Diclo-Denk 50 tablets enteric-coated

Nazione: Armenia

Lingua: inglese

Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Principio attivo:

diclofenac (diclofenac sodium)

Commercializzato da:

Denk Pharma GmbH & Co. KG

Codice ATC:

M01AB05

INN (Nome Internazionale):

diclofenac (diclofenac sodium)

Dosaggio:

50mg

Forma farmaceutica:

tablets enteric-coated

Confezione:

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

Tipo di ricetta:

Prescription

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2016-10-28

Foglio illustrativo

_Diclo-Denk 50_
Enteric coated tablet – oral use
Non-steroidal antiphlogistic/antirheumatic
Active substance: Diclofenac sodium
Package leaflet: Information for the user
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAK-
ING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFOR-
MATION 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 phar-
macist. This includes any possible side effects not list-
ed 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/an-
tirheumatic 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), especial-
ly in case of rheumatoid arthritis (chronic polyarthritis)
• Bechterew’s disease (ankylosing spondylitis) and other in-
flammatory rheumatoid disorders of the spine
• acute inflammatory condition of degenerative joint or spi-
nal disorders (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 on
-
set 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

Scheda tecnica

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.
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 tablet
(equivalent to 50 mg
diclofenac sodium)
1 - 3 tablets
(equivalent to 50 - 150 mg
diclofenac sodium)
Method of administration
2
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.
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 lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
SPEC