ELANTAN 40MG TABLETS

Active substance: ISOSORBIDE MONONITRATE

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Patient Information Leaflet

Elantan® 40mg tablets
(isosorbide mononitrate)
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.
The name of your medicine is Elantan 40mg
Tablets but will be referred to as Elantan
throughout this leaflet.
In this leaflet:
1. What Elantan is and what it is 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 it is used
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. 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 many Elantan 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 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.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6.

Contents of the pack and other
information

What Elantan contains
The active substance is isosorbide mono
nitrate.
Each tablet contains 40mg isosorbide mononitrate.
The other ingredients are talc, lactose mono
hydrate, colloidal anhydrous silica, potato
starch, microcrystalline cellulose and
aluminium stearate.
What Elantan looks like and contents of
the pack
Elantan are white, round tablets with a
scoreline on one side and plain on the other,
marked with “E” on top and “40” on the
bottom of the scoreline.
Elantan is supplied in blister packs
containing 50 tablets.
Manufactured by:
Aesica Pharmaceuticals GmbH,
Alfred Nobel Strasse 10-40789,
Monheim, Germany.
Procured from within the EU and
repackaged by the Product Licence
holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.

How to store Elantan

Keep out of the sight and reach of children.
Do not take your tablets after the expiry date
which is stated on the carton after „Exp‟. The
expiry date refers to the last day of that
month.
This medicine does not require any special
storage conditions.

Elantan® 40mg tablets,
PL No: 18799/2358

P

Leaflet date: 06.10.2014
Elantan is a registered trademark of UCB
Pharma Ltd.

Patient Information Leaflet

Isosorbide mononitrate 40mg
tablets
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.
The name of your medicine is Isosorbide
mononitrate 40mg Tablets but will be
referred to as Isosorbide mononitrate
throughout this leaflet.
In this leaflet:
1. What Isosorbide mononitrate is and
what it is used for
2. What you need to know before you take
Isosorbide mononitrate
3. How to take Isosorbide mononitrate
4. Possible side effects
5. How to store Isosorbide mononitrate
6. Contents of the pack and other
information
1.

What Isosorbide mononitrate is and
what it is used for

Isosorbide mononitrate 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.
Isosorbide mononitrate 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.

Isosorbide mononitrate 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

Do not take Isosorbide mononitrate if:
You are allergic to isosorbide
mononitrate, other nitrates or any of the
other ingredients of Isosorbide
mononitrate (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 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
with phosphodiesterase inhibitors
such as Sildenafil (“Viagra”) used for
impotence. Using Isosorbide
mononitrate with these medicines
could cause your blood pressure to
fall to a dangerously low level. You
must not stop taking Isosorbide
mononitrate 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 with food
and drink
Do not drink alcohol. It could increase the
effect of Isosorbide mononitrate 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.
Your doctor will decide whether you should
take this medicine.

Driving and using machines
Isosorbide mononitrate 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
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

Always take Isosorbide mononitrate 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 120 mg per day.
Do not use Isosorbide mononitrate 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
than you should
Do not take more Isosorbide mononitrate
than you should. If you accidentally take too
much, immediately contact the nearest
hospital casualty department or your doctor.
Too many Isosorbide Mononitrate 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
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
Do not stop taking Isosorbide mononitrate
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
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).

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6.

Contents of the pack and other
information

What Isosorbide mononitrate contain
The active substance is isosorbide mono
nitrate.
Each tablet contains 40mg isosorbide mononitrate.
The other ingredients are talc, lactose mono
hydrate, microcrystalline cellulose, potato
starch, colloidal anhydrous silica and
aluminium stearate.
What Isosorbide mononitrate look like
Isosorbide mononitrate are white, round
tablets with a scoreline on one side and plain
on the other, marked with “E” on top and
“40” on the bottom of the scoreline.
Isosorbide mononitrate is supplied in blister
packs containing 50 tablets.

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.

Manufactured by:
Aesica Pharmaceuticals GmbH,
Alfred Nobel Strasse 10-40789,
Monheim, Germany.

5.

Isosorbide mononitrate 40mg tablets,
PL No: 18799/2358
P

How to store Isosorbide mononitrate

Keep out of the sight and reach of children.
Do not take your tablets after the expiry date
which is stated on the carton after „Exp‟. The
expiry date refers to the last day of that
month.
This medicine does not require any special
storage conditions.

Procured from within the EU and
repackaged by the Product Licence
holder:
B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.

Leaflet date: 06.10.2014

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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