Isosorbide mononitrate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Imtrate. It does not contain all the available information.
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 Imtrate 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 Imtrate is used for
Imtrate is used to prevent angina pectoris (heart pain). They are not recommended and should not be taken for the treatment of acute attacks
Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms or neck and sometimes to the shoulders and back. This may be caused by too little blood and oxygen getting to the heart. The pain of angina is usually brought on by exercise or stress.
Imtrate belongs to a group of medicines called nitrates. It works by widening blood vessels to improve the blood flow around the heart which means there is more oxygen being carried by the blood.
This reduces the pain associated with angina.
Your doctor may have prescribed Imtrate for another reason. Ask your doctor if you have any questions about why Imtrate has been prescribed for you.
This medicine is available only with a doctor’s prescription.
Before you take Imtrate
When you must not take it
Do not take/use Imtrate if:
- you have an allergy to:
- Isosorbide mononitrate or any of the ingredients in Imtrate listed at the end of this leaflet.
- any medicine or food containing nitrates or nitrites.
Symptoms of an allergic reaction to these medicines may include:
- asthma, wheezing or shortness of breath
- swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
- hives, itching or skin rash
- fainting
- you are taking any of the following phosphodiesterase type 5 inhibitors:
- Sildenafil (Viagra)
- Tadalafil
- Vardenafil
- you are pregnant, or intend to become pregnant.
Imtrate may affect your developing baby if you take it during pregnancy. - you are breast-feeding or intend to breast-feed.
Imtrate passes into breast milk. The effect on the baby is unknown.
The use of Imtrate during pregnancy or breast feeding should be discussed with your doctor. Imtrate should not be taken to stop an acute angina attack. They should only be taken once daily.
Do not take Imtrate if you are in a state of shock including shock caused by very low blood pressure due to a failing heart, have hypotension (low blood pressure), weakened muscle of the heart or pericarditis (swelling around the heart).
Do not take Imtrate if the packaging is torn or shows signs of tampering.
Do not take Imtrate if the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work (as well).
If you are not sure whether you should start taking Imtrate, contact your doctor.
Do not give Imtrate to a child. The safety and effectiveness of Imtrate has not been established in children.
Tell your doctor if:
- you have any allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes
- you have or have had any medical conditions, especially the following:
- Heart failure
- Liver failure
- Kidney failure
- you know you suffer from hypotension (low blood pressure) or blood vessel disease such as hardening of the arteries.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with Imtrate and may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
The combination of Imtrate with Sildenafil (Viagra®), Tadalafil and Vardenafil may cause fainting or heart attacks.
The combination of N-acetylcysteine or captopril with Imtrate may result in a prolonged anti-angina effect.
The combination of Imtrate with a calcium channel blocker of the verapamil type may improve heart function. However, the combination of Imtrate with any other calcium channel blocker may cause hypotension (low blood pressure) requiring dose adjustment of either medicine.
The combination of Imtrate with betablocker medicines such as propranolol may cause hypotension (low blood pressure).
Be careful when drinking alcohol while you are using Imtrate. If you drink alcohol, your blood pressure may drop, making you feel dizzy or faint.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking Imtrate.
How to take Imtrate
How much to take
Take Imtrate with half a glass of water. You must swallow the tablet whole.
Food does not affect the absorption of isosorbide mononitrate from Imtrate so the tablets may be taken with or without food.
Your doctor will advise you on how many tablets you should take.
Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet.
If you do not understand the instructions on the packaging, ask your doctor or pharmacist for help.
How long to take it
If you are not sure how long to take Imtrate for, talk to your doctor.
If you forget to take it
If you miss a dose of Imtrate, take it as soon as you remember unless more than eight hours have passed. If more than eight hours have passed since the time the dose should have been taken, do not take the missed dose but take the next dose at the normal time.
A missed dose may lead to an angina attack that in turn may need medication, prescribed by your doctor, capable of treating an acute attack such as use of immediate release tablets or spray administered under the tongue. Imtrate is not recommended and should not be taken for the treatment of acute angina attacks.
Do not take a double dose to make up for the dose that you missed. If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
If you take too much Imtrate, the most common symptom is a pulsing headache. More serious symptoms are excitation, flushing, cold sweats, nausea, vomiting, vertigo, increased heart beat and a fall in blood pressure.
Induce vomiting if possible.
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much Imtrate. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep these telephone numbers handy.
While you are using Imtrate
Things you must do
Use Imtrate exactly as your doctor has prescribed. If you do not follow your doctor’s instructions, you may not get relief from your attacks of angina.
Tell your doctor if you continue to have angina attacks or if they become more frequent while you are using Imtrate.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Imtrate.
Tell your doctor or pharmacist that you are taking Imtrate if you are about to be started on any new medicines.
Things you must not do
Do not use it to treat any other complaints unless your doctor says to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Things to be careful of
Be careful driving or operating machinery until you know how Imtrate affects you. Imtrate may cause dizziness and fainting in some patients, especially when you first start to use it. Make sure you know how you react to Imtrate before you drive a car, operate machinery, or do anything else that could be dangerous.
Be careful not to overdo physical activities when you first start using Imtrate. You may feel better when you start taking it, but you will need time to improve your physical fitness.
Get up slowly when getting out of bed or standing up if you feel light-headed, dizzy or faint. You may feel light-headed or dizzy when you begin to take Imtrate or if the dose is increased. This is because your blood pressure is falling suddenly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. The problem usually goes away after the first few days.
If this problem gets worse or continues, talk to your doctor.
Be careful when drinking alcohol while you are using Imtrate. If you drink alcohol while using Imtrate your blood pressure may drop, making you feel dizzy or faint.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Imtrate. Imtrate helps most people with angina, but it may have unwanted 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 any questions you may have. Imtrate often causes adverse effects in the early stages of treatment.
More common reactions:
Headache is the main adverse reaction which is quite common when you start taking Imtrate. The incidence of headaches usually reduces as treatment is continued. Other symptoms such as dizziness, nausea, tiredness, and disturbed sleep may also occur. Again, these side effects reduce over time if Imtrate is continued.
Less common reactions:
Other side effects which have been reported are poor appetite, vomiting, diarrhoea and heartburn.
These may be serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Some people may experience other side effects while taking Imtrate.
These side effects are not listed above. Tell your doctor if you notice anything else that is making you feel unwell.
After taking Imtrate
Storage
Keep your tablets in their container until it is time to take them. If you take the tablets out of their container they may not keep well.
Keep Imtrate in a cool, dry place. Keep Imtrate blister packs below 25°C and Imtrate bottle packs below 30°C
Do not store it, or any other medicine, in a bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Ensure that they are out of the reach of children. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking Imtrate or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.
Product description
What it looks like
Imtrate Tablets 60 mg tablets are cream, film-coated oval shaped of 13mm length scored on both sides.
Ingredients
Imtrate Tablets contain 60 mg Isosorbide mononitrate.
Also contains
- stearic acid,
- carnauba wax,
- hypromellose,
- lactose,
- magnesium stearate,
- talc,
- purified,
- titanium dioxide,
- silica – colloidal anhydrous,
- macrogol 4000,
- iron oxide yellow CI77492.
Imtrate is available in packs of 30 tablets.
Supplier
Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne VIC 3205
www.ascentpharma.com.au
For further information telephone
1800 554 414
AUST R 59615 (blister)
AUST R 77093 (bottle) *
* non-marketed
This leaflet was prepared in April 2010
Published by MIMS March 2014