Ismo 20 Consumer Medicine Information

Isosorbide-5-mononitrate

20mg tablets

What is in this leaflet

This leaflet answers some common questions about ISMO 20 tablets.

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 your taking ISMO 20 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 ISMO 20 is used for

ISMO 20 contains the active ingredient isosorbide-5-mononitrate. It belongs to a class of medicines known as organic nitrate vasodilators, meaning that they cause blood vessels to widen. Widening the blood vessels means that blood flow and blood pressure is improved, and so the heart does not need to do as much work and does not need as much oxygen.

ISMO 20 will help to reduce the number and severity of angina attacks (severe chest pains due to heart disease). ISMO 20 tablets are used to stop angina attacks from happening. They cannot be used to treat a sudden attack of angina. Your doctor will probably have prescribed another treatment for you to use for sudden attacks.

ISMO 20 is also used to treat heart failure (a disease of the heart with shortness of breath, tiring easily and swelling of the feet or legs due to fluid build up) and pulmonary hypertension (high blood pressure in the arteries and veins between the lungs and the heart).

Your doctor may have prescribed ISMO 20 for another purpose.

Ask your doctor if you have any questions about why ISMO 20 has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you take ISMO 20

When you must not take ISMO 20

Do not take ISMO 20 if:

  1. you have an allergy to isosorbide-5-mononitrate or any ingredients listed at the end of this leaflet. Additionally, do not take ISMO 20 if you have an allergy to related medicines such as glyceryl trinitrate or isosorbide dinitrate.
  2. you have low blood pressure
  3. you are taking sildenafil (Viagra®).
    If Viagra® is used by patients taking nitrate preparations such as ISMO 20, a severe and possibly dangerous fall in blood pressure can occur. This would result in collapse, unconsciousness and could be fatal. You should not take Viagra® while you are taking ISMO 20.
  4. you are having a heart attack.
  5. the packaging is torn or shows signs of tampering.
  6. the expiry date 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 if you should be taking ISMO 20, talk to your doctor.

Use in Children

Safety and effectiveness of ISMO 20 for children has not been established.

Before you start to take ISMO 20

You must tell your doctor if:

  1. you are pregnant or intend to become pregnant
  2. you are breastfeeding
  3. you have any cardiac or circulatory diseases
  4. you have any blood enzyme deficiencies
  5. you get headaches
  6. you are allergic to any other medicines, foods, dyes or preservatives
  7. you have any other health problems

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or healthfood shop.

Some medicines may interfere with ISMO 20. These medicines include:

  • medicines for hypertension (high blood pressure)
  • medicines for depression called tricyclic antidepressants. They include amitriptyline (Amitrip®, Tryptanol®), clomipramine (Anafranil®, Clopress®), desipramine (Pertofran®), dothiepin (Dopress®, Prothiaden®), doxepin (Anten®), imipramine (Tofranil®), nortriptyline (Allegron®, Norpress®), trimipramine (Surmontil®, Tripress®)
  • dihydroergotamine (Ergodryl®, Cafergot®)
  • medicines given by injection for abnormal thoughts or moods
  • alcohol
  • sildenafil (Viagra®). You should not use Viagra® while taking ISMO 20. However, if you have used Viagra®, ISMO 20 should not be taken for 24 hours after taking Viagra®.

These medicines may be affected by ISMO 20, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Your doctor or pharmacist has more information on medicines to avoid or to be careful with while taking ISMO 20.

Ask your doctor or pharmacist if you are not sure about this list of medicines.

How to take ISMO 20

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

How much to take

Take ISMO 20 exactly as your doctor has prescribed.

Your doctor will tell you how many ISMO 20 tablets to take each day.

The adult dose is usually one tablet twice a day. However, some patients may require a higher dose of one tablet three times a day.

If you have not taken ISMO 20 or another organic nitrate medicine such as isosorbide dinitrate or glyceryl trinitrate before, your doctor may tell you to take a reduced dosage for a few days. Usually the dose is reduced to half a tablet twice daily for the first two days, then increased to one tablet twice daily for the next two days. Then treatment is maintained at this level or increased if necessary. This lower initial dosage helps to prevent or reduce headache, a common side effect of the medicine. Once you are used to having ISMO 20 you probably will not get these headaches.

How to take it

Tablets should be swallowed whole with a glass of water.

ISMO 20 tablets have score lines and can thus be easily broken into 2 or 4 parts to enable dose adjustment.

When to take it

It is important to take your ISMO 20 tablets at the right time each day - check carefully with your doctor about when you should take the tablets.

Take ISMO 20 at about the same time each day, usually one in the morning and one at night if you are taking 2 tablets each day. If required, one tablet can be taken shortly before going to sleep.

Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.

How long to take it

Continue taking ISMO 20 until your doctor tells you to stop.

Treatment with ISMO 20 tablets is normally long term.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

Do not take a double dose to make up for one you have missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering your dose, ask your pharmacist for some hints.

In case of an overdose

Immediately telephone your doctor or the National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for advice or go to your nearest Accident and Emergency centre if you think that you or anyone else may have taken too much ISMO 20. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

The following are some symptoms of ISMO 20 overdose, which may or may not occur:

  • headache
  • lightheadedness, dizziness
  • shortness of breath, rapid breathing
  • blueness around mouth and at extremities due to lack of oxygen
  • rapid heart beat

Keep telephone numbers for these places handy.

If you are not sure what to do contact your doctor or pharmacist.

While you are taking ISMO 20

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking ISMO 20.

Tell your doctor if you become pregnant while you are taking ISMO 20.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Things you must not do

Do not stop taking ISMO 20 or change the dose without first checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.

ISMO 20 treatment should be stopped gradually - your condition may get worse if you stop taking the tablets suddenly.

Do not give ISMO 20 to anyone else even if their symptoms seem similar to yours.

Do not use ISMO 20 to treat any other complaints unless your doctor says to.

Do not take any other medicines whether they require a prescription or not without first telling your doctor or pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how ISMO 20 affects you.

Your ability to drive cars or operate machinery may be impaired while you are taking ISMO 20. This applies particularly at the start of treatment, when another medicine is being added to your treatment programme or if you drink alcohol.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ISMO 20.

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.

  • dizziness and/or lightheadedness upon standing, flushing - these normally occur at the start of treatment and improve once you get used to taking ISMO 20
  • headache - this also normally occurs at the start of treatment and improves once you get used to taking ISMO 20
  • nausea, vomiting
  • allergic skin reactions such as rash

See your doctor immediately, or go to your nearest Accident and Emergency centre if you experience any of the following:

  • collapse
  • symptoms of angina get worse
  • chest pain

These are very serious side effects. You may need urgent medical attention or hospitalization.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking ISMO 20

Storage

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they may not keep well.

Keep ISMO 20 in a cool dry place where the temperature stays 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 windowsills.

Heat and dampness can destroy some medicines.

Keep ISMO 20 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

If your doctor tells you to stop taking ISMO 20, or the tablets have passed their expiry date, you should return any tablets remaining at the end of treatment to your pharmacist.

Product description

What it looks like

ISMO 20 tablets are white, round tablets with a score line. They are engraved with BM 3B.

ISMO 20 tablets come in packs of 100.

Ingredients

Active ingredient

  • each tablet contains 20mg isosorbide-5-mononitrate

Inactive ingredients -

  • lactose anhydrous, colloidal silicon dioxide, magnesium stearate

This leaflet was prepared 16 April 2002.