NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
IMDUR® DURULES®
Modified release tablets
Isosorbide mononitrate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about IMDUR DURULES. It does not contain all the information that is known about IMDUR DURULES.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking IMDUR DURULES against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What IMDUR DURULES are for
IMDUR DURULES are used to prevent angina. Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms or the neck and sometimes to the shoulders and back. This is caused by too little blood and oxygen getting to the heart.
The pain of angina is usually brought on by exercise or stress.
IMDUR DURULES belong to a group of medicines called nitrates.
IMDUR DURULES work by relaxing the blood vessels, letting more blood and oxygen reach the heart.
Your doctor will have explained why you are being treated with IMDUR DURULES and told you what dose to take.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
However, your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
IMDUR DURULES are not addictive.
Before you use IMDUR DURULES
When you must not use it
Do not use IMDUR DURULES if you are allergic to it or food containing nitrates or nitrites or any ingredients listed at the end of the leaflet.
Do not use IMDUR DURULES if you have the following medical conditions:
Low blood pressure
Shock including those caused by low blood pressure or failing heart
Pericarditis (swelling around the heart)
Weakened muscle of the heart
You must not use IMDUR DURULES whilst taking sildenafil (Viagra*), vardenafil (Levitra=), tadalafil (Cialis+).
Do not use IMDUR DURULES if you are pregnant or breast feeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved.
We do not know if it is safe for you to take it while you are pregnant. It may affect your baby.
It is not known if your baby can take in IMDUR DURULES from breast milk if you are breast feeding.
Do not give IMDUR DURULES to children.
There is no specific information about use in children, so IMDUR DURULES is not recommended for use in children. Always ask your doctor before giving medicines to children.
Do not use after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should take this medicine, talk to your doctor.
Before you start to use it
You must tell your doctor if:
1.you have any allergies to:
any medicine, foods, preservatives or dyes.
If you have an allergic reaction you may get a skin rash, hayfever, asthma or feel faint.
2.you have any of these medical conditions:
any illness affecting your liver or kidneys
low blood pressure (this can make you feel faint, weak or dizzy, especially when you stand up suddenly)
heart and blood vessel problems
It may not be safe for you to take IMDUR DURULES if you have any of these conditions.
Do not use IMDUR DURULES to treat acute angina.
IMDUR DURULES must be taken once daily.
Do not stop taking it abruptly.
Taking other medicines
Tell your doctor if you are taking any other medicines, including:
sildenafil (Viagra*), vardenafil (Levitra=), tadalafil (Cialis+)
medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
These medicines may affect the way IMDUR DURULES work.
Your doctor or pharmacist can tell you what to do if you are taking any other medicines.
If you have not told your doctor about any of these things, tell them before you take any IMDUR DURULES.
Using IMDUR DURULES
How to take it
Take one IMDUR DURULE modified release tablet every day, at about the same time.
If your doctor tells you to take two 60mg IMDUR DURULES each day, take both modified release tablets at the same time.
Taking IMDUR DURULES at 24 hour intervals makes sure they keep working properly.
Swallow IMDUR DURULES modified release tablets whole, with half a glass of water or other liquid e.g. fruit juice, milk. Do not chew or crush the tablets.
The 60mg modified release tablet can be broken in half if care is taken not to crumble them.
IMDUR DURULES modified release tablets are designed to let the drug out over a number of hours. If they are crushed or chewed they won’t work properly.
IMDUR DURULES modified release tablets are composed of a waxy substance that does not dissolve in the body. You may find the outer shell of the tablets in your bowel motions. The medication in them has already been absorbed by the body.
If you forget to take it
If you forget to take a dose, take it as soon as you remember, as long as it is not more than eight (8) hours late.
If it is more than eight (8) hours after you should have taken IMDUR DURULES, wait until the right time the next day to take it.
Do not double the dose.
You may find that you will need to use the tablets or spray that your doctor has given you to use during angina attacks if you miss a dose of IMDUR DURULES.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Overdose
Telephone your doctor or the Poisons Information Centre (13 11 26), or go to casualty at your nearest hospital immediately if you think that you or anyone else may have taken too much IMDUR DURULES even if there are no signs of discomfort or poisoning.
If you take too many IMDUR DURULES modified release tablets you will have a pulsing headache. You may also feel excited, flushed, have cold sweats, nausea (feeling sick) and vomit.
While you are using IMDUR DURULES
Things you must do
Take IMDUR DURULES regularly once every day.
If you don’t you will be more likely to get attacks of angina.
Tell your doctor if you continue to get angina attacks, or they become more frequent, while you are taking IMDUR DURULES.
Things you must not do
Do not use IMDUR DURULES to relieve acute attacks of angina.
Your doctor will have given you other tablets or a spray to use when you get attacks of angina.
Do not take medicines known as phosphodiesterase type 5 inhibitor used to treat impotence (or erectile dysfunction) whilst on IMDUR DURULES.
Do not stop taking IMDUR DURULES unless you have discussed it with your doctor.
Do not use IMDUR DURULES for any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Things to be careful of
You will probably feel better when you start taking IMDUR DURULES, but be careful not to overdo physical activities straight away.
You will need time to improve your physical fitness.
Be careful driving or operating machinery until you know how IMDUR DURULES affects you.
IMDUR DURULES may cause dizziness and fainting in some patients, especially when you first start to take it. Make sure you know how you feel when you are taking IMDUR DURULES before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy.
Be careful when drinking alcohol while you are using IMDUR DURULES.
If you drink alcohol while you are taking IMDUR DURULES, your blood pressure may drop, making you feel dizzy or faint.
Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking IMDUR DURULES.
IMDUR DURULES help most people with angina, but it may have unwanted side-effects in a few people. All medicines can have side effects.
Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
headache
feeling faint
dizziness
fatigue
muscle tenderness or weakness, not caused by exercise.
Headache is the most common side effect while taking IMDUR DURULES. It can occur at the beginning of treatment, but usually goes away after a few days.
These are all mild side effects of IMDUR DURULES.
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may get other side effects while taking IMDUR DURULES.
After using it
Storage
Keep your IMDUR DURULES modified release tablets in the blister pack until it is time to take them.
If you take IMDUR DURULES out of the blister pack it will not keep well.
Keep it in a cool dry place where the temperature stays below 30°C.
Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car on hot days.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
Ask your pharmacist what to do with any tablets you have left over if your doctor tells you to stop taking them, or you find that they have expired.
Product description
What IMDUR DURULES look like
IMDUR DURULES 60mg modified release tablets are yellow, oval tablets, scored on both sides, marked A/ID.
IMDUR DURULES 120mg modified release tablets are whitish, oval tablets marked A/IF.
Ingredients
Each IMDUR DURULE modified release tablet contains:
Isosorbide mononitrate 60mg or 120mg as the active ingredient;
plus,
Aluminium silicate
Paraffin special
Magnesium stearate
Hydroxypropylcellulose
Colloidal silica.
in blister packs of 30 modified release tablets.
The coating on each modified release tablet contains hydroxypropylmethylcellulose (E464), propylene glycol (E1520);
with colouring agents,
titanium dioxide (E171)
iron oxide yellow (E172).
Sponsor
Clinect Pty Ltd,
120-132 Atlantic Drive,
Keysborough, VIC 3173,
Australia
Free Call Australia: 1800 899 005
This leaflet was prepared 29 October 2018
Australian Registration Number (ARTG)
60mg 46390
120mg 62795
*Registered trademark of Pfizer
= Registered trademark of Bayer
+ Registered trademark of Eli Lilly
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