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ZEMON 40XL TABLETS

Active substance(s): ISOSORBIDE 5-MONONITRATE

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PATIENT INFORMATION LEAFLET
ZEMON 40 XL PROLONGED RELEASE TABLETS
(isosorbide-5-mononitrate)

The name of this medicine is Zemon 40 XL Prolonged Release Tablets, which will be
referred to as Zemon 40 XL throughout this leaflet.
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 your 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 the
leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Zemon 40 XL is and what it is used for
2. Before you take Zemon 40 XL
3. How to take Zemon 40 XL
4. Possible side effects
5. How to store Zemon 40 XL
6. Further Information

1. WHAT ZEMON 40 XL IS AND WHAT IT IS USED FOR
The active ingredient in your tablets is isosorbide-5-mononitrate which belongs to a group
of medicines known as nitrates. These are used to prevent heart attacks (angina pectoris)
by opening the blood vessels and reducing pain. Zemon 40 XL is used for the long term
prevention of heart attacks. It should not be used to treat a sudden (acute) attack of
angina (sudden heart attack).

2. BEFORE YOU TAKE ZEMON 40 XL
Do not take Zemon 40 XL if you:
• are allergic (hypersensitive) to isosorbide-5-mononitrate, or any of the other
ingredients in the tablets (these are listed in section 6, Further Information)
• have had an acute myocardial infarction associated with certain complications
such as very low filling pressure. Your doctor will be able to advise you.
• suffer from acute circulatory failure, have very low blood pressure or low blood
volume (hypovolaemia)
• have a heart valve disorder or suffer from low cardiac filling pressures
• suffer from a condition called hypertrophic obstructive cardiomyopathy (HCOM)
which affects the muscle of the heart(causing it to enlarge)
• suffer from inflammation of the heart lining (constrictive pericarditis) or a condition
where an increase in the fluid that surrounds the heart puts pressure on it (cardiac
tamponade)
• have ever had a serious head injury, bleeding in the brain (cerebral haemorrhage)

Code : CNXP091FUB
CCRF: 14116
Date: 23/09/15
Size: 297mm x 210mm

or a disease which is associated with increased pressure on the brain
• are severely anaemic (suffer from low haemoglobin in your blood)
• have an eye disease called closed angle glaucoma
• are taking medicines used to treat male erection problems (erectile dysfunction) such
as sildenafil, tadalafil or vardenafil.
Take special care with Zemon 40 XL
Before you take Zemon 40 XL you should tell your doctor if you:
• have recently had a heart attack (myocardial infarction)
• suffer from an under-active thyroid (hypothyroidism)
• suffer from low body temperature (hypothermia)
• are undernourished
• suffer from severe liver or kidney disease
This medicine may make you feel dizzy, light-headed or faint after the first dose or when
you stand up, particularly after drinking alcohol, so special care should be taken.
On rare occasions this medicine may cause low blood pressure which can result in a slow
heart rate and increased chest pain.
Zemon 40XL should not be used to treat a heart attack. If this happens, you should use a
glyceryl trinitrate (GTN) spray or tablets.You should follow your doctors instructions on
how to take this medicine, otherwise tolerance might develop. The doctor will prescribe
the lowest effective dose for you.
You should not suddenly stop taking your medicine, your doctor will advise you on how to
stop gradually over a period of time (see also Section 3: How to take Zemon 40XL).
Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines
as they may increase the effect of Zemon 40 XL or change the effect of the medicines
• sildenafil (Viagra), tadalafil or vardenafil for treating male erection problems (erectile
dysfunction). Taking Zemon 40 XL alongside these medicines can result in a severe
and possibly dangerous fall in blood pressure. This can result in collapse and
unconsciousness and could be fatal. You should not take these medicines whilst taking
Zemon 40 XL.
• medicines which reduce blood pressure such as beta-blockers, calcium channel
blockers,vasodilators, alprostadil, aldesleukin, or angiotensin II receptor agonists
• tricyclic antidepressants (used to treat depression)
• neuroleptics (used to treat anxiety)
• dihydroergotamine (used to treat migraine)
It may still be alright for you to take Zemon 40 XL and your doctor will be able to decide
what is suitable for you. Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained without a prescription.
Taking your medicine with food and drink
Zemon 40 XL should be taken with half a glass of water and can be taken with or without
food. The feelings of dizziness and light-headedness may be increased by drinking
alcohol.
Pregnancy, and breast-feeding
Please tell your doctor if you are pregnant, likely to become pregnant, suspect you are
pregnant or are breast-feeding, as the safety of this drug is not known during pregnancy
or breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Zemon 40 XL may cause blurred vision or may make you feel dizzy or tired especially if
you suffer from low blood pressure. The effect may be increased after drinking alcohol.
Do not drive or operate machines until you are sure you are not affected.
Important information about some of the ingredients of Zemon 40 XL
This product 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 ZEMON 40 XL
Always take Zemon 40 XL exactly as your doctor has told you to do so. You should check
with your doctor or pharmacist if you are not sure. The label on the carton will tell you how
many tablets you should take and when.
Your doctor will decide on the right starting dose for you and on any increase in the dose
depending on your condition and whether you are taking any other medicines. Do not
change your dose unless your doctor tells you to do so.
Dosage
The usual dosage for Zemon 40 XL is:
Adults
One 40 mg tablet, taken once a day in the morning. This may be increased by your doctor
to two tablets (80mg) once a day if necessary.
Elderly
The dose is as for adults; however, your doctor will take special care, especially if you
have low blood pressure, or liver or kidney disease.
Zemon 40 XL are for use in Adults only.
Method of Administration
Zemon 40 XL should be swallowed whole with half a glass of water. The tablets should be
taken regularly in the morning with or without food. The tablets should not be chewed or
crushed.
If you take more Zemon 40 XL than you should
If you have accidentally taken more than the prescribed dose, contact your nearest
hospital casualty department or tell your doctor or pharmacist immediately. Remember
to take the pack and any remaining tablets with you. The common signs of overdose are
dizziness, faintness, headache, nausea, vomiting, sweating, rapid heartbeat,
restlessness, flushing of the skin and blurred vision.
If you forget to take Zemon 40 XL
It is important that you take your medicine every day. However, if you forget to take one or
more doses, take your next dose when it is due and then go on as prescribed. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Zemon XL
Do not suddenly stop taking your medicine. Your doctor will tell you how to reduce and
then stop taking Zemon XL.
If you have any further questions about this product ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Zemon 40 XL can cause side effects, although not everybody gets
them. The following side effects have been reported:
• headaches occasionally occur when treatment is first started although these usually
disappear after 1 – 2 weeks of treatment
• a drop in blood pressure or light headedness with symptoms such as dizziness, feeling
sick (nausea) or drowsiness
• feeling sick (nausea), vomiting, flushing and allergic skin reactions may occur rarely
• uncommonly, you may experience feeling sick (nausea), vomiting, pallor and excessive
perspiration
• worsened angina due to very low blood pressure
• heartburn
• change in the rhythm of your heart leading to an increase (tachycardia) or decrease
(bradycardia) in heart rate
If any of these 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 ZEMON 40 XL
Do not store your tablets above 25°C. Store in the original package.
Do not take this medicine after the expiry date stated. The expiry date refers to the last
day of that month.
Keep all medicines out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Zemon 40 XL contain:
The active ingredient is isosorbide-5-mononitrate. Each tablet contains 40mg of
isosorbide mononitrate. The other ingredients are stearic acid, carnauba wax,
hydroxyproplymethylcellulose, lactose, magnesium stearate, talc, silica colloidal
anhydrous, polyethylene glycol 4000, titanium dioxide (E171), yellow iron oxide (E172).
What Zemon 40 XL looks like and the contents of the pack:
Zemon 40 XL are round, cream coloured tablets with ‘IM40’ marked on one side.
Your medicine is available in blister packs of 28, 30, 56, 60 and 100 tablets.
(Not all pack sizes may be marketed).
Manufacturing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last approved in September 2015
CHXP091FUB

Code : CNXP091FUB
CCRF: 14116
Date: 23/09/15
Size: 297mm x 210mm

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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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