Nicorandil 10mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Nicorandil

Saadav alates:

Rivopharm (UK) Ltd

ATC kood:

C01DX16

INN (Rahvusvaheline Nimetus):

Nicorandil

Annus:

10mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02060300; GTIN: 5060388650124

Infovoldik

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 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
Nicorandil contains a medicine 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 is used to prevent or attenuate
painful, straining symptoms (angina pectoris) of your
heart disease. It is used in adult patients who do not
tolerate or cannot take heart medicines called beta-
blockers and/or calcium antagonists.
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).
-
If you have low blood pressure (hypotension).
-
If you have heart problems such as cardiogenic
shock, or left ventricular failure with low filling
pressure or cardiac decompensation or shock.
-
If you are taking medicines to treat erectile
dysfunction such as sildenafil, tadalfil, vardenafil
(phosphodiesterase inhibitors) or medicines to
treat pulmonary hypertension such as r

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nicorandil 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of nicorandil.
For the full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Tablet
White, round, scored on one side and embossed on the other side with
’10’.
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 from 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
left
ventricular
dysfunction
with
low
filling
pressure
or
cardiac
decompensation
•
Use of p