Nicorandil 10mg Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Nicorandil

Disponible depuis:

Dexcel Pharma GmbH

Code ATC:

C01DX; C01DX16

DCI (Dénomination commune internationale):

Nicorandil

Dosage:

10 milligram(s)

forme pharmaceutique:

Tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Other vasodilators used in cardiac diseases; nicorandil

Statut de autorisation:

Not marketed

Date de l'autorisation:

2011-08-05

Notice patient

Nicorandil 10mg, 20mg Tablets
1.3: Product Information
1.3.1 Package Leaflet
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
NICORANDIL 10 MG TABLETS
NICORANDIL 20 MG TABLETS
NICORANDIL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Nicorandil Tablets are and what they are used for
2.
What you need to know before you take Nicorandil Tablets
3.
How to take
Nicorandil Tablets
4.
Possible side effects
5.
How to store Nicorandil Tablets
6.
Contents of the pack and other information
1.
WHAT NICORANDIL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Nicorandil 10 mg Tablets or Nicorandil 20
mg Tablets (referred to as
Nicorandil Tablets throughout this leaflet). Nicorandil Tablets
contain the active substance “nicorandil”.
This belongs to a group of medicines called 'potassium-channel
activators'.
Nicorandil Tablets are used to prevent or reduce painful signs
(“angina pectoris”) of your heart disease. It is
used in adults who cannot take heart medicines called
“beta-blockers” or “calcium antagonists”.
Nicorandil Tablets work by increasing the blood flow through the blood
vessels of the heart. They improve
the blood and oxygen supply of your heart muscle and reduces its
workload.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICORANDIL TABLETS
DO NOT TAKE NICORANDIL TABLETS IF:

You are allergic (hypersensitive) to nicorandil or any of the other
ingredients of this medicine (listed in
section 6).
Signs of an allergic reaction include: a rash, swallowing

Résumé des caractéristiques du produit

Health Products Regulatory Authority
12 August 2021
CRN00CCH7
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorandil 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicorandil 10mg
Excipient(s) with known effect:
Each tablet contains 10mg nicorandil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet, white to off white, round, scored on one side and engraved
with "10" on the other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nicorandil 10mg Tablets are indicated in adults for the symptomatic
treatment of patients with stable angina pectoris who are
inadequately controlled or have a contraindication or intolerance to
first-line antianginal therapies (such as beta-blockers
and/or calcium antagonists).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The usual therapeutic range is 10 to 20 mg twice daily. The usual
starting dose is 10 mg twice daily (bid), in the morning and in
the evening preferably. It is recommended that the dose be titrated
upwards in accordance with the patient's needs, response
and tolerance up to 40 mg twice daily, if necessary. A lower starting
dose of 5 mg twice daily may be used in patients
particularly prone to headache.
ELDERLY: There are no special dose requirements for elderly patients,
but as with all medicines, use of the lowest effective dose
is recommended.
PATIENTS WITH LIVER AND/OR RENAL IMPAIRMENT
There are no special dosage requirements for patients with liver
and/or renal impairment.
PAEDIATRIC POPULATION: Nicorandil Tablets are not recommended in
paediatric patients since its safety and efficacy have not
been established in this patient group.
METHOD OF ADMINISTRATION
Nicorandil Tablets are administered by oral route.
The tablets are to be swallowed in the morning and in the evening with
a glass of water. The tablets should not be crushed or
chewed.
The tablet can be divided into equal doses.
Administration is independent of food intake
4.3 CONTRAI