Diclofenac-Asteria tablets

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

diclofenac (diclofenac sodium)

Dostępny od:

Hankook Korus Pharm Co.

Kod ATC:

M01AB05

INN (International Nazwa):

diclofenac (diclofenac sodium)

Dawkowanie:

50mg

Forma farmaceutyczna:

tablets

Sztuk w opakowaniu:

(20/2x10/) in blister, (100/10x10/) in blister

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2020-12-18

Ulotka dla pacjenta

ATC code: M01AB05
Anti-inflammatory Agent
DICOFENAC-ASTERIA Tab.100mg
DICOFENAC-ASTERIA Tab. 50mg
COMPOSITION
Active ingredient
Diclofenac sodium--------50mg
Excipients: Lactose, Corn starch, Hydroxypropylcellulose, Sodium
starch glyclate,
Magnesium stearate, hydroxypropylmethylcellulose phthalate,
Polyethylene glycol
6000, Diacetylated monoglycerides, Titanum oxide, Quinoline yellow WS,
Sunset
yellow FCF.
Active ingredient
Diclofenac sodium---------100mg
Excipients: Lactose, Corn starch, Calcium carboxymethyl cellulose,
Hydroxylpropyl
cellulose,
Magnesium
stearate,
Hypromellose
phthalate,
Hypromellose
2910,
Ethylcellulose , Diacetylated Monoglyceroides, Titanum oxide, Sunset
yellow FCF.
INDICATION & USAGE
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
Pyrophosphate arthropathy and associated disorders
DOSAGE 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 Special
warnings and
precautions).
For oral administration.
It is recommended that the tablets be taken with fluid, preferably
with or after food.
To be prescribed
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
Paediatrics
For children over 14 years of age, the rec

Charakterystyka produktu

1.
NAME OF THE MEDICINAL PRODUCT
Diclofenac -Asteria Tab. 50mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/Tab.
Use
1
Diclofenac sodium
50.0mg
Active
ingredient
Excipient(s)
No.
Chemical Name
Quantity/Tab.
Use
1
Lactose
186.0mg
Inactive
2
Corn starch
40.0mg
Inactive
3
Hydroxypropylcellulose
12.0mg
Binder
4
Sodium starch glycolate
4.0mg
Disintergrant
5
Magnesium stearate
4.0mg
Lubricant
6
Hydroxypropyl methylcellulose
phthalate
22.0mg
Coating agent
7
Polyethylene glycol 6000
0.8mg
Coating agent
8
Diacetylated monoglycerides
0.8mg
Emulsifier
9
Titanium Oxide
0.4mg
Sunscreen agent
10
Quinoline yellow WS
q.s
Coloring agent
11
Sunset yellow FCF
q.s
Coloring agent
3.
PHARMACEUTICAL FORM
Tablets
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

Pyrophosphate arthropathy and associated disorders
4.2
Dosage 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 oral administration.
It is recommended that the tablets be taken with fluid, preferably
with or after food.
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