Imdur 60mg Prolonged-release, Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

isosorbide mononitrate 60 mg

Available from:

AstraZeneca AB

ATC code:

C01DA14

INN (International Name):

isosorbide mononitrate

Pharmaceutical form:

prolonged-release tablet

Authorization status:

Authorised

Authorization date:

2006-03-23

Patient Information leaflet

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 ‘ca

Summary of Product characteristics

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 
PAEDIATRIC POPULATION 
Summary of Product Characteristics 

Page 2 of 7

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 
co