Naklofen

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

diclofenac (diclofenac diethylamine)

Disponible depuis:

KRKA d.d.

DCI (Dénomination commune internationale):

diclofenac (diclofenac diethylamine)

Dosage:

10mg/g

forme pharmaceutique:

gel

Type d'ordonnance:

OTC

Résumé des caractéristiques du produit

SmPCPIL040064_3
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1.
NAME OF THE MEDICINAL PRODUCT
Naklofen 11.6 mg/g gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 g of gel contains 11.6 mg diclofenac diethylammonium.
Excipient: propylene glycol (50 mg/g)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gel.
The gel is white in colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Naklofen is used alone or in combination with the oral forms in the
treatment of various injuries and
milder forms of rheumatic diseases, such as:
•
degenerative rheumatic diseases (osteoarthritis of peripheral joints
and spine, periarthropathy),
•
extra-articular rheumatic diseases (myalgia, fibrositis, bursitis,
tendinitis, tendovaginitis,
epicondylitis, acute lumbar or shoulder pain syndrome without nerve
compression),
•
other pain syndromes (sports and other injuries of soft tissues, such
as strains, sprains and
contusions, when the skin is not damaged).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and children over 14 years: _
A 5 to 10 cm long strip of the gel should be applied to the affected
area 3 to 4 times daily and rubbed
gently into the skin. Treatment usually lasts for 7 days without
consulting a doctor.
Naklofen gel can also be used in addition to the oral forms of
nonsteroidal anti-inflammatory drugs but
with caution.
4.3
CONTRAINDICATIONS
Hypersensitivity to diclofenac or to any of the excipients.
Hypersensitivity to other nonsteroidal anti-inflammatory drugs,
especially if they have caused asthma,
rhinitis or urticaria.
Third trimester of pregnancy.
Children under 14 years of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Naklofen should be applied only to healthy and unbroken skin. It
should not be applied to wounds or
other open injuries.
The gel should not be used under an occlusive dressing.
The gel should not come into contact with the mucous membrane or eyes.
SmPCPIL040064_3
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Page 2 of 4
Caution is required with prolonged use of large amounts of the gel on
large areas of sens