DIFENE DUAL RELEASE 100MG MODIFIED-RELEASE CAPSULE, HARD

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

DICLOFENAC SODIUM

Διαθέσιμο από:

MEDILINK PHARMACEUTICALS LTD (0000003162) 30 ARMENIAS, STROVOLOS, 1640, 26576

Φαρμακολογική κατηγορία (ATC):

M01AB05

INN (Διεθνής Όνομα):

DICLOFENAC

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

MODIFIED-RELEASE CAPSULE, HARD

Σύνθεση:

DICLOFENAC SODIUM (0015307796) 100MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

DICLOFENAC

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 10 CAPS IN BLISTER(S) (220005901) 10 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 CAPS IN BLISTER(S) (220005902) 28 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Φύλλο οδηγιών χρήσης

Package leaflet: information for the user
DIFENE DUAL RELEASE 100MG Modified-release capsule, hard
Diclofenac sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE 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 Difene Dual Release 100mg is and what it is used for
2.
What you need to know before you take Difene Dual Release 100mg
3.
How to take Difene Dual Release 100mg
4.
Possible side effects
5.
How to store Difene Dual Release 100mg
6.
Contents of the pack and other information
1. WHAT DIFENE DUAL RELEASE 100MG IS AND WHAT IT IS USED FOR
Difene Dual Release 100mg is a pain-relieving and anti-inflammatory
medicine, one of the group of
non-steroidal anti-inflammatory/anti-rheumatic agents (NSAIDs).
Areas of indication for Difene Dual Release 100mg
Symptomatic treatment of pain and inflammation in:
−
Acute inflammations of the joints (acute arthritis), including attacks
of gout
−
Chronic inflammation of the joints (chronic arthritis), especially in
rheumatoid arthritis (chronic
polyarthritis)
−
Ankylosing spondylitis (Bechterew’s Disease) and other inflammatory
rheumatic diseases of the
spinal column
−
Painful conditions associated with degenerative diseases of joints and
the spinal column (arthritis
and spondylarthropathy)
−
Inflammatory rheumatic diseases of soft tissue
−
Painful swelling or inflammation after injury.
Because the release of the active substance diclofenac is delayed,
Difene Dual Release 100mg is not
suitable for starting treatment in conditions where rapid onset of
action is needed.
2. WHAT YOU NEED

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Difene Dual Release
100 mg modified-release capsule, hard
Diclofenac sodium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified -release capsule, hard contains 100 mg diclofenac
sodium.
(25 mg diclofenac sodium in gastroresistant form, 75 mg diclofenac
sodium in prolonged-release form).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Modified -release capsule, hard
Hard gelatine capsule, size 1, with a blue opaque capsule cap and
colourless transparent body and white
print "D100M", filled with white to cream-coloured pellets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in
−
Acute arthritis (including attacks of gout)
−
Chronic arthritis, including rheumatoid arthritis (chronic
polyarthritis)
−
Ankylosing spondylitis (Bechterew’s Disease) and other inflammatory
rheumatic diseases of the spinal
column
−
Painful conditions associated with arthritis and spondylarthropathy
−
Inflammatory rheumatic diseases of soft tissue
−
Painful swelling or inflammation after injury.
Because the release of active substance from Difene Dual Release 100mg
is delayed, this preparation is not
suitable for starting treatment in conditions where rapid onset of
action is needed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage:
The dose of diclofenac depends on the severity of the condition. The
recommended dose range for adults
lies between 50 and 100 mg diclofenac sodium per day.
Age:
Single dose:
Number of Difene Dual Release 100mg
modified -release capsules, hard
Total daily dose:
Number of Difene Dual Release 100mg
modified -release capsules, hard
Adults
1
(equivalent to 100 mg diclofenac sodium)
1
(equivalent to 100 mg diclofenac sodium)
Method and duration of administration:
Difene Dual Release 100mg is taken without chewing and with plenty of
fluid. Those with sensitive stomachs
are recommended to take Difene Dual Release 100mg during meals.
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The patient’s