Doloforte Denk tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tramadol (tramadol hydrochloride), paracetamol

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

N02AJ13

INN (International Name):

tramadol (tramadol hydrochloride), paracetamol

Dosage:

37,5mg+ 325mg

Pharmaceutical form:

tablets film-coated

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-08-22

Patient Information leaflet

SPECIFICATION - DENK PHARMA
product name:
Doloforte Denk
artwork:
leaflet
language(s):
EN, FR, PT
material number:
50001264/005
storage
conditions:
30°C
revision of text:
09/2021
open format:
840 x 148 mm
fold:
2 x pre-folded (Wickelfalz)
folded format:
280 x 148 mm
pharma code:
22249
paper grammar:
40 g/m
2
printing colours:
 PANTONE YELLOW C
 BLACK
revision/date:
1 / 18.11.2021, RSt
2 / 23.11.2021, RSt
3 / 24.11.2021, RSt
_Doloforte Denk_
Film-coated tablet – oral use
Analgesic
Active substances:
tramadol hydrochloride + paracetamol
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 DOLOFORTE DENK IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DOLOFORTE DENK
3. HOW TO TAKE DOLOFORTE DENK
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DOLOFORTE DENK
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Doloforte Denk is and
what it is used for
Doloforte Denk is a combination of two analgesics,
tramadol and paracetamol, which act together to
relieve your pain.
Doloforte Denk is intended for use in the treat-
ment of moderate to severe pain when your doctor
recommends that a combination of tramadol and
paracetamol is needed.
Doloforte Denk should only be taken by adults and
adolescents over 12 years.
2.
What you need to know before
you take Doloforte Denk
Do not take Doloforte Denk
•
if you are allergic to tramadol hydrochloride, parac-
etamol or any of the other ingredients of this med-
icine (listed in section 6)
�

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Doloforte Denk
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances: tramadol + paracetamol.
Each film-coated tablet contains 37.5 mg tramadol hydrochloride and
325 mg paracetamol.
Excipient with known effect: Each film-coated tablet contains less
than 1 mmol sodium
(23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light-yellow, oblong, biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Doloforte Denk is indicated for the symptomatic treatment of moderate
to severe pain.
The use of Doloforte Denk should be restricted to patients whose
moderate to severe pain is
considered to require a combination of tramadol and paracetamol (see
also section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The use of Doloforte Denk should be restricted to patients whose
moderate to severe pain is
considered to require a combination of tramadol and paracetamol.
The dose should be adjusted to intensity of pain and the sensitivity
of the individual patient. The
lowest effective dose for analgesia should generally be selected. The
total dose of 8 tablets (equivalent
to 300 mg tramadol hydrochloride and 2,600 mg paracetamol) per day
should not be exceeded. The
dosing interval should not be less than six hours.
_ _
Adults and adolescents (12 years and older)
An initial dose of 2 film-coated tablets of Doloforte Denk is
recommended. Additional doses can be
taken as needed, not exceeding 8 tablets (equivalent to 300 mg
tramadol hydrochloride and 2,600 mg
paracetamol) per day.
2
The dosing interval should not be less than six hours.
Doloforte Denk should under no circumstances be administered for
longer than is strictly necessary
(see also section 4.4). If repeated use or long-term treatment with
Doloforte Denk is required as a
result of the nature and severity of the illness, then careful,
regular monitoring should take place (with
breaks in the treatment, where possible)