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MONOSORB XL 60MG PROLONGED RELEASE TABLETS

Active substance(s): ISOSORBIDE MONONITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MONOSORB® XL 60
PROLONGED RELEASE TABLETS
(Isosorbide mononitrate)

This medicine is available without prescription.
However, you still need to use MONOSORB XL
60mg Prolonged-Release Tablets carefully to get
the best results from it.
• 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.
Font: 9

155mmx300mm

Please read all of this leaflet carefully before
you start taking Monosorb XL 60 mg because it
contains important information for you.

What is in this leaflet:
1. What MONOSORB XL 60 mg is and what it
is used for
2. What you need to know before you take
MONOSORB XL 60 mg
3. How to take MONOSORB XL 60 mg
4. Possible side effects
5. How to store MONOSORB XL 60 mg
6. Contents of the pack and other information
1. WHAT MONOSORB XL 60 mg IS AND WHAT
IT IS USED FOR
The name of your medicine is MONOSORB XL
60 mg Prolonged-Release Tablets (referred to as
MONOSORB XL 60 mg throughout this leaflet).
MONOSORB XL 60 mg contains the active
ingredient isosorbide mononitrate, which belongs
to a group of medicines called nitrates. It is used
to prevent an attack of angina pectoris (chest
pain) from happening. Angina is a crushing pain
or tightness in the chest, although the pain may
also be felt in the neck or arm. The pain happens
when the muscle in the heart does not receive
enough oxygen for the work it has to do. Monosorb
XL 60 mg works by improving the supply of
blood and oxygen to the heart muscle. The tablets
will release your medicine slowly and will treat your
condition throughout the day.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MONOSORB XL 60 mg
DO NOT use these tablets to treat sudden chest
pain (acute angina). Instead seek immediate
medical attention. These tablets work too slowly
to treat this and are only used to prevent symptoms
of angina from happening.
Do not take MONOSORB XL 60 mg if:
• you are allergic (hypersensitive) to isosorbide
mononitrate or any of the other ingredients
of Monosorb XL 60 mg (listed in Section 6:
Contents of the Pack and Other Information).
• you have ever had a stroke.
• you have very low blood pressure.
• you have severe anaemia
• you have a heart problem called
'cardiomyopathy' or 'pericarditis' or you have
narrow heart valves.
• you are taking sildenafil or similar medicines
called Phosphodiesterase Type 5 inhibitors
(used for male impotence). See the section
"What you need to know before you take
Monosorb".
Do not take Monosorb XL 60 mg if any of the above
apply to you. If you are not sure, talk to you doctor
or pharmacist before taking Monosorb XL 60 mg.
WARNINGS AND PRECAUTIONS
Take special care with MONOSORB XL 60 mg
• If you have labile (unsteady) circulation. Speak
with your doctor as treatment may be started
with a 30mg dose.

• If you suffer from an under-active thyroid gland.
• If you have hypoxaemia (low oxygen level in your
blood, due to lung disease for example).
• If you suffer from hypothermia (symptoms
include shivering, abnormal drowsiness,
confusion)
• If you suffer from malnutrition
• If you suffer from severe liver or renal disease
Check with you doctor or pharmacist before taking
Monosorb XL 60 mg if:
• you have ever had any serious damage to your
heart, such as a heart attack or operation.
If any of the above apply to you, or you are not
sure, talk to your doctor or pharmacist before
taking Monosorb XL 60 mg.
Children
This medicine is not suitable for children.
Other medicines and Monosorb XL 60 mg
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription
and herbal medicines. This is because Monosorb
XL 60 mg can affect the way some medicines
work and some medicines can have an affect on
Monosorb XL 60 mg. You should not take Viagra
(sildenafil) or other medicines from this group
such as Cialis (tadalafil) or Levitra (vardenafil),
drugs used for erectile dysfunction (impotence
in men), whilst on MONOSORB XL 60mg. If you
take one of these drugs for erectile dysfunction,
taking nitrate preparations such as MONOSORB
XL 60 mg as well can cause a severe and possibly
dangerous fall in blood pressure. This could result
in fainting, or even worse, in a heart attack.
The following medicines may interfere with the
way MONOSORB XL 60 mg works:
• noradrenaline (norepinephine) (used to treat
sharp and severe drop in blood pressure)
• acetylcholine (used to shrink the pupil of the eye
during cataract surgery and other types of eye
surgery)
• histamine (used mostly as a diagnostic agent in
some medical conditions)
• any drugs used to treat high blood pressure
(e.g. beta-blockers, calcium channel blockers,
vasodilators, angiotensin II receptor antagonists,
ACE inhibitors).
Taking MONOSORB XL 60 mg with alcohol
Avoid drinking alcohol while taking MONOSORB
XL 60 mg, as the side-effect of low blood pressure
may be worse than normal and you may feel dizzy
or faint.
Pregnancy and breast-feeding
MONOSORB XL 60 mg should not be used during
pregnancy or when breastfeeding an infant. Seek
advice from your doctor if you become pregnant
while taking this medicine.
Driving and using machines
Do not drive or operate machinery until you know
how MONOSORB XL 60 mg affects you and until
you are confident that it won't affect your driving.
If you experience headache or dizziness following
initial treatment with MONOSORB XL 60 mg,
speak to your doctor before you start driving or
using machines.
MONOSORB XL 60 mg contains lactose and
sucrose
If you have been told by your doctor that you have
an intolerance to one of more sugars, contact your
doctor before taking this medicinal product.

3. HOW TO TAKE MONOSORB XL 60 mg
This medicine has been prescribed for you and you
must take it exactly as your doctor has told you. You
should check with your doctor or pharmacist if you
are not sure.
It is important that you take this medicine only
once a day and at the same time each day.
This is important to reduce the risk of your
body becoming less sensitive to the effects of
MONOSORB XL 60 mg.

The recommended dose is:
Adults: one MONOSORB XL 60 mg tablet once
daily in the morning.
Your doctor may advise a different dose according
to your symptoms, age and other medications.
Your dose may be from half a tablet (30 mg) up to
2 tablets (120 mg) a day, both to be taken in the
morning.
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MONOSORB XL 60 mg tablets should be
swallowed with half a glass of water and must not
be crushed or chewed.

Use in Children
This medicine is not recommended for children.
Use in Elderly
If you are an elderly person, your dosage should
be the same as above, unless you suffer from low
blood pressure or have a severe liver or kidney
disorder – in any case you should follow your
doctor's instructions. If you are already taking
medication such as beta-blockers or calcium
channel blockers, let your doctor or pharmacist
know, as he/she may need to adjust your dose of
MONOSORB XL 60 mg or existing treatment (see
Section 2 "What you need to know before you take
Monosorb").
You must not take Monosorb XL 60 mg for a
sudden attack of angina. If you have a sudden
attack, take a glyceryl trinitrate tablet (follow
the instructions given on the label).
Very occasionally, some people see the remains
of the tablet in their bowel motions. This is quite
normal and does not mean that the medicine has
not been released.
If you take more MONOSORB XL 60 mg than
you should
If you take too many tablets, or someone else
has taken any of them by accident, contact your
nearest hospital casualty department or tell your
doctor immediately.
Remember to take the following to show the doctor:
• the leaflet and container
• any remaining MONOSORB XL 60 mg tablets
• any other medicines which you or the other
person are taking
Symptoms of an overdose can include:
Pounding 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 MONOSORB XL 60 mg
If you forget to take a dose, take it as soon as
you remember. However, if it is almost time for your
next dose, do not take the missed dose, just take
the next dose on time. Do not take a double dose
to make up for a forgotten dose.
If you stop taking MONOSORB XL 60 mg
Do not suddenly stop taking MONOSORB XL
60 mg tablets, as this could make your angina
worse. If your treatment is to be stopped this
should be done gradually. Be sure to follow your
doctor's instructions. Ask your doctor or pharmacist
any further questions you may have.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, MONOSORB XL 60 mg can
cause side effects, although not everybody gets
them.

Serious side effects:
If you suffer from any of the following signs, tell
your doctor immediately:
Fainting many occur but is uncommon
Rash and itching may occur but it is rare
Other side effects:
A number of side effects are known for isosorbide
mononitrate, particularly when treatment begins.
Common (may affect up to 1 in 10 people)
• Headache is the most common side effect, but it
usually disappears in time on continued use.
• Dizziness – this usually disappears with time.
• Lowering of blood pressure (which may make
you feel dizzy or sick), especially when getting
up from a lying or sitting position, but this usually
disappears in time on continued use.
• Nausea (feeling sick)
• Tachycardia (fast heart beat)
Uncommon (may affect up to 1 in 100 people)
• Vomiting (being sick)
• Diarrhoea (loose bowel movements)
Very rare (may affect up to 1 in 10,000 people)
• Muscle pain
If you develop any of these side effects and they
are severe, or they get worse, or last for more than
a few days, contact your doctor or pharmacist.
If you have any other unexpected effects whilst
taking this medicine, tell your doctor or pharmacist
immediately.
5. HOW TO STORE MONOSORB XL 60 mg
Keep this medicine out of the sight and reach of
children. These tablets should not be stored above
25°C. Do not transfer them to another container.
Do not use MONOSORB XL 60 mg after the expiry
date which is stated on the blister and carton pack
after 'Exp'. The expiry date refers to the last day of
that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required or past
their expiry date. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What MONOSORB XL 60 mg contains
• The active substance is isosorbide mononitrate
(60 mg)
• The other ingredients are colloidal anhydrous
silica, hypromellose 2208, lactose monohydrate
(milk sugar), compressible sugar (composed of
sucrose and maltodextrin), magnesium stearate,
iron oxide yellow E172.
What Monosorb XL 60 mg looks like and
contents of the pack
MONOSORB XL 60 mg tablets are light yellow,
biconvex, oval-shaped, prolonged release tablets,
scored on both sides and marked "DX 31" on one
side.
MONOSORB XL 60 mg tablets is available in
packs of 28, 30 or 98 tablets in blister strips. Not all
pack sizes may be marketed.
Marketing Authorization Holder and
Manufacturer:
Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton
Fields, Daventry, Northamptonshire, NN11 8PB,
UK.
This leaflet was last revised in March 2014.

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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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