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ELANTAN LA 25 SLOW RELEASE CAPSULES

Active substance: ISOSORBIDE MONONITRATE

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elantan

®

LA 25 mg

25mg Prolonged Release Capsules
ISOSORBIDE MONONITRATE

Patient Information 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. What Elantan LA25 is for
2. Before you take Elantan LA25
3. How to take Elantan LA25
4. Possible side effects
5. How to store Elantan LA25
6. Further information.

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1. What Elantan LA25 is for
Elantan LA25 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 LA25 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 LA25
Do not take Elantan LA25 if:
• You are allergic to isosorbide mononitrate,
other nitrates or any of the other
ingredients of Elantan LA25 (see section 6)
• You have severe anaemia (reduction in red
blood cells which can make the skin pale and

CIA76764B_MU1_GI_MON_ElantanLA25_GBR.indd 1

Aesica Id.-No.

Elantan LA

/ GBR

external Id.-No.

CIA76764B_MU1

Dimensions

140 x 260 mm

Operator

Sorek

Creation Date

17.06.2015

Amended by

02

Print Colours

Techn. Colours

Artwork Studio

black

techn. info.

PT Approval

Date

Palladio

Dispatched to

Operator

Manufacturing Site

8 pt

Linespacing

Approver

30.06.2015

Edition No.

30.06.15 08:45

Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

Meissner/Dormann

Modific. Date

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.
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 LA25 with food and drink
Do not drink alcohol. It could increase the
effect of Elantan LA25 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
LA25. Your doctor will decide whether you
should take this medicine.
Driving and using machines
Elantan LA25 may give you a headache, blurred
vision or make you feel dizzy ortired. If this
happens to you, do not drive or operate
machinery.
Warnings about the ingredients
This medicine contains lactose and sucrose. If

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

Product Name

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),
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 LA25 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 LA25 with
phosphodiesterase inhibitors such as
Sildenafil (“Viagra”) used for

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Technical Changes

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

R

you have an intolerance to some sugars, tell
your doctor before taking this medicine.
3. How to take Elantan LA25
Always take Elantan LA25 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 LA25 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 LA25 than you
should
Do not take more Elantan LA25 than you
should. If you accidentally take too much,
immediately contact the nearest hospital
casualty department or your doctor.

Too much Elantan LA25 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 LA25
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 LA25
Do not stop taking Elantan LA25 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 LA25 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 heartbeat
• Lowering of blood pressure when standing up.

CIA76764B_MU1_GI_MON_ElantanLA25_GBR.indd 2

Aesica Id.-No.

Elantan LA

/ GBR

external Id.-No.

CIA76764B_MU1

Dimensions

140 x 260 mm

Operator

Sorek

Creation Date

17.06.2015

Amended by

02

CIA76764B_MU1 10/132 1155

30.06.15 08:45

Print Colours

Techn. Colours

Artwork Studio

black

techn. info.

PT Approval

Date

Palladio

Dispatched to

Operator

Manufacturing Site

8 pt

Linespacing

Approver

30.06.2015

Edition No.

If this leaflet is difficult to see or
read or you would like it in a
different format, please contact
UCB Pharma Ltd, 208 Bath Road,
Slough, Berkshire, SL1 3WE, UK.

Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

Meissner/Dormann

Modific. Date

5. How to store Elantan LA25
Keep out of the reach and sight of children.
Do not use Elantan LA25 after the expiry date
on the carton. The expiry date refers to the last
day of that month.
Do not store above 30°C.
Medicines should not be disposed of via
waste-water or household waste. Return any
medicine you no longer need to your
pharmacist.

6. Further information
What Elantan LA25 contains
The active substance is isosorbide mono­ itrate
n
25 mg.
The other ingredients are lactose mono­ ydrate,
h
purified talc, ethyl cellulose, macrogol 20,000,
hydroxypropyl cellulose, sucrose, corn starch,
gelatin, titanium dioxide, iron oxide red (E172),
iron oxide black (E172).
What Elantan LA25 looks like
Elantan LA25 is a brown and white
coloured capsule. They come in blister packs
of 28 capsules
Marketing Authorisation Holder
UCB Pharma Ltd, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK.
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred Nobel Strasse 10, D-40789,
Monheim, Germany
This leaflet was last updated June 2015

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

Product Name

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.
You may also suffer with increased chest pain
due to a lack of oxygen to the heart muscle
and areas around the chest.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Artwork Information
Fontsize Bodytext

9 pt

Technical Changes

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

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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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