Isosorbide Mononitrate 40mg Tablets
Out of date information, search anotherElantan® 40mg Tablets
(isosorbide mononitrate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Elantan 40mg Tablets but will be referred to as Elantan throughout this leaflet.
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Elantan is and what they are used for
2. What you need to know before you take Elantan
3. How to take Elantan
4. Possible side effects
5. How to store Elantan
6. Contents of the pack and other information
1. What Elantan is and what they are used are for
Elantan belongs to a group of medicines called organic nitrates.
Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it.
Elantan is used to prevent angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing.
Elantan can also be used to treat congestive heart failure. Heart failure can happen when the heart muscle is not strong enough to pump the blood around the body. It may cause problems with breathing and swelling of the legs.
2. What you need to know before you take Elantan
Do not take Elantan if:
■ You are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of Elantan (see section 6)
■ You suffer from anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
■ You have had a heart attack (myocardial infarction)
■ You have had a brain haemorrhage (bleeding)
■ You have had a head injury (trauma)
■ You have a low blood volume (hypovolaemia)
■ You have very low blood pressure
■ Your blood has stopped circulating around your body properly (circulatory failure)
■ You take sildenafil ("Viagra") or any other phosphodiesterase inhibitor.
■ You are suffering from "shock" or vascular collapse
■ You have an eye disease called glaucoma
■ You have been diagnosed with any of the following heart
conditions: hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with raised intra-cranial (head) pressure.
If any of the above applies to you talk to your doctor or
pharmacist.
Check with your doctor before taking Elantan if:
■ You have an underactive thyroid gland
■ You are malnourished (severely underfed)
■ You have liver or kidney disease
■ You suffer from hypothermia (a very low body temperature)
■ You suffer from very poor circulation
Taking other Medicines
■ Do not take Elantan with phosphodiesterase inhibitors such as Sildenafil ("Viagra") used for impotence.
Using Elantan with these medicines could cause your blood pressure to fall to a dangerously low level. You must not stop taking Elantan to take Sildenafil as this will increase your chances of having an angina attack.
Tell your doctor if you are taking any of the following medicines:
■ Medicines to lower your blood pressure.
■ Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety).
■ Ergotamine used for migraine.
■ Any other medicine, including medicines obtained without a prescription.
If any of the above applies to you, talk to your doctor.
Using Elantan with food and drink
Do not drink alcohol. It could increase the effect of Elantan and lower your blood pressure too much. If this happens, you may feel dizzy or faint.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking Elantan. Your doctor will decide whether you should take this medicine.
Driving and using machines
Elantan may give you a headache, blurred vision or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery.
Warnings about the ingredients in Elantan
This medicine contains lactose monohydrate. If you have an intolerance to some sugars, tell your doctor before taking this medicine.
3. How to take Elantan
Always take Elantan exactly as your doctor has told you.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
■ The usual adult dose is one tablet two or three times a day
■ Your doctor will tell you when you should take your tablets. You will need to have a period of time (usually when you are sleeping) when no tablets are taken. This is called a "nitrate low" period and is needed to make sure your medicine remains effective
■ Swallow the tablets whole with a drink of water
■ Your doctor may increase your dose, up to a maximum of 120mg per day.
Do not use Elantan to treat an actual angina attack. Your doctor will give you a different medicine such as a GTN (glyceryl trinitrate) spray or tablet for this.
Children
This medicine is not suitable for children.
If you take more Elantan than you should
Do not take more Elantan than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor.
Too much Elantan may cause your blood pressure to fall too low, making you feel sick, faint and dizzy. A very large overdose could cause a coma or collapse and require immediate resuscitation.
If you forget to take Elantan
Do not take a double dose to make up for a missed dose.
Take your next dose at the usual time.
If you stop taking Elantan
Do not stop taking Elantan without first talking to your doctor.
You should keep taking your medicine until your doctor tells you to stop.
Do not stop taking it just because you feel better.
If you stop taking the tablets your condition may get worse.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Elantan can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
■ Fainting or collapse
Very common side effects (affects more than 1 in 10 people):
■ Mild headaches at the start of treatment.
Usually they disappear after a few days.
Common side effects (affects less than 1 in 10 people):
■ Dizziness
■ Tiredness
■ Feeling weak
■ Fast heartbeat
■ Flushing.
They may occur for the first few days of treatment or after your dosage has been increased.
Uncommon side effects (affects less than 1 in 100 people):
■ Fainting or collapse
■ Feeling sick or being sick
■ Skin rashes
■ Looking pale
■ Excessive sweating
■ Restlessness
■ Worse angina.
Very rare side effects (affects less than 1 in 10,000 people):
■ Heartburn
■ Red or scaly skin (exfolilative dermatitis).
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 Elantan
■ Keep out of the sight and reach of children.
■ Do not use Elantan after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
■ If your doctor tells you to stop taking the tablets, return any unused tablets to the pharmacist for safe disposal.
■ If your medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist who will advise you.
■ Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
6. Contents of the pack and other information
What Elantan contains
Each tablet contains isosorbide mononitrate 40mg.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, potato starch, talc, colloidal anhydrous silica and aluminium stearate.
What Elantan looks like and contents of the pack
Elantan are white tablets with a breakline on one side, marked 'E' and '40' on either side of the breakline and plain on the reverse.
Elantan is available in blister packs of 56 tablets.
Manufacturer
Elantan is manufactured by: Aesica Pharmaceuticals GmbH, Alfred-Nobel-Strasse 10, D-40789 Monheim, Germany.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0566
Leaflet revision and issue dated: 06.11.14
To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.
Elantan® is a registered trademark of UCB Pharma GmbH.
Isosorbide Mononitrate 40mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What Isosorbide Mononitrate 40mg Tablets are and what they are used for
2. What you need to know before you take Isosorbide Mononitrate 40mg Tablets
3. How to take Isosorbide Mononitrate 40mg Tablets
4. Possible side effects
5. How to store Isosorbide Mononitrate 40mg Tablets
6. Contents of the pack and other information
1. What Isosorbide Mononitrate 40mg Tablets and what they are used for
Isosorbide Mononitrate 40mg Tablets belong to a group of medicines called organic nitrates.
Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it.
Isosorbide Mononitrate 40mg Tablets are used to prevent angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing.
Isosorbide Mononitrate 40mg Tablets can also be used to treat congestive heart failure. Heart failure can happen when the heart muscle is not strong enough to pump the blood around the body.
It may cause problems with breathing and swelling of the legs.
2. What you need to know before you take Isosorbide Mononitrate 40mg Tablets
Do not take Isosorbide Mononitrate 40mg Tablets if:
■ You are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of Isosorbide Mononitrate 40mg Tablets (see section 6)
■ You suffer from anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)
■ You have had a heart attack (myocardial infarction)
■ You have had a brain haemorrhage (bleeding)
■ You have had a head injury (trauma)
■ You have a low blood volume (hypovolaemia)
■ You have very low blood pressure
■ Your blood has stopped circulating around your body properly (circulatory failure)
■ You take sildenafil ("Viagra") or any other phosphodiesterase inhibitor.
■ You are suffering from "shock" or vascular collapse
■ You have an eye disease called glaucoma
■ You have been diagnosed with any of the following heart
conditions: hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with raised intra-cranial (head) pressure.
If any of the above applies to you talk to your doctor or
pharmacist.
Check with your doctor before taking Isosorbide Mononitrate 40mg Tablets if:
■ You have an underactive thyroid gland
■ You are malnourished (severely underfed)
■ You have liver or kidney disease
■ You suffer from hypothermia (a very low body temperature)
■ You suffer from very poor circulation
Taking other Medicines
■ Do not take Isosorbide Mononitrate 40mg Tablets with phosphodiesterase inhibitors such as Sildenafil ("Viagra") used for impotence. Using Isosorbide Mononitrate 40mg Tablets with these medicines could cause your blood pressure to fall to a dangerously low level. You must not stop taking Isosorbide Mononitrate 40mg Tablets to take Sildenafil as this will increase your chances of having an angina attack.
Tell your doctor if you are taking any of the following medicines:
■ Medicines to lower your blood pressure.
■ Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety).
■ Ergotamine used for migraine.
■ Any other medicine, including medicines obtained without a prescription.
If any of the above applies to you, talk to your doctor.
Using Isosorbide Mononitrate 40mg Tablets with food and drink
Do not drink alcohol. It could increase the effect of Isosorbide Mononitrate 40mg Tablets and lower your blood pressure too much. If this happens, you may feel dizzy or faint.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking Isosorbide Mononitrate 40mg Tablets.
Your doctor will decide whether you should take this medicine.
Driving and using machines
Isosorbide Mononitrate 40mg Tablets may give you a headache, blurred vision or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery.
Warnings about the ingredients in Isosorbide Mononitrate 40mg Tablets
This medicine contains lactose. If you have an intolerance to some sugars, tell your doctor before taking this medicine.
3. How to take Isosorbide Mononitrate 40mg Tablets
Always take Isosorbide Mononitrate 40mg Tablets exactly as your doctor has told you.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
Adults
■ The usual adult dose is one tablet two or three times a day
■ Your doctor will tell you when you should take your tablets. You will need to have a period of time (usually when you are sleeping) when no tablets are taken. This is called a "nitrate low" period and is needed to make sure your medicine remains effective
■ Swallow the tablets whole with a drink of water
■ Your doctor may increase your dose, up to a maximum of 120mg per day.
Do not use Isosorbide Mononitrate 40mg Tablets to treat an actual angina attack. Your doctor will give you a different medicine such as a GTN (glyceryl trinitrate) spray or tablet for this.
Children
This medicine is not suitable for children.
If you take more Isosorbide Mononitrate 40mg Tablets than you should
Do not take more Isosorbide Mononitrate 40mg Tablets than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor.
Too many Isosorbide Mononitrate 40mg Tablets may cause your blood pressure to fall too low, making you feel sick, faint and dizzy. A very large overdose could cause a coma or collapse and require immediate resuscitation.
If you forget to take Isosorbide Mononitrate 40mg Tablets
Do not take a double dose to make up for a missed dose.
Take your next dose at the usual time.
If you stop taking Isosorbide Mononitrate 40mg Tablets
Do not stop taking Isosorbide Mononitrate 40mg Tablets without first talking to your doctor. You should keep taking your medicine until your doctor tells you to stop.
Do not stop taking it just because you feel better.
If you stop taking the tablets your condition may get worse.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Isosorbide Mononitrate 40mg Tablets can cause side effects, although not everybody gets them.
Seek immediate medical help if you have any of the following symptoms:
■ Fainting or collapse
Very common side effects (affects more than 1 in 10 people):
■ Mild headaches at the start of treatment.
Usually they disappear after a few days.
Common side effects (affects less than 1 in 10 people):
■ Dizziness
■ Tiredness
■ Feeling weak
■ Fast heartbeat
■ Flushing.
They may occur for the first few days of treatment or after your dosage has been increased.
Uncommon side effects (affects less than 1 in 100 people):
■ Fainting or collapse
■ Feeling sick or being sick
■ Skin rashes
■ Looking pale
■ Excessive sweating
■ Restlessness
■ Worse angina.
Very rare side effects (affects less than 1 in 10,000 people):
■ Heartburn
■ Red or scaly skin (exfolilative dermatitis).
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 Isosorbide Mononitrate 40mg Tablets
■ Keep out of the sight and reach of children.
■ Do not use Isosorbide Mononitrate 40mg Tablets after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
■ If your doctor tells you to stop taking the tablets, return any unused tablets to the pharmacist for safe disposal.
■ If your medicine appears to be discoloured or shows any other signs of deterioration, please return to your pharmacist who will advise you.
■ Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
6. Contents of the pack and other information
What Isosorbide Mononitrate 40mg Tablets contain
Each tablet contains isosorbide mononitrate 40mg.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, potato starch, talc, colloidal anhydrous silica and aluminium stearate.
What Isosorbide Mononitrate 40mg Tablets look like and contents of the pack
Isosorbide Mononitrate 40mg are white tablets with a breakline on one side, marked 'E' and '40' on either side of the breakline and plain on the reverse.
Isosorbide Mononitrate 40mg Tablets are available in blister packs of 56 tablets.
Manufacturer
Isosorbide Mononitrate 40mg Tablets are manufactured by:
Aesica Pharmaceuticals GmbH, Alfred-Nobel-Strasse 10,
D-40789 Monheim, Germany.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0566 |^Pj
Leaflet revision and issue dated: 06.11.14
To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.
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