ISOSORBIDE MONONITRATE 20MG TABLETS

Active substance: LACTOSE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER
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 any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Isosorbide Mononitrate is and what it is
used for
2. Before you take Isosorbide Mononitrate
3. How to take Isosorbide Mononitrate
4. Possible side effects
5. How to store Isosorbide Mononitrate
6. Further information

1

WHAT ISOSORBIDE MONONITRATE IS
AND WHAT IT IS USED FOR

(Main)

Pharma code 185

• 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.

2

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.
Take special care with Isosorbide Mononitrate
Tell your doctor before you start to take this
medicine 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.

Taking other medicines
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.
Taking 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.
Important information about some of the
ingredients of Isosorbide Mononitrate
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.

3

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.

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

ISOSORBIDE MONONITRATE
10 mg, 20 mg AND 40 mg TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.
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.
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.

4

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.

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).
If any of the side effects become severe, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

HOW TO STORE ISOSORBIDE
MONONITRATE

Keep out of the reach and sight of children.
Isosorbide Mononitrate should be stored below
25°C. in the original blister package. Do not use
Isosorbide Mononitrate after the expiry date that
is stated on the outer packaging. 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 ingredient contains 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 10 mg, 20 mg, 40 mg
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: May 2012

The following side effects have been reported at
the approximate frequencies shown:
Very Common (affects more than 1 in 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.

70498-V
160 x 323

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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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