Elantan 10 mg Tablets

Elantan® 10mg Tablets

Isosorbide mononitrate

Read all of this 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.

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

What is in this leaflet:

1. What Elantan is and what it is used for

2. What you need to know before you take Elantan

3. How to take Elantan

4. Possible side effects

5. How to store Elantan

6. Contents of the pack and other information.

Elantan 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 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.

Do not take Elantan:

• if you are allergic to isosorbide mononitrate, other nitrates or any of the other ingredients of this medicine (listed in section 6)

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

• if you have had a heart attack (myocardial infarction)

• if you have had a brain haemorrhage (bleeding)

• if you have had a head injury (trauma)

• if you have severely low blood volume (hypovolaemia)

• if you have severe low blood pressure

• if you are suffering from ‘shock’ as the blood has stopped circulating properly around your body (circulatory failure)

• if you take sildenafil, tadalafil or vardenafil (medicines to treat erectile dysfunction and/or pulmonary hypertension) or any other phosphodiesterase inhibitor.

• if you have an eye disease called glaucoma

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

• if you take products that contain riociguat a medicine used in treating pulmonary hypertension.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Elantan:

• if you have an underactive thyroid gland

• if you are malnourished (severely underfed)

• if you have liver or kidney disease

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

• if you suffer from very poor circulation

• if you have abnormally low level of oxygen in the blood and impaired gas exchange due to lung disease or ischaemic heart failure.

Other Medicines and Elantan

• Do not take Elantan with phosphodiesterase inhibitors such as Sildenafil, Alprostadil, Tadalafil and Vardenafil used for impotence. Using Elantan with these medicines could cause your blood pressure to fall to a dangerously low level. You must not stop taking Elantan to take these medicines as this will increase your chances of having an angina attack.

• Do not take Elantan with products that contain riociguat.

Tell your doctor if you are taking, have recently taken or might take any of the following medicines:

• Medicines to lower your blood pressure such as beta-blockers (atenolol, propranolol), calcium channel blockers (nifedipine, diltiazem), vasodilators (glycerol trinitrate, methyldopa), ACE-inhibitors, angiotensin receptor blockers (olmesartan, medoxomil, candesartan cilexetil) monoamine oxidase inhibitors.

• Tricyclic antidepressants such as amitriptyline, clomipramine (used to treat depression)

• Neuroleptics to treat psychosis (delusions, hallucinations and/or disordered thought) such as phenothiazines (fluphenazine) or butyrophenones (haloperidol)

• Ergotamine used for migraine.

• Aldesleukin (for kidney cancer)

• Sapropterine containing medicines for the treatment of hyperphenylalaninaemia (HPA)

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

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

Elantan with food, drink and alcohol

Do not drink alcohol. It could increase the effect of Elantan 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. Your doctor will decide whether you should take this medicine.

Driving and using machines

Elantan 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.

Elantan contains lactose

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

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 tablet two or three times a day

• Your doctor will tell you when you should take your tablets. You will need to have a period of time (usually when you are sleeping) when no tablets are taken. This is called a “nitrate low” period and is needed to make sure your medicine remains effective

• Swallow the tablets whole with a drink of water after meals.

• Your doctor may increase your dose, up to a maximum of 120 mg per day.

• If you do not take the dose as prescribed by your doctor, you may develop a tolerance to Elantan.

Do not use Elantan 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.

Use in children

This medicine is not suitable for children.

If you take more Elantan than you should

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

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

If you forget to take Elantan

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

If you stop taking Elantan

Do not stop taking Elantan 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.

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

 Seek immediate help if you are having an allergic reaction.  This includes any of the following symptoms:

• Difficulty in breathing

• Swelling of your eyelids, face or lips

• Rash or itching especially those covering your whole body

• Collapse

• Fainting

• Exfoliative dermatitis (serious illness with blistering of the skin, mouth, eyes and genitals)

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

• Headache

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

• Light headed on standing upright

• Dizziness

• Sleepiness

• Feeling weak

• Fast heartbeat

• Drowsiness

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

• Worsening angina (tight pain in the chest, neck or arm area)

• Flushing.

Very rare side effects (affects less than 1 in 10,000 people):

• Heartburn

Other side effects

• Red or scaly skin (exfoliate dermatitis)

• Low blood pressure

• Swelling of the skin

You may also suffer with increased chest pain due to a lack of oxygen to the heart muscle and areas around the chest.

Very slow heart rate has been reported with use of nitrates.

If you experience any symptoms of shock or collapse after first dose, please contact your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail:  medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

What Elantan 10mg tablets contain

• The active substance is isosorbide mononitrate. Each tablet contains 10mg isosorbide mononitrate.
• Other ingredients are lactose monohydrate, microcrystalline cellulose, potato starch, talc, colloidal anhydrous silica and aluminium stearate.

 What Elantan looks like and contents of the pack

Elantan 10 mg tablets are white, round tablet, flat with bevelled edge, score and engraving (E/10) on the upper side and rounded on the lower side.

They come in blister packs of 28, 30, 50, 56, 60, 84, 90 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merus Labs Luxco II S.à.R.L.

26-28, rue Edward Steichen

L-2540 Luxembourg

Manufacturer

Aesica Pharmaceuticals GmbH

Alfred Nobel Strasse 10, D-40789,

Monheim, Germany

This leaflet was last revised in: December 2017