Package leaflet: Information for the user. Azithromycin Orifarm 500 mg film-coated tablets. azithromycin

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1 Package leaflet: Information for the user Azithromycin Orifarm 250 mg film-coated tablets Azithromycin Orifarm 500 mg film-coated tablets azithromycin Read all of this leaflet carefully before you start using 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, pharmacist or nurse. - 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. See section 4. What is in this leaflet: 1. What Azithromycin Orifarm is and what it is used for 2. What you need to know before you take Azithromycin Orifarm 3. How to take Azithromycin Orifarm 4. Possible side effects 5. How to store Azithromycin Orifarm 6. Contents of the pack and other information 1. What Azithromycin Orifarm is and what it is used for Azithromycin is an antibiotic. It belongs to a group of antibiotics called `macrolides`. Azithromycin Orifarm is used to treat bacterial infections caused by `micro-organisms` such as bacteria. These infections include: - chest infections such as acute bronchitis and pneumonia - infections in your sinus, throat, tonsil or ears - mild to moderate skin and soft tissue infections e.g. infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulites), skin infection with shiny red swelling (erysipelas) - infections caused by a bacteria called Chlamydia trachomatis. They can cause inflammations of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix). 2. What you need to know before you take Azithromycin Orifarm Do not take Azithromycin Orifarm if - you are allergic to azithromycin dihydrate or any of the other ingredients of this medicine (listed in section 6). - you are allergic (hypersensitive) to erythromycin or any other `macrolide` or `ketolide` antibiotics. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Azithromycin Orifarm. Page 1

2 Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Azithromycin Orifarm if you: - have liver problems: your doctor may need to monitor your liver function or stop the treatment - have kidney problems - have severe heart problems or problems with your heart beat (shown on an electro-cardiogram or ECG machine) - blood levels of potassium or magnesium are too low - develop signs of another infection - experience worsening or onset of myasthenia gravis (muscle disease where the muscles gradually become weaker). - experience your newborn treated with azithromycin vomit or shows discomfort during feeding, contact a doctor immediately. Stop taking Azithromycin Orifarm 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, shortness of breath, shock, 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 or infections caused by the bacteria C. difficile. Other medicines and Azithromycin Orifarm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor or pharmacist if you are taking any of the following medicines: - antacids - used for heartburn and indigestion. Azithromycin Orifarm and antacids should not be taken at the same time. - ergotamine - used for migraine - pimozide - used to treat mental health problems - terfenadine - used to treat hay fever. This may cause heart problems (shown on an electrocardiogram or ECG machine). - medicines used to treat heart rhythm problems such as quinidine or amiodarone. - statins used to lower cholesterol. This may induce the side effect rhabdomyolysis (breakdown of muscle tissue). - zidovudine or nelfinavir - used to treat HIV infections. Taking nelfinavir with azithromycin may mean that you get more of the side effects listed in this leaflet. - rifabutin - used to treat tuberculosis (TB) Tell your doctor or pharmacist if you are taking any of the following medicines. Azithromycin Orifarm can make the effects of these other medicines stronger. Your doctor may change your dose: - digoxin - used to treat heart problems - colchicine used for gout and familial Mediterranean fever - warfarin or similar medicines - used to thin the blood. Azithromycin Orifarm can thin the blood even more. - cyclosporin - used to stop your body rejecting an organ transplant. Your doctor will regularly check your blood levels of cyclosporin and may change your dose. - theophylline used for breathing problems such as asthma and chronic obstructive pulmonary disease (COPD). Page 2

3 Azithromycin Orifarm with food and drink This medicine can be taken with or without food. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, do not use Azithromycin Orifarm unless your doctor specifically recommends you to. Breast-feeding Azithromycin passes into breast milk. Because it is not known whether azithromycin may have adverse effects on the breast-fed infant, nursing should be discontinued during treatment with azithromycin. Driving and using machines You may feel dizzy or have fits (convulsions) while taking this medicine. If this happens, do not drive or use any tools or machines. Azithromycin Orifarm contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Azithromycin Orifarm Always take this medicine exactly as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure. Taking this medicine - Swallow the tablets whole with a glass of water. - Do not crush or chew the tablets. The recommended dose is: Adults and young people with a body weight of 45 kg and above: The recommended 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: one 500 mg tablet each day. or - over five days: one 500 mg tablet on day 1 and then one 250 mg tablet on days 2, 3, 4 and 5. The dose is different if you have inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix). Your doctor will ask you to take a single dose of 1000 mg. Infection of the genitals The dose varies depending on the type of infection. Children and adolescents with a body weight of less than 45 kg: The tablets are not recommended. Children and adolescents with a body weight of less than 45 kg should use other forms of this medicine such as azithromycin suspension. Elderly No dose adjustment is necessary. Page 3

4 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 Orifarm than you should If you take more Azithromycin Orifarm than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: - temporary loss of hearing - feeling very sick (severe nausea), being sick (vomiting), abdominal pain and diarrhoea. If you forget to take Azithromycin Orifarm - If you forget a dose, take it as soon as you remember it. - However, if it is nearly time for the next dose, skip the missed dose. - Do not take a double dose to make up for a forgotten dose. - If you have to skip a dose, still take all of your tablets. This means that you will finish your course a day later. If you stop taking Azithromycin Orifarm Do not stop taking Azithromycin Orifarm without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Azithromycin Orifarm and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: - swelling of your face, lips, tongue, face 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 and/or angioedema (may affect up to 1 in 100 people) or anaphylaxis (not known, frequency cannot be estimated from available data). - severe diarrhoea that lasts a long time or has blood or mucus in it. These could be signs of a serious gut (intestine) problem called pseudomembranous colitis (not known, frequency cannot be estimated from the available data). - fever, red spotted skin, blistering or peeling skin, joint pain, swollen eyes. These could be signs of a serious reaction such as Steven-Johnson syndrome or toxic epidermal necrolysis (not known, frequency cannot be estimated from the available data). - serious drug reaction (DRESS) with rashes, fever, swollen lymph nodes and altered blood values (may affect up to 1 in 1,000 people). - serious drug reaction (AGEP) with rash, fever, altered blood values and blisters on the skin of millimetre size (may affect up to 1 in 1,000 people). Other side effects include: Very common (may affect more than 1 in 10 people): - diarrhoea. Common (may affect up to 1 in 10 people): - headache, nausea or vomiting - stomach pain - changes in your blood count, decreased amount of bicarbonate in your blood. Page 4

5 Uncommon (may affect up to 1 in 100 people): - constipation, gas, inflammation of the stomach lining (gastritis), difficulty in swallowing, feeling bloated, dry mouth, burping, mouth ulceration, increased salivary secretion - loss of appetite - feeling dizzy or drowsy - feeling nervous, having difficulty sleeping (insomnia) - sensation of pins and needles or numbness (paraesthesia) - muscle pain, back and neck pain, swelling and pain in the joints (osteoarthritis) - changes in your sense of taste and smell, visual impairment, ear disorder, vertigo - skin rashes and itching, hives, inflammation of the skin, dry skin, abnormally increased sweating - inflammation of the vagina - difficulties emptying the urinary bladder, kidney pain - abnormal bleeding that occurs between periods, testicular disorder - pneumonia, inflammation of the throat, stuffy and runny nose, infection of the stomach and intestine (gastroenteritis) - fungus infection (such as thrush), bacteria infection - respiratory disorder, difficulty breathing (dyspnoea), nose bleedings - feeling your heart beat (palpitations), flushing - reduction of white blood cells - general discomfort, weakness, tiredness, fluid retention (oedema), chest pain, pain, fever - abnormal laboratory tests (such as blood and lever function tests) - complications after surgery. Rare (may affect up to 1 in 1,000 people): - agitated - sunburn-like reactions - abnormal liver function, jaundice Not known (frequency cannot be estimated from the available data): - reduced number of red blood cells due to destruction (haemolytic anaemia); reduction in number of platelets - feeling angry, anxious, delirious - fainting, hallucination - reduced sense of touch or sensation - a disease causing muscle weakness (Myasthenia gravis) - red, flaking and swollen skin - hearing loss or ringing in your ears - rapid or irregular heart beat, sometimes being life-threatening, changes of the heart rhythm found by an electro-cardiogram - low blood pressure - your tongue change colour inflammation of the pancreas (pancreatitis) severe liver function disorder (hepatic failure, hepatitis fulminant, hepatic necrosis) - kidney problems - loss of taste, loss or change in smell - fits (convulsions) - joint pain. If you are taking Azithromycin Orifarm to treat or prevent Mycobacterium Avium Complex The following reactions are reported unique or more often when used for Mycobacterium Avium Page 5

6 Complex: Very common (may affect more than 1 in 10 people): Stomach pain, nausea, abdominal discomfort, loose stools or gas Common (may affect up to 1 in 10 people): loss of appetite feeling dizzy or drowsy, sensation of pins and needles or numbness (paraesthesia), taste disturbances visual impairment deafness skin rashes and itching joint pain tiredness Uncommon (may affect up to 1 in 100 people): reduced sense of touch or sensation hearing impaired, tinnitus hepatitis fever, red spotted skin, blistering or peeling skin, joint pain, swollen eyes (Stevens-Johnson syndrome), sunburn like reactions 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Azithromycin Orifarm Keep this medicine out of the sight and reach of children. Do not store above 25 C. Do not use this medicine after the expiry date which is stated on the packet after 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 protect the environment. 6. Contents of the pack and other information What Azithromycin Orifarm contains The active substance is azithromycin dihydrate equivalent to 250 mg or 500 mg azithromycin pr tablet. The other ingredients are: Tablet core: Calcium hydrogen phosphate, dihydrate, hydroxypropylcellulose (E463), croscarmellose sodium, magnesium stearate (E572). Page 6

7 Tablet coat: Hypromellose (E464), lactose monohydrate, titanium dioxide (E171), triacetin. What Azithromycin Orifarm looks like and contents of the pack Azithromycin Orifarm 250 mg film-coated tablets are white, oval, biconvex, film-coated tablets, with APO engraved on one side and AZ250 on the other. The tablets are available in blisters of 2, 3, 4, 6, 7, 9, 10, 12, 14, 20, 24, 28, 30, 35, 98, 99 and 100 tablets and bottles of 30 tablets. Azithromycin Orifarm 500 mg film-coated tablets are white, oval, biconvex, film-coated tablets, with APO engraved on one side and AZ500 on the other. The tablets are available in blisters of 2, 3, 4, 6, 7, 10, 28, 30 and 35 tablets and bottles of 30 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Orifarm Generics A/S Energivej 15, DK-5260 Odense S Denmark info@orifarm.com This medicinal product is authorised in the Member States of the EEA under the following names: Denmark, Sweden Azithromycin Orifarm This leaflet was last revised in Page 7