Elan: detailed information

Patient Information Leaflet

Elan 20 mg tablets, 40 mg tablets

Isosorbide-5-mononitrate
Equivalent Medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Elan is and what it is used for
What you need to know before taking Elan
How to take Elan
Possible side effects
How to store Elan
Contents of the pack and other information

1. What Elan is and what it is used for

Elan contains the active substance isosorbide mononitrate and belongs to a group of medicines called organic nitrates, which work by dilating both venous and arterial peripheral blood vessels, thereby reducing the workload of the heart. They also act by dilating the blood vessels of the heart, thus increasing blood supply to the area in need.
Elan is used as maintenance therapy in coronary insufficiency (a condition in which the heart's blood vessels, the coronary arteries, are unable to deliver sufficient blood to the heart muscle) and for the prevention of angina pectoris attacks. Angina typically manifests as a pressing, constricting pain in the chest, neck, and/or left arm, caused by reduced blood flow to the heart walls.
Elan is indicated as follow-up treatment after myocardial infarction (heart attack resulting in death of cardiac muscle fibers).
Elan is also indicated as maintenance therapy in chronic heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs), either alone or in combination with other medications that increase heart contractility (cardiotonics) and those that increase urine production, thereby reducing circulating fluid volume (diuretics).
Do not use Elan to treat acute angina attacks.

2. What you need to know before taking Elan

Do not take Elan:

if you are allergic to isosorbide mononitrate, to other nitrates, or to any of the other ingredients of this medicine (listed in section 6);
if you have a disease that severely impairs the heart's ability to pump blood adequately, such as cardiogenic shock (severe impairment of heart function), obstructive hypertrophic cardiomyopathy (thickening of the heart walls leading to reduced ability to contract and pump blood), constrictive pericarditis (inflammation of the pericardium, the sac surrounding the heart), or cardiac tamponade (fluid accumulation in the pericardium that prevents the heart from functioning properly);
in case of acute circulatory failure (shock, collapse);
if you have any condition in which blood pressure is very low (systolic pressure < 90 mmHg);
if you have reduced blood volume (hypovolemia);
if you suffer from severe anemia (reduction in red blood cells in the blood);
if you are taking any other medicine used for erectile dysfunction (phosphodiesterase inhibitors such as sildenafil, tadalafil, vardenafil). See sections “Warnings and precautions” and “Other medicines and Elan”;
if you are taking medicines used for pulmonary hypertension (such as riociguat, a soluble guanylate cyclase stimulator). See section “Other medicines and Elan”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Elan:

if you have a heart condition with severe impairment of the heart's pumping function (heart attack with or without left ventricular failure);
if you have narrowing of the heart valves (aortic and/or mitral valve stenosis);
if you have conditions associated with increased pressure in the head (increased intracranial pressure);
if you have had head trauma or cerebral hemorrhage;
if you have an eye disease that increases intraocular pressure, known as glaucoma;
if you suffer from orthostatic dysfunction, where blood pressure drops upon standing;
if your blood oxygenation level is insufficient (hypoxemia) due to lung disease or reduced blood supply to the heart (ischemic heart failure).

During treatment with Elan, especially in the initial stages, you may experience headache, which can be severe and persistent.

Other medicines and Elan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Elan with phosphodiesterase inhibitors such as sildenafil, vardenafil, and tadalafil, used for erectile dysfunction. Taking Elan together with these medicines may cause blood pressure to drop to dangerously low levels. Do not stop taking Elan to take phosphodiesterase inhibitors, as this may increase the risk of angina attacks.
Inform your doctor if you are taking:

medicines used to lower blood pressure (e.g. beta-blockers, calcium antagonists, vasodilators, ACE inhibitors, monoamine oxidase inhibitors), as they may cause a further drop in blood pressure;
medicines used to treat depression (tricyclic antidepressants) or other mental illnesses (neuroleptics). These may also cause a further drop in blood pressure;
medicines used for migraine (dihydroergotamine). If taken together, excessive increase in blood pressure may occur;
medicines containing sapropterin (used, for example, for the treatment of a disease called phenylketonuria);
medicines containing riociguat (used, for example, for the treatment of pulmonary hypertension). If taken concomitantly with isosorbide-5-mononitrate, they may cause a drop in blood pressure.

Elan with food, drinks and alcohol
Alcohol may enhance the blood pressure-lowering effect. Avoid consuming alcohol during treatment with Elan.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Use Elan during pregnancy only if strictly necessary and under medical supervision.
Breastfeeding
Since the active ingredient of Elan is excreted in breast milk and may cause problems in the newborn, inform your doctor if you are breastfeeding.
Fertility
There are no available data on the effect of Elan on male fertility.

Driving and using machines
Elan may affect your reaction ability, potentially impairing your ability to drive or operate machinery. This effect is enhanced by alcohol (see section “Elan with food, drinks and alcohol”). Do not drive or operate machinery until you know how this medicine affects you.

Elan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Elan

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The tablet may be divided into equal parts.
Take the tablets after meals, with a little water and without chewing.

Adults and elderly
Elan 20 mg tablets
The recommended dose is one tablet two or three times daily.
Your doctor may increase the dose up to a maximum of two tablets three times a day.

Elan 40 mg tablets
The recommended dose is one tablet two or three times daily.
Your doctor may decide to adjust the dosage according to your needs.
If your doctor has prescribed Elan twice daily, take the second dose after an interval of 8 hours.
If instead the prescription is for three doses a day, take the doses at intervals of 6 hours, in order to ensure a 12-hour “nitrate-free” interval every 24 hours.

Use in children
This medicine is not suitable for children. If you have further questions about the use of this medicine, consult your doctor or pharmacist.

If you take more Elan than you should
Possible symptoms of an Elan overdose include: a drastic drop in blood pressure, paleness, sweating, weak pulse, rapid heartbeat, dizziness when standing, headache, weakness, nausea, vomiting, and diarrhea.
An increase in pressure within the skull (intracranial pressure) may also occur, leading to symptoms of brain distress.
Cases of altered hemoglobin (methemoglobinemia) have also been reported, resulting in a bluish discoloration of the lips, nails, and skin (cyanosis), anxiety, loss of consciousness, and cardiac arrest.
Contact your doctor immediately if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for the overdose.
In any case, if your blood pressure drops, it is important to lie down with your head slightly lowered and your legs slightly raised.

If you forget to take Elan
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for a missed dose.

If you stop taking Elan
If you have any questions about using this medicine, consult your doctor or pharmacist. The medicine must be discontinued gradually, as sudden withdrawal may trigger angina attacks.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)

Headache

Common (may affect up to 1 in 100 people)

Dizziness (including dizziness upon standing)
Drowsiness
Increased heart rate
Sudden drop in blood pressure upon standing up from a sitting or lying position (orthostatic hypotension)
Feeling weak (asthenia)

Uncommon (may affect up to 1 in 100 people)

Worsening of angina symptoms (e.g. chest pain)
Circulatory collapse, sometimes with slowed heart rate and fainting (syncope)
Nausea
Vomiting
Allergic skin reactions (e.g. rash), redness

Rare (may affect up to 1 in 10,000 people)

Heartburn (pyrosis)

Not known (frequency cannot be estimated from the available data)

Syncope
Decreased blood pressure (hypotension)
Erythema, skin surface thickening with peeling (exfoliative dermatitis)
Sudden allergic reaction possibly causing swelling of arms, legs, ankles, lips, tongue and/or throat, and difficulty swallowing or breathing (angioedema)

Contact your doctor immediately if you experience:

a severe drop in blood pressure accompanied by nausea, vomiting, restlessness, paleness, and excessive sweating
or cyanosis (bluish discoloration of lips, nails, and skin).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Elan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.:.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Elan contains
The active substance is isosorbide mononitrate.
Each Elan 20 mg tablet contains 20 mg of isosorbide-5-mononitrate.
Each Elan 40 mg tablet contains 40 mg of isosorbide-5-mononitrate.
The other components are:
talc, lactose monohydrate, anhydrous colloidal silica, potato starch, microcrystalline cellulose,
aluminum stearate.

Description of the appearance of Elan and contents of the pack
Elan 20 mg tablets are white, round, flat with beveled edges, a score line, and engraved with (E/20) on the upper side and convex on the lower side.
Elan 40 mg tablets are white, round, flat with beveled edges, a score line, and engraved with (E/40) on the upper side and convex on the lower side.
The tablet can be divided into two equal parts.
Elan tablets are packed in blisters contained in cardboard boxes with the following quantities:

20 mg: 50, 60 tablets
40 mg: 30, 60 tablets

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Merus Labs Luxco II S.à.R.L.
26-28, rue Edward Steichen
L-2540 Luxembourg (Luxembourg)

Manufacturer
Aesica Pharmaceuticals GmbH
Alfred Nobel Strasse 10
40789 - Monheim
Germany

Package leaflet: Information for the user

Elan 50 mg prolonged-release hard capsules

Isosorbide-5-mononitrate
Generic Medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Elan is and what it is used for
What you need to know before taking Elan
How to take Elan
Possible side effects
How to store Elan
Contents of the pack and other information

1. What Elan is and what it is used for

Elan contains the active substance isosorbide mononitrato and belongs to a group of medicines called organic nitrates, which work by dilating both venous and arterial peripheral blood vessels, thereby reducing the workload of the heart. They also act by dilating the blood vessels of the heart, thus increasing blood supply to the areas in need.

Elan is used as maintenance therapy in coronary insufficiency (when the heart's blood vessels, the coronary arteries, are unable to deliver sufficient blood to the heart muscle) and for the prevention of angina pectoris attacks. Angina usually manifests as a constricting, oppressive pain in the chest, neck and/or left arm, caused by reduced blood flow to the walls of the heart.

Elan is indicated as treatment following a myocardial infarction (heart attack resulting in death of cardiac muscle fibers).

Elan is also indicated as maintenance therapy in chronic heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs), either alone or in combination with other medicines that increase heart contractility (cardiotonics) and those that increase urine production, thereby reducing circulating fluids (diuretics).

Do not use Elan to treat acute angina attacks.

2. What you should know before taking Elan

Do not take Elan:

if you are allergic to isosorbide mononitrate, to other nitrates, or to any of the other ingredients of this medicine (listed in section 6);
if you have a disease that severely impairs the heart's ability to pump blood adequately, such as cardiogenic shock (severe impairment of heart function), obstructive hypertrophic cardiomyopathy (thickening of the heart walls leading to reduced ability to contract and pump blood), constrictive pericarditis (inflammation of the pericardium, the sac surrounding the heart), or cardiac tamponade (fluid accumulation in the pericardium that prevents the heart from functioning properly);
in case of acute circulatory failure (shock, collapse);
if you have any condition in which blood pressure is very low (systolic pressure < 90 mmHg);
if you have reduced blood volume (hypovolemia);
if you suffer from severe anemia (reduction in red blood cells in the blood);
if you are taking any other medicine used for erectile dysfunction (phosphodiesterase inhibitors such as sildenafil, tadalafil, vardenafil). See sections “Warnings and precautions” and “Other medicines and Elan”;
if you are taking medicines used for pulmonary hypertension (such as riociguat, a soluble guanylate cyclase stimulator). See section “Other medicines and Elan”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Elan:

if you have a heart condition with severe impairment of the heart's pumping function (myocardial infarction with or without left ventricular failure);
if you have narrowing of the heart valves (aortic and/or mitral valve stenosis);
if you have conditions associated with increased pressure in the head (increased intracranial pressure);
if you have had head trauma or cerebral hemorrhage;
if you have an eye disease that increases intraocular pressure called glaucoma;
if you suffer from orthostatic dysfunction, a condition in which blood pressure drops upon standing;
if your blood oxygenation level is insufficient (hypoxemia) due to lung disease or reduced blood supply to the heart (ischemic heart failure).

During treatment with Elan, especially in the initial stages, you may experience headache, which can be severe and persistent.

Other medicines and Elan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Do not take Elan with phosphodiesterase inhibitors such as sildenafil, vardenafil, and tadalafil, used for erectile dysfunction. Taking Elan with these medicines may cause blood pressure to drop to dangerously low levels. Do not stop taking Elan to take phosphodiesterase inhibitors, as this will increase the risk of angina attacks.

Inform your doctor if you are taking:

medicines used to lower blood pressure (e.g. beta-blockers, calcium antagonists, vasodilators, ACE inhibitors, monoamine oxidase inhibitors), as they may cause a further drop in blood pressure;
medicines used to treat depression (tricyclic antidepressants) or other mental illnesses (neuroleptics). These may also cause a further drop in blood pressure;
medicines used for migraine (dihydroergotamine). If taken simultaneously, they may cause excessive increase in blood pressure;
medicines containing sapropterin (used, for example, in the treatment of a disease called phenylketonuria);
medicines containing riociguat (used, for example, in the treatment of pulmonary hypertension). If taken concomitantly with isosorbide-5-mononitrate, they may cause a drop in blood pressure.

Elan with food, drinks and alcohol
Alcohol may enhance the blood pressure-lowering effect. Avoid consuming alcohol during treatment with Elan.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Use Elan during pregnancy only if strictly necessary and exclusively under medical supervision.

Breastfeeding
Since the active ingredient of Elan is excreted in breast milk and could cause problems in the newborn, inform your doctor if you are breastfeeding.

Fertility
There are no available data on the effect of Elan on fertility in humans.

Driving and using machines
Elan may affect your reaction ability, potentially impairing your capacity to drive or operate machinery. This effect is enhanced by alcohol (see section “Elan with food, drinks and alcohol”). Do not drive or operate machinery until you have determined whether this medicine affects your ability to perform these activities.

Elan contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Elan

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor may decide to adjust the dosage according to your needs.

Adults and elderly
The recommended dose is one capsule once daily in the morning, taken with some water, without chewing.

If you suffer from headache or low blood pressure (arterial hypotension), ask your doctor, who may decide to start your treatment with one tablet of ELAN 20 mg in the morning and one in the evening.

Use in children
This medicine is not suitable for children. If you have further questions about the use of this medicine, consult your doctor or pharmacist.

If you take more Elan than you should
Possible symptoms of an Elan overdose include: a sharp drop in blood pressure, pallor, sweating, weak pulse, rapid heartbeat, dizziness when standing, headache, weakness, nausea, vomiting, and diarrhea.

An increase in pressure within the skull (intracranial pressure) may also occur, leading to symptoms of brain distress.

Cases of altered hemoglobin (methemoglobinemia) have also been reported, resulting in a bluish discoloration of the lips, nails, and skin (cyanosis), anxiety, loss of consciousness, and cardiac arrest.

Contact your doctor immediately if you have taken more capsules than recommended. Your doctor will determine the most appropriate treatment for the overdose.

In any case, if your blood pressure drops, it is important to lie down with your head slightly lowered and your legs slightly raised.

If you forget to take Elan
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed dose.

If you stop taking Elan
If you have any doubts about using this medicine, consult your doctor or pharmacist. The medicine must be discontinued gradually, as sudden interruption may trigger angina attacks.

4. Possible side effects

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

Very common (may affect more than 1 in 10 people)

Headache

Common (may affect up to 1 in 100 people)

Dizziness (including dizziness upon standing)
Drowsiness
Increased heart rate
Sudden drop in blood pressure when standing up from a sitting or lying position (orthostatic hypotension)
Feeling weak (asthenia)

Uncommon (may affect up to 1 in 100 people)

Worsening of angina symptoms (e.g. chest pain)
Circulatory collapse sometimes with slowed heart rate and fainting (syncope)
Nausea
Vomiting
Allergic skin reactions (e.g. rash), redness

Very rare (may affect up to 1 in 10,000 people)

Heartburn (pyrosis)

Not known (frequency cannot be estimated from the available data)

Syncope
Decrease in blood pressure (hypotension)
Erythema, skin surface thickening with peeling (exfoliative dermatitis)
Sudden allergic reaction with possible swelling of arms, legs, ankles, lips, tongue and/or throat, and difficulty swallowing or breathing (angioedema)

Immediately contact your doctor if you experience:

a severe drop in blood pressure accompanied by nausea, vomiting, restlessness, paleness and excessive sweating
or cyanosis (bluish discoloration of lips, nails and skin)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Elan

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 after Exp.: .
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Elan contains
The active substance is isosorbide mononitrate.
Each Elan 50 mg capsule contains 50 mg of isosorbide-5-mononitrate.
The other components are:
lactose monohydrate, hydroxypropylcellulose, polyO-(ethyl)cellulose, macrogol 20000, talc,
sucrose, maize starch.
The capsule shell (cap and body) contains: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172).
Description of the appearance of Elan and contents of the pack
The capsule has an opaque brown cap and an opaque flesh-colored body.
Elan capsules are packed in blisters within cardboard boxes containing:
30 or 40 hard prolonged-release capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Merus Labs Luxco II S.à.R.L.
26-28, rue Edward Steichen
L-2540 Luxembourg (Luxembourg)
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred Nobel Strasse 10
40789 - Monheim
Germany