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PATIENT INFORMATION LEAFLET

ETIMONIS XL 50mg Capsules

(Isosorbide Mononitrate)

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    Ask your doctor or pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Etimonis XL 50mg Capsules. Etimonis XL 50mg Capsules contain the active substance isosorbide mononitrate.

Isosorbide mononitrate belongs to a group of medicines called nitrates. Isosorbide mononitrate works by improving the blood supply to the heart by enlarging the blood vessels in the heart muscle.

Etimonis XL 50mg Capsules are used to:

■ Prevent symptoms of angina (chest pain) from happening

Angina usually occurs as a pain or tightness in the chest although it may be felt in the neck or arm. The pain happens when the muscle of the heart does not receive enough oxygen for the work it has to do.

Do not take Etimonis XL 50mg Capsules if you:

■    are under 18 years of age

■    are allergic to isosorbide mononitrate or any other medicines known as nitrates (glyceryl trinitrate, isosorbide dinitrate)

■    are anaemic (suffering from a low iron content in your body)

■    have an eye disease called glaucoma (raised pressure in the eye)

■    have very low blood pressure

■    suffer from acute circulatory failure or hypovolaemia (low blood volume)

■    have a heart valve disorder or suffer from low cardiac filling pressures

■    have had a recent severe head injury (and since had migraines and headaches), cerebral haemorrhage (bleeding in the brain) or a disease which is accompanied by increased pressure in the brain

■ suffer from a condition called hypertrophic obstructive cardiomyopathy (HOCM)

■ suffer from a condition called Constrictive Pericarditis (inflammation of the heart lining) or cardiac tamponade (where the fluid around the heart puts pressure on the heart)

■    are taking Viagra®sildenafil, tadalafil or vardenafil - which belong to a group of medicines called Phosphodiesterase type 5 inhibitors, to treat male erectile dysfunction. Taking Etimonis XL 50mg Capsules with these medicines could cause a severe and possibly dangerous fall in blood pressure. This would result in collapse, unconsciousness and it could be fatal.

Take special care with this medicine if you:

•    have recently had a heart attack

•    suffer from low blood pressure

■    suffer from liver or kidney disease

■    suffer from underactive thyroid gland (hypothyroidism)

■    suffer from hypothermia (becoming excessively cold)

■    suffer from malnutrition (severe lack of food)

Talk to your doctor or pharmacist if any of the above applies to you.

Taking other medicines

Your medicine may interfere with other medicines that you are taking. Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine even those not prescribed.

In particular, the following types of drugs can interact with Etimonis XL 50mg Capsules:

■    medicines for high blood pressure e.g. beta blockers, calcium channel blockers, aldesleukin, angiotensin II receptor antagonists, ACE inhibitors.

■    diuretics (water tablets)

■    vasodilators (used in the treatment of cold hands and feet)

■    medicines to treat male erectile problems (sildenafil, alprostadil)

■    tricyclic antidepressants (used to treat depression)

■    neuroleptics (used to treat anxiety)

■    dihydroergotamine (used to treat migraine)

Pregnancy and breast-feeding

If you are pregnant, or think you may be pregnant, or you are breast- feeding do NOT take this medicine without consulting your doctor.

Driving and using machines

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

Drinking alcohol with this medicine

Be careful when drinking alcohol. Too much may interact with this medicine causing your blood pressure to become low.

Important information about some of the ingredients in Etimonis XL 50mg Capsules

Your medicine contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

If this medicine is from your doctor or pharmacist, do exactly as they have told you. Otherwise, follow the instructions below. Check with your doctor or pharmacist if you are not sure. Swallow the capsule whole with a glass of water. Do not chew the capsule.

Dosage

Adults

The usual adult dose is 50mg per day, taken in the morning.

Your doctor may increase this dose to 100mg, to be taken as a single dose.

Children

Etimonis XL 50mg Capsules are NOT recommended for children under 18 years of age.

If you take more of your medicine than you should

If you take more capsules than you should contact your nearest casualty department or tell your doctor or pharmacist IMMEDIATELY. Take this leaflet and any remaining capsules with you.

If you forget to take your medicine

If you remember within 8 hours take the forgotten dose immediately.

If you remember after 8 hours take the dose at the usual time. DO NOT take a double dose to make up for the dose you have missed.

If you stop taking this medicine

Do not stop taking this medicine without first talking to your doctor. Do not stop taking it just because you feel better. If you stop taking the capsules your condition may get worse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Etimonis XL 50mg Capsules can cause side effects, although not everybody gets them.

If you experience the following side effects, you should STOP taking your medicine and tell your doctor IMMEDIATELY or go to your nearest casualty department.

■    Skin troubles such as rash or itching

■    Wheezing or shortness of breath These may be signs of an allergic reaction.

Very Common side effects (>1/10)

•    Headache, which may be throbbing - this usually becomes less after a few days of treatment

Common side effects (>1/100 to <1/10)

•    Dizziness or feeling light-headed

•    Lowered blood pressure (feeling light-headed, dizzy and a speeding up of the heart rate when standing up. Also feeling of weakness or drowsiness)

Uncommon side effects (>1/1,000 to <1/100)

■    nausea

■    vomiting

■    flushing

■    skin rashes

■    paleness, sweating and restlessness - if your blood pressure drops severely, leading to passing out (collapse). Worsening of angina symptoms can occur if blood pressure drops severely.

■    Heartburn

Rare side effects: (>1/10,000 to <1/1,000)

■    increase in your heart rate (tachycardia)

■    decrease in your heart rate (paroxysmal bradycardia)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

DO NOT take the capsules after the expiry date printed on the container. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store above 25^oC. Store in the original pack.

Return any left over medicine to your pharmacist.

6. FURTHER INFORMATION

What Etimonis XL 50mg Capsules contain

The active ingredient is isosorbide mononitrate. Each capsule contains 50mg of isosorbide mononitrate.

Other ingredients: lactose monohydrate, sucrose, maize starch, bleached dewaxed shellac, dewaxed shellac, talc, copolymer of methacrylic acid and methyl methacrylate (1:1) and copolymer of ethyl acrylate, methyl methacrylate and trimethylammonioethyl methacrylate chloride (1:2:0:1).

The capsule shells are made of gelatin and also contain the colouring agent titanium dioxide (E171).

The black printing ink contains shellac, propylene glycol, ammonium hydroxide, potassium hydroxide and black iron oxide (E172).

What Etimonis XL 50mg Capsules look like and contents of the pack

The capsules are white and are printed in black with “ISMN SR” and “50”.

The capsules are available in boxes of 28, 30, 56 or 60 capsules.

Marketing Authorisation Holder

Athlone Pharmaceuticals Ltd., Ballymurray, Co. Roscommon, Ireland.

PL 30464/0059

This leaflet was last revised: February 2012.