Nicorandil 20mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Nicorandil

Saadav alates:

Zentiva Pharma UK Ltd

ATC kood:

C01DX16

INN (Rahvusvaheline Nimetus):

Nicorandil

Annus:

20mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02060300; GTIN: 5000283651758

Infovoldik

140 mm
540 mm
Package leaflet: information for the user
Nicorandil 10 mg and 20 mg Tablets
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 in this leaflet
1. What Nicorandil is and what it is used for
2. What you need to know before you take Nicorandil
3. How to take Nicorandil
4. Possible side effects
5. How to store Nicorandil
6. Contents of the pack and other information
1. What Nicorandil is and what it is used for
The name of your medicine is Nicorandil 10 mg or 20 mg Tablets (called
Nicorandil in
this leaflet). The active ingredient in this medicine is called
Nicorandil. This belongs to
a group of medicines called ‘potassium channel activators’.
Nicorandil is 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
and/or calcium antagonists. This medicine works by increasing the
blood flow
through the blood vessels of the heart. It improves the blood and
oxygen supply to
your heart muscle and reduces its workload.
2. What you need to know before you take Nicorandil
Do not take Nicorandil if you:
• are allergic to nicorandil or any of the other ingredients of this
medicine (listed in
section 6).
• have low blood pressure (hypotension).
• have heart problems such as cardiogenic shock, or left ventricular
failure with low
filling pressure or heart decompensation or shock.
• are taking medicines to treat erectile dysfunction such as
sildenafil, tadalfil,
vardenafil (phosphodiesterase inhibitors) or medic

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicorandil 20 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of Nicorandil.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
White to off white coloured, round, flat bevelled edge, uncoated
tablet
debossed with ‘ND 20’ on one side and break line on other side.
The tablet can
be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nicorandil is 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 is not recommended in paediatric patients since its safety
and efficacy have not been
established in this patient group.
Method of administration
Nicorandil is administered by oral route.
The tablets are to be swallowed in the morning and in the evening as a
whole with some liquid.
Administration is independent of food intake.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to nicorandil or to any of the excipients listed in
section 6.1.
•
Patients with shock (including cardiogenic shock), severe hypotension,
or