Nicorandil (Max Health)

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Nicorandil 20mg

Disponible depuis:

Max Health Limited

Dosage:

20 mg

forme pharmaceutique:

Tablet

Composition:

Active: Nicorandil 20mg Excipient: Croscarmellose sodium Mannitol Pregelatinised maize starch Stearic acid

Type d'ordonnance:

Prescription

indications thérapeutiques:

Nicorandil is indicated for the symptomatic treatment of patients with stable angina pectoris that is inadequately controlled or have a contraindication or intolerance to first-line anti-anginal therapies.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, Alu-Alu blister with a molecular sieve insert as desiccant in carton - 60 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture 30 days opened stored at or below 25°C

Date de l'autorisation:

2022-06-30

Résumé des caractéristiques du produit

NEW ZEALAND DATA SHEET
Page
1
of
13
1
NICORANDIL
Nicorandil 10 mg and 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg tablet contains 10 mg nicorandil.
Each 20 mg tablet contains 20 mg nicorandil.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
10 mg tablets: White, round, scored on one side and embossed on the
other side with '10'.
20 mg tablets: White, round, scored on one side and embossed on the
other side with '20'.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorandil is indicated for the symptomatic treatment of patients with
stable angina pectoris that is
inadequately controlled or have a contraindication or intolerance to
first-line anti-anginal therapies.
4.2
DOSE AND METHOD OF ADMINISTRATION
The usual therapeutic range is 10 to 20 mg twice daily.
The usual starting dose is 10 mg twice daily, in the morning and in
the evening preferably, and should
be titrated upwards in accordance with patients' needs, response and
tolerance up to 40mg twice daily,
if necessary. An even lower starting dose of 5 mg twice daily may be
used in patients particularly prone
to headache.
ELDERLY
There are no special dosage requirements for elderly patients, but as
with all medicines the lowest
effective dose should be used. Nicorandil should be administered with
care, using low starting dosages,
in the elderly.
PAEDIATRIC POPULATION
Nicorandil is not recommended in paediatric patients since its safety
and effectiveness have not been
established in this age group.
DIABETES, RENAL OR HEPATIC DYSFUNCTION
Nicorandil should be used with caution in patients with serious
hepatic dysfunction.
Page
2
of
13
4.3
CONTRAINDICATIONS
•
in patients with known or idiosyncratic hypersensitivity to
nicorandil, nicotinamide, nicotinic acid
or any of the excipients listed in Section 6.1
•
in patients with severe hypotension or with a risk of developing
severe hypotension including shock
(including cardiogenic shock) or left ventricular failure with low
filling pressure and hypovolaemi