Tramadol Denk 50 tablets effervescent

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tramadol (tramadol hydrochloride)

Available from:

Losan Pharma GmbH

ATC code:

N02AX02

INN (International Name):

tramadol (tramadol hydrochloride)

Dosage:

50mg

Pharmaceutical form:

tablets effervescent

Units in package:

(10) in plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-08-10

Patient Information leaflet

SPECIFICATION - DENK PHARMA
product name:
Tramadol Denk 50
artwork:
leaflet
language(s):
EN, FR, PT
material number:
50001166/004
storage
conditions:
25°C
revision of text:
07/2021
open format:
600 x 200 mm
fold:
1 x pre-folded (Einbruchfalz)
folded format:
300 x 200 mm
pharma code:
975
paper grammar:
40 g/m
2
printing colours:
 PANTONE YELLOW C
 BLACK
revision/date:
1 / 15.12.2021, KRi
2 / 21.12.2021, KRi
3 / 22.12.2021, KRi
4 / 11.01.2022, KRi
_Tramadol Denk 50_
Effervescent tablet – oral use
Opioid analgesic
Active substance: tramadol
Package leaflet:
Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPOR-
TANT INFORMATION FOR YOU.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doc-
tor or pharmacist.
– This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. WHAT TRAMADOL DENK 50 IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TRAMADOL DENK 50
3. HOW TO TAKE TRAMADOL DENK 50
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TRAMADOL DENK 50
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Tramadol Denk 50 is and what
it is used for
Tramadol – the active substance in
Tramadol Denk 50 –
is a centrally acting analgesic (painkiller) belonging to
the opioid group. It achieves its pain-relieving effect
by acting on specific nerve cells of the spinal cord and
brain. Tramadol Denk 50 is used for the treatment of
moderate to severe pain.
2.
What you need to know before you take
Tramadol Denk 50
Do not take Tramadol Denk 50
•
if you are allergic to tramadol or any of the other ingre-
dients of this medicine (listed in section 6).
•
in acute cases of intoxication with alcohol, sleeping
tablets, p

Summary of Product characteristics

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 the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent tablet
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 insufficiency. In elderl