FL-AZITROMICINA BLUEPHARMA 500 mg coated tablet AUGUST 2003

Transcription

1 Read this leaflet carefully before taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it to the others. It may harm them, even if they have the same symptoms. In this leaflet: 1. What is and what it is used for 2. Before taking 3. How to take 4. Possible Side Effects 5. How to store Name of the medicine Composition of Each tablet contains either azitromicina ( dihydrate form ) equivalent to 500 mg azitromicina as an active substance Other ingredients : Amido pre gelificato, crospovidona, Ca hydrogenphosphato anhydrous, Na laurilsuphato, Mg extract, methyl hydroxipropilcelulose, titan dioxide, Lactose, glycerol triacetate. Marketing authorization holder Bluepharma Genéricos- Comércio de Medicamentos, S.A. Approved S. Martinho do Bispo 03/12/ COIMBRA INFRAMED Portugal

2 1. What is and what it is used for is an antibiotic used for the treatment of several infections caused by different microorganisms ( CFT : Group 1.1 H ) Pharmaceutical form : coated tablet is antibiotic used for the treatment of several infections,caused by different microorganisms, as ; Bronchitis, pneumonia, Otitis Media, Sinusitis, pharyngitis, amigdalitis Skin and soft tissue infections Sexually transmissible disease, caused by Chlamydia Trachomatis and Neisseria Gonorrhoea, in the man and woman. This product needs the medical prescription 2. Before taking How can you take You should know if you are allergic to the active substances of Azitromicina or if you are allergic of any other antibiotic of the same group ( macrolides ) or any other ingredient of the medicine ( please see the composition ) In the situations described below you should be careful using AZITROMICINA BLUEPHARMA During the treatment with you should inform you doctor if you had or have any hepatic or renal disease ( in the case of severe disease you should use with precaution ) may cause allergic reactions. So if you notice the presence of red or white patch, irritation, itching, swelling of the skin : breathing with difficulty, you should interrupt the treatment and contact your doctor. As noted below the use of in the combination with other medicines used for the Migraine relief, can cause egotism crisis intoxication accompanied with spastic contractions, directed to the total delirium.

3 Pregnancy and breast-feeding Consult your doctor or pharmacist before taking any medicine. If you are pregnant or breast feeding should not take, except the cases of an important emergency, anytime described by your doctor Driving and using machines According to the information available to date, do not cause alteration of the ability for driving or using machines Children should be used in the children with a body weight over 45 kg ( see also section 3 3. How to take ) Elderly It can be administered to the elderly without dose adjustment Before using other medicines meanwhile you are taking AZITROMICINA BLUEPHARMA you should be careful. Tell you doctor, about all the medicines you are taking or have recently taken ( including medicines without doctor prescription ) This information is especially important in the case of the following drugs Antacids : ( Medicine used for the treatment of the excess of the gastric acid ) should not be taken at the same time with azitromicine Cyclosporine : ( immunosuppressive medicine used for the transplant reject ) if it is very important to take this medicines together you should adjust the azitromicine dose Digoxin : ( heart medicine ) may increase the effects of digoxin Ergotamine s derivations ( medicines used for the relief of Migraine ) should not be used with azitromicine to prevent the egotisms Warfarin and other oral anticoagulants of the second class : ( medicines used for the prevention of the blood coagulation ) may increase the effects of warfarin, even it is not proven a casual relation Zidovudine ( antiviral ) may increase the effects of zidovudine

4 2. How to take Oral use The whole tablet must be taken with water or another non alcoholic drink, with or without food and preferably always at the same time of the day Adults (including elderly and children over 45 kg ) The recommended dose is 500 mg once daily (1 tablet of AZITROMICINA BLUEPHARMA ) for a duration of the treatment 3 days The treatment of the sexually transmitted disease is 1 g ( 2 tablets AZITROMICINA BLUEPHARMA ) administered once a day at once Tablets of 500 mg of should be administered to children over 45 kg, the treatment is the same as in adult In acute otitis media and streptococcal pharyngitis to the children over 45 kg the dose is 500 mg once day ( 1 tablet ) for 3 days consecutive. In the case of streptococcal pharyngitis to the children over 45 kg the dose is 500 mg and it should not be exceeded Treatment duration For an effective treatment, the duration of the treatment should be 3 days of treatment recommended in most indications. If you take more of than you should. If, inadvertently, have taken more than the normal dose, should contact your doctor or te nearest hospital. If possible take the container with the tablets and also the packaging of the other drugs that may be taking. If you forget to take Take as soon as possible the dose you missed and the next few days, continue treatment, as previously directed by your doctor. Do NOT take a double dose to make up for the dose that you missed. Effects of interruption of treatment with. Should maintain the treatment for the time recommended by your doctor. Approved 03/12/2009 Infarmed

5 FL-AZITROMICINA PHARMACEUTICAL BLUEPHARMA S.A 500 MG Tablet 4. Possible Side Effects As medicines, can cause side effects, although it is generally well tolerated. Side effects are, in general, rare, the most common are related to the gastrointestinal system, lack of appetite, nausea, vomiting / diarrhea, loose stools, difficult duodena digestion, cramping pain in abdomen, constipation, intestinal gas, colitis pseudomembranous, in rare cases, discolored tongue and altered taste. As seen with other antibiotics of the sane class, there might bee changes in hearing, tinnitus, dizziness / vertigo and seizures. Were also reports of producers of sleepiness, tingling or numbness of the limbs, hyperactivity, aggressive reaction, nervousness, agitation, anxiety and joint pain. Other reactions include vaginal infection, thrush and fatigue. Choose from are still reports of thrombocytopenia (decreased platelet numerous in the blood), changes in renal function and liver and even allergic reactions manifested by skin rash, itching, light sensitivity, swelling of the skin, tongue or larynx and difficulty in breathing. Tell your doctor or chemists the occurrence if any side effects mentioned above or any leaflet. 5. Storing of. KEEP OUT OF REACH AND SIGHT OF CHILDREN. Do not store above 25 C. The tablets should only be removed from the blister immediately before its use. No not use after the expiry date stated on the carton and blister. The medication that is not used out of the date, should be returned to the pharmacy for destruction. If you still have doubts or questions about, consult your doctor or pharmacist. This leaflet was last modified in August Date of approval: 03 December 2003 Approved 03/12/2009 Infarmed