ИСОСОРБИД 50 мг Капсулы с модифицированным высвобождением

Содержание инструкции

1. ISOSORBIDE MONONITRATO EG 20 mg Tablets, 40 mg Tablets
   1. What ISOSORBIDE MONONITRATO EG is and what it is used for
   2. What you need to know before taking ISOSORBIDE MONONITRATO EG
   3. How to take ISOSORBIDE MONONITRATO EG
   4. Possible side effects
   5. How to store ISOSORBIDE MONONITRATO EG
   6. Contents of the pack and other information
2. ISOSORBIDE MONONITRATO EG 50 mg prolonged-release hard capsules
   1. What is ISOSORBIDE MONONITRATO EG and what it is used for
   2. What you need to know before taking ISOSORBIDE MONONITRATE EG
   3. How to take ISOSORBIDE MONONITRATO EG
   4. Possible side effects
   5. How to store ISOSORBIDE MONONITRATO EG
   6. Contents of the pack and other information
3. ISOSORBIDE MONONITRATO EG 60 mg prolonged-release tablets
   1. What ISOSORBIDE MONONITRATO EG is and what it is used for
   2. What you need to know before taking ISOSORBIDE MONONITRATE EG
   3. How to take ISOSORBIDE MONONITRATO EG
   4. Possible side effects
   5. How to store ISOSORBIDE MONONITRATO EG
   6. Contents of the pack and other information

ISOSORBIDE MONONITRATO EG 20 mg Tablets, 40 mg Tablets

Generic medicine

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 they have the same symptoms as you, as it may 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 ISOSORBIDE MONONITRATO EG is and what it is used for
• 2. What you need to know before you take ISOSORBIDE MONONITRATO EG
• 3. How to take ISOSORBIDE MONONITRATO EG
• 4. Possible side effects
• 5. How to store ISOSORBIDE MONONITRATO EG
• 6. Contents of the pack and other information

1. What ISOSORBIDE MONONITRATO EG is and what it is used for

ISOSORBIDE MONONITRATO EG contains the active ingredient isosorbide mononitrate, belonging to the
group of medicines called "organic nitrates". "Organic nitrates" are vasodilator medicines used in
heart diseases that relax blood vessels, facilitating blood flow to the heart.
ISOSORBIDE MONONITRATO EG is indicated

• in the maintenance therapy of heart disease characterized by an obstruction of the coronary arteries, blood vessels that carry blood to the heart (coronary insufficiency);
• in the prevention of angina pectoris attacks (heart disease that manifests with chest pain)
• treatment following a heart attack (myocardial infarction) and maintenance therapy of conditions in which the heart fails to pump an adequate amount of blood (chronic myocardial insufficiency) even in association with medicines capable of increasing the force of heart contraction (cardiotonics) and medicines used to treat high blood pressure (diuretics).

ISOSORBIDE MONONITRATO EG is not indicated in case of sudden chest pain
(angina pectoris attacks).

2. What you need to know before taking ISOSORBIDE MONONITRATO EG

Do not take ISOSORBIDE MONONITRATO EG if

• you are allergic to isosorbide mononitrate, organic nitrates or any of the other ingredients of this medicine (listed in section 6);
• you are having a heart attack;
• you suffer from severe circulatory problems (acute circulatory failure, shock, circulatory collapse);
• the heart suddenly fails to pump an adequate amount of blood (cardiogenic shock) unless sufficient blood pressure is maintained;
• you have very low blood pressure (severe arterial hypotension);
• you suffer from an increase in the thickness of the heart muscle with obstruction to normal blood flow (obstructive hypertrophic cardiomyopathy);
• you have a lower than normal amount of blood circulating (severe hypovolemia);
• you suffer from inflammation of the pericardium, the lining of the heart (constrictive pericarditis);
• you have an accumulation of fluid in the lining of the heart (cardiac tamponade); you suffer from increased blood pressure in the blood vessels of the lungs (primary pulmonary hypertension);
• you are taking medicines to treat erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil) (see section “Other medicines and ISOSORBIDE MONONITRATO EG”);
• you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and ISOSORBIDE MONONITRATO EG”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ISOSORBIDE MONONITRATO EG.
In particular, tell your doctor:

• if you have a disease characterized by high pressure inside the eye (glaucoma);
• if you have a severe decrease in red blood cell levels (marked anemia); if your thyroid gland produces high amounts of hormones (hyperthyroidism);
• if you have experienced a head injury (traumatic brain injury);
• in case of bleeding in the brain (cerebral hemorrhage); if you have a narrowing of the aorta (aortic stenosis) or the function of a heart valve is reduced (mitral stenosis);
• if you suffer from a drop in blood pressure when suddenly moving from a sitting to a standing position (orthostatic hypotension);
• if you suffer from increased pressure in the brain (intracranial hypertension);
• if you suffer from severe kidney problems (renal insufficiency);
• if you suffer from an alteration of the blood vessels that carry blood to the heart (coronary artery disease), as a condition may occur in which there is a lack of oxygen to the heart (myocardial ischemia); if you are taking medicines used to treat high blood pressure (calcium channel blockers); as this may increase the effect on lowering blood pressure of this medicine (hypotension);
• if you suffer from headaches (cephalalgia). As Isosorbide Mononitrate EG may cause, in the early stages of therapy, headaches that may be severe in sensitive individuals. Your doctor will prescribe lower doses of the medicine to avoid their occurrence;
• if you have blood circulation disorders (ischemia), heart damage (myocardial damage) and alteration of its activity (advanced congestive heart failure), as they may worsen with the use of Isosorbide Mononitrate EG;
• if you notice a bluish discoloration of the skin and mucous membranes (cyanosis), in the absence of a lung disease (pneumopathy). In these cases, a specific analysis (control of metahemoglobin levels) is necessary, especially during high-dose treatments (see section “If you take more Isosorbide Mononitrate EG than you should”).
• Avoid increasing the doses and avoid the use of this medicine at high doses and for prolonged treatments, as a decrease or loss of effectiveness may occur over time (tolerance).

Other medicines and ISOSORBIDE MONONITRATO EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if you are taking the following medicines, as they may enhance
the hypotensive effect (low blood pressure) of ISOSORBIDE MONONITRATO EG:

• medicines that lower blood pressure (e.g. beta-blockers, vasodilators, diuretics, calcium channel blockers, ACE inhibitors);
• medicines for mental disorders and/or depression (neuroleptics and tricyclic antidepressants);
• medicines used in the treatment of erectile dysfunction (e.g. sildenafil, vardenafil and tadalafil). The simultaneous use of ISOSORBIDE MONONITRATO EG with these medicines may be life-threatening;
• riociguat, a medicine used to treat pulmonary hypertension. Take particular care if you are taking: dihydroergotamine, a medicine used to treat headaches (cephalalgia);
• norepinephrine, used to treat low blood pressure;
• acetylcholine, a medicine used during some operations;
• histamine, a medicine used for diagnostic purposes (allergy tests).

ISOSORBIDE MONONITRATO EG with food, drinks and alcohol
The simultaneous consumption of alcohol can alter the ability to react and reduce reflexes, therefore avoid
the simultaneous use of alcohol (see section “Driving and operating machinery”).

Pregnancy and breastfeeding
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,
If you are pregnant or breastfeeding, the medicine should only be used if absolutely necessary
and under the direct supervision of your doctor.

Driving and operating machinery
ISOSORBIDE MONONITRATO EG may impair the ability to drive and operate machinery.
This effect may be enhanced by the consumption of alcohol.

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

ISOSORBIDE MONONITRATO EG 40 mg tablets containsyellow sunset FCF (E110).
May cause allergic reactions.

3. How to take ISOSORBIDE MONONITRATO EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The tablets should be taken after meals with some liquid, without chewing.
Unless otherwise prescribed by your doctor, the recommended dose is as follows:

ISOSORBIDE MONONITRATO EG 20 mg tablets
1 tablet 3 times a day. The dose may be increased to 2 tablets 3 times a day.

ISOSORBIDE MONONITRATO EG 40 mg tablets
1 tablet 2-3 times a day.
If you experience headache or a decrease in blood pressure, your doctor will advise you to take
lower doses at the beginning of therapy (half a tablet of ISOSORBIDE MONONITRATO EG in the morning and
in the evening).
The tablet can be divided into equal parts.
To divide the tablet, place the tablet on a hard surface with the notch facing up.
Apply slight pressure to the tablet with your thumb, the tablet will break into two equal parts
(see figure).

If you take more ISOSORBIDE MONONITRATO EG than you should

• If you accidentally take excessive doses of ISOSORBIDE MONONITRATO EG you may experience the following symptoms: reduction of blood pressure (value less than or equal to 90 mmHg);
• paleness;
• sweating;

• weak pulse;
• increased heart rate (tachycardia);
• dizziness, including dizziness when assuming the upright position;
• headache;
• weakness (asthenia);
• vertigo;
• nausea
• vomiting
• diarrhea;
• drowsiness;
• hot flashes;
• increased levels in the blood of a substance called methemoglobin (methemoglobinemia) and bluish discoloration of the skin and mucous membranes (cyanosis) accompanied by increased respiratory rate, anxiety, loss of consciousness and blockage of heart function. In case of ingestion/taking an excessive dose of ISOSORBIDE MONONITRATO EG, immediately inform your doctor or go to the nearest hospital.

If you forget to take ISOSORBIDE MONONITRATO EG
Do not take a double dose to make up for a missed tablet.

If you stop taking ISOSORBIDE MONONITRATO EG
Do not stop this medicine without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• headache. If you experience this effect, inform your doctor, who may start therapy with increasing doses. The headache generally disappears as therapy continues.

Common (may affect up to 1 in 10 people)

• nausea. At the beginning of treatment or with an increase in doses, you may experience:
• dizziness (including postural dizziness, which worsens depending on position);
• drowsiness;
• increased heart rate (reflex tachycardia);
• lowering of blood pressure when suddenly moving from a sitting or lying position to standing (orthostatic hypotension);
• weakness (asthenia), which generally disappears as therapy continues. Uncommon (may affect up to 1 in 100 people)
• worsening of chest pain (angina pectoris);
• severe decrease in blood pressure (circulatory collapse), sometimes accompanied by slow and irregular heartbeat (brady-arrhythmia) and fainting (syncope);
• vomiting;
• diarrhea;
• allergic skin reactions (e.g., allergic dermatitis);
• flushing.

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

• burning sensation in the chest (pyrosis);
• muscle pain (myalgia).

Not known (frequency cannot be estimated from available data)

• low blood pressure (hypotension);
• skin inflammation with skin peeling (exfoliative dermatitis);
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema);
• reduction or loss of the therapeutic effect of this medicine or other organic nitrates (development of tolerance).

During treatment with isosorbide mononitrate, a temporary reduction in oxygen levels in the
blood may occur due to circulatory disorders, which can cause heart
problems (myocardial hypoxia). In addition, you may experience nausea, vomiting, agitation, paleness and excessive sweating
due to a severe drop in blood pressure.

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 through the national
reporting system at 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 ISOSORBIDE MONONITRATO EG

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 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 ISOSORBIDE MONONITRATO EG 20 mg tablets contain

• The active ingredient is isosorbide mononitrate. Each tablet contains 20 mg of isosorbide mononitrate.
• The other ingredients are lactose, talc, anhydrous colloidal silica, corn starch, microcrystalline cellulose, aluminium stearate.

What ISOSORBIDE MONONITRATO EG 40 mg tablets contain

• The active ingredient is isosorbide mononitrate. Each tablet contains 40 mg of isosorbide mononitrate.
• The other ingredients are lactose, talc, anhydrous colloidal silica, corn starch, microcrystalline cellulose, aluminium stearate, sunset yellow FCF (E110).

Description of the appearance of ISOSORBIDE MONONITRATO EG and contents of the pack
ISOSORBIDE MONONITRATO EG 20 mg tablets
Pack of 50 tablets for oral use.
ISOSORBIDE MONONITRATO EG 40 mg tablets
Pack of 30 tablets for oral use.

Marketing Authorisation Holder
EG S.p.A.
Via Pavia, 6
20136 Milano
Italy

Manufacturer
MIPHARM S.p.A.
Via B. Quaranta, 12
20141 Milano
Italy

ISOSORBIDE MONONITRATO EG 50 mg prolonged-release hard capsules

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

1. What is ISOSORBIDE MONONITRATO EG and what it is used for

ISOSORBIDE MONONITRATO EG contains the active ingredient isosorbide mononitrate, belonging to the
group of medicines called “organic nitrates”. “Organic nitrates” are vasodilator medicines used in
heart diseases that relax blood vessels, facilitating blood flow to the heart.
ISOSORBIDE MONONITRATO EG is indicated

• in the maintenance therapy of heart disease characterized by an obstruction of the coronary arteries, blood vessels that carry blood to the heart (coronary insufficiency);
• in the prevention of angina pectoris attacks (heart disease that manifests with chest pain)
• treatment following a heart attack (myocardial infarction) and maintenance therapy of conditions in which the heart fails to pump an adequate amount of blood (chronic myocardial insufficiency) even in association with medicines capable of increasing the force of heart contraction (cardiotonics) and medicines used to treat high blood pressure (diuretics). ISOSORBIDE MONONITRATO EG is not indicated in case of sudden chest pain attacks (angina pectoris attacks).

2. What you need to know before taking ISOSORBIDE MONONITRATE EG

Do not take ISOSORBIDE MONONITRATE EG if

• you are allergic to isosorbide mononitrate, organic nitrates or any of the other ingredients of this medicine (listed in section 6);
• you are having a heart attack;
• you suffer from severe circulatory problems (acute circulatory failure, shock, circulatory collapse);
• your heart suddenly fails to pump an adequate amount of blood (cardiogenic shock) unless sufficient blood pressure is maintained;
• you have very low blood pressure (severe arterial hypotension);
• you suffer from an increase in the thickness of the heart muscle with obstruction to normal blood flow (obstructive hypertrophic cardiomyopathy);
• you have a lower than normal amount of blood circulating (severe hypovolemia);
• you suffer from inflammation of the pericardium, the lining of the heart (constrictive pericarditis);
• you have an accumulation of fluid in the lining of the heart (cardiac tamponade); you suffer from increased blood pressure in the blood vessels of the lungs (primary pulmonary hypertension);
• you are taking medicines to treat erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil) (see section “Other medicines and ISOSORBIDE MONONITRATE EG”);
• you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and ISOSORBIDE MONONITRATE EG”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ISOSORBIDE MONONITRATE EG.
In particular, tell your doctor:

• if you have a disease characterized by high pressure inside the eye (glaucoma);
• if you have a severe decrease in the levels of red blood cells (marked anemia); if your thyroid gland produces high amounts of hormones (hyperthyroidism);
• if you have experienced a head injury (traumatic brain injury);
• in case of bleeding in the brain (cerebral hemorrhage); if you have a narrowing of the aorta (aortic stenosis) or the function of a heart valve is reduced (mitral stenosis);
• if you suffer from a drop in blood pressure when suddenly moving from a sitting to a standing position (orthostatic hypotension);
• if you suffer from high pressure in the brain (increased intracranial pressure);
• if you suffer from severe kidney problems (renal insufficiency);
• if you suffer from an alteration of the blood vessels that carry blood to the heart (coronary artery disease), as a condition may occur in which there is a lack of oxygen to the heart (myocardial ischemia); if you are taking medicines used to treat high blood pressure (calcium antagonists); as this may increase the effect on lowering blood pressure of this medicine (hypotension);
• if you suffer from headaches (cephalalgia). As Isosorbide Mononitrate EG may cause, in the early periods of therapy, headaches that may be severe in sensitive individuals. Your doctor will prescribe lower doses of the medicine to avoid their occurrence;
• if you have blood circulation disorders (ischemia), heart damage (myocardial damage) and impairment of its activity (advanced congestive heart failure), as they may worsen with the use of Isosorbide Mononitrate EG;
• if you notice a bluish discoloration of the skin and mucous membranes (cyanosis), in the absence of a lung disease (pneumopathy). In these cases, a specific analysis (metahemoglobin levels check) is necessary, especially during high-dose treatments (see section “If you take more Isosorbide Mononitrate EG than you should”).
• Avoid increasing the doses and avoid the use of this medicine at high doses and for prolonged treatments, as a decrease or loss of efficacy may occur over time (tolerance).

Other medicines and ISOSORBIDE MONONITRATE EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if you are taking the following medicines, as they may enhance
the hypotensive effect (low blood pressure) of ISOSORBIDE MONONITRATE EG:

• medicines that lower blood pressure (e.g. beta-blockers, vasodilators, diuretics, calcium antagonists, ACE inhibitors);
• medicines for mental disorders and/or depression (neuroleptics and tricyclic antidepressants);
• medicines used in the treatment of erectile dysfunction (e.g. sildenafil, vardenafil and tadalafil). The concurrent use of ISOSORBIDE MONONITRATE EG with these medicines may be life-threatening;
• riociguat, a medicine used to treat pulmonary hypertension.

Pay particular attention if you are taking:
dihydroergotamine, a medicine used to treat headaches (cephalalgia);

• norepinephrine, used to treat low blood pressure;
• acetylcholine, a medicine used during some operations;
• histamine, a medicine used for diagnostic purposes (allergy tests).

ISOSORBIDE MONONITRATE EG with food, drinks and alcohol
The simultaneous consumption of alcohol can impair reaction ability and reduce reflexes, therefore avoid
the concurrent use of alcohol (see section “Driving and using machines”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine,
If you are pregnant or breastfeeding, the medicine should only be used if absolutely necessary
and under the direct supervision of your doctor.

Driving and using machines
ISOSORBIDE MONONITRATE EG may impair the ability to drive vehicles and use machines.
This effect may be enhanced by the consumption of alcohol.

ISOSORBIDE MONONITRATE EG contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take ISOSORBIDE MONONITRATO EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The capsules should be taken with some liquid, without chewing.
Unless otherwise prescribed by your doctor, the recommended dose is one capsule in the morning:

If you take more ISOSORBIDE MONONITRATO EG than you should
If you accidentally take excessive doses of ISOSORBIDE MONONITRATO EG you may experience the
following symptoms:

• reduction of blood pressure (value less than or equal to 90 mmHg)
• paleness;
• sweating;
• weak pulse;
• increased heart rate (tachycardia);
• dizziness including dizziness when assuming an upright position;
• headache;
• weakness (asthenia);
• vertigo;
• nausea
• vomiting
• diarrhea;
• drowsiness;
• hot flashes;
• increase
• in the blood of levels of a substance called methemoglobin (methemoglobinemia) and bluish discoloration of the skin and mucous membranes (cyanosis) accompanied by increased respiratory rate, anxiety, loss of consciousness and blockage of heart function.

In case of ingestion/taking of an excessive dose of ISOSORBIDE MONONITRATO EG, immediately
inform your doctor or go to the nearest hospital.

If you forget to take ISOSORBIDE MONONITRATO EG
Do not take a double dose to make up for the forgotten capsule.

If you stop taking ISOSORBIDE MONONITRATO EG
Do not stop this medicine without consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• headache (cephalalgia). If you experience this effect, inform your doctor, who may start therapy with increasing doses. The headache generally disappears as therapy continues.

Common (may affect up to 1 in 10 people)

• nausea. At the beginning of treatment or with an increase in doses, you may experience:
• dizziness (including postural dizziness, which worsens depending on position);
• drowsiness;
• increased heart rate (reflex tachycardia);
• lowering of blood pressure when suddenly moving from a sitting or lying position to standing (orthostatic hypotension);
• weakness (asthenia), which generally disappears as therapy continues.

Uncommon (may affect up to 1 in 100 people)

• worsening of chest pain (angina pectoris);
• severe decrease in blood pressure (circulatory collapse), sometimes accompanied by slow and irregular heartbeat (brady-arrhythmia) and fainting (syncope);
• vomiting;
• diarrhea;
• allergic skin reactions (e.g., allergic dermatitis);
• flushing.

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

• burning in the chest (pyrosis);
• muscle pain (myalgia).

Not known (frequency cannot be estimated from available data)

• low blood pressure (hypotension);
• skin inflammation with skin peeling (exfoliative dermatitis);
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema);
• reduction or loss of the therapeutic effect of this medicine or other organic nitrates (development of tolerance).

During treatment with isosorbide mononitrate, a temporary reduction in oxygen levels in the
blood may occur due to circulatory disorders that can cause heart problems
(myocardial hypoxia). In addition, you may experience nausea, vomiting, agitation, paleness and excessive sweating
due to a severe drop in blood pressure.

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 through the national
reporting system at 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 ISOSORBIDE MONONITRATO EG

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 30°C.
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 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 ISOSORBIDE MONONITRATO EG contains
The active ingredient is isosorbide mononitrate. Each capsule contains 50 mg of isosorbide mononitrate.

• The other ingredients are sucrose, corn starch, shellac, ethylcellulose, talc, povidone K30, sugar spheres.
• The components of the capsule shell are gelatin, titanium dioxide (E 171), erythrosine (E 127), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172).

Description of the appearance of ISOSORBIDE MONONITRATO EG and contents of the pack
Pack of 30 hard prolonged-release capsules.

Marketing Authorisation Holder
EG S.p.A.
Via Pavia, 6
20136 Milano
Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno n. 48
20089 Quinto Dè Stampi
Rozzano (MI)
Italy
STADA Arzneimittel AG
Stadastrasse 2
18, 61118 Bad Vilbel
Germany

ISOSORBIDE MONONITRATO EG 60 mg prolonged-release tablets

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 they have the same symptoms as you, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ISOSORBIDE MONONITRATO EG is and what it is used for

ISOSORBIDE MONONITRATO EG contains the active ingredient isosorbide mononitrate, belonging to the
group of medicines called “organic nitrates”. “Organic nitrates” are vasodilator medicines used in
heart diseases that relax blood vessels, facilitating blood flow to the heart.
ISOSORBIDE MONONITRATO EG is indicated

• in the maintenance therapy of heart disease characterized by an obstruction of the coronary arteries, blood vessels that carry blood to the heart (coronary insufficiency);
• in the prevention of angina pectoris attacks (heart disease that manifests with chest pain)
• treatment following a heart attack (myocardial infarction) and maintenance therapy of conditions in which the heart fails to pump an adequate amount of blood (chronic myocardial insufficiency) even in association with medicines capable of increasing the force of heart contraction (cardiotonics) and with medicines used to treat high blood pressure (diuretics).

ISOSORBIDE MONONITRATO EG is not indicated in case of sudden chest pain
attacks (angina pectoris attacks).

2. What you need to know before taking ISOSORBIDE MONONITRATE EG

Do not take ISOSORBIDE MONONITRATE EG if

• you are allergic to isosorbide mononitrate, organic nitrates or any of the other ingredients of this medicine (listed in section 6);
• you are having a heart attack;
• you suffer from severe circulatory problems (acute circulatory failure, shock, circulatory collapse);
• your heart suddenly fails to pump an adequate amount of blood (cardiogenic shock) unless sufficient blood pressure is maintained;
• you have very low blood pressure (severe arterial hypotension);
• you suffer from an increase in the thickness of the heart muscle with obstruction to normal blood flow (obstructive hypertrophic cardiomyopathy);
• you have a lower than normal amount of circulating blood (severe hypovolemia);
• you suffer from inflammation of the pericardium, the lining of the heart (constrictive pericarditis);
• you have a build-up of fluid in the lining of the heart (cardiac tamponade); you suffer from increased blood pressure in the blood vessels of the lungs (primary pulmonary hypertension);
• you are taking medicines to treat erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil) (see section “Other medicines and ISOSORBIDE MONONITRATE EG”);
• you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and ISOSORBIDE MONONITRATE EG”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ISOSORBIDE MONONITRATE EG.
In particular, tell your doctor:

• if you have a disease characterized by high pressure inside the eye (glaucoma);
• if you have a severe decrease in the levels of red blood cells (marked anemia); if your thyroid gland produces high amounts of hormones (hyperthyroidism);
• if you have experienced a head injury (traumatic brain injury);
• in case of bleeding in the brain (cerebral hemorrhage); if you have a narrowing of the aorta (aortic stenosis) or the function of a heart valve is reduced (mitral stenosis);
• if you suffer from a drop in blood pressure after suddenly moving from a sitting to a standing position (orthostatic hypotension);
• if you suffer from high pressure in the brain (increased intracranial pressure);
• if you suffer from severe kidney problems (renal failure);
• if you suffer from an alteration of the blood vessels that carry blood to the heart (coronary artery disease), as a condition may occur in which there is a lack of oxygen to the heart (myocardial ischemia); if you are taking medicines used to treat high blood pressure (calcium channel blockers); as they may increase the effect on lowering blood pressure of this medicine (hypotension);
• if you suffer from headaches (cephalalgia). As Isosorbide Mononitrate EG may cause, in the early stages of therapy, headaches that may be severe in sensitive individuals. Your doctor will prescribe lower doses of the medicine to avoid their occurrence;
• if you have blood circulation disorders (ischemia), heart damage (myocardial damage) and impairment of its activity (advanced congestive heart failure), as they may worsen with the use of Isosorbide Mononitrate EG;
• if you notice a bluish discoloration of the skin and mucous membranes (cyanosis), in the absence of a lung disease (pneumopathy). In these cases, a specific analysis (metahemoglobin level check) is necessary, especially during high-dose treatments (see section “If you take more Isosorbide Mononitrate EG than you should”).
• Avoid increasing the doses and avoid the use of this medicine at high doses and for prolonged treatments, as a decrease or loss of efficacy may occur over time (tolerance).

Other medicines and ISOSORBIDE MONONITRATE EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if you are taking the following medicines, as they may enhance
the hypotensive effect (low blood pressure) of ISOSORBIDE MONONITRATE EG:

• medicines that lower blood pressure (e.g. beta-blockers, vasodilators, diuretics, calcium channel blockers, ACE inhibitors);
• medicines for mental disorders and/or depression (neuroleptics and tricyclic antidepressants);
• medicines used in the treatment of erectile dysfunction (e.g. sildenafil, vardenafil and tadalafil). The concurrent use of ISOSORBIDE MONONITRATE EG with these medicines may be life-threatening;
• riociguat, a medicine used to treat pulmonary hypertension.

Pay particular attention if you are taking:
dihydroergotamine, a medicine used to treat headaches (cephalalgia);

• norepinephrine, used to treat low blood pressure;
• acetylcholine, a medicine used during some operations;
• histamine, a medicine used for diagnostic purposes (allergy tests).

ISOSORBIDE MONONITRATE EG with food, drinks and alcohol
The simultaneous consumption of alcohol may alter the ability to react and reduce reflexes, therefore avoid
the simultaneous use of alcohol (see section “Driving and using machines”).

Pregnancy and breastfeeding
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.
If you are pregnant or breastfeeding, the medicine should only be used if absolutely necessary and under the direct supervision of your doctor.

Driving and using machines
ISOSORBIDE MONONITRATE EG may impair the ability to drive and use machines.
This effect may be enhanced by the consumption of alcohol.

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

3. How to take ISOSORBIDE MONONITRATO EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The tablets should be taken after meals with some liquid, without chewing.
The recommended dose is
1 tablet a day, taken in the morning unless otherwise prescribed by your doctor. Do not chew the tablets, take
them with half a glass of water after meals; to facilitate swallowing, the tablet can be divided
into 2 parts.
If you experience headache or a decrease in blood pressure, your doctor will advise you to take
lower doses at the beginning of therapy and then gradually increase the dose. If you experience pain with
a feeling of oppression in the chest, especially in the morning, your doctor will prescribe you to take one
40 mg tablet in the morning and one 20 mg tablet in the evening.
If you need to divide the tablet, you should place it on a rigid surface with the part with the notch
facing upwards. With light pressure from your thumb, break the tablet into two equal parts.

If you take more ISOSORBIDE MONONITRATO EG than you should
If you accidentally take excessive doses of ISOSORBIDE MONONITRATO EG you may experience the
following symptoms:

• reduction of blood pressure (value less than or equal to 90 mmHg);
• paleness;
• sweating;
• weak pulse;
• increased heart rate (tachycardia);
• dizziness, including dizziness when assuming an upright position;
• headache;
• weakness (asthenia);
• nausea
• vomiting
• diarrhea;
• drowsiness;
• hot flashes;
• increase
• in the blood levels of a substance called methemoglobin (methemoglobinemia) and bluish discoloration of the skin and mucous membranes (cyanosis) accompanied by increased respiratory rate, anxiety, loss of consciousness and blockage of heart function.

In case of ingestion/taking an excessive dose of ISOSORBIDE MONONITRATO EG, immediately inform
your doctor or go to the nearest hospital.

If you forget to take ISOSORBIDE MONONITRATO EG
Do not take a double dose to make up for a missed tablet.

If you stop taking ISOSORBIDE MONONITRATO EG
Do not stop this medicine without consulting your doctor.

4. Possible side effects

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

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

• headache. If you experience this effect, inform your doctor, who may start therapy with increasing doses. The headache generally disappears during continued therapy.

Common (may affect up to 1 in 10 people)

• nausea. At the beginning of treatment or with an increase in doses, you may experience:
• dizziness (including postural dizziness, which worsens based on position);
• drowsiness;
• increased heart rate (reflex tachycardia);
• lowering of blood pressure after suddenly moving from a sitting to a standing position (orthostatic hypotension);
• weakness (asthenia), which generally disappears during continued therapy.

Uncommon (may affect up to 1 in 100 people)

• worsening of chest pain (angina pectoris);
• severe decrease in blood pressure (circulatory collapse), sometimes accompanied by slow and irregular heartbeat (brady-arrhythmia) and fainting (syncope);
• vomiting;
• diarrhea;
• allergic skin reactions (e.g., allergic dermatitis);
• redness.

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

• burning in the chest (pyrosis);
• muscle pain (myalgia).

Not known (frequency cannot be estimated from available data)

• low blood pressure (hypotension);
• skin inflammation with skin peeling (exfoliative dermatitis);
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing (angioedema);
• reduction or loss of the therapeutic effect of this medicine or other organic nitrates (development of tolerance).

During treatment with isosorbide mononitrate, a temporary reduction in oxygen levels in the
blood due to circulatory disorders may occur, which can cause heart problems
(myocardial hypoxia). In addition, you may experience nausea, vomiting, agitation, paleness and excessive sweating
due to a severe drop in blood pressure.

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 through the national
reporting system at 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 ISOSORBIDE MONONITRATO EG

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 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 ISOSORBIDE MONONITRATO EG contains
The active ingredient is isosorbide mononitrate. Each tablet contains 60 mg of isosorbide mononitrate.

• The other ingredients are stearic acid, carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica, talc, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).

Description of the appearance of ISOSORBIDE MONONITRATO EG and contents of the pack
Pack of 30 prolonged-release tablets for oral use.

Marketing Authorisation Holder
EG S.p.A.
Via Pavia, 6
20136 Milano
Italy

Manufacturer
Lamp S. Prospero S.p.A.

• S. Prospero S/Secchia Modena Italy