Isosorbide mononitrate 10mg tablets

Main information

  • Trade name:
  • Isosorbide mononitrate 10mg tablets
  • Dosage:
  • 10mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Isosorbide mononitrate 10mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02060100; GTIN: 5017007026822

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 00289/0286
  • Last update:
  • 09-03-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Do not use Isosorbide Mononitrate 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.

Use in children

Isosorbide Mononitrate is not recommended for

use in children

If you take more Isosorbide Mononitrate than you

should

If you (or someone else) swallow a lot of the

tablets all together, or if you think a child has

swallowed any of the tablets, contact your nearest

hospital casualty department or your doctor

immediately. An overdose is likely to cause

nausea, vomiting, restlessness, warm flushed

skin, blurred vision, headache, fainting, dizziness,

fast heart rate, low blood pressure, irregular heart

beat or confusion. Please take this leaflet, any

remaining tablets and the container with you to

the hospital or doctor so that they know which

tablets were consumed.

If you forget to take Isosorbide Mononitrate

If you forget to take a tablet, take one as soon as

you remember, unless it is nearly time to take the

next one. Do not take a double dose to make up

for a forgotten dose.

If you stop taking Isosorbide Mononitrate

Do not stop taking your medicine without talking

to your doctor first, even if you feel better.

You should not stop taking Isosorbide

Mononitrate suddenly. If your doctor decides to

stop your treatment, he/she will reduce your dose

and how often you take the tablets gradually, and

will tell you when you can stop taking them.

If you have any further questions on the use of

this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Isosorbide Mononitrate can

cause side effects, although not everybody gets

them.

If the following happens, stop taking the tablets

and tell your doctor immediately or go to the

casualty department at your nearest hospital:

an allergic reaction (swelling of the lips, face or

neck leading to severe difficulty in breathing;

skin rash or hives).

This is a very serious but rare side effect. You may

need urgent medical attention or hospitalisation.

The following side effects have been reported at

the approximate frequencies shown:

Very Common (affecting more than 1 in 1in 10

people):

Mild headaches at the start of treatment.

Usually they disappear after a few days.

Common side effects (affects less than 1 in 10

people):

Dizziness

Tiredness

Feeling weak

Low blood pressure

A fall in blood pressure on standing up which

causes dizziness, light-headedness or fainting

Fast heartbeat

Uncommon (affects less than one person in 100):

Fainting or collapse

Nausea or vomiting

Skin rash

Looking pale

Excessive sweating

Restlessness

Slowing of the pulse rate or heart beat

Worse angina due to very low blood pressure

Flushing.

Rare (affects less than one person in 1,000):

Blueness of the face and extremities due to an

increase in the amount of methaemoglobin in

the blood. Symptoms that you may experience

include fatigue, headache or dizziness.

Very rare side effects (affects less than 1 in 10,000

people):

Heartburn

Red or scaly skin (exfolilative dermatitis)

Other medicines and Isosorbide Mononitrate

Do NOT take Isosorbide Mononitrate in

combination with

Phosphodiesterase type-5 inhibitors such as

sildenafil, tadalafil and vardenafil taken for

male erection problems. If this is used by

patients taking nitrate preparations such as

Isosorbide Mononitrate, a severe and possibly

dangerous fall in blood pressure can occur. This

would result in collapse and/or

unconsciousness and could be fatal.

Talk to your doctor if you are taking any of the

following:

alprostadil (for male erection problems)

aldesleukin (a cancer treatment)

candesartan or losartan (for treatment of high

blood pressure)

drugs with blood pressure lowering properties,

e.g. beta-blockers (e.g. propranolol), calcium

channel blockers (e.g. amlodipine), vasodilators

(e.g. hydralazine)

tricyclic antidepressants (used to treat

depression) and neuroleptics (used to treat

anxiety).

ergotamine used for migraine.

Please tell your doctor or pharmacist if you are

taking or have recently taken any other

medicines, including medicines obtained without

a prescription.

Isosorbide Mononitrate with food and drink

Do not drink alcohol. It could increase the effect of

Isosorbide Mononitrate 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. Your

doctor will decide whether you should take this

medicine.

Driving and using machines

Isosorbide Mononitrate may cause headache,

blurred vision, dizziness, tiredness, and low blood

pressure. If affected do not drive or operate

machinery.

Isosorbide Mononitrate contains lactose

Patients who are intolerant to lactose should note

that Isosorbide Mononitrate tablets contain a

small amount of lactose. If you have been told by

your doctor that you have an intolerance to some

sugars, contact your doctor before taking this

medicinal product.

HOW TO TAKE ISOSORBIDE

MONONITRATE

Always take Isosorbide Mononitrate exactly as

your doctor has told you. Your doctor will tell you

how long you should take this medicine to treat

your condition. If you are in any doubt, ask your

doctor or your pharmacist.

The tablets should be swallowed whole without

chewing, preferably with a glass of water after a

meal.

The usual dose is:

Adults including the elderly

The recommended dosage is from 20 to 120 mg

daily in divided doses.

Most people will require a dosage in the range of

40 to 60 mg daily in divided doses.

Your doctor may increase your dose, up to a

maximum of 120 mg per 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.

A reduced dose may be given to elderly patients

who are known to be susceptible to the effects of

medication that lowers blood pressure.

If you have not taken Isosorbide Mononitrate

before, your doctor may tell you to take

Isosorbide Mononitrate 10 mg tablets for a few

days i.e.10 mg (1 tablet) daily for 2 days followed

by a dosage of 20 mg daily (1 tablet morning and

evening) for a further 3 days. Subsequently the

daily dose may be increased to the level required

to treat your medical condition.

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.

HOW TO STORE ISOSORBIDE

MONONITRATE

Keep this medicine out of the sight and reach of

children. Isosorbide Mononitrate should be stored

below 25°C. in the original blister package. Do not

use this medicine after the expiry date which is

stated on the outer packaging. The expiry date

refers to the last day of that month. Do not throw

away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will

help to protect the environment.

CONTENTS OF THE PACK AND OTHER

INFORMATION

What Isosorbide Mononitrate contains:

The active substance is either 10 mg, 20 mg or

40 mg of isosorbide mononitrate.

The other ingredients are lactose,

microcrystalline cellulose (E460), povidone

(E1201), sodium starch glycolate and

magnesium stearate (E572).

What Isosorbide Mononitrate tablets look like

and contents of the pack:

Isosorbide mononitrate 10 mg tablets are

'White round bevel edged tablets, engraving

1J1 : plain with breakline

Isosorbide mononitrate 20 mg tablets are

'White round bevel edged tablets, engraving

1J2 : plain with breakline

Isosorbide mononitrate tablets 40 mg tablets

are 'White round bevel edged tablets,

engraving 1J3 : plain with breakline

Isosorbide Mononitrate 10mg, 20mg, 40mg

tablets packs are Blister strips in multiples of

10,14 or 20 tablets in packs of 10,14, 28, 30, 50,

56, 60 or 100 tablets.

HDPE or polypropylene containers with caps or

child resistant closures in packs of 28, 30, 50,

56, 60, 100, 250, 500 or 1000 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG

PL 00289/0286-0288.

This leaflet was last revised in February 2015

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 signs of illness 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.

1. What Isosorbide Mononitrate is and what it is

used for

2. What you need to know before you take

Isosorbide Mononitrate

3. How to take Isosorbide Mononitrate

4. Possible side effects

5. How to store Isosorbide Mononitrate

6. Contents of the pack and other information

WHAT ISOSORBIDE MONONITRATE IS

AND WHAT IT IS USED FOR

Isosorbide mononitrate belongs to a group of

drugs called nitrates. These drugs open out

blood vessels and allow more blood to flow

through them.

Isosorbide Mononitrate is used:

in the treatment and prevention of angina

pectoris attacks which is a chest pain

associated with the heart that usually occurs

with exertion.

in the treatment of heart failure where the

heart does not pump with enough force to

maintain effective circulation of the blood

around the body.

WHAT YOU NEED TO KNOW BEFORE

YOU TAKE ISOSORBIDE

MONONITRATE

Do NOT take Isosorbide Mononitrate if you:

are allergic (hypersensitive) to isosorbide

mononitrate or any of the other ingredients of

this medicine

have ever suffered a reaction to medicines

containing nitrates before

have low blood pressure

have ever suffered from a heart attack

have any other problems with your heart or

your blood has stopped circulating around your

body properly (circulatory failure)

are suffering from “shock” or vascular collapse

suffer from glaucoma (loss of vision due to

high pressure in the eye)

have ever suffered a head injury causing

pressure in the brain

have had a brain haemorrhage (bleeding)

have had a head injury (trauma)

have a low blood volume (hypovolaemia)

suffer from severe anaemia which is a

reduction in red blood cells

suffer from galactosaemia which is an inability

to digest carbohydrates and sugars found in

food and milk products

take sildenafil, tadalafil and vardenafil or any

other phosphodiesterase inhibitor (see taking

other medicines)

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...

Warnings and precautions

Talk to your doctor before taking Isosorbide

Mononitrate if you:

suffer from hypothyroidism (underactive

thyroid gland)

suffer from liver or kidney problems

are suffering from hypothermia (a body

temperature below normal)

are suffering from malnutrition

have recently had a heart attack.

suffer from very poor circulation

PACKAGE LEAFLET: INFORMATION

FOR THE USER

Top of page cut-off to middle of registration mark: 44 mm.

Isosorbide Mononitrate

10 mg, 20 mg and 40 mg Tablets

WHAT IS IN THIS LEAFLET:

PAGE 1: FRONT FACE (INSIDE OF REEL)

1

2

3

Pharma code 185

Version

REG0069657

Approved

Page 1 of 3

Do not use Isosorbide Mononitrate 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.

Use in children

Isosorbide Mononitrate is not recommended for

use in children

If you take more Isosorbide Mononitrate than you

should

If you (or someone else) swallow a lot of the

tablets all together, or if you think a child has

swallowed any of the tablets, contact your nearest

hospital casualty department or your doctor

immediately. An overdose is likely to cause

nausea, vomiting, restlessness, warm flushed

skin, blurred vision, headache, fainting, dizziness,

fast heart rate, low blood pressure, irregular heart

beat or confusion. Please take this leaflet, any

remaining tablets and the container with you to

the hospital or doctor so that they know which

tablets were consumed.

If you forget to take Isosorbide Mononitrate

If you forget to take a tablet, take one as soon as

you remember, unless it is nearly time to take the

next one. Do not take a double dose to make up

for a forgotten dose.

If you stop taking Isosorbide Mononitrate

Do not stop taking your medicine without talking

to your doctor first, even if you feel better.

You should not stop taking Isosorbide

Mononitrate suddenly. If your doctor decides to

stop your treatment, he/she will reduce your dose

and how often you take the tablets gradually, and

will tell you when you can stop taking them.

If you have any further questions on the use of

this product, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Isosorbide Mononitrate can

cause side effects, although not everybody gets

them.

If the following happens, stop taking the tablets

and tell your doctor immediately or go to the

casualty department at your nearest hospital:

an allergic reaction (swelling of the lips, face or

neck leading to severe difficulty in breathing;

skin rash or hives).

This is a very serious but rare side effect. You may

need urgent medical attention or hospitalisation.

The following side effects have been reported at

the approximate frequencies shown:

Very Common (affecting more than 1 in 1in 10

people):

Mild headaches at the start of treatment.

Usually they disappear after a few days.

Common side effects (affects less than 1 in 10

people):

Dizziness

Tiredness

Feeling weak

Low blood pressure

A fall in blood pressure on standing up which

causes dizziness, light-headedness or fainting

Fast heartbeat

Uncommon (affects less than one person in 100):

Fainting or collapse

Nausea or vomiting

Skin rash

Looking pale

Excessive sweating

Restlessness

Slowing of the pulse rate or heart beat

Worse angina due to very low blood pressure

Flushing.

Rare (affects less than one person in 1,000):

Blueness of the face and extremities due to an

increase in the amount of methaemoglobin in

the blood. Symptoms that you may experience

include fatigue, headache or dizziness.

Very rare side effects (affects less than 1 in 10,000

people):

Heartburn

Red or scaly skin (exfolilative dermatitis)

Other medicines and Isosorbide Mononitrate

Do NOT take Isosorbide Mononitrate in

combination with

Phosphodiesterase type-5 inhibitors such as

sildenafil, tadalafil and vardenafil taken for

male erection problems. If this is used by

patients taking nitrate preparations such as

Isosorbide Mononitrate, a severe and possibly

dangerous fall in blood pressure can occur. This

would result in collapse and/or

unconsciousness and could be fatal.

Talk to your doctor if you are taking any of the

following:

alprostadil (for male erection problems)

aldesleukin (a cancer treatment)

candesartan or losartan (for treatment of high

blood pressure)

drugs with blood pressure lowering properties,

e.g. beta-blockers (e.g. propranolol), calcium

channel blockers (e.g. amlodipine), vasodilators

(e.g. hydralazine)

tricyclic antidepressants (used to treat

depression) and neuroleptics (used to treat

anxiety).

ergotamine used for migraine.

Please tell your doctor or pharmacist if you are

taking or have recently taken any other

medicines, including medicines obtained without

a prescription.

Isosorbide Mononitrate with food and drink

Do not drink alcohol. It could increase the effect of

Isosorbide Mononitrate 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. Your

doctor will decide whether you should take this

medicine.

Driving and using machines

Isosorbide Mononitrate may cause headache,

blurred vision, dizziness, tiredness, and low blood

pressure. If affected do not drive or operate

machinery.

Isosorbide Mononitrate contains lactose

Patients who are intolerant to lactose should note

that Isosorbide Mononitrate tablets contain a

small amount of lactose. If you have been told by

your doctor that you have an intolerance to some

sugars, contact your doctor before taking this

medicinal product.

HOW TO TAKE ISOSORBIDE

MONONITRATE

Always take Isosorbide Mononitrate exactly as

your doctor has told you. Your doctor will tell you

how long you should take this medicine to treat

your condition. If you are in any doubt, ask your

doctor or your pharmacist.

The tablets should be swallowed whole without

chewing, preferably with a glass of water after a

meal.

The usual dose is:

Adults including the elderly

The recommended dosage is from 20 to 120 mg

daily in divided doses.

Most people will require a dosage in the range of

40 to 60 mg daily in divided doses.

Your doctor may increase your dose, up to a

maximum of 120 mg per 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.

A reduced dose may be given to elderly patients

who are known to be susceptible to the effects of

medication that lowers blood pressure.

If you have not taken Isosorbide Mononitrate

before, your doctor may tell you to take

Isosorbide Mononitrate 10 mg tablets for a few

days i.e.10 mg (1 tablet) daily for 2 days followed

by a dosage of 20 mg daily (1 tablet morning and

evening) for a further 3 days. Subsequently the

daily dose may be increased to the level required

to treat your medical condition.

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.

HOW TO STORE ISOSORBIDE

MONONITRATE

Keep this medicine out of the sight and reach of

children. Isosorbide Mononitrate should be stored

below 25°C. in the original blister package. Do not

use this medicine after the expiry date which is

stated on the outer packaging. The expiry date

refers to the last day of that month. Do not throw

away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away

medicines you no longer use. These measures will

help to protect the environment.

CONTENTS OF THE PACK AND OTHER

INFORMATION

What Isosorbide Mononitrate contains:

The active substance is either 10 mg, 20 mg or

40 mg of isosorbide mononitrate.

The other ingredients are lactose,

microcrystalline cellulose (E460), povidone

(E1201), sodium starch glycolate and

magnesium stearate (E572).

What Isosorbide Mononitrate tablets look like

and contents of the pack:

Isosorbide mononitrate 10 mg tablets are

'White round bevel edged tablets, engraving

1J1 : plain with breakline

Isosorbide mononitrate 20 mg tablets are

'White round bevel edged tablets, engraving

1J2 : plain with breakline

Isosorbide mononitrate tablets 40 mg tablets

are 'White round bevel edged tablets,

engraving 1J3 : plain with breakline

Isosorbide Mononitrate 10mg, 20mg, 40mg

tablets packs are Blister strips in multiples of

10,14 or 20 tablets in packs of 10,14, 28, 30, 50,

56, 60 or 100 tablets.

HDPE or polypropylene containers with caps or

child resistant closures in packs of 28, 30, 50,

56, 60, 100, 250, 500 or 1000 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG

PL 00289/0286-0288.

This leaflet was last revised in February 2015

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 signs of illness 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.

1. What Isosorbide Mononitrate is and what it is

used for

2. What you need to know before you take

Isosorbide Mononitrate

3. How to take Isosorbide Mononitrate

4. Possible side effects

5. How to store Isosorbide Mononitrate

6. Contents of the pack and other information

WHAT ISOSORBIDE MONONITRATE IS

AND WHAT IT IS USED FOR

Isosorbide mononitrate belongs to a group of

drugs called nitrates. These drugs open out

blood vessels and allow more blood to flow

through them.

Isosorbide Mononitrate is used:

in the treatment and prevention of angina

pectoris attacks which is a chest pain

associated with the heart that usually occurs

with exertion.

in the treatment of heart failure where the

heart does not pump with enough force to

maintain effective circulation of the blood

around the body.

WHAT YOU NEED TO KNOW BEFORE

YOU TAKE ISOSORBIDE

MONONITRATE

Do NOT take Isosorbide Mononitrate if you:

are allergic (hypersensitive) to isosorbide

mononitrate or any of the other ingredients of

this medicine

have ever suffered a reaction to medicines

containing nitrates before

have low blood pressure

have ever suffered from a heart attack

have any other problems with your heart or

your blood has stopped circulating around your

body properly (circulatory failure)

are suffering from “shock” or vascular collapse

suffer from glaucoma (loss of vision due to

high pressure in the eye)

have ever suffered a head injury causing

pressure in the brain

have had a brain haemorrhage (bleeding)

have had a head injury (trauma)

have a low blood volume (hypovolaemia)

suffer from severe anaemia which is a

reduction in red blood cells

suffer from galactosaemia which is an inability

to digest carbohydrates and sugars found in

food and milk products

take sildenafil, tadalafil and vardenafil or any

other phosphodiesterase inhibitor (see taking

other medicines)

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...

Warnings and precautions

Talk to your doctor before taking Isosorbide

Mononitrate if you:

suffer from hypothyroidism (underactive

thyroid gland)

suffer from liver or kidney problems

are suffering from hypothermia (a body

temperature below normal)

are suffering from malnutrition

have recently had a heart attack.

suffer from very poor circulation

70498-X

160 x 323

PAGE 2: REAR FACE (OUTSIDE OF REEL)

4

5

6

Version

REG0069657

Approved

Page 2 of 3