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ELANTAN LA 50MG CAPSULES

Active substance(s): ISOSORBIDE MONONITRATE / ISOSORBIDE MONONITRATE

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PATIENT INFORMATION LEAFLET

ELANTAN® LA 50MG CAPSULES





(isosorbide mononitrate)

Your medicine is available using the name ELANTAN LA 50MG
CAPSULES, but will be referred to as Elantan LA throughout
the 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 LA is for
Before you take Elantan LA
How to take Elantan LA
Possible side effects
How to store Elantan LA
Further information



If any of the above applies to you talk to your doctor or
pharmacist.

Check with your doctor before taking Elantan LA if:








Elantan LA 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 LA
Do not take Elantan LA if:












You are allergic to isosorbide mononitrate, other nitrates
or any of the other ingredients of Elantan LA (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 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
You take products that contain riociguat a medicine used
in treating pulmonary hypertension.

Taking other Medicines


1. What Elantan LA is for
Elantan LA 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.

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.



Do not take Elantan LA25 with phosphodiesterase
inhibitors such as Sildenafil (“Viagra”) used for
impotence.
Using Elantan LA25 with these medicines could
cause your blood pressure to fall to a dangerously
low level. You must not stop taking Elantan LA25
to take Sildenafil as this will increase your chances
of having an angina attack.
Do not take Elantan LA 50 with products that contain
riociguat a medicine used in treating pulmonary
hypertension.

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






If

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 LA with food and drink

Do not drink alcohol. It could increase the effect of Elantan LA
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 breastfeeding, ask your doctor or pharmacist for advice before
taking Elantan LA. You doctor will decide whether you should
take this medicine.

Driving and using machines

Elantan LA 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

This medicine contains lactose monohydrate and sucrose. If
you have an intolerance to some sugars, tell your doctor
before taking this medicine.

3. How to take Elantan LA
Always take Elantan LA 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 capsule once a day, in the
morning.
If your doctor increases your dose to two capsules, you
should take them together in the morning.
To remove the capsule from the packaging, carefully
push one end of the capsule through the foil. If you push
in the middle you may damage the capsule.
Swallow the capsule whole with a drink of water.

Do not use Elantan LA 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 LA than you should

Do not take more Elantan LA than you should. If you
accidentally take too much, immediately contact the nearest
hospital casualty department or your doctor.
Too much Elantan LA may cause your blood pressure to fall
too low, making you feel sick, faint and dizzy. A very large
over-dose could cause a coma or collapse and require
immediate resuscitation.

If you forget to take Elantan LA

Do not take a double dose to make up for a missed dose.
Take your next dose at the usual time.
Page 1 of 2

If you stop taking Elantan LA

Do not stop taking Elantan LA 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.

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 Yellow Card
Scheme, Website: 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 LA

4. Possible side effects

Keep out of the sight and reach of children.

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

Do not use this medicine after its expiry date shown on the
carton label or blister strip. The expiry date refers to the last
day of that month.

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 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
Increasing 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.

If your doctor decides to stop your treatment return any left
over medicine to a pharmacist. Only keep it if the doctor tells
you to.
If the capsules become discoloured or show any other signs
of deterioration you should seek the advice of your
pharmacist who will advise you what to do.
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 LA contains

Your medicine is called Elantan LA. Each capsule contains
50mg of the active ingredient isosorbide mononitrate in a
modified-release formulation.
Elantan LA also contains the following:
Gelatin, lactose monohydrate, purified talc, ethyl cellulose,
hydroxypropylcellulose, macrogol 20,000, sucrose,
titanium dioxide (E171), iron oxide red (E172),
indigotin (E132) and erythrosine (E127).

What Elantan LA looks like

The hard, prolonged release capsules have a bright red upper
half and a blue lower half. They contain white to off-white
pellets.
Elantan LA is available as blister packs of 30 capsules.

Manufacturer

Manufactured by: Schwarz Pharma Ltd, Shannon Industrial
Estate, Shannon, Co. Clare, Ireland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

Page 2 of 2

Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0254

POM

Leaflet revision date: 09.02.17
Elantan® is a registered trademark of Schwarz Pharma AG,
Germany.

Blind or partially sighted?
Is this leaflet hard to see or
read? Call 01302 365000
(Regulatory)
Please be ready to give the
following information:
Product name:
Elantan LA 50mg Capsules
Reference No: 21828/0254

Expand Transcript

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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