Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROXITHROMYCIN
IMEKS PHARMA SDN. BHD.
ROXITHROMYCIN
500 Tablets; 100 Tablets; 100Tablet Tablets; 500 Tablet Tablets
Sriprasit Pharma Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ROXY TABLET Roxithromycin (150 mg) _ _ 1 WHAT IS IN THE LEAFLET 1. What Roxy is used for 2. How Roxy works 3. Before you use Roxy 4. How to use Roxy 5. While you are using it 6. Side effects 7. Storage and Disposal of Roxy 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ROXY IS USED FOR Roxy contains the active ingredient Roxithromycin. Roxy is used to treat various infections caused by bacteria such as: • Respiratory tract infections - Sore throat and discomfort when swallowing - Sinusitis - Infection of the bronchi causing coughing - Pneumonia (lung infection characterised by fever, malaise, headache) • Skin and soft tissue infections • Urinary tract infection • Prevention of meningitis (inflammation of meninges covering brain and spinal cord) HOW ROXY WORKS Roxithromycin is an antibiotics that belongs to a group of medicines called macrolides. It prevents bacteria from growing by interfering with their protein synthesis. BEFORE YOU USE ROXY _ _ - _When you must not use it_ Do not take Roxy if you: • Have ever had a reaction or been told that you are allergic to roxithromycin or to any of the excipients. • Allergic to any other macrolide antibiotics. • Are concurrently taking medicines for migraine headache e.g. ergotamine. • Have severe liver problem. - _Before you start to use it _ Tell your doctor if you: • Have allergies to any other medicines, food, preservatives or dyes. • Have or have had kidney or liver problems. • Are pregnant, planning to become pregnant or are breastfeeding. If you are not sure whether you should start taking this medicine, consult your doctor. - _Taking other medicines _ Tell your doctor if you are taking any other medicine, including any that you buy without a prescription. You may need to use different amounts of these medicines, or you may need to take different medicines. Your doctor will advise you. In particular, tell your doctor if you take any of the follo Leggi il documento completo
DESCRIPTION White round biconvex film-coated tablet, embossed with “Roxy” and “SPS” on one side and scored on the other side. Each film-coated tablet contains Roxithromycin 150 mg. INDICATION Roxithromycin is indicated for: Upper respiratory tract infections, e.g. acute pharyngitis and sinusitis. Lower respiratory tract infections, e.g. pneumonia, bronchitis, atypical pneumonia. Skin and skin structural infections. Non-gonococcal urethritis. Prophylaxis of meningococcal meningitis subjects who have come in contact with the patients. RECOMMENDED DOSAGE Adults: For most infections, oral roxithromycin is effective in doses of 150 mg twice a day or 300 mg once a day. Therapy should be continued for at least 10 days. The maximum duration of therapy is 4 weeks. Doses should be taken in the morning and evening before meals. CONTRAINDICATIONS Hypersensitivity to roxithromycin, macrolides or to any of the excipients. Severely impaired hepatic function. Concomitant therapy with vasoconstrictive ergot alkaloids. WARNINGS AND PRECAUTIONS Roxithromycin, like erythromycin, has been shown _ in vitro_ to elicit a concentration-dependent lengthening in cardiac action potential duration. Such an effect is manifested only at supratherapeutic concentrations. Accordingly, the recommended doses should not be exceeded. Prolonged or repeated use of antibiotics including roxithromycin may result in superinfection by resistant organisms. In the event of superinfection, roxithromycin should be discontinued and appropriate therapy instituted. When indicated, incision, drainage or other appropriate surgical procedures should be performed in conjunction with antibiotic therapy. Pseudomembranous colitis Antibiotic associated pseudomembranous colitis has been reported with many antibiotics. A toxin produced by _Clostridium difficile _appears to be the primary cause. If pseudomembranous colitis is suspected, roxithromycin must be stopped immediately. The severity of the colitis may range from mild to life Leggi il documento completo