Tramadol Denk 50 tablets effervescent

Страна: Вірменія

мова: англійська

Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активний інгредієнт:

tramadol (tramadol hydrochloride)

Доступна з:

Losan Pharma GmbH Otto- Hahn-Str. 13

Код атс:

N02AX02

ІПН (Міжнародна Ім'я):

tramadol (tramadol hydrochloride)

Дозування:

50mg

Фармацевтична форма:

tablets effervescent

Одиниць в упаковці:

(10) in plastic container

Тип рецепту:

Prescription

Статус Авторизація:

Registered

Дата Авторизація:

2019-12-30

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tramadol Denk 50
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance : tramadol
Each effervescent tablet contains 50 mg tramadol hydrochloride.
Excipients with known effect: Each effervescent tablet contains 10 mg
aspartame, 75 mg lactose
monohydrate and 214 mg sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablets
Tramadol Denk 50
are white, round, flat effervescent tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moderately severe to severe pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage 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.
Unless otherwise prescribed, Tramadol Denk 50 should be dosed as
follows:
_Adults and adolescents aged 12 years and older_
For moderately severe pain, 1 Tramadol Denk 50 effervescent tablet
(equivalent to 50 mg tramadol
hydrochloride). If no pain relief occurs within 30 - 60 minutes, a
second effervescent tablet can be
taken.
If the demand is likely to be higher for severe pain, 2 Tramadol Denk
50 effervescent tablets
(equivalent to 100 mg tramadol hydrochloride) are taken as a single
dose.
Depending on the pain, the effect lasts for 4 - 8 hours. It is
generally not necessary to exceed daily
doses of 8 effervescent tablets (equivalent to 400 mg tramadol
hydrochloride). However, even
much higher doses may be required for tumour pain and severe
postoperative pain. More suitable
pharmaceutical forms may have to be selected.
2
_Children and adolescents_
Tramadol Denk 50 is not intended for use in children below 25 kg body
weight and does not
generally allow for individual dosing in children below 12 years of
age. More suitable
pharmaceutical forms should therefore be selected.
_Geriatric patients_
A dose adjustment is not usually necessary in patients up to 75 years
without clinically manifest
hepatic or renal insuff