Diclofenac-Asteria tablets

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

diclofenac (diclofenac sodium)

Inapatikana kutoka:

Hankook Korus Pharm Co.

ATC kanuni:

M01AB05

INN (Jina la Kimataifa):

diclofenac (diclofenac sodium)

Kipimo:

100mg

Dawa fomu:

tablets

Vitengo katika mfuko:

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

Dawa ya aina:

Prescription

Idhini hali ya:

Registered

Idhini ya tarehe:

2015-12-17

Tabia za bidhaa

Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Diclofenac -Asteria Tab. 100mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/Tab.
Use
1
Diclofenac sodium
100.0mg
Active
ingredient
Excipient(s)
No.
Chemical Name
Quantity/Tab.
Use
1
Lactose
180.0mg
Inactive
2
Corn starch
55.0mg
Inactive
3
Calcium carboxymethyl
cellulose
3.0mg
Disintegrant
4
Hydroxylpropyl cellulose
9.0mg
Binder
5
Magnesium stearate
3.0mg
Lubricant
6
Hypromellose phthalate
16.2mg
Coating agents
7
Hypromellose 2910
1.125mg
Coating agents
8
Ethylcellulose
0.1mg
Coating agents
9
Diacetylated Monoglycerides
0.96mg
Emulsifier
10
Titanium oxide
q.s
Sunscreen agent
11
Sunset yellow FCF
q.s
Coloring agent
3. PHARMACEUTICAL FORM
Tablets
Summary of Product Characteristics
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis.
Treatment of post traumatic
pain and inflammation. Symptomatic treatment of primary dysmenorrhoea.
4.2 Posology and method of administration
Usual Adult Dose: 25 to 50 mg taken three times daily. The tablet must
be taken whole during
or after meals. Initially this dose may be increased to 150 mg daily
and may be reduced to 75 to
100 mg daily in milder cases or for long-term and maintenance therapy.
Diclofenac sodium is
not recommended for use in children as safety and efficacy have not
been established.
The dosage of diclofenac should be individualized to the lowest
effective dose to minimize
adverse effects.
4.3 Contraindications
Diclofenac
is
contraindicated
in
patients
with
known
hypersensitivity
to
diclofenac
and
diclofenac-containing
products.
Diclofenac
should
not
be
given
to
patients
who
have
experienced asthma, urticaria, or other allergic-type reactions after
taking aspirin or other
NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to
diclofenac have been reported in
such patients.
4.4 Special warnings and precautions
WARNINGS
Gastrointestinal Effects
Peptic
ulceration
and
gastrointestinal
bleedin