Voltaren Rapid tablets sugar-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

diclofenac (diclofenac potassium)

Available from:

Novartis Saglik

ATC code:

M01AB05

INN (International Name):

diclofenac (diclofenac potassium)

Dosage:

50mg

Pharmaceutical form:

tablets sugar-coated

Units in package:

(20/2x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-04-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Voltaren
®
Rapid Tablets 25mg
Voltaren
®
Rapid Tablets 50mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of diclofenac potassium
Chemical name:
Potassium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sugar-coated tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Rheumatoid arthritis
•
Osteoarthrosis.
•
Low back pain.
•
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.
•
Migraine attacks.
•
Control of pain and inflammation in orthopaedic, dental and other
minor surgery.
In keeping with standard therapeutic principles, the underlying
disease should be treated with
specific therapy as appropriate. Fever alone is not an indication.
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.
The tablets should be swallowed whole with liquid, preferably before
meals, and must not be
chewed or divided.
Adults
The recommended daily dose is 100-150mg in two or three divided doses.
For milder cases,
75-100 mg daily in two or three divided doses is usually sufficient.
In migraine an initial dose of 50 mg should be taken at the first
signs of an impending attack. In
cases where relief 2 hours after the first dose is not sufficient, a
further dose of 50 mg may be
taken. If needed further doses of 50 mg may be taken at intervals of
4-6 hours, not exceeding a
total dose of 150 mg per day.
SPECIAL POPULATIONS
Paediatric patients (below 18 years of age)
For children over 14 years of age, the recommended daily dose is
50-100 mg in two or three
divided doses.