NICORANDIL 10 Milligram Tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

NICORANDIL

Dostupné s:

Dexcel-Pharma Limited

ATC kód:

C01DX16

INN (Mezinárodní Name):

NICORANDIL

Dávkování:

10 Milligram

Léková forma:

Tablets

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Other vasodilators used in cardiac diseases

Stav Autorizace:

Authorised

Datum autorizace:

2011-08-05

Informace pro uživatele

Nicorandil 10mg, 20mg Tablets

1.3: Product Information

1.3.1 Package Leaflet

Page 1 of 5 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

NICORANDIL 10MG TABLETS 

NICORANDIL 20MG 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
10mg Tablets or Nicorandil 20mg Tablets (referred to as 
Nicorandil Tablets throughout this leaflet). The active ingredient
in this medicine is called nicorandil. This 
belongs to a group of medicines called 'potassium-channel activators'. 

It works by increasing the blood flow through the blood vessels
of the heart. It improves the blood and 
oxygen supply of your heart muscle and reduces its workload. 

Nicorandil
Tablets are used to prevent or attenuate painful, straining symptoms (angina pectoris) of your 
heart disease. It is used in adult patients who do not
tolera

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nicorandil 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicorandil 10mg
Each tablet contains 10 mg nicorandil.
For a 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 halves.
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 antagonist).
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 halves.
Administration is independent of food intake.
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