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AZITHROMYCIN 500MG FILM COATED TABLETS

Active substance(s): AZITHROMYCIN / AZITHROMYCIN MONOHYDRATE

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AZITHROMYCIN
250mg and 500mg
FILM-COATED TABLETS

If you develop severe or 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.
PACKAGE LEAFLET
Taking other medicines
INFORMATION FOR THE USER
Check with your doctor if you are taking any of the
Read all of this leaflet carefully before you start
following:
taking this medicine.
Antacids e.g. aluminium hydroxide: take
Keep this leaflet. You may need to read it again
azithromycin at least 1 hour before or 2 hours after
If you have any further questions, ask your doctor or
taking an antacid
pharmacist
Ergot derivatives e.g. ergotamine, (used to treat
This medicine has been prescribed for you. Do not
migraine): azithromycin should not be taken at the
pass it on to others. It may harm them, even if their
same time, as ergotism may develop (a potentially
symptoms are the same as yours
serious side effect with numbness or tingling
If any of the side effects get serious, or if you notice
sensations in the limbs, muscle cramps, headaches,
any side effects not listed in this leaflet, please tell
convulsions, abdominal or chest pain)
your doctor or pharmacist
Coumarin derivatives e.g. warfarin (used to stop the
This medicine is called either Azithromycin 250mg Filmblood clotting): the risk of bleeding may be
Coated Tablets or Azithromycin 500mg Film-Coated
increased
Tablets but will be referred to as Azithromycin
Digoxin (used to treat heart failure): the levels of
throughout the leaflet.
digoxin in your blood may increase
Zidovudine nelfinavir (used in the treatment of HIV):
IN THIS LEAFLET
the levels of zidovudine or azithromycin might be
increased
1. What Azithromycin is and what it is used for
Rifabutin (used in the treatment of HIV and bacterial
2. Before you take Azithromycin
infections including tuberculosis): decreases in your
3. How to take Azithromycin
number of white blood cells could occur
4. Possible side effects
Ciclosporin (an immunosuppressant used following
5. How to store Azithromycin
organ transplant): your doctor will need to monitor
6. Further information
your ciclosporin blood levels
WHAT AZITHROMYCIN IS AND WHAT IT IS
Cisapride (used to treat stomach problems): heart
1 USED FOR
problems may occur
Astemizole, terfenadine (antihistamines used to treat
Azithromycin is one of a group of antibiotics called
allergic reactions): their effect might be increased
macrolides. It is used to treat bacterial infections
Alfentanil (a painkiller): the effect of alfentanil might
caused by micro organisms such as bacteria. These
be increased
infections include:
Fluconazole (for fungal infections): the levels of
Chest infections such as acute bronchitis and
azithromycin might be reduced.
pneumonia
No
interactions have been observed between
Infections in your sinuses, throat, tonsils or ears
azithromycin and cetirizine (an antihistamine);
Mild to moderate skin and soft tissue infections
didanosine, efavirenz, indinavir (for HIV infection);
e.g. infection of the hair follicles (folliculitis),
atorvastatin (for cholesterol and heart problems);
bacterial infection of the skin and its deeper layers
carbamazepine (for epilepsy); cimetidine (an antacid);
(cellulitis), skin infection with shiny red swelling
methylprednisolone (to suppress the immune system);
(erysipelas)
midazolam, triazolam (sedatives); sildenafil (for
Infections caused by bacterium called Chlamydia
impotence) and trimethoprim/ sulphamethoxazole (an
trachomatis. They can cause inflammations of the
antibiotic combination).
tube that carries urine from your bladder (urethra)
or where your womb joins your vagina (cervix).
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
2 BEFORE YOU TAKE AZITHROMYCIN
Pregnancy and breast-feeding
Do NOT take Azithromycin:
There is insufficient information regarding the safety of
If you are allergic (hypersensitive) to azithromycin
azithromycin during pregnancy. Consequently,
or any of the other ingredients of this medicine or
azithromycin is not recommended if you are pregnant
any other macrolide or ketolide antibiotic, e.g.
or planning to become pregnant. However, your doctor
erythromycin or telithromycin.
may prescribe it under serious circumstances.
Take special care with Azithromycin
You should not breast-feed whilst you are taking
Talk to your doctor before you start to take this
azithromycin, because it may cause side effects
medicine if you:
including diarrhoea and infection in your baby. You may
have ever had a serious allergic reaction causing
resume nursing two days after stopping your treatment
swelling of the face and throat, possibly with
with azithromycin.
breathing problems
Ask
your doctor for advice before taking any medicine.
have severe kidney problems: your doctor may alter
the dose
Driving and using machines
have liver problems: your doctor may need to
Azithromycin may cause dizziness and fits. If affected,
monitor your liver function or stop the treatment
do not drive or operate machinery.
are aware of ever being diagnosed with prolonged
QT interval (a heart condition): azithromycin is not
3 HOW TO TAKE AZITHROMYCIN
recommended
Always take Azithromycin exactly as your doctor has
are aware that you have a slow or irregular heart
told you. You should check with your doctor or
beat or reduced heart function: azithromycin is not
pharmacist if you are not sure.
recommended
know that you have low levels of potassium or
The tablets should be swallowed preferably with a drink
magnesium in your blood: azithromycin is not
of water, and can be taken with or without food.
recommended
The usual dose is:
are taking medicines known as antiarrhythmics
Adults (including the elderly) and children with a
(used to treat abnormal heart rhythms), cisapride
body weight of over 45kg:
(used to treat stomach problems) or terfenadine
The usual dose is 1500mg divided over either 3 or 5
(an antihistamine that is used to treat allergies):
days as follows:
azithromycin is not recommended
When taken over 3 days, 500mg a day
are taking medicines known as ergot alkaloids
When taken over 5 days, 500mg on the first day and
(such as ergotamine), which are used to treat
then 250mg on days 2 through to 5
migraine: azithromycin is not recommended (see
Inflammation of the urethra or cervix caused by
'Taking other medicines' below)
Chlamydia: 1000mg taken as a single dose, for one
have been diagnosed with a neurological disease
day only.
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.
(continued overleaf)

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

230415-AZI001-PIL-06
N/A

Azithromycin PIL - Side 1
323 x 160mm
23 April 2015
14056/06 PIL S1.ai
1 Colour - Black

M1

Children and Adolescents under 45kg:
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
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
product, ask your doctor or pharmacist

4

POSSIBLE SIDE EFFECTS

Like all medicines, Azithromycin 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 difficultly in breathing; skin
rash or hives)
blisters/bleeding of the lips, eyes, nose, mouth and
genitals, which may be caused by Stevens-Johnson
syndrome or toxic epidermal necrosis, which are
serious illnesses
an irregular heart beat
prolonged diarrhoea with blood and mucus.
These are very serious but rare side effects. You may
need urgent medical attention or hospitalisation.
The following other side effects have been reported:
Very common (affecting more than 1 user in 10):
Diarrhoea, stomach pain, feeling sick, wind.
Common (affecting 1 to 10 users in 100):
Changes in the numbers of some white blood cells
and blood bicarbonate
Dizziness, headache, pins and needles or
numbness
Taste disorders
Sight disorders
Deafness
Vomiting, indigestion, loss of appetite
Rash, itching
Joint pain
Tiredness.
Uncommon (affecting 1 to 10 users in 1,000):
Yeast infection e.g. of the mouth (thrush), vaginal
infection
Blood disorders characterised by fever or chills,
sore throat, ulcers in your mouth or throat
Allergic reactions
Loss of sensation, sleepiness, difficulty sleeping
Hearing disturbances including ringing in the ears
Abnormality of the rhythm or rate and awareness of
the heart beat (palpitations)
Inflammation of the stomach, constipation, loose
stools
Hepatitis (inflammation of the liver)
Reddening and blistering of the skin when exposed
to sunlight, hives (nettle rash)
Inflammation of the vagina
Chest pain, swelling, feeling unwell, lethargy
Changes in liver enzymes and laboratory blood
values.
Rare (affecting 1 to 10 users in 10,000):
Agitation
A feeling of things being unreal
Confusion, especially in the elderly
Spinning sensation
Teeth discolouration
Abnormal liver function.

The frequency of the following side effects is not
known:
Blood disorders characterised by unusual bleeding
or unexplained bruising, low blood count causing
unusual tiredness or weakness
Aggression, anxiety
Fainting, fits, hyperactivity, alteration or loss of the
sense of smell, loss of the sense of taste,
myasthenia gravis (fatigue and exhaustion of the
muscle, see 'Take special care with Azithromycin'
above)
Change in heart rate
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
Kidney problems
Pain.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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 out of the sight and reach of children.
Do not store above 25ºC. Store in the original package.
Do not transfer the tablets to another container.
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.
If the tablets become discoloured or show any signs of
deterioration, you should seek the advice of your
pharmacist.

6

FURTHER INFORMATION

What Azithromycin tablets contain:
Each film-coated tablet contains either 250mg or
500mg azithromycin (as azithromycin monohydrate
hemiethanolate).
The other ingredients are colloidal anhydrous silica,
butyl hydroxytoluene (E321), pregelatinised starch,
calcium hydrogen phosphate anhydrous, talc,
magnesium stearate, sodium lauryl sulphate,
lactose monohydrate, hypromellose, titanium
dioxide (E171) and glycerol triacetate (E1518).
What Azithromycin tablets look like and contents of
the pack:
Azithromycin 250mg tablets are white ,oval, filmcoated tablets, engraved "ATM 250" on one side
and plain on the other side
Azithromycin 500mg tablets are white ,oval, filmcoated tablets, engraved "ATM 500" on one side
and plain on the other side
The 250mg tablets are available in a pack size of 6
tablets.
The 500mg tablets are available in a pack size of 3
tablets.
PL holder:
Manx Pharma Ltd, Taylor Group House, Wedgnock
Lane, Warwick, CV34 5YA, UK
PL 15833/0051 Azithromycin 250mg Film-Coated
Tablets
PL 15833/0036 Azithromycin 500mg Film-Coated
Tablets
Procured from within the EU.
Manufactured by
Pharmachemie BV, Swensweg 5, Postbus 552, 2003
RN, Haarlem, The Netherlands.
To request a copy of this leaflet in large print, audio or
Braille please call 01926 482511.
This leaflet was last revised
in April 2015
WIP URN: 230415-AZI001-PIL-06

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

230415-AZI001-PIL-06
N/A

Azithromycin PIL - Side 2
323 x 160mm
23 April 2015
14056/06 PIL S2.ai
1 Colour - Black

M1

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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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