Naklofen duo capsules prolonged-release

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

diclofenac (diclofenac sodium)

Dostopno od:

KRKA d.d.

Koda artikla:

M01AB05

INN (mednarodno ime):

diclofenac (diclofenac sodium)

Odmerek:

75mg

Farmacevtska oblika:

capsules prolonged-release

Enote v paketu:

(20/2x10/) in blister

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2016-02-26

Lastnosti izdelka

1.3.1
Diclofenac sodium
SPC, Labeling and Package Leaflet
SmPCPIL150431_2
25.05.2020 – Updated: 16.06.2020
Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Naklofen duo 75 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 75 mg diclofenac sodium (25 mg as
gastro-resistant pellets and 50 mg as
prolonged-release pellets).
Excipient:
-
Sucrose: 88.32 mg/capsule
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release capsule.
The capsule body is white and the capsule cap is blue. The capsules
are filled with white to yellow-
white coloured pellets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naklofen duo is indicated for:
-
rheumatoid arthritis,
-
osteoarthrosis,
-
low back pain,
-
migraine attacks ,
-
acute musculo-skeletal disorders and trauma such as periarthritis
(especially frozen shoulder),
tendinitis, tenosynovitis, bursitis, sprains, strains and
dislocations;
-
relief of pain in fractures,
-
ankylosing spondylitis,
-
acute gout,
-
control of pain and inflammation in orthopaedic, dental and other
minor surgery,
-
pyrophosphate arthropathy and associated disorders.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment may consist of taking only one form of the drug or a
combination, but the total daily dose
of 150 mg has to be taken into account.
ADULTS
DAILY DOSAGE
INITIAL TREATMENT
MAINTENANCE TREATMENT
Capsules (75 mg)
2 x 1 capsule
1 capsule
When the symptoms are very severe (especially in the morning), the
patient may, for a shorter period
of time, take the whole daily dose of Naklofen duo capsules (2
capsules) at once.
CONFIDENTIAL
Naklofen duo prolonged-release capsules 75 mg
VOL: 1; P: 13 / 42
1.3.1
Diclofenac sodium
SPC, Labeling and Package Leaflet
SmPCPIL150431_2
25.05.2020 – Updated: 16.06.2020
Page 2 of 12
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to controlsymptoms (see section 4.4 Special warnings and
precautions for use).
_Paediatric population_
Naklofe