Nicorandil 20mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Nicorandil

Dostopno od:

DE Pharmaceuticals

Koda artikla:

C01DX16

INN (mednarodno ime):

Nicorandil

Odmerek:

20mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02060300

Navodilo za uporabo

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 Tablets are and what they are
used for
2. What you need to know before you take Nicorandil
Tablets
3. How to take Nicorandil Tablets
4. Possible side effects
5. How to store Nicorandil Tablets
6. Contents of the pack and other information
1. 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). Nicorandil
Tablets contain the active substance “nicorandil”.
This
belongs
to
a
group
of
medicines
called
'potassium-channel activators'.
Nicorandil Tablets are used to prevent or reduce
painful
signs
(“angina
pectoris”)
of
your
heart
disease.
It
is
used
in
adults
who
cannot
take
heart medicines called “beta-blockers” or “calcium
antagonists”.
Nicorandil Tablets work by increasing the blood flow
through the blood vessels of the heart. They improve
the blood and oxygen supply of your heart muscle
and reduces its workload.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE NICORANDIL TABLETS
DO NOT TAKE NICORANDIL TABLETS IF:
• You are allergic (hypersensitive) to nicorandil or
any of the other ingredients of this medicine (listed
in section 6). Signs of an allergic reaction include:
a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
• You
have
severe
low
blood
pressure
(“hypotension”). Signs include feeling dizzy, light-
headed or faint.
• You hav

Lastnosti izdelka

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