Isoket Retard 40 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide dinitrate

Available from:

Forum Health Products Ltd

ATC code:

C01DA08

INN (International Name):

Isosorbide dinitrate

Dosage:

40mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100; GTIN: 5015366084842

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Isoket Retard is and what it is used for
2. What you need to know before you take Isoket
Retard
3. How to take Isoket Retard
4. Possible side effects
5. How to store Isoket Retard
6. Contents of the pack and other information.
1. WHAT ISOKET RETARD IS AND WHAT IT IS
USED FOR
Isoket Retard belongs to a group of medicines
called organic nitrates. Organic nitrates work by
widening the blood vessels in your heart to
allow an increased amount of blood to flow to
areas which need it.
Isoket Retard is used to prevent and treat angina
pectoris. Angina usually feels like a tight pain in the
chest, neck or arm area. The pain comes
from the heart muscle and is a sign that part of it
is not getting enough oxygen for the amount of
work it is doing.
4021406 22291202 10/387 1410
ISOKET
®
RETARD
40 MG
TABLETS
Isosorbide dinitrate
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ISOKET RETARD
DO NOT TAKE ISOKET RETARD IF:
•
You are allergic to isosorbide dinitrate, other
nitrates or any of the other ingredients of
this medicine (listed in section 6)
•
You suffer from anaemia (reduction in red
blood cells which can make the skin pale and
cause weakness or breathlessness)
•
You have had a heart attack (myocardial
infarction)
•
You have had a brain haemorrhage (bleeding)
•
You have had a head injury (trauma)
•
You have a low blood volume (hypovolaemia)
•
You have very low blood pressure
•
Your blood has stopp

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ISOKET RETARD 40 TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains isosorbide dinitrate 40 mg in a prolonged release
formulation.
Excipients with known effect: 162.70 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged release tablets.
White with break score, marked IR 40 on the upper side and with
SCHWARZ
PHARMA on the reverse side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis and treatment of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults:_ One tablet to be taken once daily without chewing and with a
sufficient amount of
fluid. For patients with higher nitrate requirements the dose may be
increased to one tablet
twice daily; but ensuring a 12 hours treatment free interval every 24
hours.
_Elderly population:_ Clinical experience has not necessitated
alternative advice for use in
elderly patients.
_Paediatric population:_ The safety and efficacy of Isoket Retard has
yet to be established.
Method of administration
For oral administration
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
This product should not be given to patients with a known sensitivity
to nitrates, very low
blood pressure, acute myocardial infarction with low filling pressure,
marked anaemia, head
trauma, cerebral haemorrhage, acute circulatory failure, severe
hypotension or hypovolaemia.
Phosphodiesterase inhibitors (e.g. Sildenafil) have been shown to
potentiate the hypotensive
effects of nitrates, and their co-administration with nitrates or
nitric oxide donors is therefore
contraindicated.
During nitrate therapy, the soluble guanylate cyclase stimulator
riociguat must not be used
(see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
These tablets should be used with caution in patients who are
suffering from hypothyroidism,
hypothermia, malnutrition, severe liver disease or