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RELOSORB XL 60MG TABLETS

Active substance(s): ISOSORBIDE 5-MONONITRATE

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Relosorb XL 60mg Tablets

Driving and using machines
Do not drive or operate machinery when taking
Relosorb XL 60mg tablets if you develop low blood
pressure (you may experience this as dizziness,
tiredness or feeling sick)

Isosorbide 5-mononitrate
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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
1. What Relosorb XL 60mg Tablets are and
what they are used for
2. Before you take Relosorb XL 60mg Tablets
3. How to take Relosorb XL 60mg Tablets
4. Possible side effects
5. How to store Relosorb XL 60mg Tablets
6. Further information
1. WHAT RELOSORB XL 60MG TABLETS
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Relosorb XL 60mg
Tablets. Relosorb XL 60mg tablets contain the
active ingredient isosorbide mononitrate.
Isosorbide mononitrate is a type of medicine called
a nitrate. They work by relaxing the smooth venous
muscle. This can help prevent an attack of angina
(chest pain).
2. BEFORE YOU TAKE RELOSORB XL
60MG TABLETS
Do not take Relosorb XL 60mg Tablets
• If you are allergic (hypersensitive) to isosorbide
mononitrate or any of the other ingredients in
Relosorb XL 60mg tablets (see Section 6
Further Information)
• If you suffer from increased intracranial
pressure (high pressure within your skull, e.g.
from a blow to your head) or cerebral
haemorrhage bleeding from a ruptured blood
vessel in the brain
• If you are taking sildenafil or similar products
e.g. Viagra for male erectile dysfunction
• If you have been diagnosed with any of the
following:
hypertrophic
obstructive
cardiomyopathy (HOCM), constrictive
pericarditis, cardiac tamponade or aortic/mitral
valve stenosis
• If you have very low iron levels in your blood
(severe anaemia)
• If you suffer from high pressure in the eye
(closed angle glaucoma)
• If you have low blood pressure

Take special care with Relosorb XL 60mg
Tablets
Tell your doctor or pharmacist if:
• you suffer from malnutrition
• you suffer from hypothermia (body
temperature which is lower than normal)
• you are pregnant, think you might be pregnant,
considering becoming pregnant or are breast
feeding
• you have severe liver or kidney disease
• your thyroid gland is underactive or you are
taking thyroxine
• you have recently suffered from a heart attack
• you are taking any other medication, even those
you may have bought for yourself without
prescription
Relosorb XL 60mg tablets should not be used for
the relief of sudden (acute) attacks of angina. If you
have an attack of angina you should speak to your
doctor or pharmacist who may supply you with
other medicines for this. Treatment with this
medicine should not be discontinued suddenly.
Withdrawal from Relosorb XL 60mg tablets should
be tapered gradually.
Taking other medicines
Relosorb XL 60mg tablets may lower blood
pressure (you may experience this as dizziness,
tiredness or feeling sick) so take special care when
taking other medicines that may also lower blood
pressure.
Do not take Relosorb XL 60mg tablets if you are
taking sildenafil or similar products, e.g. Viagra for
male erectile dysfunction. When taken together a
severe and possibly dangerous fall in blood
pressure can occur, which may result in collapse,
unconsciousness and could be fatal.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines
including medicines taken without a prescription.
Taking Relosorb XL 60mg Tablets with food
and drink:
You are advised NOT to drink alcohol with this
medicine, as the effects of alcohol may become
worse. Alcohol may also increase the side effects of
this medicine and make you feel dizzy or lightheaded if you stand up or move suddenly.
Pregnancy and breast- feeding
Ask your doctor or pharmacist for advice before
taking any medicine.

CP.IMN.XL.60T.RC.V3P2

4. POSSIBLE SIDE EFFECTS

Like all medicines, Relosorb XL 60mg Tablets can
cause side effects, although not everybody gets
them.

Important information about some of the
ingredients of Relosorb XL 60mg Tablets
This product contains lactose. If you have been told
by your doctor that you have intolerance to some
sugars, then contact your doctor before taking this
medicinal product.



3. HOW TO TAKE RELOSORB XL 60mg
TABLETS



Always take Relosorb XL 60mg Tablets exactly as
your doctor has told you. You should check with
your doctor or pharmacist if you are not sure. The
tablets must not be chewed or crushed and should
be swallowed whole with half a glass of water.
Adults
The usual dose is one or sometimes two tablets a
day taken in the morning. The dose can be titrated
to minimise the possibility of a headache by starting
treatment with half a tablet for the first 2 - 4 days.
The Elderly
Usual adult dosage can be given.
Children
These tablets should not be given to children.
Very occasionally some people find that the tablet
appears in their bowel motions (faeces).This is quite
normal and does not mean that the medicine has not
been released.
If you take more Relosorb XL 60mg Tablets
than you should.
If you (or someone else) swallow a lot of tablets at
the same time, or you think a child has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
Symptoms of an overdose can include:
Headache, excitation, cold sweat, nausea (feeling
sick), vomiting (being sick), vertigo (a feeling of
dizziness or "spinning"), fainting, racing pulse.
If you forget to take Relosorb XL 60mg Tablets
If you forget to take a dose take it as soon as you
remember. However if it is almost time for your
next dose, just take the next dose at the usual time.
Do not take two doses together.
If you stop taking Relosorb XL 60mg Tablets
Angina is a condition which may need treatment for
life, always talk to your doctor or pharmacist before
stopping using Relosorb XL 60mg tablets.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
CP.IMN.XL.60T.RC.V3P2







Headaches may occur when treatment is first
started but usually disappear after 1 to 2 weeks.
Low blood pressure may occasionally occur
(you may experience this as dizziness, faintness
on standing, tiredness, feeling sick and
vomiting).
More rarely, becoming flushed and allergic
reactions (including rashes) can occur.
Increased and decreased heart rate have also
been reported.
Muscle pain has been reported very rarely.

If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
5. HOW TO STORE RELOSORB XL 60mg
TABLETS

Keep out of the reach and sight of children.
Do not use Relosorb XL 60mg Tablets after the
expiry date which is stated on the carton. The expiry
date refers to the last day of that month.
Do not store above 30ºC.
Medicines should not be disposed of via the
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help protect the
environment.
6. FURTHER INFORMATION

What Relosorb XL 60mg Tablets contain
• The
active
substance
is
isosorbide
mononitrate. Each tablet contains 60mg of
isosorbide mononitrate.
• The
other
ingredients
are
lactose
monohydrate, hydroxypropylmethyl cellulose,
maize starch, glyceryl palmitostearate and
magnesium stearate
What Relosorb XL 60mg Tablets look like and
the contents of the pack
Each tablet has a white body with a score line and
marked 'IM' on one side. Relosorb XL 60mg Tablets
are supplied in blister packs of 7, 14, 28 or 98
tablets.
Marketing
Authorisation
Holder
and
Manufacturer
Relonchem Limited, Cheshire House, Gorsey
Lane, Widnes, Cheshire, WA8 0RP, U.K.
Distributor
Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
PL 20395/0039

POM

This leaflet was last revised in October 2012.

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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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