ELANTAN 20MG TABLETS

Package Leaflet: Information for the
patient

Elantan® 20mg 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 20mg
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
7. 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 severe 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 severely low blood volume
(hypovolaemia)
You have severely 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), const-rictive
pericarditis, cardiac tamponade, low
cardiac filling pressures, aortic/mitral
valve stenosis and diseases associated
with raised intra-cranial (head) pressure
You take products that contain riociguat
a medicine used in treating pulmonary
hypertension.
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
You have slower than normal bowel
movements
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
Do not take Elantan with products
that contain riociguat a medicine
used in treating pulmonary
hypertension.
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.
Sapropterin used for phenylketonuria
(PKU)
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 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):
Headaches
Common side effects (affects less than 1 in
10 people):
Dizziness
Sleepiness
Feeling weak
Fast heart beat
Lowering of blood pressure when
standing up

They may occur for the first few days of
treatment or after your dosage has been
increased.

If the tablets become discoloured or show
any signs of deterioration, seek the advice of
your pharmacist.

Uncommon side effects (affects less than
1 in 100 people):
Fainting or collapse
Feeling sick or being sick
Skin rashes
Looking pale
Flushing
Excessive sweating
Restlessness
Increase in chest pain/angina.

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.

Very rare side effects (affects less than 1 in
10,000 people):
Heartburn
Other side effects:
Red or scaly skin (exfoliative dermatitis)
Low blood pressure
Swelling of the skin
You may also suffer with increased chest
pain due to a lack of oxygen to the heart
muscle and areas around the chest.
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.

6. Contents of the pack and other
information
What Elantan contains
The active ingredient in Elantan is isosorbide
mononitrate.
Each tablet contains 20mg isosorbide
mononitrate.
The other ingredients are talc, lactose
monohydrate, colloidal anhydrous silica,
potato starch, microcrystalline cellulose and
aluminium stearate.
What Elantan looks like and contents of
the pack
Elantan is white, round tablet with a
scoreline on one side and plain on the other,
marked with ‘E’ on top and ‘20’ 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.

Keep out of the sight and reach of children.

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

This medicine does not require any special
storage condition.

Elantan® 20mg tablets,
PL 18799/2357

Do not take the tablets after the expiry date
which is stated on the carton and blister
label after ‘Exp’. The expiry date refers to the
last day of that month.

Leaflet date: 07.07.2016

5. How to store Elantan

P

Elantan is a registered trademark of UCB
Pharma Ltd.

Package Leaflet: Information for the
patient

Isosorbide mononitrate 20mg
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 20mg 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
7. 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 severe 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 severely low blood volume
(hypovolaemia)
You have severely 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), const-rictive
pericarditis, cardiac tamponade, low
cardiac filling pressures, aortic/mitral
valve stenosis and diseases associated
with raised intra-cranial (head) pressure
You take products that contain riociguat
a medicine used in treating pulmonary
hypertension.
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
You have slower than normal bowel
movements
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
Do not take Isosorbide Mononitrate
with products that contain riociguat
a medicine used in treating
pulmonary hypertension.
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.
Sapropterin used for phenylketonuria
(PKU)
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 120mg 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 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):
Headaches

Common side effects (affects less than 1 in
10 people):
Dizziness
Sleepiness
Feeling weak
Fast heart beat
Lowering of blood pressure when
standing up
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
Flushing
Excessive sweating
Restlessness
Increase in chest pain/angina.
Very rare side effects (affects less than 1 in
10,000 people):
Heartburn
Other side effects:
Red or scaly skin (exfoliative dermatitis)
Low blood pressure
Swelling of the skin
You may also suffer with increased chest
pain due to a lack of oxygen to the heart
muscle and areas around the chest.
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
Keep out of the sight and reach of children.
This medicine does not require any special
storage condition.
Do not take the tablets after the expiry date
which is stated on the carton and blister
label after ‘Exp’. The expiry date refers to the
last day of that month.
If the tablets become discoloured or show
any signs of deterioration, seek the advice of
your pharmacist.
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 ingredient in Isosorbide
mononitrate is isosorbide mononitrate.
Each tablet contains 20mg isosorbide
mononitrate.
The other ingredients are talc, lactose
monohydrate, microcrystalline cellulose,
potato starch, colloidal anhydrous silica and
aluminium stearate.
What Isosorbide mononitrate looks like
and contents of the pack
Isosorbide mononitrate is white, round tablet
with a scoreline on one side and plain on the
other, marked with ‘E’ on top and ‘20’ on the
bottom of the scoreline.
Isosorbide mononitrate 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.
Isosorbide mononitrate 20mg tablets,
PL 18799/2357
P
Leaflet date: 07.07.2016