Isosorbide mononitrate 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isosorbide mononitrate

Available from:

Actavis UK Ltd

ATC code:

C01DA14

INN (International Name):

Isosorbide mononitrate

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANGITATE
® 20 MG TABLETS
ANGITATE
® 40 MG TABLETS
Isosorbide Mononitrate
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 Angitate
®
is and what it is used for
2 .
What you need to know before you take Angitate
®
3 .
How to take Angitate
®
4 .
Possible side effects
5 .
How to store Angitate
®
6 .
Contents of the pack and other information
1. WHAT ANGITATE
® IS AND WHAT IT IS USED FOR
This medicine contains an active ingredient called Isosorbide
Mononitrate, which 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.
Isosorbide Mononitrate is used to prevent 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.
Angitate
®
20 mg and 40 mg Tablets can also be used to treat congestive heart
failure. Heart
failure can happen when the heart muscle is not strong enough to pump
the blood around
the body. It may cause problems with breathing and swelling of the
legs.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGITATE
®
DO NOT TAKE THIS MEDICINE:
•
If you are allergic to isosorbide mononitrate, other nitrates or to
any of the other
ingredients of this medicine (listed in section 6)
•
If you suffer from severe anaemia (reduction in red blood c

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isosorbide Mononitrate Tablets 20 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Isosorbide Mononitrate, 20 mg.
Excipients with a known effect:
Each tablet contains approximately 109 mg of lactose and approximately
59 mg
sucrose.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White round tablets with an embossment "IM 20" on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Isosorbide Mononitrate Tablets is indicated for the prophylaxis of
angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Dosage should be reduced in patients with renal or hepatic impairment.
ADULTS
One tablet to be taken asymmetrically (to allow a nitrate low period)
two or three
times a day. Patients already accustomed to prophylactic nitrate
therapy may
normally be transferred directly to a therapeutic dose of isosorbide
mononitrate. For
patients not already receiving prophylactic nitrate therapy it is
recommended that the
initial dose be one tablet of Isosorbide Mononitrate Tablets 20 mg
twice a day. _ _
The maintenance dose in individual patients is usually between 20- 120
mg daily.
The lowest effective dose should be used.
ELDERLY
No evidence of a need for routine dosage adjustment in older people
has been found,
but special care may be needed in those with increased susceptibility
to hypotension
or marked hepatic or renal insufficiency.
CHILDREN
The safety and efficacy of Isosorbide Mononitrate Tablets 20 mg has
yet to be
established in children.
Treatment with Isosorbide Mononitrate Tablets, as with any other
nitrates, should not
be stopped suddenly. Both the dosage and frequency should be tapered
gradually (see
section 4.4)
Method of administration
It is recommended that the tablets should be swallowed whole with a
drink of water.
4.3
CONTRAINDICATIONS
Isosorbide Mononitrate Tablets 20 mg should not be used in cases of
acute
myocardial infarction with low filling pressures, acute circulatory