ELANTAN 10MG TABLETS

Active substance: ISOSORBIDE MONONITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Elantan® 10mg Tablets
(isosorbide mononitrate)
Your medicine is available using the name Elantan 10mg Tablets
but will be referred to as Elantan throughout this leaflet.

Read all of this leaflet carefully before you start
taking this medicine.

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.
2.
3.
4.
5.
6.

What Elantan is for
Before you take Elantan
How to take Elantan
Possible side effects
How to store Elantan
Further information

1. What Elantan is 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.

2. 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
You
You
You
You

have an underactive thyroid gland
are malnourished (severely underfed)
have liver or kidney disease
suffer from hypothermia (a very low body temperature)
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.

Page 1 of 2

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

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 labels. The expiry date refers to the last
day of that month.
This medicine does not require any special storage
conditions.
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. Further information
What Elantan contains

Each tablet contains isosorbide mononitrate 10mg.
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, round tablets with a break line on one side,
marked 'E' and '10' on either side of the break line and plain on
the other.
Elantan is available in 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.

If you get any side effects, talk to your doctor, pharmacist or
nurse. 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.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.

By reporting side effects, you can help provide more information
on the safety of this medicine.

Leaflet revision and issue dated: 09.01.14

PL No: 21828/0564

P

To request a copy of this leaflet in Braille, large print or audio
please call 01302 552940 and ask for the Regulatory Department.
Elantan® is a registered trademark of UCB Pharma GmbH.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Isosorbide Mononitrate 10mg Tablets
Read all of this leaflet carefully before you start
taking this medicine.

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.
2.
3.
4.
5.
6.

What Isosorbide Mononitrate 10mg Tablets are for
Before you take Isosorbide Mononitrate 10mg Tablets
How to take Isosorbide Mononitrate 10mg Tablets
Possible side effects
How to store Isosorbide Mononitrate 10mg Tablets
Further information

1. What Isosorbide Mononitrate 10mg
Tablets are for
Isosorbide Mononitrate 10mg 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.

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 10mg Tablets if:
You
You
You
You
You

have an underactive thyroid gland
are malnourished (severely underfed)
have liver or kidney disease
suffer from hypothermia (a very low body temperature)
suffer from very poor circulation

Taking other Medicines

Do not take Isosorbide Mononitrate 10mg Tablets with
phosphodiesterase inhibitors such as Sildenafil
(“Viagra”) used for impotence. Using Isosorbide
Mononitrate 10mg Tablets with these medicines could
cause your blood pressure to fall to a dangerously low
level. You must not stop taking Isosorbide
Mononitrate 10mg 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:

Isosorbide Mononitrate 10mg 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.

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.

2. Before you take Isosorbide Mononitrate
10mg Tablets

Using Isosorbide Mononitrate 10mg Tablets with
food and drink

Do not take Isosorbide Mononitrate 10mg Tablets
if:

You are allergic to isosorbide mononitrate, other nitrates or
any of the other ingredients of Isosorbide Mononitrate 10mg
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.

Do not drink alcohol. It could increase the effect of Isosorbide
Mononitrate 10mg 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 10mg Tablets. Your doctor will decide whether you
should take this medicine.

Driving and using machines

Isosorbide Mononitrate 10mg 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 10mg Tablets

This medicine contains lactose monohydrate. If you have an
intolerance to some sugars, tell your doctor before taking this
medicine.
Page 1 of 2

3. How to take Isosorbide Mononitrate 10mg
Tablets
Always take Isosorbide Mononitrate 10mg 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 10mg 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 10mg
Tablets than you should

Do not take more Isosorbide Mononitrate 10mg Tablets than you
should. If you accidentally take too much, immediately contact
the nearest hospital casualty department or your doctor.
Too many Isosorbide Mononitrate 10mg 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 10mg
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 10mg
Tablets

Do not stop taking Isosorbide Mononitrate 10mg 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 10mg 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):

5. How to store Isosorbide Mononitrate
10mg Tablets
Keep out of the sight and reach of children.
Do not use Isosorbide Mononitrate 10mg Tablets after the
expiry date stated on the carton and blister labels. The
expiry date refers to the last day of that month.
This medicine does not require any special storage
conditions.
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.

Dizziness
Tiredness
Feeling weak
Fast heartbeat
Flushing.
They may occur for the first few days of treatment or after your
dosage has been increased.

6. Further information

Uncommon side effects (affects less than 1 in 100
people):

The other ingredients are: lactose monohydrate,
microcrystalline cellulose, potato starch, talc,
colloidal anhydrous silica and aluminium stearate.

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, pharmacist or
nurse. 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.

What Isosorbide Mononitrate 10mg Tablets contain
Each tablet contains isosorbide mononitrate 10mg.

What Isosorbide Mononitrate 10mg Tablets look
like and contents of the pack

Isosorbide Mononitrate 10mg are white, round tablets with a
break line on one side, marked 'E' and '10' on either side of the
break line and plain on the other.
Isosorbide Mononitrate 10mg Tablets are available in packs of
56 tablets.
Manufacturer
Isosorbide Mononitrate 10mg 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: 21828/0564

P

Leaflet revision and issue dated: 09.01.14
To request a copy of this leaflet in Braille, large print or audio
please call 01302 552940 and ask for the Regulatory Department.

Page 2 of 2

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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