Tramapa Fort Tablets 75/650

Država: Tanzanija

Jezik: engleski

Izvor: Tanzania Medicinces & Medical Devices Authority

Aktivni sastojci:

Tramadol

Dostupno od:

Ferrer Internacional, S.A., SPAIN

ATC koda:

Pharmacotherapeutic group: Analgesic, Other Opioid

INN (International ime):

Tramadol

Doziranje:

75/650

Farmaceutski oblik:

Tablets

Proizveden od:

Ferrer International, S.A, SPAIN

Proizvod sažetak:

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

Status autorizacije:

Registered/Compliant

Datum autorizacije:

2021-08-20

Svojstava lijeka

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