Imdur 60 mg Prolonged-release Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

ISOSORBIDE MONONITRATE

Доступна з:

Imbat Limited

Код атс:

C01DA; C01DA14

ІПН (Міжнародна Ім'я):

ISOSORBIDE MONONITRATE

Дозування:

60 milligram(s)

Фармацевтична форма:

Prolonged-release tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Organic nitrates; isosorbide mononitrate

Статус Авторизація:

Authorised

Дата Авторизація:

2007-03-16

інформаційний буклет

_ Page 1 of 2 Page 2 of 2 _
PATIENT INFORMATION LEAFLET
IMDUR
® 60MG PROLONGED-RELEASE TABLETS
(ISOSORBIDE MONONITRATE)
Your medicine is available using the name Imdur 60mg
prolonged release Tablets, but will be referred to as Imdur
throughout this leaflet.
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.

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. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1.
What Imdur is and what it is used for
2.
Before you take Imdur
3.
How to take Imdur
4.
Possible side effects
5.
How to store Imdur
6.
Further 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.
BEFORE YOU TAKE IMDUR
DO NOT TAKE IMDUR IF:

You are allergic (hypersensitive) to isosorbide mononitrate
or any of the other ingredients of Imdur (listed in Section
6: Further information).

You have ever had a stroke.

You have low blood pressure.

You have severe anaemia.

You have a heart problem called ‘cardiomyopathy’ or
‘pericarditis’ or you have narrow heart valves.
Do not take Imdur if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Imdur.
TAKE SPECIAL CARE WITH IMDUR
Check with your doctor or pharmacist before taking Imdur if:

You have ever had any serious damage to your heart, such
as a heart attack or operation.

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imdur 60 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60mg Isosorbide mononitrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated prolonged-release tablet.
_Product imported from Greece:_
A yellow, oval, bi-convex, film-coated, prolonged-release tablet,
scored on both sides, engraved 'A/ID'
on side, and
plain on the other.
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
DOSAGE
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
CHILDREN
The safety and efficacy of Imdur in children has not been established.
ELDERLY
No evidence of a need for routine dosage adjustment in the elderly 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 disintegrating and
may be visible