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MENISOR XL 60MG PROLONGED-RELEASE TABLETS

Active substance(s): ISOSORBIDE MONONITRATE DILUTED IN LACTOSE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

MENISOR XL 60 mg
PROLONGED-RELEASE
TABLETS
ISOSORBIDE MONONITRATE

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or
advice.
- 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.
- You must talk to a doctor if you do not feel better or if
you feel worse.

WHAT IS IN THIS LEAFLET
1. What Menisor XL is and what it is used for
2. What you need to know before you take
Menisor XL
3. How to take Menisor XL
4. Possible side effects
5. How to store Menisor XL
6. Contents of the pack and other information

1. WHAT MENISOR XL IS AND
WHAT IT IS USED FOR
The name of your medicine is Menisor XL 60 mg
Prolonged-Release Tablets, (referred to as Menisor XL
throughout this leaflet).
It contains the active ingredient isosorbide mononitrate,
which belongs to a group of medicines called ‘nitrates’.
These work by relaxing and widening the blood vessels of
the heart, making it easier for the heart to pump blood
around the body.
Menisor XL tablets are used to prevent angina, (chest
pain).
They have been made so that they release the medicine
slowly over a number of hours.

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE MENISOR XL

DO NOT take Menisor XL, if you;
 are allergic to isosorbide mononitrate, or any of the
other ingredients of this medicine (listed in section 6)
 have ever suffered a reduced supply of blood to the
brain, which may have lead to a stroke
 have low blood pressure, (hypotension)
 have severe anaemia

 suffer from a heart problem such as;
- cardiomyopathy, (heart muscle disease)
- pericarditis, (inflammation of the lining of the heart)
- cardiac tamponade, (fluid build-up in the lining of the
heart)
- aortic stenosis or mitral stenosis, (a narrowing of the
main artery of the heart or of the heart valves)
 are taking phosphodiesterase type 5 inhibitors, such as
sildenafil, (for male impotence), see ‘other medicines
and Menisor XL’ below
Do not take Menisor XL if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before
taking Menisor XL.
Warnings and precautions
Menisor XL are used for the prevention of angina, and
should not be used for the relief of a sudden angina
attack.
Talk to your doctor or pharmacist before taking Menisor XL,
if you;
 have ever had any serious damage to your heart, such
as a heart attack or an operation
If the above applies to you, or if you are unsure, talk to your
doctor or pharmacist before taking Menisor XL.
Children
These tablets are not recommended for use in children.
Other medicines and Menisor XL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
includes medicines bought without a prescription and
herbal medicines. This is because Menisor XL can affect
the way some medicines work, and some medicines can
affect the way Menisor XL works, especially;
 medicines called phosphodiesterase type 5 inhibitors,
such as sildenafil or similar medicines, (used for male
impotence)
Do not take Menisor XL if the above applies to you. If you
are not sure, talk to your doctor or pharmacist before taking
Menisor XL.
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.
Driving and using machines
You may experience dizziness after first taking Menisor XL.
If this happens, do not drive or use any tools or machines.
Menisor XL contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.

3. HOW TO TAKE MENISOR XL
Always take this medicine exactly as described in this
leaflet, or as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
Swallow the tablets whole (or broken in half if this is easier
to swallow) with half a glass of water. Do not crush or chew
the tablets.

The recommended dose is:
Adults (including the elderly):
The usual dose is one tablet a day, taken in the morning.
This may be increased to two tablets on the advice of your
doctor, if so both tablets should be taken in the morning.
To reduce the possibility of getting headaches, you may
start on half a tablet once a day for the first 2-4 days.
The blister strips are marked with the days of the week. If
you are taking two tablets a day, make sure you take one
tablet from each strip marked with the same day of the
week.
You must not take Menisor XL for a sudden attack of
angina. If you have a sudden attack, take a glyceryl
trinitrate tablet (follow the instructions given on the label).
Use in children:
These tablets are not recommended for use in children.
The tablet can be divided into equal doses.
If you take more Menisor XL than you should
If you take more of this medicine than you should, contact
your doctor or go to the nearest hospital casualty
department immediately. Take this leaflet and the package
with you so they know what has been taken.
The symptoms of an overdose include:
 excitation, pulsing headache or fainting
 vertigo, (a feeling of dizziness or “spinning”)
 a faster heart beat or a fall in blood pressure
 flushing (sudden reddening of skin) or cold sweat
 nausea or vomiting
If you forget to take Menisor XL
If you forget to take a dose, take it as soon as you
remember. However, if it is less than 12 hours to the next
dose, skip the missed dose and take the next dose when it
is due. Do not take a ‘double dose’ (two doses at the same
time), to make up for a forgotten dose.
If you stop taking Menisor XL
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.
The following side effects may happen with this medicine
 headache
 feeling sick (nausea)
 feeling dizzy
The above problems usually disappear with time during
continued treatment.
Other possible side effects:
Common (may affect up to 1 in 10 people)
 low blood pressure (hypotension), which may cause
you to feel faint or dizzy
 faster heartbeat
 headache
 feeling sick (nausea)

Uncommon (may affect up to 1 in 100 people)
 being sick (vomiting)
 diarrhoea
Rare (may affect up to 1 in 1,000 people)
 fainting
 rash
 itchy skin
Very rare (may affect up to 1 in 10,000 people)
 muscle pain
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 the
Yellow Card Scheme at: 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 MENISOR XL
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which is
stated on the 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
protect the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Menisor XL contains
The active substance (the ingredient that makes the tablets
work) is isosorbide mononitrate. Each tablet contains 60
mg of isosorbide mononitrate.
The other ingredients are; lactose monohydrate,
hydroxypropylmethylcellulose, glyceryl palmitostearate,
maize starch and magnesium stearate.
What Menisor XL looks like and contents of the pack
Menisor XL are white capsule-shaped prolonged-release
tablets with MP86 imprinted on one side and scored on the
other side.
Menisor XL are available in blister packs of 28 tablets.
Marketing Authorisation Holder
Genethics Europe Limited,
41-43 Klimentos, Klimentos Tower,
Nicosia 1061, Cyprus
Manufacturer
Edmond Pharma S.R.L.
Via Dei Giovi, 131
20037 Paderno Dugnano (MI)
For any information about this medicine, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 11/2016

GE0064/P/PIL-Br/GE2

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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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