Diclo-Denk 100 Retard tablets prolonged-release

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

diclofenac (diclofenac sodium)

Available from:

Denk Pharma GmbH & Co. KG

ATC code:

M01AB05

INN (International Name):

diclofenac (diclofenac sodium)

Dosage:

100mg

Pharmaceutical form:

tablets prolonged-release

Units in package:

(10/1x10/) in blister, (100/10x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-10-29

Patient Information leaflet

_Diclo-Denk 100 Retard_
Prolonged-release tablet – oral use
Non-steroidal antiphlogistic/antirheumatic
Active substance: diclofenac
Package leaflet: Information for the patient
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDI-
CINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor 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 DICLO-DENK 100 RETARD IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLO-DENK 100 RETARD
3.
HOW TO TAKE DICLO-DENK 100 RETARD
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DICLO-DENK 100 RETARD
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Diclo-Denk 100 Retard is and what it is used for
Diclo-Denk 100 Retard is a pain-relieving and anti-inflammatory drug
and belongs to the class of non-steroidal antiphlogistic/antirheumatic
agents (NSAIDs).
Therapeutic indications
Symptomatic treatment of pain and inflammation in case of:
•
acute joint inflammation (acute arthritides) including gout attack
•
chronic joint inflammation (chronic arthritides), especially in case
of
rheumatoid arthritis (chronic polyarthritis)
•
Bechterew’s disease (ankylosing spondylitis) and other inflammato
-
ry rheumatoid disorders of the spine
•
acute inflammatory condition of degenerative joint or spinal disor
-
ders (arthroses and spondylarthroses)
•
inflammatory soft tissue rheumatisms
•
painful swelling or inflammation after injuries.
Due to the delayed release of the active ingredient diclofenac,
Diclo-Denk 100 Retard is not suitable for initiating therapy in
patients
where a rapid onset of effect is required.
2.
What you need to know before you take

Summary of Product characteristics

_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diclo-Denk 100 Retard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: diclofenac sodium
Each prolonged-release tablet contains 100 mg diclofenac sodium.
Excipient with known effect:
Each prolonged-release tablet contains 119.0 mg of sucrose and less
than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
Round, brown-red biconvex tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in case of:
-
acute arthritides (including gout attack)
-
chronic arthritides, especially rheumatoid arthritis (chronic
polyarthritis)
-
ankylosing spondylitis (Bechterew’s disease) and other inflammatory
rheumatoid disorders of the
spine
-
acute inflammatory condition of arthroses and spondylarthroses
-
inflammatory soft tissue rheumatisms
-
painful swelling or inflammation after injuries.
As there may be delayed release of the active ingredient from the
enteric coated formulation of Diclo-
Denk 100 Retard, there may be a delayed onset of effect. Diclo-Denk
100 Retard should therefore not be
used for initiating therapy in patients where a rapid onset of effect
is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of diclofenac depends on the severity of the illness. The
recommended daily dose for adults is
between 50 mg and 150 mg of diclofenac sodium.
AGE
SINGLE DOSE
TOTAL DAILY DOSE
Adults
1 prolonged-release tablet
(equivalent to 100 mg
diclofenac sodium)
1 prolonged-release tablet
(equivalent to 100 mg diclofenac
sodium)
_ _
2
Method of administration
Diclo-Denk 100 Retard is swallowed whole with ample fluids. Patients
with sensitive stomachs are
advised to take Diclo-Denk 100 Retard with meals. Do not break the
tablets.
Duration of administration
The attending doctor will decide how long the treatment should take.
Prolonged intake of Diclo-Denk 100 Retard can be necessary for
rheumatic diseases.
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