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IMDUR 60MG PROLONGED RELEASE FILM-COATED TABLETS

Active substance(s): ISOSORBIDE MONONITRATE / ISOSORBIDE MONONITRATE / ISOSORBIDE MONONITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

IMDUR® 60mg 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.
• The name of this medicine is IMDUR 60mg Prolonged-release Filmcoated Tablets but will be referred to as Imdur throughout the
remainder of this leaflet.
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 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 are taking sildenafil or similar medicines called
Phosphodiesterase Type 5 Inhibitors, (used for male impotence). See
the section “Other medicines and Imdur”.
Do not take Imdur if any of the above applies to you. If you are not sure,
talk to your doctor or pharmacist before taking Imdur.
Warnings and precautions
Talk to 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.
If any of the above applies to you, or you are not sure, talk to your doctor
or pharmacist before taking Imdur.
Other medicines and Imdur
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This includes medicines that you buy
without a prescription and herbal medicines. This is because Imdur can
affect the way some medicines work and some medicines can have an
effect on Imdur.
Do not take Imdur if you are taking the following medicines:
• Sildenafil or similar medicines called Phosphodiesterase Type 5
Inhibitors, (used for male impotence).
Do not take Imdur if any of the above applies to you. If you are not sure,
talk to your doctor or pharmacist before taking Imdur.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
You may feel dizzy after taking Imdur. If this happens, do not drive or use
any tools or machines.
3) HOW TO TAKE IMDUR
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Swallow the tablets whole or broken in half (if this is easier to swallow).
• Take the tablets with half a glass of water.
• Do not crush or chew the tablets.
How much to take
• The recommended dose is one or two tablets a day.
• Take the medicine in the morning.
• Your doctor may ask you to start on a low dose so that you are less
likely to have a reaction to starting Imdur.
• The blister strips are marked with the days of the week. If you are
taking two tablets a day, make sure you take one tablet from each strip
marked with the same day of the week.
You must not take Imdur for a sudden attack of angina. If you have a
sudden attack, take a glyceryl trinitrate tablet (follow the
instructions given on the label).
Very occasionally, some people see the remains of the tablet in their
bowel motions. This is quite normal and does not mean that the medicine
has not been released.
Use in children
Do not give these tablets to children.
If you take more Imdur than you should
If you take more Imdur than you should, talk to a doctor or go to a
hospital straight away. Take the medicine pack with you so the tablets
can be identified.
If you forget to take Imdur
• If you forget a dose, take it as soon as you remember it. However, if it
is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them. The following side effects may happen with this
medicine:
• Headaches
• Feeling sick (nausea)
• Feeling dizzy
The above problems usually disappear with time.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Low blood pressure. This may make you feel faint or dizzy.
• Faster heartbeat
• Headache
• Feeling dizzy
• Feeling sick (nausea)
Uncommon (may affect up to 1 in 100 people)
• Being sick (vomiting)
• Diarrhoea

Rare (may affect up to 1 in 1,000 people)
• Fainting
• Rash
• Itchy skin
Very rare (may affect up to 1 in 10,000 people)
• Pain in muscles
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5) HOW TO STORE IMDUR
• Do not take your tablets after the expiry date shown on the carton and
blister strip.
• Store out of the sight and reach of children.
• Do not store above 30°C.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist (chemist).
6) CONTENTS OF THE PACK AND OTHER INFORMATION
Each tablet is a yellow, oval, biconvex, prolonged-release, film-coated
tablet, scored on both sides, engraved A/ID on one side and contains
60mg of isosorbide mononitrate in an extended release formulation.
Each tablet also contains the following inactive ingredients: aluminium
silicate, paraffin special, hyprolose, magnesium stearate, colloidal
anhydrous silica, hypromellose, macrogol 6000, titanium dioxide (E171)
and ferric oxide (E172).
The tablets are made so that they release the medicine slowly over a
number of hours.
IMDUR® 60mg Prolonged-release Film-coated Tablets come in blister
strips containing 7 tablets, which have the days of the week shown. A
pack contains 28 tablets as multiples of the 7 tablet blister strip.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, U.K.
Repackaged by XXXXXXXXXXXXXXXXXX
IMDUR® 60mg Prolonged-release Film-coated Tablets
PL: 33532/0166

P

IMDUR® 60mg Prolonged-release Film-coated Tablets are manufactured
by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK.
IMDUR® is a registered trademark of the AstraZeneca group of
companies
Leaflet dated 1st August 2017
Leaflet coded XXXXXXXXXX

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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