Nidol

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

nimesulide

Dostopno od:

Polipharm Co.

INN (mednarodno ime):

nimesulide

Odmerek:

100mg

Farmacevtska oblika:

powder for oral suspension

Tip zastaranja:

Prescription

Lastnosti izdelka

NIDOL
®
SUMMARY OF PRODUCT CHARACTERISTICS
(NIMESULIDE 100 MG PER SACHET)
1.
NAME OF THE MEDICINAL PRODUCT
NIDOL
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 100 mg nimesulide.
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of acute pain (see section 4.2)
Symptomatic treatment of osteoarthritis (see section 4.2)
Primary dysmenorrhoea
The decision to prescribe nimesulide should be based on an assessment
of the individual patient's
overall risks (see sections 4.3 and 4.4).
4.2. POSOLOGY AND ADMINISTRATION:
The minimum effective dose should be used for the shortest duration to
reduce the undesirable
effects.
The maximum duration of a treatment course with nimesulide is 15 days.
NIDOL
®
should be used for the shortest possible duration, as required by the
clinical situation.
Adults
100mg nimesulide b.i.d. after meal.
Elderly
In elderly patients there is no need to reduce the daily dosage (see
section 5.2).
Children (<12 years)
NIDOL
®
is contraindicated in these patients (see also section 4.3).
Adolescents (From 12 to 18 years)
On the basis of the kinetic profile in adults and on the
pharmacodynamic characteristics of
nimesulide, no dosage adjustment in these patients is necessary.
Impaired renal function
On the basis of pharmacokinetics, no dosage adjustment is necessary in
patients with mild to
moderate renal impairment (creatinine clearance of 30-80 ml/min),
while NIDOL
®
is contraindicated
in case of severe renal impairment (creatinine clearance < 30 ml/min)
(see sections 4.3 and 5.2).
Hepatic impairment
The use of NIDOL
®
is contraindicated in patients with hepatic impairment (see section
5.2).
4.3. CONTRAINDICATIONS:
Known hypersensitivity to Nimesulide or to any of the excipients of
the products.
History
of
hypersensitivity
reactions
(e.g.
bronchospasm,
rhinitis,
urticaria)
in
response
to
acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
History of hepatotoxic reacti