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ISOSORBIDE MONONITRATE TABLETS 20MG

Active substance(s): ISOSORBIDE MONONITRATE / ISOSORBIDE MONONITRATE DILUTED IN LACTOSE

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Isosorbide Mononitrate
10mg, 20mg and 40mg tablets
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.
• If you have any of the side effects, or if
you notice any not listed, please tell your
doctor or pharmacist.

In this leaflet:
1 What
Isosorbide Mononitrate

tablets are and what they are
used for
2 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 Further information

1 What
Isosorbide Mononitrate

tablets are and what they are
used for

Isosorbide Mononitrate belongs to a group
of medicines called nitrate vasodilators.
These work by relaxing the blood vessels of
the heart, reducing the strain on the heart
making it easier to pump blood.
Isosorbide Mononitrate tablets may be used
to:
• relieve the pain and frequency of angina
attacks
• help control certain types of heart failure.

2 Before
you take Isosorbide

Mononitrate tablets

Do not take Isosorbide Mononitrate
tablets if you:

• are allergic (hypersensitive) to isosorbide
mononitrate, isosorbide dinitrate or any of
the ingredients in the tablet (see section
6). An allergic reaction may include a rash,
itching or difficulty breathing

• have any condition where your blood pressure is
very low or your blood is not circulating properly
(such as shock)
• have angina that is caused by an enlarged heart
muscle
• have suffered from a head injury or bleeding in the
brain
• have severe anaemia.

Check with your doctor or pharmacist before
taking Isosorbide Mononitrate tablets if you:
• have glaucoma (increased pressure in the eye)
• have severe kidney or liver problems
• have an underactive thyroid gland
• are undernourished as a result of a poor diet
• are suffering from hypothermia

Taking other medicines

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription. Especially:
• noradrenaline (norepinephrine) – to treat high blood
pressure or heart attack
• acetylcholine – used in some operations
• medicines to treat high blood pressure such as ACE
inhibitors, beta blockers, alphablockers, angiotensinII receptor agonists, clonidine, diazoxide, diuretics
(water tablets), methyldopa, moxonidine
• histamine – to treat allergic reactions
• sildenafil, tadalafil and vardenafil, used to treat male
erection dysfunction, should not be taken if taking
nitrate preparations such as Isosorbide Mononitrate
tablets because a severe and possibly dangerous
fall in blood pressure can occur. This would result in
collapse, unconsciousness and could be fatal.

Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant
or breastfeeding speak to a doctor before taking
Isosorbide Mononitrate tablets.

Driving and using machines

Isosorbide mononitrate may make you feel dizzy, make
sure you are not affected before you drive or operate
machinery.

Sugar intolerance

If you have been told that you have an intolerance to
some sugars, contact your doctor before taking this
medicine, as it contains lactose.

Taking Isosorbide Mononitrate tablets with
alcohol

You are advised not to drink alcohol with this medicine
as it may increase the blood pressure lowering affect of
the tablets.

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Isosorbide Mono Tablets
all strengths x 56’s (UK)

Isosorbide Mononitrate 10mg, 20mg & 40mg 56 Tablets PIL - UK
approved for print/date

Item number:
Originator:
Origination Date:
Revision Date:
Revised By:

Proof Round

4

BBBA1623
Dimensions:
148 x 210
Min Body Text Size: 7.25pt
Supplier:
Actavis UK

S.Anson
04.01.18
23.01.18
S.Anson

JDE No.:
Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

Date Sent:
20/12/17
Technologist: R.Wrey

4.

Date sent:
N/A
Date received: N/A

Technically Approved

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 2838

5.

Technical
Approval

50943963

Version 2
01.11.2017

If you see another doctor or go into hospital, let them know
what medicines you are taking.

3 How to take Isosorbide Mononitrate tablets
Always take Isosorbide Mononitrate tablets exactly as your
doctor has told you. If you are not sure, check with your
doctor or pharmacist.
Swallow the tablets with water after meals.
The usual doses are:
• 
Adults
- Angina: initially 20mg two or three times a day, then a
maintenance dose of between 20-120mg a day.
- Congestive heart failure: 20mg two or three times a day
depending on your condition. Your doctor may also be
treating you with other drugs.
• 
Patients with kidney or liver disease: A lower dose may
be given.
• 
Elderly: Dose should be reduced especially in patients
with kidney or liver disease.
• 
Children: Not recommended

If you take more Isosorbide Mononitrate tablets
than you should

If you (or someone else) swallow a lot of tablets at the
same time, or you think a child may have swallowed any
contact your nearest hospital casualty department or tell
your doctor immediately. Signs of an overdose over excited,
flushing, feeling or being sick, cold sweats, feeling dizzy or
spinning sensation, fainting or passing out, fast heart beat
or fall in blood pressure.

If you forget to take Isosorbide Mononitrate
tablets

Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose take it as soon as you remember
it and then take the next dose at the right time.

If you stop taking the tablets

Do not stop taking the tablets without talking to your
doctor and follow their advice.

4 Possible side effects

Like all medicines, Isosorbide Mononitrate tablets can cause
side effects, although not everybody gets them. Please tell
your doctor or pharmacist if you notice any of the following
effects or any not listed.
Contact your doctor at once if you experience:
- symptoms of an allergic reaction skin rash, swelling of the
skin of the extremities or face, swelling of lips, tongue,
or the mucous membranes in mouth, throat, or airways,
resulting in shortness of breath or difficulty to swallow.
- Isosorbide Mononitrate tablets may cause changes in
vision, sudden headaches, low blood pressure, and feeling
or being sick in people with an undiagnosed pituitary
tumour (brain tumour). Talk to you doctor if you have any
concerns.

Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
• headaches, which can be relieved with painkillers and
usually get better after 1-3 weeks of treatment
• dry or flaky skin rash
• being sick, heartburn
• glaucoma (pressure within the eye)
• flushing, dizziness, weakness, fainting on standing, fast
or slow heart rate, temporary low levels of oxygen in the
blood.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist
or nurse. 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 or
search for MHRA Yellow Card in the Google Play or Apple
App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Isosorbide Mononitrate tablets
Keep out of the reach and sight of children.
Store below 25°C in a dry place.
Do not use Isosorbide Mononitrate tablets after the expiry
date stated on the label/carton/bottle. The expiry date
refers to the last day of that month.
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 Further information

What Isosorbide Mononitrate tablets contain

• The active substance (the ingredient that makes the
tablets work) is isosorbide mononitrate. Each tablet
contains either 10mg, 20mg or 40mg of the active
ingredient.
• The other ingredients are crospovidone, lactose,
magnesium stearate, maize starch, povidone
and E460 (10mg and 40mg only).

What Isosorbide Mononitrate tablets
look like and contents of the pack

Isosorbide Mononitrate tablets are circular,
biconvex, white to off white uncoated tablets.
Pack sizes are 56 tablets
Marketing Authorisation holder and
manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised
January 2018

Continued top of next column
50943963 BBBA1623

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Isosorbide Mono Tablets
all strengths x 56’s (UK)

Isosorbide Mononitrate 10mg, 20mg & 40mg 56 Tablets PIL - UK
approved for print/date

Item number:
Originator:
Origination Date:
Revision Date:
Revised By:

Proof Round

4

BBBA1623
Dimensions:
148 x 210
Min Body Text Size: 7.25pt
Supplier:
Actavis UK

S.Anson
04.01.18
23.01.18
S.Anson

JDE No.:
Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

Date Sent:
20/12/17
Technologist: R.Wrey

4.

Date sent:
N/A
Date received: N/A

Technically Approved

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 2838

5.

Technical
Approval

50943963

Version 2
01.11.2017

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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