What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 44374/0016.

Elantan LA 50 mg prolonged release capsules

elantan® LA 50 mg

50mg prolonged release capsules

Isosorbide mononitrate

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start talking 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 LA50 is and what it is used for
2. What you need to know before you take Elantan LA50
3. How to take Elantan LA50
4. Possible side effects
5. How to store Elantan LA50
6. Contents of the pack and other information

1. What Elantan LA50 is and what it is used for

Elantan LA50 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 LA50 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. What you need to know 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 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 severely low blood pressure
  • if your blood has stopped circulating around your body properly (circulatory failure)
  • if you take sildenafil (“Viagra”) or any other phosphodiesterase inhibitor.
  • if you are suffering from “shock” or vascular collapse
  • if you have an eye disease called glaucoma
  • if 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 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 LA50:

  • 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 slower than normal bowel movements
  • 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 LA50

  • Do not take Elantan LA50 with phosphodiesterase inhibitors such as Sildenafil (“Viagra”) used for impotence. Using Elantan LA50 with these medicines could cause your blood pressure to fall to a dangerously low level. You must not stop taking Elantan LA50 to take Sildenafil as this will increase your chances of having an angina attack.
  • Do not take take Elantan LA 50 with products that contain riociguat a medicine used in treating pulmonary hypertension.

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

  • Medicines to lower your blood pressure.
  • Monoamine oxidase inhibitors (used to treat depression)
  • Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety).
  • Ergotamine used for migraine.
  • Sapropterin used for phenylketonuria (PKU).
  • Any other medicine, including medicines obtained without a prescription.

Elantan LA50 with alcohol

Do not drink alcohol. It could increase the effect of Elantan LA50 and lower your blood pressure too much. If this happens, you may feel dizzy or faint.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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.

Elantan LA50 contains lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor or pharmacist before taking this medicinal product.

3. How to take Elantan LA50

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 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 LA50 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 LA50 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 LA50

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 LA50

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):

  • Headaches

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

  • Dizziness
  • Sleepiness
  • Feeling weak
  • Fast heartbeat
  • Lowering of blood pressure when standing up

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
  • Flushing
  • Excessive sweating
  • Restlessness
  • Increasing chest pain/angina

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

  • Heartburn

Other side effects

  • Red or scaly skin (exfolilative 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

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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Elantan LA50

Keep this medicine out of the 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.

Do not store above 30°C.

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.

6. Contents of the pack and other 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 LA50 looks like and content of the pack

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

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

If this leaflet is difficult to see or read or you would like it in a different format, please contact

Merus Labs Luxco II S.à r.l.
26-28, rue Edward Steichen
L-2540
Luxembourg