DIFENE DUAL RELEASE 75MG CAPSULE,HARD

מדינה: קפריסין

שפה: יוונית

מקור: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

מרכיב פעיל:

DICLOFENAC SODIUM

זמין מ:

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

קוד ATC:

M01AB05

INN (שם בינלאומי):

DICLOFENAC

כמות:

75MG

טופס פרצבטיות:

CAPSULE,HARD

הרכב:

DICLOFENAC SODIUM (0015307796) 75MG

מסלול נתינה (של תרופות):

ORAL USE

סוג מרשם:

Εθνική Διαδικασία

איזור תרפויטי:

DICLOFENAC

leaflet_short:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 20 CAPS IN BLISTER(S) (220005801) 20 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

עלון מידע

Package leaflet: information for the user
DIFENE DUAL RELEASE 75MG
Modified-release capsule, hard
Diclofenac sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
−
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
−
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Difene Dual Release 75mg is and what it is used for
2.
Before you take Difene Dual Release 75mg
3.
How to take Difene Dual Release 75mg
4.
Possible side effects
5.
How to store Difene Dual Release 75mg
6.
Further information
1. WHAT DIFENE DUAL RELEASE 75MG IS AND WHAT IT IS USED FOR
Difene Dual Release 75mg 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 75mg
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 75mg is not suitable
for starting treatment in conditions where rapid onset of action is
needed.
2. BEFORE YOU TAKE DIFENE DUAL RELEASE 75MG
Do not take Difene Dual Release 75mg
−
If you are allergic (hypersensitive) to diclofenac or any of t

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Difene Dual Release
75 mg modified-release capsule, hard
Diclofenac sodium
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified -release capsule, hard contains 75 mg diclofenac sodium.
(25 mg diclofenac sodium in gastroresistant form, 50 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 2, with a light blue upper part and
transparent lower part.
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 75 mg
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 75 mg
modified -release capsules, hard
Total daily dose:
Number of Difene Dual Release 75 mg
modified -release capsules, hard
Adults
1
(equivalent to 75 mg diclofenac sodium)
2
(equivalent to 150 mg diclofenac sodium)
Method and duration of administration:
Difene Dual Release 75 mg is taken without chewing and with plenty of
fluid. Those with sensitive stomachs
are recommended to take Difene Dual Release 75 mg during meals.
The patient’s doctor decides the length of administration.
For rheumatic diseases, it can be necessary t