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ISMO RETARD

Active substance(s): ISOSORBIDE MONONITRATE

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Ismo Retard 40 mg
Großbritannien
30.06.2015 10:50
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173 x 420 mm, P075
P 281
magenta
298
Century Schoolbook 9 Pkt.
SKU / DU: XXXXXXX

PACKAGE LEAFLET: INFORMATION FOR THE USER

ISMO Retard

40 mg prolonged-release 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.
What is in this leaflet
1. What ISMO Retard is and what it is used for
2. What you need to know before you take ISMO
Retard
3. How to take ISMO Retard
4. Possible side effects
5. How to store ISMO Retard
6. Contents of the pack and other information
1. What ISMO Retard is and what it is used for
ISMO Retard 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.
ISMO Retard 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 Retard will help to:
• lower the number of episodes of angina
• lower the severity of your attacks of your angina
2. What you need to know before you take
ISMO Retard
Do NOT take ISMO Retard
• 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 Retard)
• 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 Retard.
ISMO Retard is used to stop angina attacks from
happening. It is not intended to treat a sudden
attack of angina.
Patients who have not previously received nitrates
may initially be started with a low dose which
should be gradually increased before introducing
ISMO Retard. The lowest effective dose should be
used.
Do not stop taking ISMO Retard suddenly. It
should be withdrawn gradually.
Take special care with ISMO Retard, 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)
• if you are already taking medicine to lower
blood pressure
• you are taking any other medication
• you are pregnant or breast-feeding

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 Retard 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.
Children
The safety and effectiveness of ISMO Retard in
children has not been established.
Other medicines and ISMO Retard
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 Retard can increase the blood pressure
lowering (hypotensive) effect of ISMO Retard:
• 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
You must not take any treatments for erectile
dysfunction whilst taking ISMO Retard.
Do not take sildenafil (as in Viagra® ), vardanafil
or tadalafil whilst taking ISMO Retard. Treatments for erectile dysfunction can cause a severe
and dangerous fall in blood pressure when taken
together with ISMO Retard. This can be fatal.
ISMO Retard with food, drink and alcohol
Do not drink alcohol whilst taking ISMO Retard as
it may increase the blood pressure lowering
(hypotensive) effect of ISMO Retard.
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 Retard 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 Retard 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 Retard contains glucose, sucrose and
milk sugar (lactose)
ISMO Retard contains less than 36 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 Retard
Always take ISMO Retard exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.

The usual dose is one tablet per day. Your doctor
will tell you how many to take.
You should always take ISMO Retard in the
morning. You should swallow the tablets whole,
with a drink of water.
Duration of treatment
Angina needs long-term treatment.
Keep taking your ISMO Retard unless your doctor
tells you to stop.
If you take more ISMO Retard 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 Retard
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 Retard
You may feel unwell if you suddenly stop taking
ISMO Retard. 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












By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store ISMO Retard
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 of medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What ISMO Retard contains
The active substance is:
• isosorbide-5-mononitrate
Each ISMO Retard prolonged-release tablet contains
40 mg of isosorbide-5-mononitrate.
The other ingredients are
Tablet:
• anhydrous lactose
• montan glycol wax
• povidone K25
• colloidal silicon dioxide
• magnesium stearate
Sugar coating:
• methacrylic acid copolymer
• talc
• sucrose
• kaolin
• macrogol 35000
• titanium dioxide
• povidone K25
• liquid glucose
• montan glycol wax.
What ISMO Retard 40 mg tablets look like and
contents of the pack
ISMO Retard 40 mg tablets are round and white.
ISMO Retard 40 mg tablets are available in blister
strips.
Pack sizes:
Packs of 28 or 30 tablets.
Marketing Authorisation Holder and Manufacturer
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.

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)

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
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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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