Tramadol capsules

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

tramadol (tramadol hydrochloride)

Dostupno od:

KRKA d.d.

ATC koda:

N02AX02

INN (International ime):

tramadol (tramadol hydrochloride)

Doziranje:

50mg

Farmaceutski oblik:

capsules

Jedinice u paketu:

(20/2x10/) in blister

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2017-04-03

Uputa o lijeku

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Tramadol
hydrochloride
SPC,
Labeling and Packa
e Leaflet
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Svojstava lijeka

Summary of Product Characteristics
CONFIDENTIAL
Tramadol 50 mg capsules
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1.3.1
Tramadol
SPC, Labeling and Package Leaflet
AM-Armenia
PI_Text007697_4
- Updated:
Page 1 of 13
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
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.
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 should be
matched to clinical need.
PAIN ASSOCIATED WITH CHRONIC CONDITIONS: An initial dose of 50 mg is
advised and then titration
CONFIDENTIAL
Tramadol 50 mg capsules
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1.3.1
Tramadol
SPC, Labeling and Package Leaflet
AM-