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Aw. No.: 20000XXXX

Monomil XL Leaflet



Code: PB/Drugs/1802-OSP

Revision No.:
Prev. Aw. No.:


Packaging Development


Leaflet Dimension: 280 x 180mm
Paper / GSM: Maplitho (60 GSM)
No. of Folds: Flat
Pantone no.:


Regulatory Affairs



Quality Control

Quality Assurance

Party Approval








Read all of this leaet 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.
In this leaet:
1. What Monomil XL Tablets are and what are they used for
2. What you need to know before you take Monomil XL Tablets
3. How to take Monomil XL Tablets
4. Possible side effects
5. How to store Monomil XL Tablets
6. Contents of the pack and other information
1. What Monomil XL Tablets are and what are they used for
Monomil XL contains a medicine called isosorbide mononitrate.
The tablets are used to prevent chest pain (angina). It works by relaxing and opening
the blood vessels to the heart, so the blood and oxygen supply to the heart is increased.
2. What you need to know before you take Monomil XL Tablets
Do not take Monomil XL Tablets if you:
Ÿ are allergic (hypersensitive) to isosorbide mononitrate or any of the other
ingredients in the tablets (see Section 6 and end of Section 2).
Ÿ suffer from a condition called constrictive pericarditis (inflammation of the lining
around the heart), or cardiac tamponade (where the fluid around the heart puts
pressure on the heart).
Ÿ are having a heart attack (acute myocardial infarction)
Ÿ suffer from very low blood pressure (hypotension)
Ÿ suffer from a condition called aortic stenosis (narrowing of the main artery coming
from the heart).
Ÿ suffer from a condition called mitral stenosis (narrowing of the mitral valve on the left
side the heart).
Ÿ suffer from a condition called hypertrophic cardiomyopathy (a heart disease which
causes the heart muscle to become thick and can cause symptoms such as chest
pain, dizziness and collapse).
Ÿ suffer from a condition which can increase the pressure on the brain e.g. a recent
serious head injury and bleeding into the brain (cerebral haemorrhage).
Ÿ suffer from severe anaemia (reduction in the number of red blood cells)


suffer from closed angle glaucoma (a condition which can causes sudden attack of
eye pain due to rapid increases in eye pressure, with symptoms such as blurred
vision, painful red eye and headache)
are taking any medicines for erectile problems, such as Viagra (Sildenafil), which
belong to a group of medicines called phosphodiesterase type 5 inhibitors (see
section 'Other Medicines and Monomil XL Tablets').
are in the first three months of pregnancy

Warnings and precautions
You should let your doctor know if you:
Ÿ have had a recent heart attack
Ÿ suffer from liver or kidney disease
Ÿ suffer from hypothyroidism (underactive thyroid gland)
Ÿ suffer from hypothermia (very low body temperature)
Ÿ suffer from malnutrition (severe lack of food)
Ÿ drink alcohol - alcohol should be avoided during treatment with Monomil XL Tablets.
This medicine should not be used to treat a sudden angina attack. Your doctor
should prescribe (GTN) glyceryl trinitrate (tablets or spray) if you have a sudden angina
attack. Monomil XL Tablets is used to prevent attacks of angina, and should be used
regularly, as prescribed by the doctor.
Other Medicines and Monomil XL Tablets
Please tell your doctor or pharmacist before using Monomil XL Tablets if you are taking:
Ÿ medicines which reduce blood pressure such as:
ACE inhibitors, e.g. enalapril, captopril
beta-blockers, e.g. atenolol, propranolol
calcium channel blockers, e.g. diltiazem, verapamil, nifedipine
angiotensin II receptor antagonists, e.g. candesartan
phosphodiesterase type 5 inhibitors e.g. sildenafil
alprostadil used to treat erectile dysfunction
aldesleukin used to treat kidney cancer and melanoma
Ÿ benzodiazepines, e.g. temazepam
Ÿ tricyclic antidepressants, e.g. amitriptyline.
Pregnancy and breast-feeding
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 when you start taking Monomil XL Tablets. You should
know how you react to Monomil XL Tablets before you drive or use machines.
Important information about some of the ingredients of Monomil XL Tablets
These tablets contains lactose. Consult your doctor if you have been told you have an
intolerance to some sugars before taking these tablets.

3. How to take Monomil XL Tablets
Always take Monomil XL Tablets exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
These tables should not be chewed or crushed and should be swallowed whole with
drink of water.
Adults: One tablet to be taken once daily in the morning. This may be increased to two
tablets on the advice of your doctor, in which case both tablets should be taken once
daily in the morning.
Treatment is sometimes started for the first 2-4 days, with half a tablet once daily in the
morning in order to minimise the possibility of headache.
Elderly: The usual dose is the same as the adult dose.
Children: Not recommended for use in children.
If you take more Monomil XL 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 these tablets, contact your nearest hospital casualty department
or your doctor immediately. Take this leaflet and your tablets with you. The symptoms of
an overdose may be pulsing headache, reddening of the skin, cold perspiration,
nausea, vomiting and a fast heart beat.
If you forget to take Monomil XL Tablets
If you forget to take your tablet(s) but remember within 12 hours of your usual time, take
it when you remember. If you remember more than 12 hours after your usual time, don’t
take the tablet and just carry on with the next dose when it is due.
If you stop taking Monomil XL Tablets
Do not stop taking your tablets without first discussing this with your doctor as this may
be harmful.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
You may suffer an allergic reaction, symptoms of which include rash, itching, difficulty in
breathing or swelling of the face, lips, throat or tongue. If this happens to you, STOP
TAKING the tablets and seek immediate medical help.
Other possible side effects:
Common (may affect up to 1 in 10 people)
Ÿ Low blood pressure (this may make you feel faint or dizzy)
Ÿ Faster heartbeat (tachycardia)
Ÿ Headache
Ÿ Feeling dizzy
Ÿ Feeling sick (nausea)
Uncommon (may affect up to 1 in 100 people)
Being sick (vomiting)


Artwork Same Size
Size : 280 x 210 mm
Kaypee Design
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Ÿ Flushing (redness of face, neck and chest)
Rare (may affect up to 1 in 1,000 people)
Ÿ Fainting
Ÿ Rash
Ÿ Itchy skin
Very rare (may affect up to 1 in 10,000 people)
Ÿ Pain in muscles
Not known
Ÿ Slow heartbeat (paradoxical bradycardia)
Ÿ Fatigue

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This include any side
effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme: By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Monomil XL Tablets
Keep this medicine out of the sight and reach of children.
Store your tablets in the original package.
Do not store above 25°C
Do not use your medicine after the expiry date shown on the carton.
Do not throw away any medicines via wastewater. 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 Monomil XL Tablets contain
Each tablet contains 60mg of the active ingredient isosorbide-5-mononitrate.
The other substances are lactose monohydrate, hypromellose, maize starch,
glyceryl palmitostearate and magnesium stearate.
What Monomil XL Tablets looks like and contents of the pack
The tablets are white, capsule shaped, biconvex and uncoated with scoring. They are
supplied in carton containing two strip of blister packs - each strip containing 14 tablets
(28 tablets per carton)
Marketing Authorization Holder and Manufacturer
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD,
United Kingdom
This Leaflet was last revised in (01/2016)

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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.