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ISMO 20

Active substance(s): ISOSORBIDE MONONITRATE

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• severe hypotensive responses including nausea,
vomiting, restlessness, pallor, and excessive
sweating have been reported for organic nitrates
• severe inflammatory skin disease (exfoliative
dermatitis)

Pack sizes:
Packs of 60 tablets.

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

Marketing Authorisation Holder
RIEMSER Pharma GmbH
An der Wiek 7
D-17493 Greifswald-Insel Riems
Germany

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Manufacturer
Kern Pharma S.L.
Polígono Ind. Colón II
Venus II
08228 Terrassa (Barcelona)
Spain

By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store ISMO 20

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Marketing Authorisation Holder and Manufacturer

ISMO 20

20 mg tablets
isosorbide-5-mononitrate

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
only. 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.

This leaflet was last revised in 06/2015.

Keep this medicine out of the reach and sight of
children.
Do not use this medicine after the expiry date
which is stated on the blister strip and carton.
The expiry date refers to the last day of that
month.

What is in this leaflet
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.

1. What ISMO 20 is and what it is used for
2. What you need to know before you take
ISMO 20
3. How to take ISMO 20
4. Possible side effects
5. How to store ISMO 20
6. Contents of the pack and other information

6. Contents of the pack and other information
What ISMO 20 tablets contain

1. What ISMO 20 is and what it is used for

The active substance is:
• isosorbide-5-mononitrate

ISMO 20 belongs to a group of medicines called
nitrates. The nitrates make the arteries of the
heart dilate, increasing the blood supply to the
heart muscle.

What ISMO 20 tablets look like and contents
of the pack
ISMO 20 tablets are round, uncoated and white.
Each tablet is marked with a score line and BM
3B on both faces.
ISMO 20 tablets are available in blister strips.

Description:
Country / Lang.:
Date / Time:
Material No.:
MAH No.:
Manufact. No.:
Dimensions / TD:
Color:
Cutting die:
LAETUS Code:
Font Type / Size:

Ismo 20 mg
Großbritannien
30.06.2015 11:25
XXXXXXX/XX

XXXXXXX-XX
310 x 203 mm (Plegado 155 x 203 mm) P061
P 281
magenta
174
Century Schoolbook 8 Pkt.
SKU / DU: XXXXXXX

XXXXXXX/XX

The other ingredients are:
• anhydrous lactose
• colloidal silicon dioxide
• magnesium stearate

XXXXXXX-XX

Each ISMO 20 tablet contains 20 mg isosorbide5-mononitrate.

ISMO 20 is used to treat:
• angina pectoris. Angina pectoris is a type of
chest pain caused when your heart muscle
does not get enough blood supply. ISMO 20
will help to:
- lower the number of your episodes of
angina
- lower the severity of your attacks of
angina
• heart failure (when your heart cannot pump
enough blood around the body)

2. What you need to know before you take
ISMO 20
Do NOT take ISMO 20
• if you are allergic to isosorbide-5-mononitrate
or any of the other ingredients of this medicine
(listed in section 6)
• if you are allergic to isosorbide dinitrate (the
same type of medicine as ISMO 20)
• if you have marked low blood pressure (systolic
blood pressure ≤ 90 mmHg)
• if you suffer from circulatory collapse or shock
• if you suffer from cardiogenic shock
• if you suffer from acute myocardial infarction
with low left ventricular filling pressure
• if you have been diagnosed with any of the
following:
- hypertrophic obstructive cardiomyopathy (a
thickened heart muscle),
- constrictive pericarditis (an inflammation of
the heart sac),
- cardiac tamponade (accumulation of fluid
around the heart),
- aortic/mitral valve stenosis (narrowing of
heart valves).
• if you suffer from severe anaemia (low level of
red blood cells)
• if you suffer from closed angle glaucoma (high
pressure in the eye)
• if you suffer from conditions associated with
raised pressure on the brain (e.g. following
head trauma and cerebral haemorrhage)
• if you suffer from severe hypovolaemia
(decreased blood volume)
• if you are taking sildenafil (as in Viagra ® ),
vardenafil or tadalafil used in the treatment
of male erectile dysfunction (when you cannot
get an erection)
Warnings and precautions
Talk to your doctor or pharmacist before taking
ISMO 20.
ISMO 20 is used to stop angina attacks from
happening. It is not intended to treat a sudden
attack of angina.
The lowest effective dose should be used.
Do not stop taking ISMO 20 suddenly. It should
be withdrawn gradually.
Take special care with ISMO 20, if
• you suffer from hypothyroidism (your thyroid
gland does not produce sufficient amounts of
thyroid hormone)
• you suffer from malnutrition
• you have severe problems with your liver or
kidneys

• you have low body temperature (hypothermia)
• you have recent history of myocardial
infarction (heart attack)
• you are already taking medicine to lower
blood pressure
• you are taking any other medication
• you are pregnant or breast-feeding

• neuroleptics (used to treat psychiatric
disorders),
• sapropterin (used to lower phenylalanine levels
in the blood of patients with phenylketonuria),
• alprostadil (for male erection problems),
• aldesleukin (for cancer treatment), and
• alcohol

If any of the above apply to you, you should
not take this medicine until you have
talked to your doctor about it.
A low blood pressure caused by nitrates may occur
with paradoxical bradycardia (slowing of the heart
rate) and worsening of the symptoms of angina.

You must not take any treatments for erectile
dysfunction whilst taking ISMO 20.
Do not take sildenafil (as in Viagra®), vardanafil
or tadalafil whilst taking ISMO 20. Treatments
for erectile dysfunction can cause a severe and
dangerous fall in blood pressure when taken
together with ISMO 20. This can be fatal.

A severe drop in blood pressure,when standing
up or move suddenly, with light-headedness and
dizziness is frequently observed after drinking
alcohol.

ISMO 20 with food, drink and alcohol
Do not drink alcohol whilst taking ISMO 20 as it
may increase the blood pressure lowering
(hypotensive) effect of ISMO 20.

You can develop a tolerance to this medicine or if
you are taking another medicine containing
nitrates. In order to avoid any lessening or loss
of the effect of the medicine, you should not take
high doses on a continual basis.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.

Taking ISMO 20 may cause transient hypoxaemia
(an abnormally low level of oxygen in the blood).
This happens because blood flow in your body is
redistributed with an increase in perfusion of
poorly ventilated areas of the lung.
This may cause ischaemia (not enough blood
going to your heart muscle) if you have coronary
heart disease.

Pregnancy
There is insufficient experience with the use of
isosorbide-5-mononitrate in pregnant women.
Animal studies having shown no adverse effects
on the foetus. Use of ISMO 20 in pregnancy is
not recommended unless considered essential by
your doctor.

Increasing doses and/or changes in intervals
between doses can lead to this medicine not
working with the effect that it should or not
work at all.

Lactation
It is unknown if isosorbide-5-mononitrate is
excreted in breast milk. Use during breast-feeding
is not recommended unless considered essential by
your doctor.

Children
The safety and effectiveness of ISMO 20 in
children has not been established.

Fertility
There are no fertility data.

Other medicines and ISMO 20
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Taking the following medicines at the same time
as ISMO 20 can increase the blood pressure
lowering (hypotensive) effect of ISMO 20:
• other vasodilatators,
• antihypertensives (medicines to treat high
blood pressure) such as ACE-inhibitors,
angiotensin-II-receptor antagonists, beta
blockers, calcium antagonists and diuretics,

Driving and using machines
When you take ISMO 20 you may feel dizzy or
light-headed if you stand up or move suddenly.
You may experience blurred vision.
If you experience such symptoms you should not
drive or operate machinery.
ISMO 20 contains milk sugar (lactose)
ISMO 20 contains 148 mg milk sugar (lactose)
per tablet.
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 ISMO 20
Always take ISMO 20 exactly as your doctor has
told you. Check with your doctor or pharmacist
if you are not sure.
The usual dose is 2 to 3 tablets per day (40 mg –
60 mg), but can range from 20 mg to 120 mg daily.
Your doctor will tell you how many to take.
You should always take ISMO 20 at the times
your doctor has told you to take it. You should
swallow the tablets whole, with a drink of water.
If you have not taken ISMO 20 before, your
doctor may prescribe you an ISMO Starter Pack
with 10 mg tablets for a few days. In this case you
will take one ISMO 10 mg tablet daily for 2 days,
followed by two ISMO 10 mg tablets (one tablet
in the morning and one in the evening) for a
further 3 days.
Duration of treatment
Angina needs long-term treatment.
Keep taking your ISMO 20 unless your doctor
tells you to stop.
If you take more ISMO 20 than you should
If you have taken too many tablets (overdose), tell
your doctor at once, or contact the nearest
hospital casualty department. If you feel faint or
dizzy, lie flat with your legs raised higher than
your head.
Symptoms of an overdose may be the following:
nausea, vomiting, restlessness, warm flushed skin,
blurred vision, headache, fainting, tachycardia (a
fast heart beat), hypotension and palpitations.
At high doses (more than 20 mg/kg body weight),
methaemoglobin formation (an oxidation form of
haemoglobin in the blood), bluish discoloration of
the skin and mucous membranes due to reduced
oxygen content of the blood (cyanosis), shortness
of breath (dyspnoea) and rapid shallow breathing
(tachypnoea) can be expected.
At very high doses, increased pressure within
the scull (intracranial pressure) with related
symptoms may occur.
If you forget to take ISMO 20
If you forget to take a tablet, take one as soon as
you remember on that day. Continue your
treatment as usual the following morning.
Do not take a double dose to make up for a
forgotten tablet.

If you stop taking ISMO 20
You may feel unwell if you suddenly stop taking
ISMO 20. Tell your doctor if you stop taking this
medicine.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you develop chest pains or experience worsening
of chest pains, contact your doctor.
If you experience any of the following side effects,
please tell your doctor or pharmacist.
Very Common (in more than 1 in 10 patients
treated)
• Particularly at the start of treatment, a
temporary “nitrate headache” may occur which
normally subsides after some days of continued
treatment.
Common (in 1 to 10 out of 100 patients
treated)
• low blood pressure (hypotension) and/or drop
in blood pressure when standing up or move
suddenly (postural hypotension), especially at
the beginning of treatment, which may be
accompanied by a fast heart beat (tachycardia),
slight states of dizziness or feeling weak
• gastro-intestinal symptoms, e.g. nausea and/or
vomiting, especially when first used
Uncommon (in 1 to 10 out of 1,000 patients
treated)
significant drop in blood pressure may lead to an
increase in chest pain (exacerbation of angina
pectoris symptoms)
• states of collapse, sometimes with
bradyarrhythmias (slowing of the heart beat)
and syncope (fainting)
• skin flushing
• allergic skin reactions
Not known (frequency cannot be estimated
from the available data)
• heartburn
• formation of methaemoglobin, in particular
in susceptible patients such as those with
methaemoglobin reductase deficiency or in
patients with diaphorase deficiency and
abnormal haemoglobin structure

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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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