Voltaren Rapid

Country: Armenía

Tungumál: enska

Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Vara einkenni Vara einkenni (SPC)
31-01-2017

Virkt innihaldsefni:

diclofenac (diclofenac potassium)

Fáanlegur frá:

Novartis Urunleri

INN (Alþjóðlegt nafn):

diclofenac (diclofenac potassium)

Skammtar:

50mg

Lyfjaform:

tablets sugar-coated

Gerð lyfseðils:

Prescription

Vara einkenni

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Voltaren
®
Rapid Tablets 50mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg 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
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
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 200 mg per day.
SPECIAL POPULATIONS
Paediatric patients (below 18 years of age)
For children over 14 years of age, the recommended daily dose is
75-100 mg in two or three divided doses.
Voltaren Rapid tablets are not recommended for children under 14 years
of age.
The use of Voltaren Rapid (all forms) in migraine attacks has not been
established in children.
Elderly (aged 65 years or above)
Although the pharmacokin
                                
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