Krajina: Tanzánia
Jazyk: angličtina
Zdroj: Tanzania Medicinces & Medical Devices Authority
Tramadol
Ferrer Internacional, S.A., SPAIN
Pharmacotherapeutic group: Analgesic, Other Opioid
Tramadol
75/650
Tablets
Ferrer International, S.A, SPAIN
Physical description: Oblong, scored white tablets that can be split into two halves of 37.5/325 mg each tramadol hydrochloride and paracetamol, respectively; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited
Registered/Compliant
2021-08-20
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tramapa Fort 75 mg/650 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EACH TABLET CONTAINS: TRAMAPA FORT 75 MG/650 MG TABLETS: One tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, scored oblong tablet. The score line is used to split and facilitate swallowing and also to divide the tablet into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tramadol/Paracetamol tablets are indicated for the symptomatic treatment of moderate to severe pain. The use of Tramadol/Paracetamol should be limited to patients whose moderate to severe pain requires the combination of tramadol and paracetamol (see also Section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents _(ages 12 and over). The use of Tramadol/Paracetamol should be limited to patients whose moderate to severe pain requires the combination of tramadol and paracetamol. The dose should be adjusted to the intensity of the pain and the sensitivity of each patient. The lowest effective dose for analgesia should be used. An initial dose of one tablet of Tramapa Fort 75 mg/650 mg is recommended. Additional doses may be taken as necessary, without exceeding 4 tablets of Tramapa Fort 75 mg/650 mg (equivalent to 300 mg of tramadol and 2,600 mg of paracetamol) per day. The interval between doses should not be less than 6 hours. Under no circumstances should Tramadol/Paracetamol be taken for longer than is strictly necessary (see section 4.4). If repeated use or long-term treatment with Tramapa Fort is required as a result of the nature and severity of the disease, regular, careful monitoring should be carried of 1 13 out (with interruptions in the treatment, if possible), to assess whether continuation of the treatment is necessary. _Paediatric population _ The safety and efficacy of Tramadol/Paracetamol has not been established in children under Prečítajte si celý dokument