Naklofen

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

diclofenac (diclofenac sodium)

Dostopno od:

KRKA d.d.

INN (mednarodno ime):

diclofenac (diclofenac sodium)

Odmerek:

100mg

Farmacevtska oblika:

tablets film-coated prolonged-release

Tip zastaranja:

Prescription

Lastnosti izdelka

Summary of product characteristics
/
CONFIDENTIAL
52
317
1.3.1
Diclofenac sodium
SPC, Labeling and Package Leaflet
AM
SmPCPIL041905/1
17.09.2013 – Updated: 17.09.2013
Page 1 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Naklofen 100 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 100 mg diclofenac sodium.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablets: round, highly biconvex, smooth, red-brown
tablets.
4.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Diseases in which anti-inflammatory and/or analgesic activity is
required:

inflammatory rheumatic diseases: rheumatoid arthritis, seronegative
spondylarthritis, juvenile
arthritis, arthritides of other etiologies,

degenerative rheumatism of the musculoskeletal system: arthrosis,
spondylosis,

crystal-induced arthritides: gouty arthritis and pseudogouty
arthritis,

extra-articular rheumatism: periarthritis, bursitis, myositis,
tendinitis, synovitis,

other inflammatory and painful states of the musculoskeletal system,
when pain syndrome is
present.
As an analgesic, Naklofen is used in soft tissue injuries, after
delivery if the mother does not
breastfeed, in primary and secondary dysmenorrhea, in various dental
procedures, after surgery, in
renal and biliary colics.
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage for the initial and maintenance treatment is one tablet
once daily.
If a daily dosage of 150 mg diclofenac is required, Naklofen
prolonged-release tablets can be
combined with a 50 mg Naklofen gastro-resistant tablet or a 50 mg
Naklofen suppository.
The tablets should be taken during or immediately after meals and
swallowed whole with some liquid.
The prolonged-release tablets are not suitable for use in children.
CONTRAINDICATIONS

Hypersensitivity to any of the ingredients of the drug, salicylates
and other nonsteroidal anti-
inflammatory drugs, which is manifested as bronchial asthma, urticaria
and rhinitis.

Active gastric and duodenal ulcer