Nidol Gel gel

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

nimesulide

Available from:

Polipharm Co.

ATC code:

M02AA26

INN (International Name):

nimesulide

Dosage:

20mg/g

Pharmaceutical form:

gel

Units in package:

aluminium tube 30g

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-03-25

Summary of Product characteristics

NIDOL
® GEL 2% SUMMARY OF PRODUCT CHARACTERISTICS
(NIMESULIDE 2G/100 MG)
1.
NAME OF THE MEDICINAL PRODUCT
Nidol
®
Gel 2%, nimesulide 2g /100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nidol Gel 2% contains 2% w/w nimesulide (1 g of gel contains 20 mg of
nimesulide).
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Gel.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Symptomatic relief of pain associated with sprains and acute traumatic
tendinitis.
4.2. POSOLOGY AND ADMINISTRATION:
Adults
Nimesulide 2% gel (usually 3 g, corresponding to a line 6-7 cm long)
should be applied in a thin layer
to the affected area 2-3 times daily and massaged until it is
completely absorbed.
Duration of treatment: 7-15 days.
Children under 12 years
Nimesulide 2% gel has not been studied in children. Therefore, safety
and efficacy have not been
established and the product should not be used in children (see
section 4.3).
4.3. CONTRAINDICATIONS:
Known hypersensitivity to nimesulide or to any of the excipients in
the gel.
Use in patients in whom aspirin, or other medical products inhibiting
prostaglandin synthesis,
induced allergic reactions such as rhinitis, urticaria or
bronchospasm.
Use on broken or denuded skin or in the presence of local infection.
Simultaneous use with other topical creams.
Use in children under 12 years.
Patients with gastro-intestinal bleeding, active or suspected peptic
ulcer, severe renal or hepatic
dysfunction, severe coagulation disorders or severe/non controlled
heart failure should be treated
with caution.
Severe renal and hepatic impairment (creatinine clearance < 30
ml/min).
4.4. PRECAUTIONS AND WARNINGS:
Nimesulide 2% gel should not be applied to skin wounds or open
injuries.
Nimesulide 2% gel should not be allowed to come into contact with the
eyes or mucous membranes;
in case of accidental contact, wash immediately with water.
The product should never be taken by mouth. Hands should be washed
after applying the product.
Nimesulide 2% gel should not be used with occlusive dressings.
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