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Isosorbide Dinitrate
Consumer Medicine Information
Disclaimer
This information answers some common questions about Isordil Sublingual and Oral tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist or asking questions.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Isordil Sublingual and Oral tablets against the benefits they expect it will have for you.
If you have any concerns about taking Isordil, ask your doctor or pharmacist.
What Isordil is used for
Isordil Sublingual tablets are for the prevention and treatment of attacks of angina. Isordil Oral tablets are for the prevention of attacks of angina.
Isordil tablets will not reduce the pain of an angina attack, but when taken regularly may prevent an attack from occurring.
Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms, neck and sometimes to the shoulders and back. The pain may be caused by too little blood and oxygen getting to the heart.
Isordil belongs to a group of medicines called nitrates. Isordil works by opening up blood vessels which allows more blood and oxygen to reach the heart.
Isordil may also be helpful in the treatment of some types of heart failure.
Your doctor may have prescribed Isordil for another purpose. Ask your doctor if you have any questions why Isordil has been prescribed for you.
There is no evidence that Isordil Sublingual and Oral tablets are addictive.
Before you use Isordil Sublingual or Oral tablets
When you must not use Isordil (discuss with your doctor)
1. If you have allergies to:
• Isordil
• any medication or food containing nitrates or nitrites
• any ingredients listed at the end of this information
Symptoms of an allergic reaction may include skin rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing, hay fever, and feeling faint.
2. If you have any of the following medical conditions:
• you suffer from certain types of heart disease (your doctor will advise you if this applies)
• you have very low blood pressure
• you have anaemia
• you are pregnant or breastfeeding, unless your doctor advised that you can use Isordil. Ask your doctor about the risks or benefits involved.
3. Do not use Isordil after the expiry date (Exp) printed on the pack.
4. Do not take Isordil if the package shows any sign of tampering.
5. Isordil is not recommended for use in children (your doctor will advise you if this applies).
Before you start to use Isordil
See your doctor for a check-up before you start to use Isordil.
You must tell your doctor if you are taking any other medicines, including any medicines that you have bought from a pharmacy or supermarket.
Tell your doctor if you have any of the following conditions
• heart, liver or kidney disease
• blood disorders or hardening of the arteries
• low blood pressure
• if you have recently had a heart attack, stroke or head injury
• other medical conditions
Tell your doctor or pharmacist if you take any other medicines, including any of the following:
• medications for high blood pressure and other heart medications
• tranquillisers/sedatives
• medications for arthritis
• medications for depression
These medicines may affect the way Isordil works.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Do not start to take any other medicine unless prescribed or approved by your doctor.
This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
Using Isordil
Isordil Sublingual tablets are for the relief of an anginal attack.
Isordil Oral tablets are used to reduce the number of angina attacks, and should not be taken for relief of an anginal attack that has already started.
How to take Isordil
Isordil Sublingual tablets
At the first signs of an anginal attack, place one or two tablets under your tongue. If your angina is not relieved after taking these tablets you should call your doctor or nearest hospital immediately.
Isordil Oral tablets
The recommended dose for angina is 5 mg to 30 mg (1/2 to 3 tablets) taken four times a day, with a break of at least 8 hours between the evening dose and the next morning dose.
Your doctor may recommend a different dose for you.
Follow your doctor's instructions if they are different from these.
Swallow Isordil tablets with a glass of water.
Do not chew or crush Isordil oral tablets.
Take this medicine exactly as directed by your doctor.
Elderly patients may need a lower dose.
If you forget to take Isordil
If you should be taking your next dose within 2 hours, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take Isordil as soon as you remember, and then go back to take it as you would normally.
Do not try to make up for the dose that you missed by taking more than one dose at a time.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Overdose
Immediately telephone your doctor or Poisons Information Centre (Ph 13 11 26) for advice or go to Casualty of your nearest hospital if you think that you or anyone else may have takentoo much Isordil, even if there are no signs of discomfort or poisoning. Keep the telephone number for these places handy whilst taking any medications.
If you take too many Isordil tablets, you may experience a headache, become flushed, experience cold sweats, nausea, vomiting, very low blood pressure and a fast heartbeat.
While you are using Isordil tablets
Things you must do
Visit your doctor regularly for a check up and always discuss with your doctor any problems you have with Isordil tablets.
Tell your doctor immediately if your angina attacks are getting worse or more frequent whilst using Isordil.
Take Isordil as your doctor has prescribed.
Keep enough Isordil to last weekends and holidays.
If you do happen to run out, Isordil can be purchased from a pharmacy without a prescription.
Before having any type of surgery, tell your doctor or anaesthetist you are taking Isordil.
If a headache occurs after taking Isordil, pain relievers are recommended. The headache usually disappears on continual therapy with Isordil.
If the headache persists, contact your doctor.
Things to be careful of
You may feel light-headed or dizzy or faint when you begin to take Isordil. This is because your blood pressure is falling suddenly.
Get up slowly when getting out of bed or standing up from a sitting position if you feel light-headed, dizzy or faint.
If you drink alcohol, dizziness or faintness may be worse.
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 doses.
Be careful driving or operating machinery until you know how Isordil affects you.
Even though you may feel better when you start taking Isordil, be careful to avoid excessive physical activities.
Things you must not do
Do not chew or crush the tablets.
If you have been taking Isordil regularly for some time, do not suddenly stop taking it as this may bring on an angina attack. Check with your doctor for the best way to slowly reduce the amount of Isordil you are taking before stopping completely.
Do not give this medicine to anyone else.
Do not take any other medicines unless you have discussed this with your doctor or pharmacist.
This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Isordil.
Isordil helps most people with angina, but it may have unwanted side effects in some 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 any of the following side effects.
More common effects
• headache (temporary or persistent)
• dizziness, light-headedness, or feeling faint, especially when getting up from sitting or lying down
Less common
• nausea and vomiting
• flushing
• swollen hands and feet
• skin rash and flaking of the skin
• anaemia
• increase in your heart rate
Serious side effects
• severe drops in blood pressure and an increase in your heart rate
• sensitive patients may experience a decrease in blood flow, which could damage your heart or result in heart failure.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Some people may get other side effects while taking Isordil.
Ask your doctor or pharmacist to answer any questions you may have.
Storage
Keep your Isordil tablets in the bottle or blister pack until it is time to take them.
If you take the tablets out of the bottle or the blister pack they will not keep well.
Keep Isordil in a cool dry place where the temperature stays below 30°C.
Do not store Isordil or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy some medicines.
Keep Isordil and all medication 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.
Do not leave Isordil in the car on hot days.
Disposal
Return any unused medicine to your pharmacist.
Product Description
What Isordil looks like
Isordil is available in two strengths of tablets.
• Isordil 5 mg Sublingual tablets - pink round tablet, supplied in a bottle containing 100 tablets.
• Isordil 10 mg Oral tablets - white round tablet with a W marked on one side and a score line on the other side supplied in a box containing 100 tablets.
Ingredients
Isordil 5 mg Sublingual
Active ingredient: 5 mg isosorbide dinitrate
Inactive ingredients:
• lactose
• starch
• magnesium stearate
• microcrystalline cellulose
• Erythrosine Lake
• CI 45430 colouring agent
Isordil 10 mg Oral
Active ingredient: 10 mg isosorbide dinitrate
Inactive ingredients:
• lactose
• ammonium phosphate monobasic
• magnesium stearate
• microcrystalline cellulose
Manufacturer
Isordil is made in Australia by:
Wyeth Australia Pty Limited
ACN: 000 296 211
5 Gibbon Road
Baulkham Hills NSW 2153
Australia
Phone: (02) 9624 9333
This information was last revised on 24 October 1997
Australian Registration Numbers:
Isordil 5 mg: AUST R 12957
Isordil 10 mg: AUST R 40257
® Registered Trademark
ISOmdf01.aci
Consumer Medicine Information
Disclaimer
This information answers some common questions about Isordil Sublingual and Oral tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist or asking questions.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Isordil Sublingual and Oral tablets against the benefits they expect it will have for you.
If you have any concerns about taking Isordil, ask your doctor or pharmacist.
What Isordil is used for
Isordil Sublingual tablets are for the prevention and treatment of attacks of angina. Isordil Oral tablets are for the prevention of attacks of angina.
Isordil tablets will not reduce the pain of an angina attack, but when taken regularly may prevent an attack from occurring.
Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms, neck and sometimes to the shoulders and back. The pain may be caused by too little blood and oxygen getting to the heart.
Isordil belongs to a group of medicines called nitrates. Isordil works by opening up blood vessels which allows more blood and oxygen to reach the heart.
Isordil may also be helpful in the treatment of some types of heart failure.
Your doctor may have prescribed Isordil for another purpose. Ask your doctor if you have any questions why Isordil has been prescribed for you.
There is no evidence that Isordil Sublingual and Oral tablets are addictive.
Before you use Isordil Sublingual or Oral tablets
When you must not use Isordil (discuss with your doctor)
1. If you have allergies to:
• Isordil
• any medication or food containing nitrates or nitrites
• any ingredients listed at the end of this information
Symptoms of an allergic reaction may include skin rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or troubled breathing, hay fever, and feeling faint.
2. If you have any of the following medical conditions:
• you suffer from certain types of heart disease (your doctor will advise you if this applies)
• you have very low blood pressure
• you have anaemia
• you are pregnant or breastfeeding, unless your doctor advised that you can use Isordil. Ask your doctor about the risks or benefits involved.
3. Do not use Isordil after the expiry date (Exp) printed on the pack.
4. Do not take Isordil if the package shows any sign of tampering.
5. Isordil is not recommended for use in children (your doctor will advise you if this applies).
Before you start to use Isordil
See your doctor for a check-up before you start to use Isordil.
You must tell your doctor if you are taking any other medicines, including any medicines that you have bought from a pharmacy or supermarket.
Tell your doctor if you have any of the following conditions
• heart, liver or kidney disease
• blood disorders or hardening of the arteries
• low blood pressure
• if you have recently had a heart attack, stroke or head injury
• other medical conditions
Tell your doctor or pharmacist if you take any other medicines, including any of the following:
• medications for high blood pressure and other heart medications
• tranquillisers/sedatives
• medications for arthritis
• medications for depression
These medicines may affect the way Isordil works.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Do not start to take any other medicine unless prescribed or approved by your doctor.
This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
Using Isordil
Isordil Sublingual tablets are for the relief of an anginal attack.
Isordil Oral tablets are used to reduce the number of angina attacks, and should not be taken for relief of an anginal attack that has already started.
How to take Isordil
Isordil Sublingual tablets
At the first signs of an anginal attack, place one or two tablets under your tongue. If your angina is not relieved after taking these tablets you should call your doctor or nearest hospital immediately.
Isordil Oral tablets
The recommended dose for angina is 5 mg to 30 mg (1/2 to 3 tablets) taken four times a day, with a break of at least 8 hours between the evening dose and the next morning dose.
Your doctor may recommend a different dose for you.
Follow your doctor's instructions if they are different from these.
Swallow Isordil tablets with a glass of water.
Do not chew or crush Isordil oral tablets.
Take this medicine exactly as directed by your doctor.
Elderly patients may need a lower dose.
If you forget to take Isordil
If you should be taking your next dose within 2 hours, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take Isordil as soon as you remember, and then go back to take it as you would normally.
Do not try to make up for the dose that you missed by taking more than one dose at a time.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Overdose
Immediately telephone your doctor or Poisons Information Centre (Ph 13 11 26) for advice or go to Casualty of your nearest hospital if you think that you or anyone else may have takentoo much Isordil, even if there are no signs of discomfort or poisoning. Keep the telephone number for these places handy whilst taking any medications.
If you take too many Isordil tablets, you may experience a headache, become flushed, experience cold sweats, nausea, vomiting, very low blood pressure and a fast heartbeat.
While you are using Isordil tablets
Things you must do
Visit your doctor regularly for a check up and always discuss with your doctor any problems you have with Isordil tablets.
Tell your doctor immediately if your angina attacks are getting worse or more frequent whilst using Isordil.
Take Isordil as your doctor has prescribed.
Keep enough Isordil to last weekends and holidays.
If you do happen to run out, Isordil can be purchased from a pharmacy without a prescription.
Before having any type of surgery, tell your doctor or anaesthetist you are taking Isordil.
If a headache occurs after taking Isordil, pain relievers are recommended. The headache usually disappears on continual therapy with Isordil.
If the headache persists, contact your doctor.
Things to be careful of
You may feel light-headed or dizzy or faint when you begin to take Isordil. This is because your blood pressure is falling suddenly.
Get up slowly when getting out of bed or standing up from a sitting position if you feel light-headed, dizzy or faint.
If you drink alcohol, dizziness or faintness may be worse.
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 doses.
Be careful driving or operating machinery until you know how Isordil affects you.
Even though you may feel better when you start taking Isordil, be careful to avoid excessive physical activities.
Things you must not do
Do not chew or crush the tablets.
If you have been taking Isordil regularly for some time, do not suddenly stop taking it as this may bring on an angina attack. Check with your doctor for the best way to slowly reduce the amount of Isordil you are taking before stopping completely.
Do not give this medicine to anyone else.
Do not take any other medicines unless you have discussed this with your doctor or pharmacist.
This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Isordil.
Isordil helps most people with angina, but it may have unwanted side effects in some 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 any of the following side effects.
More common effects
• headache (temporary or persistent)
• dizziness, light-headedness, or feeling faint, especially when getting up from sitting or lying down
Less common
• nausea and vomiting
• flushing
• swollen hands and feet
• skin rash and flaking of the skin
• anaemia
• increase in your heart rate
Serious side effects
• severe drops in blood pressure and an increase in your heart rate
• sensitive patients may experience a decrease in blood flow, which could damage your heart or result in heart failure.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Some people may get other side effects while taking Isordil.
Ask your doctor or pharmacist to answer any questions you may have.
Storage
Keep your Isordil tablets in the bottle or blister pack until it is time to take them.
If you take the tablets out of the bottle or the blister pack they will not keep well.
Keep Isordil in a cool dry place where the temperature stays below 30°C.
Do not store Isordil or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy some medicines.
Keep Isordil and all medication 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.
Do not leave Isordil in the car on hot days.
Disposal
Return any unused medicine to your pharmacist.
Product Description
What Isordil looks like
Isordil is available in two strengths of tablets.
• Isordil 5 mg Sublingual tablets - pink round tablet, supplied in a bottle containing 100 tablets.
• Isordil 10 mg Oral tablets - white round tablet with a W marked on one side and a score line on the other side supplied in a box containing 100 tablets.
Ingredients
Isordil 5 mg Sublingual
Active ingredient: 5 mg isosorbide dinitrate
Inactive ingredients:
• lactose
• starch
• magnesium stearate
• microcrystalline cellulose
• Erythrosine Lake
• CI 45430 colouring agent
Isordil 10 mg Oral
Active ingredient: 10 mg isosorbide dinitrate
Inactive ingredients:
• lactose
• ammonium phosphate monobasic
• magnesium stearate
• microcrystalline cellulose
Manufacturer
Isordil is made in Australia by:
Wyeth Australia Pty Limited
ACN: 000 296 211
5 Gibbon Road
Baulkham Hills NSW 2153
Australia
Phone: (02) 9624 9333
This information was last revised on 24 October 1997
Australian Registration Numbers:
Isordil 5 mg: AUST R 12957
Isordil 10 mg: AUST R 40257
® Registered Trademark
ISOmdf01.aci
