TRAMAL CAPSULES

Страна: ПАР

мова: англійська

Джерело: South African Health Products Regulatory Authority (SAHPRA)

Доступна з:

Janssen Pharmaceutica (Pty) Ltd

Дозування:

See ingredients

Фармацевтична форма:

CAPSULES

Склад:

EACH CAPSULE CONTAINS TRAMADOL HYDROCHLORIDE 50 mg

Статус Авторизація:

Registered

Дата Авторизація:

1992-05-05

інформаційний буклет

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name: TRAMAL® CAPSULES
______________________________________________________________________________________________________ PAGE 1 OF 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 5
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
TRAMAL
® (CAPSULE): 50 MG TRAMADOL HYDROCHLORIDE.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TRAMAL
CAPSULES.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your
pharmacist.

TRAMAL capsules have been prescribed for you personally and you should
not share your medicine with other people. It may harm them, even if
their
symptoms are the same as yours.
1. WHAT TRAMAL CAPSULES CONTAIN

The active ingredient is tramadol hydrochloride.

The other ingredients in the capsule powder are: colloidal anhydrous
silica,
magnesium stearate microcrystalline cellulose, sodium starch
glycolate.
The capsule shell is made of: gelatine, sodium lauryl sulphate,
titanium dioxide
(E171), and yellow iron oxide (E172).
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name: TRAMAL® CAPSULES
______________________________________________________________________________________________________ PAGE 2 OF 12
2. WHAT TRAMAL CAPSULES ARE USED FOR
Tramadol, the active substance in TRAMAL capsules, is a painkiller
belonging to the
class of the opioids that acts on the central nervous system. It is
used for the
management of moderate to moderately severe pain.
3. BEFORE YOU TAKE TRAMAL CAPSULES
DO NOT TAKE TRAMAL CAPSULES:

if you are allergic to tramadol or any of the other ingredients of
TRAMAL
capsules. (Refer to WHAT TRAMAL CONTAINS, above.);

in acute poisoning with alcohol, sleeping pills, pain relievers or
other
psychotropic medicines (medicines that affect mood and emotions);

if you are taking MAO inhibitors (certain medicines used for
depression) or
have taken them in the last 14 days before treatment with TRAMAL

Характеристики продукта

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name: TRAMAL® CAPSULES
______________________________________________________________________________________________________
_ _
PAGE 1 OF 16
PACKAGE INSERT
_ _
SCHEDULING STATUS
Schedule 5
PROPRIETARY NAME AND DOSAGE FORM
TRAMAL
®
Capsules
COMPOSITION
Each capsule contains tramadol hydrochloride 50 mg.
Capsule powder excipients are as follows: colloidal anhydrous silica,
magnesium
stearate, microcrystalline cellulose and sodium starch glycolate.
The capsule shell comprises of: gelatine, sodium lauryl sulphate,
titanium dioxide
(E171) and yellow iron oxide (E172).
PHARMACOLOGICAL CLASSIFICATION
A.2.9.Other analgesics
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Tramadol hydrochloride is a centrally acting analgesic with binding to
specific opioid
receptors. It is a non-selective, agonist at mu (µ), delta (

) and kappa (k) opioid
receptors with a higher affinity for the µ receptor. Other
mechanisms, which
contribute to its analgesic effect, are inhibition of neuronal
re-uptake of noradrenaline
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name: TRAMAL® CAPSULES
______________________________________________________________________________________________________
_ _
PAGE 2 OF 16
as well as the enhancement of serotonin release. The relationship
between serum
concentrations and the analgesic effect is dose-dependent, but varies
considerably.
Patients devoid of CYP2D6 may need higher doses of tramadol, to
achieve adequate
analgesia.
PHARMACOKINETIC PROPERTIES
After oral administration of TRAMAL capsules, tramadol hydrochloride
is absorbed
with an absorption half-life (t
½
ka
) of 0,38 ± 0,18 hours. The mean systemic
bioavailability is 68 %, independent of food intake.
Tramadol has a linear pharmacokinetic profile within the therapeutic
dosage range.
The elimination half-life is 5 to 7 hours. Tramadol is mainly
metabolised in the liver
(90 %).
Tramadol hydrochloride and its metabolites are almost completely
excreted by the