mg tablets only),
titanium dioxide (E171), polysorbate
80 and talc.
What Azithromycin look like and
contents of the pack

Rare (may affect up to 1 in 1000 people): • Azithromycin 250 mg tablets are
white, oblong, biconvex, film-coated
• Agitation
tablets, with imprint Al 250 on one
• Feeling of unreality to the self and
side
own feeling
• Azithromycin 500 mg tablets are pale
• Teeth discolouration
blue, oblong, biconvex film-coated
• Abnormal liver function, jaundice
tablets, with imprint AI 500 and break
(yellowish pigmentation of the skin)
line on one side. The tablet can be
• Reddening and blistering of the skin
divided into equal doses.
when exposed to sunlight
• The 250 mg tablets are available in
Not known (frequency cannot be
pack sizes of 2, 4, 6 or 10 tablets
estimated from the available data):
• The 500 mg tablets are available in
• Gut (colon) infection
pack sizes of 1, 2, 3, 6 or 30 tablets.
(pseudomembranous colitis)
Not
all pack sizes may be marketed.
• Blood disorders characterised by
unusual bleeding or unexplained
Marketing Authorisation holder:
bruising, low red blood cell count
TEVA UK Limited, Eastbourne,
causing unusual tiredness or
BN22 9AG
weakness
• Anaphylactic reaction
Manufacturer:
• Feeling angry, anxiety, confusion,
Teva Operations Poland Sp. z.o.o., ul.
seeing or hearing things not really
Mogilska 80, 31-546 Krakow, Poland
there
• Fainting, fits, reduced sense of touch, This leaflet was last approved in
hyperactivity, alteration or loss of the January 2017
sense of smell, loss of the sense of
PL 00289/0584-0585
taste, myasthenia gravis (fatigue and
exhaustion of the muscle, see
‘Warnings and precautions above)
• Hearing disturbances including
deafness and/or ringing in the ears
• Change in heart rate, changes of the
heart rhythm found by an
electro-cardiogram (QT prolongation
and torsade de pointes)
88321-D

REG0073428

Version 5.4

Approved

Page 2 of 3

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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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