Azithromycin 500 Mg Film-Coated Tablets
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Package leaflet: Information for the user
Azithromycin 500 mg Film-coated tablets Azithromycin
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet
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. Howto store Azithromycin
6. Contents of the pack and other information
1. What Azithromycin is and what it is used
Your medicine belongs to a class of medicines called macrolide antiobiotics. It is used to treat a number of infections including:
• tonsillitis, pharyngitis, sinusitis, bronchitis and pneumonia
• skin and soft tissue infections (eg abscesses and other infections)
• acutemiddle earinfections
• uncomplicated genital infections caused by an organism called Chlamydia
following organ transplants
• terfenadine (an antihistamine)
• theophylline (for breathing problems)
Azithromycin with food, drink and alcohol
You may take your medicine with or without food as it does not affect the absorption of your tablets.
Pregnancy, breast-feeding and fertility
Azithromycin is not recommended if you are pregnant or planning to become pregnant. Azithromycin should only be used during pregnancy when clearly necessary.
You should not breast-feed whilst you are
taking Azihtromycin, because a risk to the
suckling infant can not be excluded
Ask your doctor for advice before taking any
medicine.
Driving and using machines
Azithromycin may make you feel dizzy. If affected, do not drive or operate machinery.
3. Howto take Azithromycin
2. What you need to know before you take Azithromycin
Do nottakeAzithromycin
• if you are allergic to azithromycin (the active ingredient in your medicine), erythromycin or to any other macrolide or ketolide antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking taking Azithromycin.
Your doctor needs to know before you take Azithromycin if you have or have had any of the following conditions:
• kidney problems
• heart conditions, in particular problems with your heart beat such as long QT syndrome (shown on an electro-cardiogram or ECG machine)
• liver problems: your doctor may need to monitor your liver function or stop the treatment
• nervous (neurological) or mental health (psychiatric) problems
• and if you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with Azithromycin.
Stop taking Azithromycin and see a doctor straight away if you notice any of the following serious side effects while taking this medicine:
• swelling of your face, lips, tongue or throat, difficulty breathing or swallowing, rash which may range from itchy skin rash to serious blistering of the skin or ulcers on your lips, eyes, nose, mouth and genitals. These could be signs of a severe allergic reaction, angioedema or anaphylaxis.
• severe diarrhoea that lasts a long time or has blood and mucous in it. These could be signs of a serious gut (intestine) problem called 'pseudomembranous colitis'.
Other medicines and Azithromycin
Tell your doctor or, pharmacist if you are taking, have recently taken or might take any other medicines
• Azithromycin should be taken at least one hour before or two hours after you take your antiacids
• digoxin(forheartproblems)
• 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
• rifabutin (for HIV or tuberculosis)
• medicines known as ergot derivatives e.g. ergotamine or dihydroergotamine (medicines used for migraines or reducing bloodflow) should not be taken together with azithromycin
• warfarin or other medicines to thin your blood
• ciclosporin ( a medicine used for skin conditions, rheumatoid arthritis, or
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacistif you are not sure. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
This medicine should be taken in a single daily dose. The tablets should be swallowed whole and may be taken with or without food. The length of treatment for various infectious diseases is set outbelow.
Always continue with the course even if you feel better. If your infection gets worse or you do not start to feel better within a few days or a new infection develops, go back and see your doctor.
The recommended dose is:
Adults: Respiratory tract and skin or soft tissue infections:
The usual total dose is 1500 mg. This can be taken in two ways. Your doctor will tell you which way to take it:
• Over three days: 500 mg (1 tablet) each day. or
• Over five days: 500 mg on day 1 and then 250 mg on days 2,3,4 and 5.
Uncomplicated genital infections: 1000 mg (2 tablets) as asingledose.
Eldery: The usual adult doses may be used Use in children: For children weighing more than 45kg the usual adult dose maybe used Use in children and adolescents with a body weight below 45 kg:
Tablets are not indicated for these patients. Other pharmaceutical forms of azithromycin may be used, such as suspensions.
Patients with kidney or liver problems 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 nearest hospital casualty department or your doctor immediately.
It is important to stick to the dose on the label of your medicine. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets. Symptons of overdose may include severe nausea, vomiting and diarrhoea and reversible loss of hearing.
Ifyou forget to take Azithromycin
If you forgot to take a dose of your medicine then do not take the missed dose between meals. Wait until your next scheduled dose and meal and continue taking your tablets as per normal Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse
DATE: 15-05-12
If you stop taking Azithromycin
If you stop taking Azithromycin too soon, the infection may return. Take the tablets for the full time of treatment, even when you begin to feel better.
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. 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 tablets 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 tablets:
• 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 alleTgic reactions)
• severe, persistent diarrhoea especially if it has blood or mucus in it (this may be Pseudomembranous colitis)
The following side effects have also been reported:
• Very common (affects more than 1 user in 10
• Common (affects 1 to 10 users in 100
• Uncommon (affects 1 to 10 users in 1,000):
• Rare (affects 1 to 10 users in 10,000):
• Very rare (affects less than 1 user ini0,000)
• not known - frequency cannot be estimated from available data
Very Common:
• Diarrhoea
• abdominal pain
• Nausea
• intestinal gas (wind)
Common
• Loss of appetite
• Dizziness
• Headache
• Numbness in the fingers
• Change in the sense of taste
• Problems in sight
• Hearing problems
• Indigestion
• rashes or itching
• Jointpain
• feeling tired or weak
• Changes in blood test levels Uncommon:
• vaginal infections
• changes to the number of certain types of blood cells
• vaginal infections
• Allergic reactions which may range from skin rash, swollen itchy skin and skin eruptions to difficulty in breathing and dizziness
• Nervousness
• Somnolence
• inability to sleep
• hearing problems, hearing loss or tinnitus (ringing in the ears)
• heart palpitations (a strong or forceful heartbeat)
• Stomach pain
• Constipation
• hepatitis (an inflammation of the liver)
• Severe hypersensitivity reaction with high fever, red spotted skin, joint pain and /or inflammation of the eyes
• increased sensitivity to sunlight and sun beds, or other serious skin reactions
• Chest pain
• Swelling (oedema)
• General sensation of malaise
• feeling tired or weak
• Changes in laboratory tests
• headache, dizziness or fits
• alleTgic reactions with rashes or itching
• taste disturbances, indigestion, inflammation of the gut, loss of appetite or wind
• jointpain Rare:
• Restlessness
• vertigo
• liver problems
• allergic reactions
Not known - frequency cannot be estimated from available data
• Severe prolonged diarrhoea which may indicate a very rare inflammation of the large intestine
• Reduction in blood cells with bruises and tendency to bleed (thrombocytopenia)
• Anaemia (decrease in red blood cells)
• Severe allergic reactions which may reach shock (drop in blood pressure, weak rapid pulse, clammy skin, reduced consciousness
• aggressive reaction, anxiety,
• Fainting or fits
• Hyperactivity
• Changes or loss in the sense of taste and smell
• Worsening of the symptoms of myasthenia gravis (muscular weakness and fatigue)
• Heart symptoms with change in the speed of your heart beat
■ Decrease of blood pressure
■ Inflammation of the pancreas (pancreatitis)
■ tongue discolouration
• hepatitis (an inflammation of the liver), jaundice (yellowing of the skin or the whites of the eyes), liver failure and liver damage
• Kidney damage
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
5. How to store Azithromycin
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the outer carton alter EXP. The expiry date refers to the last day of that month.
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 to protect the environment.
6. Contents of the pack and other information
What Azithromycin contains
The active substance is azithromycin.
Each film-coated tablet of Azithromycin contains 500 mg of the active substance azithromycin
The other ingredients are: pregelatinised starch, crospovidone, calcium hydrogen phosphate, anhydrous sodium laurilsulfate and magnesium stearate. The coating contains hypromellose, titanium dioxide (El71), lactose monohydrate and triacetin.
What Azithromycin looks like and contents of the pack
White, oblong, biconvex, film coated tablets, scored on one side.
Azithromycin 500 mg film-coated tablets is available inpacks of 3 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue,
Kenton, Middlesex, HA3 0BU United Kingdom
Manufacturer:
Bluepharma Indtistria Farmac£utica S. A.
S. Martinho do Bispo 3045-016 COIMBRA Portugal
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder This leaflet was last revised in: July 2014
DATE: 15-05-12