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AZITHROMYCIN 250MG CAPSULES

Active substance(s): AZITHROMYCIN

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Azithromycin 250 mg Capsules
(azithromycin)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others.
It may harm them, even if their symptoms 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.
In this leaflet:
1) What Azithromycin 250 mg Capsules are and what they are used for
2) Before you take Azithromycin 250 mg Capsules
3) How to take Azithromycin 250 mg Capsules
4) Possible side-effects
5) How to store Azithromycin 250 mg Capsules
6) Further information

1) What Azithromycin 250 mg Capsules are and what they are
used for
Azithromycin is one of the group of macrolide antibiotics. It is used to treat a
number of infections including:
• Upper and lower respiratory tract infections (eg tonsillitis, pharyngitis,
sinusitis, bronchitis and pneumonia)
• Skin and soft tissue infections (eg abscesses and other infections)
• Ear infections
• Sexually transmitted diseases caused by an organism called Chlamydia.

2) Before you take Azithromycin 250 mg Capsules
Do not take Azithromycin 250 mg Capsules
• If you are allergic (hypersensitive) to azithromycin or to any other macrolide
or ketolide antibiotics (e.g. clarithromycin, erythromycin, telithromycin), or to
any of the other ingredients of Azithromycin 250 mg Capsules
• If you are taking any of the medicines listed under ‘Taking other medicines;
Do not take’.
Take special care with Azithromycin 250 mg Capsules
Talk to your doctor before you start to take this medicine if you:
• have severe kidney problems
• have liver problems: your doctor may need to monitor your liver function or
stop the treatment
have heart problems
are taking cisapride or terfenadine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
It is especially important to tell your doctor or pharmacist if you are
taking:
• Antacids. Your Azithromycin 250 mg Capsules should be taken at least one
hour before or two hours after you take your antacids.
• Cyclosporin (a medicine used for skin conditions, rheumatoid arthritis, or
following organ transplants)
• Digoxin (for heart problems)
• Ergot derivatives e.g. ergotamine or dihydroergotamine (medicines used for
migraines or reducing blood flow)
• Rifabutin (for HIV or tuberculosis)
• Theophylline (for breathing problems)
• Warfarin or other medicines to thin your blood
• Zidovudine (for HIV). Azithromycin may reduce the blood levels of
zidovudine and should therefore be taken at least 1-2 hours before or after
zidovudine

Taking Azithromycin 250 mg Capsules with food and drink
Your medicine should be taken at least 1 hour before or 2 hours after food.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, may be pregnant or are breast-feeding.
Azithromycin 250 mg Capsules should not be used during pregnancy or
breast-feeding unless this has been discussed with your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Azithromycin 250 mg Capsules may make you feel dizzy. If affected, do not
drive or operate machinery.
Important information about some of the ingredients of Azithromycin
250 mg Capsules
This medicine contains sulphur dioxide (E220) which may rarely cause severe
allergic reactions and cause difficulty in breathing

3) How to take Azithromycin 250 mg Capsules
Always take Azithromycin 250 mg Capsules exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are not sure.
Adults
Respiratory tract and skin or soft tissue infections: 500 mg (two capsules)
once daily for three days. Sexually transmitted diseases: 1000 mg (four
capsules) as a single dose.
Elderly
The usual adult doses may be used.
Children
Azithromycin 250 mg Capsules are not recommended for use in children
weighing less than 45kg. For children weighing more than 45kg the usual
adult dose 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.
It is very important that you follow your doctor’s instructions as to the dosage
of Azithromycin 250 mg Capsules and for how long you should continue to
take your capsules. Keep taking then for as long as your doctor tells you.
If you take more Azithromycin 250 mg Capsules than you should
It is important to stick to the dose on the label of your medicine. If you or
someone else swallows several of these capsules all together, or you think a
child has swallowed any of these capsules, contact your doctor, pharmacist or
hospital emergency department immediately. Always take any capsules left
over with you and also the box, as this will allow easier identification of the
capsules.
Symptoms of overdose may include severe nausea, vomiting and diarrhoea
and reversible loss of hearing.
If you forget to take your Azithromycin 250 mg Capsules
Do not take a double dose to make up for a forgotten dose. If a dose is
forgotten, it should be taken as soon as it is remembered. However, if it is
nearly time for the next doses, miss the forgotten dose altogether and
continue with the rest of the medicine as normal.
If you stop taking your Azithromycin 250 mg Capsules
Even when you start to feel better it is important for you to keep on taking
your capsules for as long as your doctor tells you.
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 250 mg Capsules can cause side effects,
although not everybody gets them. These are usually mild to moderate, and
stop when treatment is stopped.
If you suffer from any of the following side effects, stop taking your
Azithromycin 250 mg Capsules and either tell your doctor
IMMEDIATELY or go to your nearest hospital emergency department.
You may be experiencing a rare severe allergic reaction to the capsules:
• Swelling of the hands, feet, ankles, face, lips, mouth or throat
• Problems with swallowing or breathing
• Serious skin reactions including Stevens- Johnson Syndrome (a severe skin
rash) and other severe skin rashes which may involve blistering or peeling
(these may be severe allergic reactions)
• Severe, persistent diarrhoea especially if it has blood or mucus in it (this
may be Pseudomembranous colitis).

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 250 mg Capsules
• Keep all medicines out of the sight and reach of children.
• Do not store above 25°C. 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.

6) Further Information
Very common side-effects (affecting more than 1 in 10 people):
• Diarrhoea, abdominal pain, feeling sick, flatulence.
Common side-effects (affecting less than 1 in 10 people):
• Loss of appetite
• Dizziness, headache, pins and needles, taste disturbance
• Visual impairment
• Deafness
• Vomiting, indigestion
• Rash, itching
• Joint pain
• Tiredness
• Reduction in the number of white blood cells in the blood, identified by
blood tests, which can make you more susceptible to infections, such as
mouth ulcers and sore throat
• Change to the acidity of the blood, identified by blood tests.
Uncommon side-effects (affecting less than 1 to 100 people):
• Thrush, a fungal infection, infection of the mouth, vaginal infection
• Nervousness
• Reduced sense of touch, sleepiness, inability to sleep
• Hearing impaired, ringing in the ears
• Awareness of your heartbeat, which may be faster than usual
• Inflammation of the stomach, constipation
• Inflammation of the liver
• Hives
• Chest pain, swelling, general feeling of being unwell, muscle weakness
• Change in liver enzymes (shown by blood tests)
• Change in levels of certain chemicals in the blood (shown by blood tests).
Rare side-effects (affecting less than 1 to 1000 people):
• Agitation
• Dizziness
• Abnormal liver function.
Not known (frequency cannot be estimated from the available data)
• Reduction in the number of red blood cells in the blood, which may cause
you to bruise more easily
• Aggression, anxiety
• Fainting, fits, hyperactivity, lack of smell, loss of taste, disturbance of ability
to smell
• Muscle weakness and tiredness (symptoms of a condition called
myasthenia gravis)
• Heart problems, such as a fast heart beat, or a life-threatening irregular
heart beat
• Inflammation of the pancreas, tongue discolouration
• Liver failure and other liver problems, yellowing of the skin and eyes
• Acute kidney failure, and other kidney problems

What Azithromycin 250 mg Capsules contains
The active substance is azithromycin. Each capsule contains 250 mg
azithromycin (as dihydrate).
The other ingredients are microcrystalline cellulose, magnesium stearate and
sodium lauryl sulphate.
The capsule is made of gelatin, sulphur dioxide (E220) and the colouring
agents titanium dioxide (E171), FD & C Blue 2 (E132) and indigo carmine
(E132).
What Azithromycin 250 mg Capsules looks like and contents of the pack
Hard gelatin capsule with opaque, dark blue cap and opaque, light blue body
containing white to pale yellow, odourless crystalline powder. There are no
markings on the capsule.
They are available in blister packs of 6 capsules.
PL 10383/1968

Azithromycin 250 mg Capsules

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Teva Operations Poland Sp. z.o.o. ul.
Mogilska 80, 31-546 krakko, Poland. and is procured from within the EU and
repackaged by the Product Licence holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 05.03.2016

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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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