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AZITHROMYCIN 500MG TABLETS

Active substance: AZITHROMYCIN MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Azithromycin 500 mg Tablets
Azithromycin

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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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1.
What Azithromycin Tablets are and what they are used for
2.
Before you take Azithromycin Tablets
3.
How to take Azithromycin Tablets
4.
Possible side effects
5.
How to store Azithromycin Tablets
6.
Further information

1.

WHAT AZITHROMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR

Azithromycin Tablets is an antibiotic. It belongs to a group of antibiotics called macrolides. It is used to treat infections
caused by bacteria.
This medicine is usually prescribed to treat:
• chest infections such as bronchitis, pneumonia
• infections of the tonsils, throat (pharyngitis) and sinuses
• ear infections
• skin and soft tissue infections, with exception of infected burn wounds
• urethra and cervix infections caused by chlamydia.

2.

BEFORE YOU TAKE AZITHROMYCIN TABLETS

Do not take this medicine if you are allergic (hypersensitive) to:
• azithromycin
• any other macrolide or ketolide antibiotic
• any of the other ingredients of this medicine (see “Important information about some of the ingredients of
Azithromycin Tablets” for information on soya lecithin).
Take special care with this medicine.
Tell your doctor if you have any of the following illnesses before taking this medicine:
• Liver problems: if you have severe liver problems or if these occur during treatment, your doctor may stop treatment
• Kidney problems: if you have severe kidney problems, the dose may have to be adjusted.
• Nervous (neurological) or mental (psychiatric) problems.
• A certain type of muscle weakness called myasthenia gravis.
Since azithromycin may increase the risk of abnormal heart rhythm please tell your doctor if you have any of the
follwing problems before taking this medicine:
• Heart problems such as a weak heart (heart failure), very slow heart rate, irregular heart beat, or something called
“long QT syndrome” (found by an electro-cardiogram)
• Low potassium or magnesium in your blood.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines. This includes any medicines
obtained without a prescription. It is especially important to mention before taking this medicine:
• Theophylline (used to treat asthma): the effect of theophylline may be increased.
• Warfarin or any similar medicine to prevent blood clots: concomitant use can increase the risk of bleeding.
• Ergotamine, dihydroergotamine (used to treat migraine): ergotism (ie. itching in the limbs, muscle cramps and
gangrene of hands and feet due to poor blood circulation) may occur. Concomitant use is therefore not recommended.
• Cyclosporin (used to suppress the immune system to prevent and treat rejection of an organ or bone marrow
transplant): if concomitant use is required, your doctor will check your blood levels regularly and may adapt the
dose.
• Digoxin (for heart failure): digoxin levels may increase. Your doctor will check your blood levels.
• Antacids (for indigestion): see section 3
• Cisapride (for stomach problems), terfenadine (used to treat hay fever): concomitant use with azithromycin may
cause heart disorders
• Medicines for irregular heart beat (called anti-arrythmics).
• Nelfinavir (used to treat HIV infections): concomitant use can increase the side effects of azithromycin.
• Alfentanil (used for narcosis) or astemizol (used to treat hay fever): concomitant use with azithromycin may
increase the effect of these medicinal products.
Taking Azithromycin Tablets with food and drink
The tablets may be taken with or without food.
Pregnancy and breast-feeding
Tell your doctor or pharmacist if you are pregnant, or are planning to become pregnant or if you are breast-feeding
before taking any medicine. You should not use this medicine during pregnancy and when you are breast-feeding
unless your doctor has specifically recommended it.
This medicine goes into human milk. So, you should stop breastfeeding until 2 days after you have finished taking this
medicine.
Driving and using machines
This medicine may cause side effects such as dizziness or convulsions. This may make you less able to do certain
things, such as driving or using machines.
Important information about some of the ingredients of Azithromycin Tablets
This medicine has soya lecithin in it. If you are allergic to peanut or soya, do not use this medicine.

3.

HOW TO TAKE AZITHROMYCIN TABLETS

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you
are not sure. These doses are for adults and children weighing more than 45 kg. Children weighing less than this
should not take these tablets.
Azithromycin Tablets is taken as a 3 or 5 day course
• 3 day course: Take 500 mg (two 250 mg or one 500 mg tablet) once each day
• 5 day course:
- Take 500 mg on Day 1 (two 250 mg tablets)
- Take 250 mg (one 250 mg tablet) on Days 2, 3, 4 and 5
For urethra & cervix infections caused by chlamydia, it is taken as a 1 day course:
• 1 day course: 1,000 mg ( four 250 mg tablets or two 500 mg tablets).
Take the tablets together on one day only. Swallow these tablets whole with a drink of water.
• You can take these tablets with or without food.
Taking Azithromycin Tablets with medicines for indigestion
• If you need to take a medicine for indigestion, such as an antacid, take your tablets at least one hour before or two
hours after the antacid.
If you forget to take this medicine:
• If you forgot to take a dose, take it as soon as possible. Then go on as before. Do not take more than one dose in
a single day.

If you take more of this medicine than you should:
If you take too many tablets you may feel unwell. You also may experience other side effects such as deafness and
diarrhoea. Tell your doctor or talk to your nearest hospital casualty department immediately. If possible, take your
tablets or the box with you to show the doctor what you have taken.
If you stop taking this medicine:
Always keep taking the tablets until the course is finished, even if you feel better. If you stop taking the tablets too
soon, the infection may come back. Also, the bacteria may become resistant to the medicine and will then be more
difficult to treat. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
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.
• increased or reduced urine output, or traces of blood in your urine caused by kidney problems
• skin rash caused by sensitivity to sunlight
• unusual bruising or bleeding
• irregular or rapid heart beat
These are all serious side effects. You may need urgent medical attention. Serious side effects are uncommon
(affecting less than 1 in 100 patients), rare (affecting less than 1 in 1000 patients) or the frequency cannot be
estimated from the available data.
Other possible side effects:
Very common side effects (affecting more than 1 in 10 people):
• stomach upset, stomach cramps, feeling sick, diarrhoea, wind
Common side effects (affecting less than 1 in 10 people):
• loss of appetite or taste disturbance
• tiredness, dizziness, headache, tingling of the hands or feet
• vision impairment
• deafness
• indigestion, vomiting
• skin rash, itching
• joint pains
• changes in white blood cells and decreased blood bicarbonate
Uncommon side-effects (affecting less than 1 in 100 patients):
• yeast infections especially of the mouth, infections of the vagina
• nervousness, decreased skin sensitivity, drowsiness, sleeplessness
• ringing in the ear, impaired hearing
• pounding heart beat
• inflammation of the bowel, constipation
• inflammation of the liver, changes in liver enzymes
• hypersensitivity, itchy rash, being sensitivity to sunlight
• chest pain, skin swelling, generally feeling unwell, weakness
• abnormal kidney function test results, abnormal blood potassium
• reductions in white blood cells
Rare side-effects (affecting less than 1 in 1000 patients):
• agitation, a feeling of loss of identity, spinning sensation
• abnormal liver function
• reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness
• reduction in blood platelets, which increases risk of bleeding or bruising
Side effects of unknown frequency:
• muscle weakness (myasthenia gravis)
• anxiety, fainting, fits, feeling hyperactive, feelings of aggression
• disturbed sense of smell, loss of sense of smell or taste
• low blood pressure
• staining of the tongue
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

5.

HOW TO STORE AZITHROMYCIN TABLETS

Keep out of the reach and sight of children.
Do not use Azithromycin Tablets after the expiry date which is stated on the carton after EXP: The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage conditions.
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

What Azithromycin Tablets contains
• Azithromycin 500 mg Tablets The active substance is azithromycin monohydrate equivalent to 500 mg azithromycin.
• The other ingredients are in the:
- Core: microcrystalline cellulose, pregelatinised maize starch, sodium starch glycolate Type A, colloidal
anhydrous silica, sodium laurilsulfate, magnesium stearate,
- Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.
What Azithromycin Tablets looks like and contents of the pack
Azithromycin 500 mg Tablets are white to off-white, oblong, film-coated, deep break line on one side and scoreline on
other side. The tablet can be divided into equal halves.
Azithromycin 500 mg Tablets are packed in a PVC/PVdC//Aluminium-blister.
The 500 mg tablets are packed in the following pack sizes:
Carton box with blister(s) containing: 2, 3, 6, 12, 24, 30, 50, or 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder: Sandoz Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR,UK.
Manufacturer: Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria or Lek d.d. Pharmaceuticals, Verovśkova 57,
1526 Ljubljana, Slovenia or Sandoz S.R.L., Livenzeni Street no 7A, Targu Mures, Romania.
This leaflet was last approved in 09/2010

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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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