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ELANTAN 10MG TABLETS

Active substance(s): ISOSORBIDE MONONITRATE

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PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

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 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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See Section 4.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Elantan is and what it is used for
What you need to know before you take Elantan
How to take Elantan
Possible side effects
How to store Elantan
Contents of the pack and other information

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), constrictive 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


1. What Elantan is and what it is used for
Elantan belongs to a group of medicines called organic
nitrates.

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 Isosorbide Mononitrate Tablets with
products that contain riociguat a medicine used in
treating pulmonary hypertension.

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.

Tell your doctor if you are taking any of the
following medicines:

2. What you need to know before you take
Elantan





Do not take Elantan if:

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)




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.
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.
Page 1 of 2

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breastfeeding, 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.
Check with your doctor if you are not sure.

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.

Other Side Effects

Manufacturer

You may also suffer with increase chest pain due to a lack of
oxygen to the heart muscle and areas around the chest.

Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.





Red or scaly skin (exfoliative dermatitis)
Low blood pressure
Swelling of the skin

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.

4. Possible side effects

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

Like all medicines, Elantan can cause side effects, although
not everybody gets them.

5. How to store Elantan

Seek immediate medical help if you have any of the
following symptoms:




Very common side effects (affects more than 1 in 10
people):



Common side effects (affects less than 1 in 10 people):







Fainting or collapse

Headaches


Dizziness

Sleepiness

Feeling weak

Fast heartbeat

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





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. Contents of the pack and other
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.

Page 2 of 2

Elantan is manufactured by: Aesica Pharmaceuticals GmbH,
Alfred-Nobel-Strasse 10, D-40789 Monheim, Germany.

Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0564

P

Leaflet revision and issue dated: 02.06.16
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.

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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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