Voltaren Retard tablets prolonged-release

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

diclofenac (diclofenac sodium)

可用日期:

Novartis Farma S.p.A.

ATC代码:

M01AB05

INN（国际名称）:

diclofenac (diclofenac sodium)

剂量:

75mg

药物剂型:

tablets prolonged-release

每包单位数:

(20/2x10/) in blister

处方类型:

Prescription

授权状态:

Registered

授权日期:

2017-04-03

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Voltaren
®
Retard 75mg or 100mg SR tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is
sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac
sodium).
Each slow release tablet contains 75mg diclofenac sodium Ph.Eur.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Slow release tablet.
Pale pink, triangular, slightly biconvex with bevelled edges. One side
debossed “ID”, the other “CG”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults and Elderly_
:
Relief of all grades of pain and inflammation in a wide range of
conditions, including:
(i)
arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis, acute gout,
(ii)
acute musculo-skeletal disorders such as periarthritis (for example
frozen shoulder),
tendinitis, tenosynovitis, bursitis.
(iii)
other painful conditions resulting from trauma, including fracture,
low back pain, sprains,
strains, dislocations, orthopaedic, dental and other minor surgery.
_Children_
: Voltaren
®
Retard 75mg or 100mg SR tablets are not suitable for children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4 Special warnings and
precautions for use).
For oral administration
ADULTS
One tablet once or twice daily, taken whole with liquid, preferably at
meal times.
The recommended maximum daily dose of Voltaren
®
Retard is 150mg.
SPECIAL POPULATIONS
ELDERLY
(aged 65 years or above)
Although the pharmacokinetics of Voltaren
®
Retard are not impaired to any clinically relevant extent
in elderly patients, nonsteroidal anti-inflammatory drugs should be
used with particular caution in
such patients who generally are more prone to adverse reactions. In
particular it is recommended that
the lowest effective dosage be used in frail elderly patients or those
with a low body weight (see also
P