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ISOSORBIDE MONONITRATE 10 MG TABLETS

Active substance(s): ISOSORBIDE MONONITRATE

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Package Leaflet: Information for the
patient

Isosorbide Mononitrate

CIA79268A_MU2 10/2 1025

10 mg Tablets

CIA79268A_MU2_GI_MON_ISMN10_GBR.indd 1

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. What Isosorbide Mononitrate Tablets are
and what they are used for
2. What you need to know before you take
Isosorbide Mononitrate Tablets
3. How to take Isosorbide Mononitrate
Tablets
4. Possible side effects
5. How to store Isosorbide Mononitrate
Tablets
6. Contents of the pack and other
information

1. What Isosorbide Mononitrate
Tablets are and what they are
used for
Isosorbide Mononitrate Tablets belong 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 Tablets are 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. What you need to know before you
take Isosorbide Mononitrate Tablets
Do not take Isosorbide Mononitrate
Tablets if:
• You are allergic to isosorbide
mononitrate, other nitrates or any of the
other ingredients of Isosorbide
Mononitrate Tablets (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)
• ou 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
Isosorbide Mononitrate Tablets 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
Tablets with phosphodiesterase
inhibitors such as Sildenafil
(“Viagra”) used for impotence.
Using Isosorbide Mononitrate
Tablets with these medicines could
cause your blood pressure to fall to
a dangerously low level. You must
not stop taking Isosorbide
Mononitrate Tablets 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.
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 Tablets
with food and drink
Do not drink alcohol. It could increase the
effect of Isosorbide Mononitrate Tablets 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 Tablets.
Your doctor will decide whether you should
take this medicine.
Driving and using machines
Isosorbide Mononitrate Tablets 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 Tablets
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 Tablets
Always take Isosorbide Mononitrate Tablets
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 120 mg per day.
Do not use Isosorbide Mononitrate
Tablets 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 Tablets than you should
Do not take more Isosorbide Mononitrate
Tablets 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 Tablets
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 Tablets
Do not stop taking Isosorbide Mononitrate
Tablets 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

R

Like all medicines Isosorbide Mononitrate
Tablets can cause side effects, although not
everybody gets them.
Seek immediate medical help if you
have any of the following symptoms:
• Fainting or collapse

23.09.15 13:43

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
• 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

CIA79268A MU2 GI MON ISMN10 GBR.indd 2

You may also suffer with increase 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 Tablets
Keep this medicine out of the reach and
sight of children.
Do not use Isosorbide Mononitrate Tablets
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
wastewater or household waste.
Ask your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Isosorbide Mononitrate 10 mg
Tablets contain
The active substance is isosorbide
mononitrate 10 mg.
The other ingredients are lactose
monohydrate, microcrystalline cellulose,
potato starch, purified talc, colloidal silicon
dioxide and aluminium stearate.
What Isosorbide Mononitrate 10 mg
Tablets look like
Isosorbide Mononitrate 10 mg Tablets are
white with “E/10” marked on them.
They come in blister packs of 14, 50, 56,
60, 84 and 90 tablets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder
UCB Pharma Ltd, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK.
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel-Straße 10
40789 Monheim, Germany
This leaflet was last updated September 2015.
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.

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CIA79268A_MU2 10/2 1025

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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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