Imdur 60mg Prolonged-release, Film-coated Tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

ISOSORBIDE MONONITRATE

Saadav alates:

Topridge Pharma (Ireland) 6-9 TRINITY STREET, D02EY47, Dublin 2 , Ireland

ATC kood:

C01DA14

INN (Rahvusvaheline Nimetus):

ISOSORBIDE MONONITRATE 60 mg

Ravimvorm:

PROLONGED-RELEASE TABLET

Koostis:

ISOSORBIDE MONONITRATE 60 mg

Retsepti tüüp:

POM

Terapeutiline ala:

CARDIAC THERAPY

Volitamisolek:

Authorised

Loa andmise kuupäev:

2006-03-23

Infovoldik

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMDUR
® 60 MG PROLONGED-RELEASE, FILM-COATED 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 Imdur is and what it is used for
2. What you need to know before you take Imdur
3. How to take Imdur
4. Possible side effects
5. How to store Imdur
6. Contents of the pack and other information
1.
WHAT IMDUR IS AND WHAT IT IS USED FOR
Imdur contains a medicine called isosorbide mononitrate. This belongs
to a group of
medicines called ‘nitrates’.

It is used to prevent chest pain (angina).

It works by making the blood vessels relax and widen. This makes it
easier for the heart to
pump blood around the body.
The tablets are made so that they release the medicine slowly over a
number of hours.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMDUR
DO NOT TAKE IMDUR:

If you are allergic to isosorbide mononitrate or any of the other
ingredients of this
medicine (listed in section 6).

If you are allergic to any other nitrate medicines. These include
glyceryl trinitrate and
isosorbide dinitrate.

If you have ever had a stroke.

If you have very low blood pressure.

If you have severe anaemia.

If you have a heart problem called ‘cardiomyopathy’ or
‘pericarditis’ or you have narrow
heart valves.

If you have recently had a head injury, which may have caused bleeding
in your brain.

If you may have ‘hypovolaemia’. Symptoms may include faster
breathing or pulse, with
sweating.


Toote omadused

Summary of Product Characteristics
Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Imdur
®
60 mg Prolonged-release, Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Isosorbide mononitrate 60 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated, prolonged-release tablet.
A yellow, oval, bi-convex, film-coated, prolonged-release tablet,
scored on both
sides, engraved ‘A/ID’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic management of angina pectoris. Imdur is not indicated in
the
management of acute attacks of angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Imdur 60 mg once daily to be taken in the morning. The dose may be
increased to
120 mg daily, the whole dose to be given together in the morning. This
will produce
effective nitrate blood levels during the day with low blood levels at
night to
prevent the development of tolerance.
The dose can be titrated to minimise the possibility of headache, by
initiating
treatment with a 30 mg dose, for the first two to four days.
Whole Imdur tablets, or if needed, the divided halves, must not be
chewed or
crushed. They should be swallowed together with half a glass of water.
Note that Imdur is not indicated for the relief of acute attacks, in
the event of an
acute attack, sublingual or buccal glyceryl trinitrate tablets should
be used
Summary of Product Characteristics
Page 2 of 7
PAEDIATRIC POPULATION
The safety and efficacy of Imdur in children has not been established.
OLDER PEOPLE
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.
An additional anti-anginal effect has been achieved when Imdur has
been used in
combination with beta-blockers.
The matrix of the tablet is insoluble but disintegrates when the
active substance is
released. Occasionally, the matrix may pass through the
gastrointestinal tract
without d