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ISMO 10

Active substance(s): ISOSORBIDE MONONITRATE / ISOSORBIDE MONONITRATE / ISOSORBIDE MONONITRATE

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Ismo 10 mg
Großbritannien
30.06.2015 10:45
XXXXXXX/XX

XXXXXXX-XX
155 x 390 mm, P019
P 281
cyan
182
CentSchbook BT 8 Pkt.
SKU / DU: XXXXXXX

PACKAGE LEAFLET: INFORMATION FOR
THE USER

ISMO 10
10 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.

1.
2.
3.
4.
5.
6.

What is in this leaflet
What ISMO 10 is and what it is used for
What you need to know before you take ISMO 10
How to take ISMO 10
Possible side effects
How to store ISMO 10
Contents of the pack and other information

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.
A severe drop in blood pressure, when standing up or
move suddenly, with light-headedness and dizziness
is frequently observed after drinking alcohol.
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.
Taking ISMO 10 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.
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.

1. What ISMO 10 is and what it is used for

Children
The safety and effectiveness of ISMO 10 in children
has not been established.

ISMO 10 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.

Other medicines and ISMO 10
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

ISMO 10 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 10 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)

Taking the following medicines at the same time as
ISMO 10 can increase the blood pressure lowering
(hypotensive) effect of ISMO 10:
• other vasodilatators,
• antihypertensives (medicines to treat high blood
pressure) such as ACE-inhibitors, angiotensinII-receptor antagonists, beta-blockers, calcium
antagonists and diuretics,
• 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

2. What you need to know before you take
ISMO 10















Do NOT take ISMO 10
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 10)
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 10.
ISMO 10 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 10 suddenly. It should be
withdrawn gradually.
Take special care with ISMO 10, 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

You must not take any treatments for erectile
dysfunction whilst taking ISMO 10.
Do not take sildenafil (as in Viagra®), vardanafil or
tadalafil whilst taking ISMO 10. Treatments for
erectile dysfunction can cause a severe and
dangerous fall in blood pressure when taken
together with ISMO 10. This can be fatal.
ISMO 10 with food, drink and alcohol
Do not drink alcohol whilst taking ISMO 10 as it
may increase the blood pressure lowering
(hypotensive) effect of ISMO 10.
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.
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 10 in pregnancy is not
recommended unless considered essential by your
doctor.
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.
Fertility
There are no fertility data.
Driving and using machines
When you take ISMO 10 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 10 contains milk sugar (lactose)
ISMO 10 contains 74 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 10
Always take ISMO 10 exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.

The usual dose is 4 to 6 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 10 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 10 before, your doctor
may tell you to take less ISMO 10 for a few days,
i.e. 10 mg daily (one tablet) for 2 days, followed by
20 mg daily (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 ISMO 10 unless your doctor tells you
to stop.
If you take more ISMO 10 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.

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
Yellow Card Scheme
Website: 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 ISMO 10
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.
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.
6. Contents of the pack and other information
What ISMO 10 tablets contain
The active substance is:
• isosorbide-5-mononitrate
Each ISMO 10 tablet contains 10 mg isosorbide-5mononitrate.

At very high doses, increased pressure within the
scull (intracranial pressure) with related symptoms
may occur.

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

If you forget to take ISMO 10
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.

What ISMO 10 tablets look like and contents of
the pack
ISMO 10 tablets are round and white. Each tablet is
marked “ISMO” on one face and “10” on the reverse.

Do not take a double dose to make up for a forgotten
tablet.

ISMO 10 tablets are available in blister strips.

If you stop taking ISMO 10
You may feel unwell if you suddenly stop taking
ISMO 10. 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.














Marketing Authorisation Holder
RIEMSER Pharma GmbH
An der Wiek 7
D-17493 Greifswald-Insel Riems
Germany
Manufacturer
Kern Pharma S.L.
Polígono Ind. Colón II
Venus II
08228 Terrassa (Barcelona)
Spain
This leaflet was last revised in 06/2015.

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

XXXXXXX-XX



Marketing Authorisation Holder and Manufacturer

XXXXXXX/XX



Pack sizes:
Packs of 60 tablets.

Expand Transcript

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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