PATIENT INFORMATION LEAFLET

EUMON 40 XL Modified Release Tablets

(Isosorbide mononitrate)

0 What this medicine is and what it is used for

Eumon 40 XL belongs to a group of medicines called antianginals (nitrates) and is used to prevent chest pain (angina pectoris).

It works by opening up blood vessels and reducing the pain.

[2 Before you take

Do not take Eumon 40 XL if:

■    you are hypersensitive to the active ingredient isosorbide mononitrate, nitrates or any of the other ingredients of the tablets (see Section 6 for full list of ingredients)

■    you have very low blood pressure

■    you are at risk of having a stroke

■    you have had an acute (short-lived) heart attack

■    you are suffering from shock or vascular collapse which causes the blood to stop circulating around your body (acute circulatory failure)

■    you have a heart condition which causes the heart muscle to become thick (hypertrophic obstructive cardiomyopathy). This can cause chest pain, dizziness, fainting, heart failure (disease of the heart with shortness of breath, and swelling of the feet or legs due to fluid build-up), light-headedness, feeling the heartbeat (palpitations), and shortness of breath

■    you have inflammation of the lining surrounding the heart which can cause difficulty breathing, tiredness, swelling of the ankles and feet and feeling weak (constrictive pericarditis)

■    you have narrowing of the main artery which may cause breathlessness, dizziness, fainting, or chest pain (aortic stenosis)

■    you have narrowing of the mitral valve, which may cause shortness of breath, fainting, dizziness, tiredness, irregular heart beat (atrial fibrillation) and chest pain (mitral stenosis)

■    you have a severe reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (severe anaemia)

■    you suffer from excessive fluid around the heart which can cause anxiety, restlessness, difficult or rapid breathing, swelling of the abdomen, fainting or light-headedness, feeling the heart beat and chest pain (cardiac tamponade)

■    you have a low water content of the blood, which may cause an increase in pulse rate, low blood pressure, pale skin, feeling dizzy or faint, and feeling very thirsty (hypovolaemia)

■    you have a rapid increase in pressure in the eye, which can cause pain, red eye, blurred vision and headache (closed-angle glaucoma)

■    you have had bleeding in the brain or a head injury

■    you are taking viagra (sildenafil) for erectile dysfunction or other phosphodiesterase-5-inhibitors e.g. tadalafil or vardenafil. You must not take Eumon 40 XL with such medicines. When taken together a severe drop in blood pressure can occur which may result in, collapse, unconsciousness and may even be fatal.

Take special care:

■    if you suffer from an underactive thyroid gland which can cause tiredness or weight gain

■    if you have a poor diet and your body lacks nutrients

■    if you have severe kidney or liver problems

■    if you suffer from a very low body temperature (hypothermia)

■    if you have recently had a heart attack Remember:

This medicine should not be used to treat an

angina attack. Your doctor should prescribe glyceryl trinitrate (GTN) sublingual tablets for you to take if you have an angina attack. Eumon 40 XL should be taken regularly, as prescribed, to prevent an angina attack.

If any of the above apply to you, please consult your doctor or pharmacist.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription, or the following:

■    Viagra (sildenafil) for erectile dysfunction or other phosphodiesterase-5-inhibitors e.g. tadalafil or vardenafil. You must not take Eumon 40 XL with such medicines (see 'Do not take', beginning of section 2)

■    Hydralazine for high blood pressure

■    Medicines which may cause low blood pressure such as:

-    Vasodilators e.g. diazoxide

-    Calcium channel blockers, such as diltiazem

-    Diuretics (water tablets)

-    Medicines for high blood pressure e.g. ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists such as losartan

-    Alprostadil for erectile dysfunction

-    Aldesleukin for kidney cancer and melanoma

■    Dihydroergotamine for migraines

Taking with alcohol

If you drink alcohol whilst taking Eumon 40 XL it may cause a severe drop in blood pressure making you feel dizzy or light-headed, especially on standing up.

Pregnancy and breast-feeding

The safety of this medicine for use during pregnancy or whilst breast-feeding has not been established.

If you are pregnant, think you might be pregnant or you are breast-feeding you should ask your doctor for advice before taking this medicine. This medicine should only be used during pregnancy or whilst breast-feeding if your doctor thinks the benefits outweigh the possible risks.

Driving or operating machinery

This medicine may make you feel dizzy, lightheaded or cause blurred vision. If affected, do not drive or operate machinery.

Important information about some of the ingredients

This medicine contains lactose. If you have been told by your doctor that you have an intolerance

Continued....

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to some sugars contact your doctor before taking this product.

\3 How to take

You should always take this medicine as prescribed by your doctor. Do not take more than the doctor has told you to. Read and follow the instructions on the pharmacist's label. If you are not sure about anything, please ask your doctor or pharmacist.

■    The tablets should be swallowed with half a glass of water

■    The tablets should not be crushed or chewed

Adults

The usual dose for adults is 1 tablet (40mg) taken in the morning. Your doctor may increase this dose to 2 tablets (80mg), to be taken at the same time.

In order to minimise the possibility of headache, your doctor may tell you to take a smaller dose for the first 2 - 4 days.

Elderly

The usual dose for the elderly is as for adults. However, your doctor will take special care, if you have low blood pressure or liver or kidney disease.

Children

This medicine is not recommended for children.

If you forget to take Eumon 40 XL

If you forget to take your tablet(s) but remember within 12 hours of the usual time, take it when you remember. If you remember more than 12 hours after your usual time, do not take it, just carry on with the next dose when it is due. Do not take a double dose to make up for a missed dose. If you are unsure of anything, ask your doctor or pharmacist.

If you take more Eumon 40 XL tablets than you should

Contact your nearest hospital casualty department or doctor immediately. Take this leaflet and any remaining tablets with you to show the doctor.

Symptoms of an overdose may include headache, excitation, cold perspiration, feeling or being sick, feeling of dizziness or 'spinning', restlessness, warm flushed skin, blurred vision, fainting, faster heart beat, fall in blood pressure, feeling your heart beat (palpitations), confusion and neurological problems, such as difficulty speaking and loss of balance.

Other symptoms are a bluish appearance of the skin, change in mental state, difficulty breathing, fits, irregular heart beat and circulation failure.

If you stop taking Eumon 40 XL You should keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better.

Treatment with Eumon 40 XL should not be stopped suddenly. When stopping, your doctor will help you to reduce the dose and frequency gradually. This should be done over several days and you should be monitored by your doctor.

[4 Possible side effects

Like all medicines, Eumon 40 XL can cause side effects, although not everyone gets them.

Tell your doctor immediately if you have the following:

■    Allergic skin reaction, such as red, bumpy, scaly, itchy or swollen skin

Side effects on starting treatment

■    Throbbing headache may occur. This usually disappears after 1 or 2 weeks of treatment

Very common side effect (affects more than 1 in 10 people)

■    Headache

Rare side effects

■    Rash

■    Itching

Other reported side effects

■    Low blood pressure (hypotension), which may cause dizziness, tiredness and nausea (feeling sick).These symptoms usually disappear during long-term treatment

■    Severe low blood pressure, which may cause being sick, pale skin colour and excessive perspiration. Although uncommon, collapse (sometimes with a slow heart beat and fainting) and increased symptoms of chest pain (angina) may occur

■    A drop in blood pressure on standing from a lying or sitting position (postural hypotension), which may cause dizziness or feeling lightheaded

■    Flushing

■    Dizziness

■    Feeling sick

■    Increased heart rate

■    Decreased heart rate

■    Muscle pain

■    Feeling sleepy

■    Diarrhoea

■    Being sick

■    Scaling of the skin

If any of these side effects become serious or you notice any not listed, please tell your doctor or pharmacist.

© How to store

■    Keep your medicine out of reach and sight of children

■    Store in a dry place below 25°C. Keep it in the dark.

■    Do not use your medicine if the pack is damaged or after the expiry date which is stated on the carton 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. These measures will help to protect the environment.

Further information

What Eumon 40 XL tablets contain:

The active ingredient: Each tablet contains 40mg of isosorbide mononitrate.

The other ingredients: hypromellose, stearic acid, talc, silica colloidal anhydrous, lactose, carnauba wax, magnesium stearate, macrogol 4000, titanium dioxide (E171) and iron oxide (E172).

This medicine contains lactose (see 'Important information about some of the ingredients' at the end of section 2)

What Eumon 40 XL tablets look like and the contents of the pack:

Eumon 40 XL are round, biconvex tablets with a cream colour, marked "IM40" on one side.

They are available in packs of 28, 30, 56, 60 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St. Neots Cambs.

PE198ET

Product Licence Number:

PL 11311/0455

Date of last revision: May 2012

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Till-Ver.9.5s