Nicorandil 20mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Nicorandil

から入手可能:

Kent Pharma (UK) Ltd

ATCコード:

C01DX16

INN（国際名）:

Nicorandil

投薬量:

20mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 02060300

情報リーフレット

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

製品の特徴

OBJECT 1
NICORANDIL 20MG 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 20mg Tablets
2. Qualitative and quantitative composition
Nicorandil 20mg
Each tablet contains 20mg 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 "20" on the other side.
The tablet can be divided into equal halves.
4. Clinical particulars
4.1 Therapeutic indications
Nicorandil 20mg 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