Tramapa Fort Tablets 75/650 mg

País: Tanzânia

Língua: inglês

Origem: Tanzania Medicinces & Medical Devices Authority

Ingredientes ativos:

Tramadol

Disponível em:

Ferrer Internacional, S.A., SPAIN

Código ATC:

Pharmacotherapeutic group: Analgesic, Other Opioid

DCI (Denominação Comum Internacional):

Tramadol

Dosagem:

75/650 mg

Forma farmacêutica:

Tablets

Fabricado por:

Ferrer International, S.A, SPAIN

Resumo do produto:

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: Laborex Tanzania Limited

Status de autorização:

Registered/Compliant

Data de autorização:

2021-08-20

Características técnicas

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