Diclo-Denk 50 tablets enteric-coated

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

diclofenac (diclofenac sodium)

제공처:

Denk Pharma GmbH & Co. KG

ATC 코드:

M01AB05

INN (International Name):

diclofenac (diclofenac sodium)

복용량:

50mg

약제 형태:

tablets enteric-coated

패키지 단위:

(20/2x10/) in blister, (100/10x10/) in blister

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2021-10-29

환자 정보 전단

_Diclo-Denk 50_
Enteric coated 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 50 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICLO-DENK 50
3.
HOW TO TAKE DICLO-DENK 50
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DICLO-DENK 50
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
What Diclo-Denk 50 is and what it is used for
Diclo-Denk 50 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 inflammatory
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.
Since there may be delayed release of the active ingredient diclofenac
from Diclo-Denk 50, there may be a delayed onset of effect. Diclo-Denk
50
should therefore not be used for initiating therapy in patients where
a
rapid onset of effect is required.
2.
What you need to know befor

제품 특성 요약

_ _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diclo-Denk 50
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: diclofenac sodium
Each enteric coated tablet contains 50 mg diclofenac sodium.
Excipient with known effect:
Each enteric coated tablet contains 40.0 mg of lactose monohydrate and
less than 1 mmol sodium (23
mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Enteric coated tablet
Round, light-brown 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 50, there may be a delayed onset of effect. Diclo-Denk 50 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 enteric coated tablet
(equivalent to 50 mg
diclofenac sodium)
1 - 3 enteric coated tablets
(equivalent to 50 - 150 mg
diclofenac sodium)
_ _
2
Method of administration
Diclo-Denk 50 is swallowed whole with ample fluids (a glass of water)
on an empty stomach one to two
hours before meals. The tablet must not be broken.
Duration of administration
The attending doctor will decide how long the treatment should take.
Prolonged intake of Diclo-Denk 50 can be necessary for rheumatic
diseases.
Undesirable effects may be minimised by using the l