Nicorandil 10mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Nicorandil

Διαθέσιμο από:

Somex Pharma

Φαρμακολογική κατηγορία (ATC):

C01DX16

INN (Διεθνής Όνομα):

Nicorandil

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02060300; GTIN: 15060089610608

Φύλλο οδηγιών χρήσης

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 symptoms 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.
IN THIS LEAFLET:
1. What Nicorandil is and what it is used for
2. Before you take Nicorandil
3. How to take Nicorandil
4. Possible side effects
5. How to store Nicorandil
6. Further information 1. WHAT NICORANDIL IS AND WHAT IT IS
USED FOR
Nicorandil tablet 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 tablet 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.
You must talk to a doctor if you do not feel better or
if you feel worse. 2. 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, tadalafil,
vardenafil (phosphodiesterase inhibitors) or
medicines to treat pulmonary hypertension such
as riociguat (guanylate cyclase stimulators). This
may seriously affect your blood pressure.
�

Αρχείο Π.Χ.Π.

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