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AZITHROMYCIN 250 MG FILM-COATED TABLETS

Active substance(s): AZITHROMYCIN DIHYDRATE

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Package leaflet:
Information for the user
Azithromycin 250 mg
film-coated tablets
Azithromycin 500 mg
film-coated tablets
Azithromycin

1. What Azithromycin is
and what it is used for
Azithromycin belongs to a
group of medicines called
macrolide antibiotics.
Antibiotics are used to treat
infections caused by
micro-organisms like
bacteria.
Azithromycin is used for the
treatment of certain infections
caused by bacteria that are
sensitive to it, such as:
• chest, throat or nasal
infections (such as
bronchitis, pneumonia,
tonsillitis, sore throat
(pharyngitis) and
sinusitis)
• ear infections
• skin and soft tissue
infections
• infection of the tube that
carries urine from the
bladder (urethra) or the
neck of the womb
(cervix) caused by
Chlamidia trachomatis
(bacteria).
2. What you need to know
before you take
Azithromycin
Do not take Azithromycin :
• if you are allergic to
azithromycin dihydrate,
erythromycin or any
macrolide or ketolide
antibiotic
• if you are allergic to any
of the other ingredients of
this medicine (listed in
section 6).
Warnings and precautions
Talk with your doctor or
pharmacist before taking
Azithromycin if:
• you have severe liver or
kidney problems
• you have severe heart
problems or problems
with your heart beat such
as long QT syndrome
(shown on an
electro-cardiogram or
ECG machine)
• your blood levels of
potassium or magnesium
are
too low
• you develop signs of
another infection
• you are taking any ergot
derivatives such as
ergotamine (to treat
migraine) as these
medicines should not be
taken together with
Azithromycin (see
section “Taking other
medicines”)
• you have a certain type
of muscle weakness
called myasthenia gravis
• you have nervous
(neurological) or mental
(psychiatric) problems.
Other medicines and
Azithromycin
Tell your doctor or
pharmacist if you are taking,
have recently taken or might
take any of the following
medicines:
• antacids - used for
heartburn and
indigestion. Azithromycin
should be taken at least
1 hour before or 2 hours
after the antacid
• ergotamine - (used for
migraine) should not be
taken at the same time
as serious side effects
may develop (with
numbness or tingling
sensations in the limbs,
muscle cramps,
headaches, convulsions,
abdominal or chest pain)
• cholesterol lowering
medicines (statins)
• warfarin or similar
medicines - used to thin
the blood. Azithromycin
can thin the blood even
more
• cisapride - (used to treat
stomach problems)
should not be taken at
the same time as this
may cause severe heart
problems (shown on an
electro-cardiogram or
ECG machine)
• terfenadine - (used to
treat hay fever) should
not be taken at the same
time as this may cause
severe heart problems
(shown on an
electro-cardiogram or
ECG machine)
• zidovudine or nelfinavir used to treat HIV
infections. Taking
nelfinavir with
Azithromycin may mean
that you get more of the
side effects listed in this
leaflet
• rifabutin - used to treat
tuberculosis (TB)
• quinidine - used to treat
heart rhythm problems
• cyclosporin - used to stop
your body rejecting an
organ transplant. Your
doctor will regularly
check your blood levels
of cyclosporin and may
change your dose.
Tell your doctor or
pharmacist if you are taking
any of the following
medicines. Azithromycin can
make the effects of these
other medicines stronger.
Your doctor may change your
dose:
• theophylline - used for
breathing problems such
as asthma and chronic
obstructive pulmonary
disease (COPD)

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digoxin - used to treat
heart problems
• pimozide - used to treat
mental health problems.
Azithromycin with food and
drink
This medicine can be taken
with or without food.
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.
There is insufficient
information available about
the use of Azithromycin
during pregnancy. Therefore
you should not use
Azithromycin during
pregnancy, unless explicitly
advised by your doctor.
Azithromycin is partially
passed through the mother’s
milk, therefore Azithromycin
should not be used if you are
breastfeeding.
Driving and using
machines
There are no data available
about the influence of
Azithromycin on the ability to
drive or operate machines.
However Azithromycin may
cause dizziness and seizures
so make sure you are not
affected before driving or
operating machinery.
Azithromycin contains
lactose monohydrate. If you
have been told by your
doctor that you have an
intolerance to some sugars,
contact your doctor before
taking medicinal product.
3. How to take
Azithromycin
Always take this medicine
exactly as your doctor or
pharmacist has told you.
Check with your doctor or
pharmacist if you are not
sure.
The recommended dose:
For adults and young
people with a body weight
of 45 kg or over
500 mg once daily for three
days with a total dose of
1500 mg. Alternatively your
doctor may decide to
prescribe the total dose of
1500 mg over a period of
5 days, with 500 mg the first
day and 250 mg on days
2 to 5.
For infections of the neck
of the womb and urethra
caused by Chlamydia
trachomatis
One dose of 1000 mg, to be
taken one time.
Children and adolescents
under 45 kg
The tablets are not
recommended. Young people
with a body weight of less
than 45kg should use other
forms of this medicine.
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.
Dosage for elderly
For elderly the same dosage
as for adults applies.
The tablet can be divided into
equal doses.
Method of administration

The tablets should be taken
with ½ glass of water.
The tablets can be taken with
or without food.
If you take more
Azithromycin than you
should
If you have taken too much
Azithromycin, contact your
doctor, pharmacist or go to
your nearest hospital at once.
Symptoms of overdose are
loss of hearing, feeling sick
or being sick and diarrhoea.
In case of overdosage
admission into hospital may
be necessary.
If you forget to take
Azithromycin
If you forget to take
Azithromycin, take your dose
as soon as possible. If it is
almost time for the next dose,
just skip that dose and take
the next one when it is due. If
in doubt, please contact your
doctor or pharmacist. If you
have to skip a dose, still take
all of your tablets. This
means that you will finish
your course a day later.
Do not take a double dose to
make up for a forgotten dose.
If you stop taking
Azithromycin
Never stop the treatment with
Azithromycin on your own,
but first discuss this with your
doctor. If the prescribed
treatment is not completely
finished, the infection may
come back again.
If you have any further
questions on 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.
If you have any of the
following symptoms of a
severe allergic reaction stop
taking this medicine and tell
your doctor immediately or
go to the casualty
department at your nearest
hospital
• Sudden difficulty in
breathing, speaking and
swallowing
• Swelling of the lips,
tongue, face and neck
• Extreme dizziness or
collapse
• Severe or itchy skin rash,
especially if this shows
blistering and there is
soreness of the eyes,
mouth or genital organs.
If you experience any of the
following side effects contact
your doctor as soon as
possible
• Diarrhoea that is serious,
lasts a long time or has
blood in it, with stomach
pain or fever. This can be
a sign of a serious bowel
inflammation. This is
something that can rarely
happen after taking
antibiotics
• Yellowing of the skin or
whites of the eyes
caused by liver
problems
• Inflammation of the
pancreas, which
causes severe pain
in the abdomen and
back

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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





Increased or reduced
urine output, or traces of
blood in your urine
Skin rash caused by
sensitivity to sunlight
Unusual bruising or
bleeding
Irregular heart beat.

These are all serious
side effects. You may
need urgent medical
attention. Serious side
effects are uncommon
(may affect up to 1 in
100 people) or the
frequency cannot be
estimated from the
available data. Other
side effects include
Very common (may affect
more than 1 in 10 people)
• diarrhoea
Common (may affect up to 1
in 10 people)
• headache
• being sick (vomiting),
stomach pain or cramps,
loss of appetite
• change in the quantity of
the white blood cells and
the concentration of
bicarbonate in the blood.
Uncommon (may affect up
to 1 in 100 people)
• thrush (candidiasis) - a
fungal infection
• fungal infection
• bacterial infection
• inflammation of the throat
(pharyngitis)
• breathlessness, chest
pain, wheeze and cough
(respiratory disorder)
• inflammation of the
mucous membrane
inside the nose (rhinitis)
• stomach flu
(gastroenteritis)
• inflammation inside your
vagina (vaginitis)
• pneumonia
• changes in the number of
white blood cells
• angioedema
• hypersensitivity
• lack of appetite
(anorexia)
• nervousness
• feeling drowsy
(somnolence)
• changes in your sense of
taste
• sensation of pins and
needles or numbness
(paraesthesia)
• visual impairment
• having difficulty sleeping
(insomnia)
• ear disorder
• dizziness
• spinning sensation
(vertigo)
• palpitations
• hot flushes
• shortness of breath
• nosebleed
• inflammation of the lining
of the stomach (gastritis)
• constipation
• loose wind (flatulence)
• difficulty swallowing
• swollen abdomen
• dry mouth
• belching
• mouth ulcer
• increased salivary flow
• skin rash
• itching
• inflammation of the skin
(dermatitis)
• dry skin
• increased sweating
• pain, swelling and
reduced motion in your
joints (osteoarthritis)
• muscle pain
• back pain
• neck pain
• increase in blood urea
levels
• painful or difficult
urination
• pain in the upper back
(renal pain)
• spotting
• testicular disorder
• urticaria
• chest pain
• face swelling
• fever
• pain
• swelling of extremities
(peripheral edema)
• swelling (oedema)
• general feeling of being
unwell (malaise)
• fatigue
• weakness (asthenia)
• change in liver enzyme
levels and blood levels
• post procedural
complications
Rare (may affect up to 1 in
1,000 people)
• feeling agitated
• abnormal hepatic
function, yellowing of the
skin and whites of the
eyes, dark urine, pale
stool
• allergic skin reactions
such as being sensitive
to sunlight
Not known (frequency
cannot be estimated from the
available data)
• gut (colon) infection
(pseudomembranous
colitis)
• reduced number of red
blood cells due to
destruction (haemolytic
anaemia); reduction in
number of platelets
(thrombocytopenia)
• anaphylactic reaction
• feeling angry, aggressive
• anxiety
• confusion
• hallucination
• fainting (syncope)
• fits (convulsions)
• reduced sense of touch
(hypoaesthesia)
• feeling hyperactive
• change in your sense of
smell (anosmia,
parosmia)
• change in your sense of
taste (ageusia)
• exacerbation or
aggravation of muscle
weakness (myasthenia
gravis)
• impaired hearing
including loss of hearing,
ringing in your ears
• rapid (ventricular
tachycardia) or irregular
heart beat, sometimes
being life-threatening,
changes of the heart
rhythm found by an
electro-cardiogram (QT
prolongation and torsade
de pointes)
• low blood pressure
• inflammation of the
pancreas (pancreatitis)
• your tongue changes
colour
• liver failure
• severe allergic skin
reactions
• joint pain (arthralgia)
• kidney failure,
inflammation within the
kidneys.

5. How to store
Azithromycin
Keep this medicine out of the
sight and reach of children.
Do not use this medicine
after the expiry date which is
stated on the carton after
EXP. The expiry date refers
to the last day of that month.
The medicinal product does
not require any special
storage conditions.
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.
6. Contents of the pack
and other information
What Azithromycin
contains
- The active substance is
azithromycin dihydrate.
Each film-coated tablet
contains 250 mg of
azithromycin (as
dihydrate).
Each film-coated tablet
contains 500 mg of
azithromycin (as
dihydrate).
The other ingredients are
Tablet core: Calcium
hydrogen phosphate,
anhydrous, starch,
pregelatinized (maize
starch), croscarmellose
sodium, sodium lauryl
sulfate, magnesium
stearate.
Tablet coating: Lactose
monohydrate,
hypromellose, titanium
dioxide (E 171), triacetin.
What Azithromycin looks
like and contents of the
pack
Film-coated tablet.
Azithromycin 250 mg
film-coated tablets:
White to off-white, oblong
shaped, film coated biconvex
tablets, debossed with “66”
on one side and “D” on other
side. The size is 13.5 mm x
6.6 mm
Azithromycin 500 mg
film-coated tablets:
White to off-white, oval
shaped, film coated biconvex
tablets debossed with “6” and
“7” on either side of the
score-line on one side and
“D” on other side. The size is
17.1 mm x 8.5 mm
Azithromycin film-coated
tablets are available in clear
PVC- Aluminium blister
packs.
Blister packs: 2, 3, 4, 6 and
12 film-coated tablets
Not all pack sizes may be
marketed.
Marketing Authorisation
Holder and Manufacturer
Milpharm Limited
Ares Block, Odyssey
Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta)
Limited
Hf26, Hal Far Industrial
Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey
Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last
revised in 07/2016.

P15XXXXX



The following side effects
have been reported in
prophylactic treatment
against Mycobacterium
Avium complex (MAC):
Very common (may affect
more than 1 in 10 people)
• diarrhoea
• abdominal pain
• feeling sick (nausea)
• loose wind (flatulence)
• abdominal discomfort
• loose stools
Common (may affect up to 1
in 10 people):
• lack of appetite
(anorexia)
• feeling dizzy
• headache
• sensation of pins and
needles or numbness
(paraesthesia)
• changes in your sense of
taste
• visual impairment
• deafness
• being sick (vomiting),
stomach pain or cramps,
loss of appetite,
problems digesting your
food
• skin rashes and itching
• joint pain (arthralgia)
• fatigue
Uncommon (may affect up
to 1 in 100 people):
• reduced sense of touch
(hypoaesthesia)
• hearing loss or ringing in
your ears
• palpitations
• liver problems such as
hepatitis
• severe form of skin
flushing
• allergic skin reactions
such as being sensitive
to sunlight, red, flaking
and swollen skin
• general feeling of being
unwell (malaise)
• weakness (asthenia)
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 Yellow Card
Scheme
Website:
www.mhra.gov.uk/yellowcard
. By reporting side effects
you can help provide more
information on the safety of
this medicine.

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.

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