Nicorandil 10mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Nicorandil

Beschikbaar vanaf:

Alliance Healthcare (Distribution) Ltd

ATC-code:

C01DX16

INN (Algemene Internationale Benaming):

Nicorandil

Dosering:

10mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02060300

Bijsluiter

IN THIS LEAFLET:
1. What Nicorandil Tablets are and what they
are used for
2. Before you take Nicorandil Tablets
3. How to take Nicorandil Tablets
4. Possible side effects
5. How to store Nicorandil Tablets
6. Further information
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).
These tablets contain a medicine called
nicorandil. This belongs to a group of medicines
called 'potassium-channel activators'.
Nicorandil Tablets work by increasing the
blood flow through the blood vessels of the
heart.
Nicorandil Tablets are used to prevent and
treat long-term chest pain (angina).
BEFORE YOU TAKE NICORANDIL
TABLETS
DO NOT TAKE NICORANDIL TABLETS AND TELL YOUR
DOCTOR
IF:
• You are allergic (hypersensitive) to nicorandil
or any of the other ingredients of Nicorandil
Tablets (see section 6 -"Further information").
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
• You have low blood pressure
(signs include
feeling dizzy, light-headed or faint)
• You have a heart problem where the heart
is damaged and cannot pump enough blood
around the body
• You have heart failure
(signs include shortness
of breath, swollen ankles and legs, and
feeling tired)
• You are taking medicines for erectile
dysfunction (impotence) such as sildenafil,
tadalafil or vardenafil
Do not take this medicine if any of these apply
to you. If you are not sure, talk to your doctor
or pharmacist before taking Nicorandil Tablets.
TAKE SPECIAL CARE WITH NICORANDIL TABLETS
Check with your doctor or pharmacist before
taking this medicine if:
• You have been told by your doctor that you
have low blood volume or low systolic blood
pressure
• You have recently had a heart attack
• You have a build up of fluid in the lungs
(pulmonary oedema)
• You have mouth ulcers
If you are not sure if any of these apply to
you, talk to your do

Productkenmerken

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