Diclofenac-Asteria tablets

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

diclofenac (diclofenac sodium)

Διαθέσιμο από:

Hankook Korus Pharm Co.

Φαρμακολογική κατηγορία (ATC):

M01AB05

INN (Διεθνής Όνομα):

diclofenac (diclofenac sodium)

Δοσολογία:

50mg

Φαρμακοτεχνική μορφή:

tablets

Μονάδες σε πακέτο:

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

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2020-10-22

Αρχείο Π.Χ.Π.

Summary of Product Characteristics
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, 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
bleeding
have
been
reported