Nicorandil 10mg 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:

10mg

טופס פרצבטיות:

tablets

יחידות באריזה:

(60/6x10/), in blister

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2016-02-26

עלון מידע

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 breathing problems, swelling
of your lips, face, throat or tongue.
• You
have
severe
low
blood
pressure
(“hypotension”). Signs include feeling dizzy, light-
headed or faint.
• You hav

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicorandil 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nicorandil 10mg
Each tablet contains 10mg 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 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 halves.
Administration is independent of food intake.
4.3
CONTRAINDICATIONS
• Hypersensitivity to nicorandil or to any of the excipients listed
in section 6.1.
• Pat