Nicorandil 20mg Tablets tablets

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

nicorandil

זמין מ:

Dexcel-Pharma Ltd.

קוד ATC:

C01DX16

INN (שם בינלאומי):

nicorandil

כמות:

20mg

טופס פרצבטיות:

tablets

יחידות באריזה:

(60/6x10/) in blister

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2021-02-27

עלון מידע

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). 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 or

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicorandil 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicorandil 20mg
Excipient(s) with known effect:
Each tablet contains 20mg 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 "20" on the
other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorandil 20mg 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
medicine, 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 CONTRAINDICATIONS
• Hypersensitivity to nicorandil or to any of the excipients