PACKAGE LEAFLET: INFORMATION FORTHE USER

nogen Pharma

Modisal XL 40mg Prolonged Release Tablets

(Isosorbide mononitrate)

Read all ofthis leaflet 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 or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Modisal XL 40mg Prolonged Release Tablets are and what they are used for

2.    What you need to know before you take Modisal XL 40mg Prolonged Release Tablets

3.    How to take Modisal XL 40mg Prolonged Release Tablets

4.    Possible side effects

5.    How to store Modisal XL 40mg Prolonged Release Tablets

6.    Contents of the pack and other information

1. WHAT MODISAL XL 40MG PROLONGED RELEASE TABLETS ARE AND WHAT THEY ARE USED FOR

Modisal XL 40mg Prolonged Release Tablets contain a medicine called isosorbide mononitrate. This belongs to a group of medicines called nitrates that act on your cardiovascular system (the heart and blood vessels). They work by reducing the frequency ofyour angina attacks. They are called prolonged release tablets because they have been made in a way that allows the isosorbide mononitrate to be released and slowly absorbed by your body over a period of several hours.

These tablets work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it.

Modisal Tablets are used to prevent angina pectoris.

Angina usually feels like a tight pain in the chest, arm or neck area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount ofwork it is doing.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MODISAL XL 40MG PROLONGED RELEASE TABLETS

Do not take Modisal XL 40mg Prolonged

Release Tablets ifyou:

•    Are taking the drug Sildenafil, or similar productsfor the treatment of male erectile dysfunction (see section Other medicines and Modisal XL 40mg Prolonged Release Tablets)

•    Are allergic (hypersensitive) to isosorbide mononitrate, other nitrates (e.g. glyceryl trinitrate) or any of the other ingredients in Modisal Tablets (listed in section 6)

•    Suffer from increased intracranial pressure (high pressure within your skull, e.g. from a blow to your head) or cerebral haemorrhage -bleeding from a ruptured blood vessel in tne brain

•    Have been diagnosed with any of the following: hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade or aortic/mitral valve stenosis

•    Suffer from anaemia, a reduction in red blood cells which can make the skin pale and cause you to feel weak and breathless

•    Suffer from high pressure in the eye (closed angle glaucoma)

•    Have very low blood pressure.

Warnings and precautions:

Talk to your doctor, or pharmacist or nurse before taking Modisal Tablets ifyou:

•    Suffer from an underactive thyroid gland or you are taking thyroxine

•    Suffer from an abnormally low body temperature

•    Suffer from poor health as a result of a poor diet

•    Suffer from severe liver or kidney disease

•    Have been told by your doctor that you have an intolerance to some sugars (see Modisal XL 40mg Prolonged Release Tablets contain lactose)

•    Are intending to drink alcohol as it may cause severe low blood pressure

•    Have recently suffered from a heart attack

•    Suffer from very poor circulation.

Modisal Tablets should not be used for the relief ofsudden attacks ofangina. Yourdoctorwill have given you another medicine to treat these sudden attacks.

You should notjust stop treatmentwith these tablets. If you wish to stop taking them you should see your doctor first (see section 3, How to take).

Other medicines and Modisal XL 40mg Prolonged Release Tablets:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Modisal Tablets may lower blood pressure so tell your doctor if you are taking any other medicines that may lower your blood pressure, such as:

•    Beta-blockers e.g. atenolol

•    Diuretics e.g. furosemide

•    ACE-inhibitors e.g. ramipril

•    Calcium channel blockers e.g. nifedipine

•    Vasodilators e.g. hydralazine

•    Angiotensin II receptor antagonists e.g. losartan

•    Aldesleukin used to treat certain types of cancer

•    Alcohol.

Taking these types of medicines with Modisal Tablets can increase the risk of low blood pressure occurring, especially ifyou are elderly.

Do not take Modisal Tablets at the same time as Sildenafil or Alprostadil, used for the treatment of male erectile dysfunction. If taken at the same time it could cause a severe fall in blood pressure resulting in collapse, unconsciousness and may be fatal.

Modisal XL 40mg Prolonged Release Tablets with food, drink and alcohol:

If you drink alcohol while taking Modisal Tablets it can increase the risk of low blood pressure occurring, especially ifyou are elderly with light

headedness and dizziness on standing. You should not drink alcohol while taking this medicine.

Pregnancy and breastfeeding:

Modisal Tablets should only be used in pregnancy or breastfeeding under close supervision of a doctor.

Driving and using machines:

Do not drive or operate machinery when taking Modisal Tablets if you develop low blood pressure (you may experience this as dizziness, tiredness or feeling sick) or if you have blurred vision.

Modisal XL 40mg Prolonged Release Tablets contain lactose:

Modisal Tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars you should not take this medicine.

3. HOW TO TAKE MODISAL XL 40mg PROLONGED RELEASE TABLETS

Always take Modisal Tablets exactly as your doctor has instructed you. You should checkwith your doctor or pharmacist if you are unsure.

These tablets should be taken whole, with a glass ofwater. They should not be crushed orchewed.

Adults and the elderly:

One tablet (40mg) once daily in the morning.

This may be increased to two tablets (80mg) daily, taken at the same time, if necessary.

If you are elderly and suffer from low blood pressure, liver or kidney disease, your doctor may prescribe a lower dose for you to take.

Children:

These tablets are unsuitable for children.

Ifyou take more Modisal XL 40mg Prolonged Release Tablets than you should:

If you take too many tablets by mistake, contact your nearest hospital casualty department or tell your doctor immediately. Take your tablet pack with you.

Ifyou have taken more tablets than you should, symptoms may include nausea (feeling sick), vomiting (being sick), restlessness, confusion, warm flushed skin, blurred vision, headache, fainting, dizziness (caused by low blood pressure -hypotension), fast heart beats and palpitations.

Ifyou stop taking Modisal XL 40mg Prolonged Release Tablets:

These tablets should not be discontinued suddenly but should be tapered gradually. Consult your doctor on how to stop taking these tablets.

If you forget to take Modisal XL 40mg Prolonged Release Tablets:

If you have forgotten to take a dose, leave out that dose completely. Take your next dose at the normal time. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.

Very Common Side Effects (affects more than 1 user in 10)

•    headache.

Common Side Effects (affects 1to10 users in 100)

•    dizziness

•    drowsiness

•    tiredness

•    feeling weak

•    low blood pressure

•    increase in heartbeat

•    nausea.

Uncommon Side Effects (affects 1to10 users in 1000)

•    cnest pain

•    vomiting

•    diarrhoea.

Rare Side Effects (affects 1to10 users in 10,000)

•    fainting.

Very Rare (affects less than 1 user in 10,000)

•    upset stomach

•    indigestion.

Medicine should be stopped immediately and medical attention sought if any of the symptoms occur.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 MODISAL XL 40MG PROLONGED RELEASE TABLETS

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

In case of any visible signs of deterioration, you should discard the package.

Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the sight and reach of children.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Seek immediate medical help ifyou have any of the following symptoms:

•    skin rashes

•    itching

•    excessive sweating

•    allergic skin reaction

•    flushing

•    faintingorcollapse.

Most side effects are dose-dependent. The most common side effect is headache. This side effect occurs in approximately 25% of patients at the beginning oftreatment. The headache usually disappears within about a week.

What Modisal XL 40mg Prolonged Release Tablets contain:

Modisal Tablets contain the active substance isosorbide mononitrate 40mg in each tablet.

The other ingredients are:

Stearic acid, carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, talc, purified siliceous earth, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172).

What Modisal Tablets look like and contents of the pack:

Modisal Tablets are round, cream coloured tablets marked IM40 on one side and plain on the other side.

Modisal Tablets are available in packs of28, 30, 56, 60 or 100. Not all pack sizes are sold.

Marketing Authorisation Holderand Manufacturer

Ennogen Pharma Limited

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

This leaflet was last revised May 2014.