AzitroFort contains the macrolide antibiotic azithromycin. It is active against a large number of microorganisms causing some common human diseases.

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1 Package leaflet: Information for the user AzitroFort 500 mg capsules, hard 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 or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What AzitroFort is and what it is used for 2. What you need to know before you take AzitroFort 3. How to take AzitroFort 4. Possible side effects 5. How to store AzitroFort 6. Contents of the pack and other information 1. What AzitroFort is and what it is used for AzitroFort contains the macrolide antibiotic azithromycin. It is active against a large number of microorganisms causing some common human diseases. It is used in both adults and children for the treatment of infections caused by azithromycinsusceptible bacteria and other microorganisms, such as: inflammation of the throat and tonsils, sinuses, the middle ear; bronchitis, certain types of pneumonia; infections of skin and soft tissues: erythema chronicum migrans (first stage of the socalled Lyme disease), rose (erysipelas), bacterial skin infections (impetigo, secondary pyoderma); sexually transmitted diseases caused by the microorganism called Chlamydia. 2. What you need to know before you take AzitroFort Do not take AzitroFort if you are allergic to azithromycin or any of the other ingredients of this medicine (listed in section 6); if you are allergic to erythromycin or other antibiotics of the macrolide and ketolide group; if you are currently taking medicines containing ergot derivatives. Warnings and precautions Talk to your doctor or pharmacist before taking AzitroFort. Tell your doctor: if you have or have ever had a liver disease. 1

2 Your doctor will decide whether it is necessary to monitor the health of your liver or to discontinue the treatment with this medicine. if you have experienced diarrhoea while taking antibiotics. If during or after the treatment with this medicine you have diarrhoea or loose stools, contact your doctor and do not take any other medicines before consulting with your doctor. Tell your doctor if the diarrhoea persists. if you have or have ever had a kidney disease. if you have any heart disease or complaints Contact immediately your doctor if during the treatment palpitations or other similar disturbances appear, or if you experience dizziness or weakness. if you are taking medicines to treat migraine, containing ergot derivatives such as ergotamine. These medicines should not be co-administered with azithromycin, as there is a possibility of the emergence of the so-called ergotism (bruising of the extremities, limping). It is important to know that during the treatment with this medicine, severe allergic reactions (rarely life-threatening), such as swelling of the face, lips, tongue and/or throat, shortness of breath, wheezing may appear. Some of these may occur again due to the long retention time of the medicine in the tissues. Upon occurrence or suspected occurrence of allergic reactions, you should immediately stop taking the medicine and contact your doctor. AzitroFort capsules are not suitable for use in children weighing less than 45 kg, due to the lack of accurate dosing. Other medicines and AzitroFort Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is important to know that this product may alter the effects of some simultaneously received medicines. It is therefore particularly important to tell your doctor if you take: medicines that reduce the acidity of the stomach, the so-called anti-acids. The interval between the individual doses should be not less than 2 hours. rifabutin (an antibiotic) It is possible to decrease the number of white blood cells. ciclosporine (used to suppress the rejection of organ or bone marrow after transplantation) Your doctor will assess the benefits of co-administration of azithromycin with cyclosporine. In patients, requiring this combination, plasma levels of cyclosporine should be controlled and the dose should be adjusted, if needed. warfarin, coumarin anticoagulants (used to reduce blood clotting) There is an increased risk of bleeding when co-administered with azithromycin. Your doctor may decide that it is necessary to monitor the prothrombin time or other laboratory parameters. digoxin (used to treat heart disease) Digoxin levels in the blood may increase while taking azithromycin. 2

3 ergotamine and other ergot derivatives It is possible to develop ergotism, manifested by bruising of the extremities, limping (see Warnings and precautions). terfenadine (used in allergic rhinitis or skin allergy) Irregular heartbeat and changes in the electrocardiogram may occur. AzitroFort with food, drink and alcohol AzitroFort should be taken at least 1 hour before or 2 hours after a meal. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you may be treated with azithromycin if you are pregnant or breastfeeding. Your doctor will examine the ratio of benefit to you and the risks to your baby. It is not known whether azithromycin is excreted in human milk. Your doctor will decide whether you need to discontinue breast-feeding during your treatment with azithromycin. Driving and using machines There are no data of untoward effects of AzitroFort on the ability to drive and use machines. AzitroFort contains lactose monohydrate and azorubine This product contains the excipient lactose (milk sugar), making it unsuitable for people with congenital or acquired intolerance to some sugars. If you have been told by your doctor that you have such an intolerance, contact your doctor before taking this product. The gelatin capsule contains the colourant azorubine, carmoisine (E122), which may cause allergic reactions. 3. How to take AzitroFort Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults and children weighing over 45 kg is: 1 capsule daily for 3 days in inflamed throat, tonsils, middle ear, bronchitis, pneumonia. 2 capsules, taken as a single dose, in sexually transmitted diseases, caused by the microorganism Chlamydia. Your doctor will determine the appropriate dose and treatment regime for your acne or other infections of the skin and soft tissues. AzitroFort capsules are not suitable for use in children weighing less than 45 kg, due to the lack of accurate dosing. If you have a kidney or a liver disease, your doctor may prescribe treatment with doses other than those specified. Method of administration AzitroFort capsules should be swallowed whole, once daily. Like a number of other antibiotics, the product should be taken at least one hour before or two hours after a meal. 3

4 If you take more AzitroFort than you should If you have taken more than the prescribed dose, promptly contact your doctor or go to the nearest hospital. The typical symptoms of an overdose with antibiotics of this group include reversible loss of hearing, severe nausea, vomiting and diarrhoea. The doctor will decide whether you need any kind of treatment, if you have taken a higher dose. If you forget to take AzitroFort If you forget to take a dose, take it as soon as possible after you remember. Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time. If you stop taking AzitroFort Do not stop taking your capsules even if you feel better, unless your doctor tells you to do that. If you stop taking the medicine too soon, the infection may return or your condition may worsen. 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. Contact your doctor immediately, if any of the following occurs: sudden wheezing, difficulty breathing, swelling of eyelids, face or lips, rash and itching (especially of the whole body); severe or persistent diarrhoea that contain blood or mucus during the treatment or after its termination, since it may be a manifestation of a serious inflammatory bowel disease; severe skin rash accompanied by redness and formation of scales and blisters; fast or irregular heart beats; low blood pressure. During treatment with azithromycin, the following side effects may occur: Very common (affects more than 1 in 10 users) - abdominal pain, diarrhoea, fatigue, increased flatulence and bloating. Common (affects at least 1 in 100 and less than 1 in 10 users) - hearing impairment, vomiting, indigestion, rash, itching, loss of appetite, dizziness, headache, numbness of hands and feet, change in taste, blurred vision, joint pain, fatigue, decreased number of lymphocytes (a type of white blood cells), increased eosinophils (a type of white blood cells), decreased level of bicarbonate in the blood. Uncommon (affects at least 1 in 1,000 and less than 1 in 100 users) - fungal infections of the mouth and vagina, decreased total number of the white blood cells, severe allergic reaction which causes swelling of the face or throat, nervousness, decreased sensitivity to touch, drowsiness, sleeplessness, ringing in the ears, shaking, abdominal pain accompanied by diarrhoea and fever, constipation, inflammation of the liver, Stevens-Johnson syndrome (a serious illness accompanied by blistering of the skin, mouth, eyes and genitals), photosensitivity (increased skin sensitivity to sunlight), urticaria (hives), pain in the chest, swelling, malaise, weakness, elevated values of some laboratory blood tests (liver enzymes, bilirubin, urea, creatinine), altered level of potassium in the blood. Rare (affects at least one in 10,000 and less than one in 1,000 users) - agitation, feeling of dizziness or vertigo, impairment of liver function. Not known (the frequency cannot be estimated from the available data) - fatigue, aggression or anxiety, hyperactivity, muscle weakness, loss and impairment of smell, loss of taste, discoloration of the tongue, inflammation of the pancreas, inflammation of the kidneys or renal failure, jaundice or 4

5 hepatic failure (sometimes life-threatening), prolonged bleeding after injury, severe skin reactions, formation of scales and blistering of the skin, changes in the electrocardiogram. If any of the side effects gets serious, or you get any side effects not listed in this leaflet, please contact your doctor or pharmacist. 5. How to store AzitroFort Keep this medicine out of the sight and reach of children. Do not store above 25 0 С. Do not use AzitroFort after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not use AzitroFort, if you notice a change in the appearance of the capsules. 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 AzitroFort contains - The active substance in each capsule is azithromycin dihydrate, equivalent to 500 mg azithromycin. - The other ingredients are sodium lauryl sulphate, lactose monohydrate/maize starch (85:15), magnesium stearate. The gelatin capsule contains titanium dioxide (colourant Е171), gelatin, azorubine/carmoisine (colourant E 122). What AzitroFort looks like and contents of the pack Hard gelatin capsules with white body and pink cap, containing white to off-white powder. 3 (three) or 6 (six) hard gelatin capsules in a PVC/Al foil blister. 1 (one) blister with a leaflet/information for the user per carton. Marketing Authorisation Holder Antibiotic-Razgrad AD Office 201, 68 Aprilsko vastanie Blvd. Manufacturer Balkanpharma-Razgrad AD 68 Aprilsko vastanie Blvd. For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Antibiotic-Razgrad AD Office 201, 68 Aprilsko vastanie Blvd. This leaflet was last revised in June