Nicorandil 10mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Nicorandil

Disponible depuis:

DE Pharmaceuticals

Code ATC:

C01DX16

DCI (Dénomination commune internationale):

Nicorandil

Dosage:

10mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 02060300

Notice patient

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

Résumé des caractéristiques du produit

OBJECT 1
NICORANDIL 10MG TABLETS
Summary of Product Characteristics Updated 29-Jul-2018 | Dexcel Pharma
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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
t