Diclo-Denk 100 Retard tablets prolonged-release

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

diclofenac (diclofenac sodium)

Disponible des:

Denk Pharma GmbH & Co. KG

Codi ATC:

M01AB05

Designació comuna internacional (DCI):

diclofenac (diclofenac sodium)

Dosis:

100mg

formulario farmacéutico:

tablets prolonged-release

Unidades en paquete:

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

tipo de receta:

Prescription

Estat d'Autorització:

Registered

Data d'autorització:

2018-04-17

Informació per a l'usuari

_Diclo-Denk 100 Retard_
Prolonged-release 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 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-inflamma-
tory drug and belongs to the class of non-steroidal antiphlo-
gistic/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), 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.
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 kno

Fitxa tècnica

_ _
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.
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.
Due to the delayed release of active ingredient from Diclo-Denk 100
Retard, this preparation is not
suitable 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.
The attending doctor will decide how long the treatment should take.
Prolonged intake of Diclo-Denk 100 Retard 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).
SPECIAL PATIENT GROUPS