Tramadol capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tramadol (tramadol hydrochloride)

Available from:

KRKA d.d.

ATC code:

N02AX02

INN (International Name):

tramadol (tramadol hydrochloride)

Dosage:

50mg

Pharmaceutical form:

capsules

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-05-12

Summary of Product characteristics

1.3.1
Tramadol
SPC, Labeling and Package Leaflet
AM-Armenia
PI_Text028491_1
- Updated:
Page 1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
Tramadol 50 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 50 mg tramadol hydrochloride.
For a list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
Two-coloured capsules: the body of the capsule is white and the cap is
blue. The content of capsules:
white or almost white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe pain in adults and adolescents aged 12
years and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a
strategy for ending treatment with tramadol in order to minimise the
risk of addiction and drug
withdrawal syndrome (see section 4.4).
Posology
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient.
The lowest effective dose for analgesia should generally be selected.
The total daily dose of 400 mg
active substance should not be exceeded, except in special
circumstances.
Unless otherwise prescribed, Tramadol should be administered as
follows:
_Adults and adolescents aged 12 years and over _
_ _
Dosage form
Single dose
Total daily dose
Tramadol
50-100 mg
Every 4 to 6 hours
(1 to 2 hard capsules)
(see section 5.1)
400 mg
(Up to 8 hard capsules)
_ _
If
there
is
no
sufficient
pain
relief
after
administration
of
a
single
dose
of
50
mg
tramadol
hydrochloride within 30 to 60 minutes, a second single dose of 50 mg
can be administered.
If in severe pain the demand is likely to be higher, the higher single
dose of Tramadol (100 mg
tramadol hydrochloride) may be given as the initial dose.
1.3.1
Tramadol
SPC, Labeling and Package Leaflet
AM-Armenia
PI_Text028491_1
- Updated:
Page 2 of 14
ACUTE PAIN: An initial dose of 100 mg is usually necessary. This can
be followed by doses of 50 or
100 mg at 4 - 6 hourly intervals, and duration of treatment