ELAN 20 mg Coated Tablet

Содержание инструкции

1. Elan 20 mg tablets, 40 mg tablets
   1. What Elan is and what it is used for
   2. What you need to know before taking Elan
   3. How to take Elan
   4. Possible side effects
   5. How to store Elan
   6. Contents of the pack and other information
2. Elan 50 mg prolonged-release hard capsules
   1. What is Elan and what it is used for
   2. What you need to know before taking Elan
   3. How to take Elan
   4. Possible side effects
   5. How to store Elan
   6. Contents of the pack and other information

Elan 20 mg tablets, 40 mg tablets

Isosorbide-5-mononitrate
Generic Equivalent

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Elan is and what it is used for
• 2. What you need to know before you take Elan
• 3. How to take Elan
• 4. Possible side effects
• 5. How to store Elan
• 6. 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 drugs
called organic nitrates which work by dilating both venous and peripheral arteries, making
the heart's work less burdensome. They also work by dilating the blood vessels of the heart, allowing
thus an increase in blood supply to the area that needs it.
Elan is used as maintenance therapy in coronary insufficiency (i.e. when the vessels of the
heart, the coronary arteries, are unable to deliver enough blood to the heart muscle) and for
the prevention of angina pectoris attacks. Angina usually manifests as oppressive and constricting pain
in the chest, neck and/or left arm caused by a reduction in blood flow
to the heart walls.
Elan is indicated as a treatment following a heart attack (cardiac attack with death of
cardiac muscle fibers).
Elan is also indicated as maintenance therapy in chronic heart failure (a condition
in which the heart fails to pump enough blood to meet the needs of the whole
body), even in association with other medicines that increase the strength of the heart (cardiotonics) and to
those that increase urine production, reducing circulating fluids (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 condition that severely impairs the heart's ability to pump blood into the vessels adequately, such as cardiogenic shock (severe impairment of heart function), obstructive hypertrophic cardiomyopathy (increase in the volume of the heart walls leading to a reduction in its ability to contract and pump blood into the vessels), constrictive pericarditis (inflammation of the pericardium, the envelope surrounding the heart) or cardiac tamponade (accumulation of fluid in the pericardium that prevents the heart from functioning);
• 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 a reduced blood volume (hypovolemia);
• if you suffer from severe anemia (reduction of 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 a 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 a head injury or cerebral hemorrhage;
• if you have an eye disease that increases intraocular pressure called glaucoma;
• if you suffer from a condition in which blood pressure drops when you stand up (orthostatic dysfunction);
• If the level of oxygen in the blood is insufficient (hypoxemia) due to a lung condition or reduced blood supply to the heart (ischemic heart failure).

During therapy with Elan, especially in the initial stages, you may experience headache (cephalalgia)
which may also be severe and persistent.

Other medicines and Elan
Tell 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. The use of Elan with these medicines may cause a
dangerous drop in blood pressure. Do not stop
taking Elan to take phosphodiesterase inhibitors as this will increase the
likelihood of having an angina attack.
Tell your doctor if you are taking:

• medicines used to lower blood pressure (e.g. beta-blockers, calcium channel blockers, vasodilators, ACE inhibitors, monoamine oxidase inhibitors) because 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, there may be an excessive increase in blood pressure;
• 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 in combination with isosorbide-5-mononitrate, they may cause a drop in blood pressure.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice 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 may cause problems for
the newborn, if you are breastfeeding, inform your doctor.
Fertility
There are no data available on the effect of Elan on fertility in men.

Driving and operating machinery
Elan can affect your ability to react, to the point of 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 and do not use machinery until you have verified whether this
medicine affects your ability to perform these activities.

Elan contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

3. How to take Elan

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The tablet can be divided into equal parts.
Take the tablets after meals, with some water and without chewing.

Adults and the elderly
Elan 20 mg tablets
The recommended dose is one tablet two or three times a day.
Your doctor may increase the dose up to a maximum of 2 tablets three times a day.

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

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

If you take more Elan than you should
Possible symptoms of an Elan overdose are: drastic lowering of blood pressure, paleness,
sweating, weak pulse, rapid heartbeat, dizziness when standing up, headache,
weakness, dizziness, nausea, vomiting and diarrhea.
An increase in pressure in the head (intracranial pressure) with
consequent symptoms of brain suffering may also occur.
Cases of alteration of hemoglobin (metahemoglobinemia) with
consequent bluish discoloration of the lips, nails and skin (cyanosis), anxiety, loss of
consciousness and cardiac arrest have also been described.
Contact your doctor if you have taken more tablets than you should. The doctor will establish the
best possible treatment for the overdose.
However, in case of low blood pressure, it is important that you 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 doubts about the use of this medicine, consult your doctor or pharmacist; it is
necessary to discontinue the drug gradually because sudden interruption can
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 10 people)

• Dizziness (including postural dizziness)
• Somnolence
• Increased heart rate
• Sudden drop in blood pressure when moving from a sitting or lying position to standing (orthostatic hypotension)
• Feeling weak (asthenia)

Uncommon (may affect up to 1 in 100 people)

• Increased symptoms of angina (e.g. chest pain)
• Circulatory collapse sometimes with slowing of the heartbeat 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 available data)

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

Seek medical attention immediately if you experience:

• a severe drop in blood pressure with nausea, vomiting, agitation, paleness and excessive sweating
• or cyanosis (bluish color of the lips, nails and skin).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
web: 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 pack after Exp.:.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Elan contains
The active ingredient 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 ingredients are:
talc, lactose monohydrate, anhydrous colloidal silica, potato starch, microcrystalline cellulose,
aluminium stearate.

Description of the appearance of Elan and contents of the pack
Elan 20 mg tablets are white, round and flat with a beveled edge, a fracture line and
an inscription (E/20) on the upper side and rounded on the lower side.
Elan 40 mg tablets are white, round and flat with a beveled edge, a fracture line and
an inscription (E/40) on the upper side and rounded on the lower side.
The tablet can be divided into two equal parts.
Elan tablets are packaged in blisters inserted into cardboard boxes containing:

• 20 mg: 50, 60 tablets
• 40 mg: 30, 60 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 (Luxembourg)

Manufacturer
Aesica Pharmaceuticals GmbH
Alfred Nobel Strasse 10

• 40789 - Monheim Germany

Elan 50 mg prolonged-release hard capsules

Isosorbide-5-mononitrate
Equivalent Medicinal Product

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Elan is and what it is used for
• 2. What you need to know before you take Elan
• 3. How to take Elan
• 4. Possible side effects
• 5. How to store Elan
• 6. Contents of the pack and other information

1. What is Elan and what it is used for

Elan contains the active ingredient isosorbide mononitrate and belongs to a group of drugs
called organic nitrates which work by dilating both venous and peripheral arteries, reducing
the workload on the heart. They also work by dilating the blood vessels of the heart, allowing
thus an increase in blood supply to the area that needs it.
Elan is used as maintenance therapy in coronary insufficiency (when the vessels of the
heart, the coronary arteries, are unable to deliver enough blood to the heart muscle) and for
the prevention of angina pectoris attacks. Angina usually manifests as oppressive and constricting pain
in the chest, neck and/or left arm caused by a reduction in blood flow
to the heart walls.
Elan is indicated as treatment following a heart attack (cardiac attack with death of
cardiac muscle fibers).
Elan is also indicated as maintenance therapy in chronic heart failure (a condition
in which the heart fails to pump enough blood to meet the needs of the whole
body), even in association with other medicines that increase the strength of the heart (cardiotonics) and to
those that increase urine production, reducing circulating fluids (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 into the vessels adequately, such as cardiogenic shock (severe impairment of heart function), obstructive hypertrophic cardiomyopathy (increase in the volume of the heart walls leading to a reduction in its ability to contract and pump blood into the vessels), constrictive pericarditis (inflammation of the pericardium, the envelope surrounding the heart) or cardiac tamponade (accumulation of fluid in the pericardium that prevents the heart from functioning);
• 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 a reduced blood volume (hypovolemia);
• if you suffer from severe anemia (reduction of 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 problem with severe impairment of the heart's pumping function (heart attack with or without left ventricular failure);
• if you have a 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 a head injury or cerebral hemorrhage;
• if you have an eye disease that increases intraocular pressure called glaucoma;
• if you suffer from a condition in which blood pressure drops when you stand up (orthostatic dysfunction);
• If the level of oxygen in the blood is insufficient (hypoxemia) due to a lung disease or reduced blood supply to the heart (ischemic heart failure).

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

Other medicines and Elan
Tell 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. The use of Elan with these medicines may cause a
dangerous drop in blood pressure. Do not stop
taking Elan to take phosphodiesterase inhibitors as this will increase the
likelihood of having an angina attack.
Tell your doctor if you are taking:

• medicines used to lower blood pressure (e.g. beta-blockers, calcium channel blockers, vasodilators, ACE inhibitors, monoamine oxidase inhibitors) because 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, there may be an excessive increase in blood pressure;
• 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 in combination with isosorbide-5-mononitrate, they may cause a drop in blood pressure.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice 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 may cause problems for
the newborn, if you are breastfeeding, inform your doctor.
Fertility
There are no data available on the effect of Elan on fertility in men.

Driving and operating machinery
Elan can affect your ability to react, to the point of 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 and do not use machinery until you have verified whether this
medicine affects your ability to perform these activities.

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

3. How to take Elan

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor may decide to adjust the dosage to your needs.

Adults and the elderly
The recommended dose is one capsule once a day, in the morning, to be swallowed with a little water,
without chewing.
If you suffer from headache or low blood pressure (arterial hypotension), ask your doctor who may
start your treatment with one ELAN 20 mg tablet in the morning and evening.

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

If you take more Elan than you should
Possible symptoms of an Elan overdose are: drastic lowering of blood pressure, paleness,
sweating, weak pulse, rapid heartbeat, dizziness when standing up, headache,
weakness, dizziness, nausea, vomiting and diarrhea.
An increase in pressure in the head (intracranial pressure) with
consequent symptoms of brain suffering may also occur.
Cases of altered hemoglobin (metahemoglobinemia) with
consequent bluish discoloration of the lips, nails and skin (cyanosis), anxiety, loss of
consciousness and cardiac arrest have also been reported.
Contact your doctor if you have taken more capsules than you should. The doctor will establish the best
possible treatment for the overdose.
However, in case of low blood pressure, it is important that you 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 doubts about the use of this medicine, consult your doctor or pharmacist; it is
necessary to discontinue the drug gradually because sudden discontinuation 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 10 people)

• Dizziness (including postural dizziness)
• Somnolence
• Increased heart rate
• Sudden drop in blood pressure when moving from sitting or lying down to standing (orthostatic hypotension)
• Feeling weak (asthenia)

Uncommon (may affect up to 1 in 100 people)

• Increase in angina symptoms (e.g. chest pain)
• Circulatory collapse sometimes with slowing of the heartbeat 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 available data)

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

Seek medical attention immediately if you experience:

• a severe drop in blood pressure with nausea, vomiting, agitation, paleness and excessive sweating
• or cyanosis (bluish discoloration of the lips, nails and skin)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to
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 pack after Exp.: .
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Elan contains
The active ingredient is isosorbide mononitrate.
Each Elan 50 mg capsule contains 50 mg of isosorbide-5-mononitrate
The other ingredients are:

lactosemonohydrate, hydroxypropylcellulose, poly(ethyl)cellulose, macrogol 20000, talc,

sucrose, corn starch.
The head and body of the capsule contain: 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 head and an opaque flesh-colored body.
Elan capsules are packaged in blisters inserted into cardboard boxes containing:
30 or 40 prolonged-release hard capsules
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 (Luxembourg)

Manufacturer
Aesica Pharmaceuticals GmbH
Alfred Nobel Strasse 10

• 40789 - Monheim Germany