Package leaflet: Tell your doctor or pharmacist if

Information for the user you are taking any of the following
medicines. Azithromycin can make
Azithromycin 250 mg the effects of these other medicines
film-coated tablets stronger. Your doctor may change
your dose:
Azithromycin 500 mg • Alfentanil - a painkiller used e.g.
film-coated tablets during operations
• Theophylline - used for
Azithromycin
breathing problems such as
Read all of this leaflet carefully asthma and chronic obstructive
before you start taking this pulmonary disease (COPD)
medicine because it contains • Digoxin - used to treat heart
important information for you. failure
- Keep this leaflet. You may need • Colchicine - used for gout and
to read it again. familial Mediterranean fever
- If you have any further questions, • Astemizol - used to treat hay
ask your doctor or pharmacist. fever
- This medicine has been • Pimozide - used to treat mental
prescribed for you only. Do not health problems.
pass it on to others. It may harm Azithromycin with food and drink
them, even if their signs of illness You should take Azithromycin either
are the same as yours. 1 hour before a meal or 2 hours after
- If you get any side effects talk to a meal.
your doctor or pharmacist. This
includes any possible side effects Pregnancy, breast-feeding and
not listed in this leaflet. See fertility
section 4. If you are pregnant or breast-feeding,
think you may be pregnant or are
What is in this leaflet planning to have a baby, ask your
1. What Azithromycin is and what it doctor or pharmacist for advice
is used for before taking this medicine.
2. What you need to know before
you take Azithromycin There is insufficient information
3. How to take Azithromycin available about the use of
4. Possible side effects Azithromycin during pregnancy.
5. How to store Azithromycin Therefore you should not use
6. Contents of the pack and other Azithromycin during pregnancy,
information unless explicitly advised by your
doctor.
1. What Azithromycin is and Azithromycin is partially passed
what it is used for through the mother’s milk,
Azithromycin belongs to a group It is not known whether azithromycin
of medicines called macrolide may have adverse effects on the
antibiotics. Antibiotics are used to breast-fed infant. Breastfeeding
treat infections caused by micro- should therefore be discontinued
organisms like bacteria. during treatment with Azithromycin. It
is recommended to discard the milk
Half Fold : 365 mm

Azithromycin is used for the during treatment and up until 2 days

treatment of certain infections after discontinuation of treatment.
caused by bacteria that are sensitive Breast-feeding may be resumed
to it, such as: thereafter.
• chest, throat or nasal infections
(such as bronchitis, pneumonia, Driving and using machines
tonsillitis, sore throat (pharyngitis) Azithromycin is not expected to affect
and sinusitis) your ability to drive or use machines.
• ear infections Azithromycin contains lactose
• skin and soft tissue infections, monohydrate.If you have been
with exception of infected burn told by your doctor that you have
wounds. an intolerance to some sugars,
• infection of the tube that carries contact your doctor before taking this
urine from the bladder (urethra) medicinal product.
or the neck of the womb (cervix) Sodium
caused by Chlamidia trachomatis
Azithromycin contains less than 1
bacteria and Neisseria
mmol (23 mg) of sodium per tablet,
gonorrhoeae.
that is to say it is essentially ‘sodium-
free.’
2. What you need to know
before you take Azithromycin 3. How to take Azithromycin
Do not take Azithromycin : Always take this medicine exactly
• if you are allergic to azithromycin as your doctor or pharmacist has
or any other macrolide antibiotic told you. Check with your doctor or
such as erythromycin or ketolide pharmacist if you are not sure.
antibiotic, clarithromycin or any of
the ingredients of this medicine The recommended dose:
(listed in section 6). An allergic For adults and children with a
reaction may cause skin rash or body weight of 45 kg or more
wheezing.
Azithromycin is taken as a 3 or 5 day
Warnings and precautions course:
Talk with your doctor or pharmacist
• 3 days course: Take 500 mg (two
before taking Azithromycin if you
250 mg or one 500 mg tablet)
have or have had any of the
once each day
following conditions:
• you have ever had a serious • 5 days course:
allergic reaction causing swelling - Take 500 mg on Day 1 (two
of the face and throat, possibly 250 mg tablets)
with breathing problems, rash, - Take 250 mg (one 250 mg
fever, swollen glands or increase tablet) on Days 2, 3, 4 and 5
in eosinophils (certain type of For infections of the neck of the
white blood cells) womb and urethra caused by
• kidney problems Chlamydia trachomatis
• heart conditions:you have severe One dose of 1000 mg, (four 250 mg
heart problems or problems with tablets or two 500 mg tablets) to be
your heart beat such as long QT taken one time.
syndrome (shown on an electro-
cardiogram or ECG machine) For gonorrhoea the recommended
• your blood levels of potassium or dose is 1 g or 2 g of azithromycin in
magnesium are too low combination with 250 or 500 mg of
• liver problems: your doctor ceftriaxone.
may need to monitor your liver Children and adolescents under
function or stop the treatment 45kg
• myasthenia gravis (a The tablets are not recommended.
condition that causes Children with a body weight of less
certain muscles to than 45kg should use other forms of
become weak) this medicine.
• or if you are taking any Patients with kidney or liver
ergot derivatives such problems
as ergotamine (used to You should tell your doctor if you
treat migraine) as these have kidney or liver problems as
medicines should not your doctor may need to alter the
be taken together with normal dose.
Azithromycin (see section
“Other medicines and Doctors sometimes prescribe
Azithromycin”). different doses to the recommended
Tell your doctor immediately if: dose. The label on the pack will tell
• you feel your heart beating in you which dose you should take. If
your chest or have an abnormal you are still not sure, ask your doctor
heartbeat, or get dizzy or faint or or pharmacist.
suffer from any muscle weakness Always continue with the course
when taking Azithromycin. even if you feel better. If your
• you have nervous (neurological) infection gets worse or you do not
or mental (psychiatric) problems. start to feel better within a few days
• your newborn child develops or a new infection develops, go back
vomiting and irritability during and see your doctor.
feeding. Dosage for elderly
• you are giving this medicine to For elderly the same dosage as for
an infant (less than 6 weeks of adults applies.
age) and they vomit or become
irritable when fed. 500 mg tablet can be divided into
equal doses.
If you develop diarrhoea or loose
stools during or after treatment, tell Method of administration
your doctor at once. Do not take The tablets should be taken with ½
any medicine to treat your diarrhoea glass of water.
without first checking with your The tablets can be taken with or
doctor. If your diarrhoea continues, without food.
please inform your doctor. If you take more Azithromycin
than you should
Other medicines and Azithromycin If you have taken too much
Tell your doctor or pharmacist if you Azithromycin you may feel unwell,
are taking,have recently taken or contact your doctor, pharmacist or
might take or might take any other go to your nearest hospital casualty
medicines. department immediately.
In particular, Azithromycin may Symptoms of overdose are loss of
interact with the medicines listed hearing, feeling sick or being sick
below: and diarrhoea. In case of overdosage
• Antacids - used for heartburn admission into hospital may be
and indigestion. Azithromycin necessary.
should be taken at least 1 hour
before or 2 hours after the If you forget to take Azithromycin
antacid If you forget to take Azithromycin,
take your dose as soon as possible.
• Ergotamine -dihydroergotamine
If it is almost time for the next dose,
(used for migraine) should
just skip that dose and take the next
not be taken at the same time
one when it is due. If in doubt, please
as serious side effects may contact your doctor or pharmacist. If
develop (ergotism - i.e. itching you have to skip a dose, still take all
in the limbs, muscle cramps of your tablets. This means that you
and gangrene of hands and feet will finish your course a day later.
due to poor blood circulation) Do not take a double dose to make
see ‘Warnings and precautions’ up for a forgotten dose.
section
• Cholesterol lowering medicines If you stop taking Azithromycin
(statins) Never stop the treatment with
• Warfarin or any similar Azithromycin on your own, but
medicines - to prevent blood first discuss this with your doctor.
If the prescribed treatment is not
clots: concomitant use can
completely finished, the infection
increase the risk of bleeding
may come back again.
• Hydroxychloroquine or
chloroquine- (used to treat If you have any further questions on
autoimmune diseases including the use of this medicine, ask your
rheumatoid arthritis, or to treat or doctor or pharmacist.
prevent malaria): heart problems
4. Possible side effects
may occur. Taking these
medicines at the same time as Like all medicines, this medicine
azithromycin may increase the can cause side effects, although not
chance of you getting side effects everybody gets them.
that affect your heart.
Tell your doctor immediately if you
• Cisapride - (used to treat
experience any of the following
stomach problems), or symptoms after taking this
terfenadine (used to treat hay medicine as the symptoms can be
fever or a skin allergy): should severe.
not be taken at the same time • sudden wheeziness, difficulty
as this may cause severe heart in breathing, speaking and
problems (shown on an electro- swallowing
cardiogram or ECG machine) • swelling of eyelids, face or
• Zidovudine or nelfinavir - used lips, rash or itching (especially
to treat HIV infections. Taking affecting the whole body)
nelfinavir with Azithromycin may • Extreme dizziness or collapse
mean that you get more of the • severe or prolonged diarrhoea,
side effects listed in this leaflet which may have blood or mucus
• Rifabutin - used to treat in it, during or after treatment
tuberculosis (TB) with azithromycin as this may
• Quinidine - used to treat heart be a sign of serious bowel
rhythm problems (called anti- inflammation
arrythmics) • severe skin rash causing redness
• Cyclosporin - used to and flaking
suppress the immune system • rapid or irregular heartbeat
to prevent and treat rejection of • low blood pressure
a transplanted organ or bone • Serious skin reactions:
- blistering of the skin,
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marrow. Your doctor will regularly

check your blood levels of mouth, eyes and genitals
cyclosporin and may change your (Stevens-Johnson
dose. Syndrome (SJS))

Black
Version: 17
Date & Time: 03.01.2025 & 4.00 PM
Submission Code: N07860_u7f
 - blistering of the skin, severe • skin eruption that is characterised
skin reaction (Toxic Epidermal by the rapid appearance of areas
Necrosis (TEN)) of red skin studded with small
- skin rash accompanied by pustules (small blisters filled with
other symptoms such as white/yellow fluid).
fever, swollen glands and • swelling of the hands, feet, lips,
an increase of eosinophils genitals or throat (angioneurotic
(a type of white blood cell). oedema)
A rash appears as small, • kidney problems
itchy red bumps (Drug Not known (frequency cannot be
Reaction with Eosinophilia estimated from the available data)
and Systemic Symptoms • gut (colon) infection
(DRESS)) (pseudomembranous colitis)
Stop taking azithromycin if you • reduced number of red blood
develop these skin symptoms and cells due to destruction
contact your doctor or seek medical (haemolytic anaemia which can
attention immediately. make the skin pale and cause
The most common side effects that weakness or breathlessness);
occur when taking azithromycin reduction in number of platelets
are listed below. These may go (thrombocytopenia)
away during treatment as your body • anaphylactic reaction
adjusts to the medicine. Tell your • feeling angry, aggressive
doctor if any of these side effects • anxiety
• confusion
continue to bother you.
• hallucination
If you experience any of the • fainting (syncope)
following side effects contact your • fits (convulsions)
doctor as soon as possible • reduced sense of touch
Rare (may affect up to 1 in 1,000 (hypoaesthesia)
people): • feeling hyperactive
• Increased or reduced urine • change in your sense of smell
(anosmia, parosmia)
output, or traces of blood in your
• change in your sense of taste
urine
(ageusia)
• Skin eruption that is
• exacerbation or aggravation of
characterised by the rapid
muscle weakness (myasthenia
appearance of areas of red skin gravis)
studded with small pustules • blurred vision
(small blisters filled with white/ • rapid (ventricular tachycardia) or
yellow fluid) (Acute Generalized irregular heart beat, sometimes
Exanthematous Pustulosis being life-threatening, changes
(AGEP)). of the heart rhythm found by
Not known (frequency cannot be an electro-cardiogram (QT
estimated from the available data) prolongation and torsade de
• Diarrhoea that is serious, lasts pointes)
a long time or has blood in it, • low blood pressure
with stomach pain or fever. This • inflammation of the pancreas
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can be a sign of a serious bowel (pancreatitis)

inflammation. This is something • tongue discolouration
that can rarely happen after • liver failure
taking antibiotics • severe allergic skin reactions
• Yellowing of the skin or whites of • inflammation of the kidney or
the eyes (jaundice) caused by kidney failure
liver problems
The following side effects have been
• Inflammation of the pancreas
reported in prophylactic treatment
(pancreatitis), which causes
against Mycobacterium Avium
severe pain in the abdomen and
complex (MAC):
back Very common (may affect more
• Increased or reduced urine than 1 in 10 people)
output, or traces of blood in your • diarrhoea
urine • abdominal pain
• Skin rash caused by sensitivity to • feeling sick (nausea)
sunlight • loose wind (flatulence)
• bruising or prolonged bleeding • abdominal discomfort
after injury • loose stools
• Irregular heart beat.
Common (may affect up to 1 in 10
These are all serious side effects. people):
You may need urgent medical • lack of appetite (anorexia)
attention. • feeling dizzy
Other side effects include: • headache
• sensation of pins and needles or
Very common (may affect more numbness (paraesthesia)
than 1 in 10 people) • changes in your sense of taste
• diarrhoea • visual impairment
• abdominal pain • deafness
• feeling sick (nausea) • being sick (vomiting), stomach
• loose wind (flatulence) pain or cramps, loss of appetite,
• stomach cramps problems digesting your food
Common (may affect up to 1 in 10 • skin rashes and itching
people) • joint pain (arthralgia)
• lack of appetite (anorexia) • fatigue
• headache Uncommon (may affect up to 1 in
• feeling dizzy 100 people):
• sensation of pins and needles or • reduced sense of touch
numbness (paraesthesia) (hypoaesthesia)
• changes in your sense of taste • hearing loss or ringing in your
• visual impairment ears
• deafness • palpitations
• being sick (vomiting), stomach • liver problems such as hepatitis
pain or cramps, loss of appetite, • severe form of skin flushing
problems digesting your food • allergic skin reactions such as
• skin rashes and itching being sensitive to sunlight, red,
• joint pain (arthralgia) flaking and swollen skin
• fatigue • general feeling of being unwell
• low numbers of lymphocytes (a (malaise)
type of white blood cell), higher • weakness (asthenia)
number of eosinophils (a type of Reporting of side effects
white blood cell) If you get any side effects,talk to
• low blood bicarbonate your doctor or pharmacist. This
• tiredness or weakness includesany possible side effects
Uncommon (may affect up to notlisted in this leaflet. You can also
1 in 100 people) report side effects directly via Yellow
• yeast infections of Card Scheme Website:
www.mhra.gov.uk/yellowcard or
the mouth and thrush
search for MHRA Yellow Card in the
(candidiasis) - a fungal
Google Play or Apple App Store. By
infection
reporting side effects you can help
• bacterial infection
provide more information on the
• inflammation of the throat safety of this medicine.
(pharyngitis)
• breathlessness, chest 5. How to store Azithromycin
pain, wheeze and cough
Keep this medicine out of the sight
(respiratory disorder)
and reach of children.
• inflammation of the
mucous membrane inside Do not use this medicine after the
the nose (rhinitis) expiry date which is stated on the
• stomach flu (gastroenteritis) carton after EXP. The expiry date
• inflammation inside your vagina refers to the last day of that month.
(vaginitis) The medicinal product does
• pneumonia not require any special storage
• low numbers of leukocytes (a conditions.
type of white blood cell), low
number of neutrophils (a type of Do not throw away any medicines
white blood cell) via wastewater or household waste.
• angioedema Ask your pharmacist how to throw
• hypersensitivity away medicines you no longer use.
• nervousness These measures will help protect the
environment.
• reduced sense of touch or
sensation (hypoaesthesia) 6. Contents of the pack and
• feeling drowsy (somnolence) other information
• having difficulty sleeping
(insomnia) What Azithromycin contains
- The active substance is
• ear disorder
azithromycin dihydrate.
• impaired hearing, ringing in your Each film-coated tablet contains
ears 250 mg of azithromycin (as
• dizziness dihydrate).
• heart palpitations Each film-coated tablet contains
• hot flushes 500 mg of azithromycin (as
• shortness of breath dihydrate).
• nosebleed The other ingredients are
• inflammation of the lining of the Tablet core: Calcium hydrogen
stomach (gastritis) phosphate, starch, pregelatinized
• constipation, stomach pain (maize starch), croscarmellose
associated with diarrhoea and sodium, sodium lauryl sulfate,
fever magnesium stearate.
• difficulty swallowing Tablet coating: Lactose
• swollen abdomen monohydrate, hypromellose,
• dry mouth titanium dioxide (E 171), triacetin.
• belching What Azithromycin looks like and
• mouth ulcer contents of the pack
• increased salivary flow Film-coated tablet.
• inflammation of the liver Azithromycin 250 mg film-coated
(hepatitis) tablets:
• allergic skin reactions such as White to off-white, oblong shaped,
skin more sensitive to sunlight film coated biconvex tablets,
than normal, red, flaking and debossed with “66” on one side and
swollen skin “D” on other side.The size is 13.5
• skin rash mm x 6.6 mm
• itching Azithromycin 500 mg film-coated
• inflammation of the skin tablets:
(dermatitis) White to off-white, oval shaped, film
• dry skin coated biconvex tablets debossed
• increased sweating with “6” and “7” on either side of the
• pain, swelling and reduced score-line on one side and “D” on
motion in your joints other side.The size is 17.1 mm x
8.5 mm
(osteoarthritis)
• muscle pain The tablet can be divided into equal
• back pain doses.
• neck pain Azithromycin film-coated tablets are
• increase in blood urea levels available in clear PVC-Aluminium
• painful or difficult urination blister packs.
• pain in the upper back (renal Blister packs: 2,3,4,6 and 12 film-
pain) coated tablets
• spotting Not all pack sizes may be marketed.
• testicular disorder
Marketing Authorisation Holder
• urticaria and Manufacturer
• chest pain Milpharm Limited
• face swelling Ares Block, Odyssey
• fever Business Park
• pain West End Road
• swelling of extremities(peripheral Ruislip HA4 6QD
edema) United Kingdom
• swelling (oedema) Manufacturer
• general feeling of being unwell APL Swift Services (Malta)
(malaise) Limited
• weakness (asthenia) Hf26, Hal Far Industrial
• change in liver enzyme levels Estate, Hal Far
and blood levels Birzebbugia, BBG 3000
• post procedural complications Malta
• general discomfort or
• abnormal laboratory test values
Milpharm Limited
(e.g. blood or liver tests). Ares Block, Odyssey
Rare (may affect up to 1 in 1,000 Business Park
people) West End Road
• feeling agitated, feeling of Ruislip HA4 6QD
unreality to the self and own United Kingdom
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feeling This leaflet was last revised

• vertigo in 01/2025.
• abnormal hepatic function,
• allergic skin reactions