elantarf la so

50mg Prolonged Release Capsules

ISOSORBIDE MONONITRATE

Patient Information 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 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.

In this leaflet:

1.    What Elantan LA50 is for

2.    Before you take Elantan LA50

3.    How to take Elantan l_A50

4.    Possible side effects

5.    How to store Elantan LA50

6.    Further information.

1.    What Elantan LA50 is for

Elantan l_A50 belongs to a group of medicines called organic nitrates. Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it.

Elantan l_A50 is used to prevent angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing.

2.    Before you take Elantan LA50

Do not take Elantan LA50 if:

• You are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of Elantan LA50 (see section 6)

•    You suffer from anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)

•    You have had a heart attack (myocardial infarction)

•    You have had a brain haemorrhage (bleeding)

•    You have had a head injury (trauma)

•    You have a low blood volume (hypovolaemia)

•    You have very low blood pressure

•    Your blood has stopped circulating around your body properly (circulatory failure)

•    You take sildenafil (“Viagra”) or any other phosphodiesterase inhibitor.

•    You are suffering from “shock” or vascular collapse

•    You have an eye disease called glaucoma

•    You have been diagnosed with any of the following heart conditions: hypertrophic obstructive cardiomyopathy (HOCM), con-strictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with raised intra-cranial (head) pressure.

If any of the above applies to you talk to your

doctor or pharmacist.

Check with your doctor before taking

Elantan LA50 if:

•    You have an underactive thyroid gland

•    You are malnourished (severely underfed)

•    You have liver or kidney disease

•    You suffer from hypothermia (a very low body temperature)

•    You suffer from very poor circulation

Taking other Medicines

•    Do not take Elantan LA25 with phosphodiesterase inhibitors such as Sildenafil (“Viagra”) used for impotence. Using Elantan LA25 with these medicines could cause your blood pressure to fall to a dangerously low level. You must not stop taking Elantan LA25 to take Sildenafil as this will increase your chances of having an angina attack.

Tell your doctor if you are taking any of the following medicines:

•    Medicines to lower your blood pressure.

•    Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety).

•    Ergotamine used for migraine.

•    Any other medicine, including medicines obtained without a prescription.

If any of the above applies to you, talk to your doctor.

Using Elantan LA50 with food and drink

Do not drink alcohol. It could increase the effect of Elantan l_A50 and lower your blood pressure too much. If this happens, you may feel dizzy or faint.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking Elantan l_A50.

You doctor will decide whether you should take this medicine.

Driving and using machines

Elantan LA50 may give you a headache, blurred vision or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery.

Warnings about the ingredients

This medicine contains lactose and sucrose. If you have an intolerance to some sugars, tell your doctor before taking this medicine.

3. How to take Elantan LA50

Always take Elantan LA50 exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.

Adults

•    The usual adult dose is one capsule once a day, in the morning.

•    If your doctor increases your dose to two capsules, you should take them together in the morning.

•    To remove the capsule from the packaging, carefully push one end of the capsule through the foil. If you push in the middle you may damage the capsule.

•    Swallow the capsule whole with a drink of water.

Do not use Elantan l_A50 to treat an actual angina attack. Your doctor will give you a different medicine such as a GTN (glyceryl trinitrate) spray or tablet for this.

Children

This medicine is not suitable for children.

If you take more Elantan l_A50 than you should

Do not take more Elantan LA50 than you should. If you accidentally take too much, immediately contact the nearest hospital casualty department or your doctor.

Too much Elantan LA50 may cause your blood pressure to fall too low, making you feel sick, faint and dizzy. A very large over-dose could cause a coma or collapse and require immediate resuscitation.

If you forget to take Elantan l_A50

Do not take a double dose to make up for a missed dose. Take your next dose at the usual time.

If you stop taking Elantan l_A50

Do not stop taking Elantan LA50 without first talking to your doctor. You should keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the tablets your condition may get worse.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines Elantan LA50 can cause side effects, although not everybody gets them.

Seek immediate medical help if you have any of the following symptoms:

Fainting or collapse

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

•    Mild headaches at the start of treatment. Usually they disappear after a few days.

Common side effects (affects less than 1 in 10 people):

•    Dizziness

•    Tiredness

•    Feeling weak

•    Fast heartbeat

•    Flushing.

They may occur for the first few days of treatment or after your dosage has been increased.

Uncommon side effects (affects less than 1 in 100 people):

•    Fainting or collapse

•    Feeling sick or being sick

•    Skin rashes

•    Looking pale

•    Excessive sweating

•    Restlessness

•    Worse angina.

Very rare side effects (affects less than 1 in 1 0,000 people):

•    Heartburn

•    Red or scaly skin (exfolilative dermatitis).

If any of the 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 Elantan LA50

Keep out of the reach and sight of children.

Do not use Elantan LA50 after the expiry date on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6. Further information What Elantan LA50 contains

The active substance is isosorbide mononitrate 50 mg.

The other ingredients are lactose monohydrate, purified talc, ethyl cellulose, macrogol 20,000, hydroxypropyl cellulose, sucrose, corn starch, gelatin, titanium dioxide, iron oxide red (E172), iron oxide black (E172).

What Elantan l_A50 looks like

Elantan LA50 is a brown and flesh coloured capsule. They come in blister packs of 28 capsules.

Marketing Authorisation Holder UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK.

Manufacturer

Aesica Pharmaceuticals GmbH

Alfred Nobel Strasse 10, D-40789,

Monheim, Germany

This leaflet was last updated February 2013 If this leaflet is difficult to see or read or you would like it in a different format, please contact UCB Pharma Ltd, 208 Bath Road, Slough, Berkshire, SL1 3WE, UK.

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