Monoket: detailed information

Package leaflet: Information for the patient

Monoket 20 mg tablets, 40 mg tablets

Isosorbide-5-mononitrate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

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

Contents of this leaflet:

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

1. What Monoket is and what it is used for

Monoket contains the active substance isosorbide-5-mononitrate, which belongs to a group of medicines called "organic nitrates".
"Organic nitrates" are vasodilator medicines used in heart diseases; they relax blood vessels, thus facilitating blood flow supplying nutrients to the heart.
Monoket is indicated:

for the maintenance treatment of heart disease characterized by obstruction of the coronary arteries, the blood vessels supplying blood to the heart (coronary insufficiency);
for the prevention of heart attacks in heart disease presenting with chest pain (angina pectoris), which may occur following a myocardial infarction, possibly accompanied by weakening of the heart (heart failure), either alone or in combination with medicines able to increase the force of heart contraction (cardiotonics) and medicines used to treat high blood pressure (diuretics).

Monoket is not indicated for sudden attacks of chest pain (acute angina pectoris attacks).

2. What you need to know before taking Monoket

Do not take Monoket if:

you are allergic to isosorbide-5-mononitrate, organic nitrates, or any of the other ingredients of this medicine (listed in section 6);
you are currently having a heart attack;
you have a marked drop in blood pressure (which may occur in many serious conditions such as circulatory collapse, cardiogenic shock, hypovolemia);
you suffer from thickening of the heart muscle with obstruction to normal blood flow (obstructive hypertrophic cardiomyopathy);
you have a disease affecting the lining of the heart, i.e. the pericardium (in particular, constrictive pericarditis, cardiac tamponade);
you suffer from high blood pressure in the blood vessels of the lungs (primary pulmonary hypertension);
you are taking medicines for erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil) (see section “Other medicines and Monoket”);
you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and Monoket”).

Warnings and precautions
Talk to your doctor before taking Monoket.
In particular, inform your doctor:

if you suffer from eye disease caused by increased pressure of the fluid inside the eye (glaucoma);
if you suffer from severe reduction in hemoglobin in the blood, the substance that carries oxygen in the blood (marked anemia);
if you suffer from overactivity of a gland known as the “thyroid”, leading to increased levels in the blood of certain hormones called “thyroid hormones” (hyperthyroidism);
if you have head injuries (cranial trauma);
if you have bleeding in the brain due to rupture of a blood vessel (cerebral hemorrhage);
if you have narrowing (stenosis) of a heart valve;
if you are prone to low blood pressure upon sudden change from sitting to standing position (orthostatic hypotension);
if you suffer from high blood pressure in the brain (increased intracranial pressure);
if you have kidney disease (renal failure);
if you suffer from diseases of the heart's blood vessels (coronary artery disease), as lack of oxygen to the heart may occur due to an abnormal decrease in oxygen content in the blood (transient hypoxemia).

Following treatment with high doses and/or prolonged treatment:

bluish discoloration of the skin and mucous membranes (cyanosis) may occur;
a reduction or loss of effect of this medicine may occur. Reduced effectiveness may also occur if you have previously been treated with another organic nitrate (a medicine similar to Monoket).

IN ALL THESE CASES, CONSULT YOUR DOCTOR, WHO MAY PRESCRIBE AN
APPROPRIATE THERAPY.
Other medicines and Monoket
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines, as they may enhance the hypotensive effect (low blood pressure) of Monoket:

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). Concurrent use of Monoket with these medicines may be life-threatening;
riociguat, a medicine used to treat pulmonary hypertension.

Also inform your doctor if you are taking:

dihydroergotamine (a medicine mainly used to treat headache), as concomitant administration with Monoket may increase blood levels and the effect of dihydroergotamine.

Monoket with food, drinks and alcohol
Consuming alcohol at the same time may impair reaction abilities and reduce reflexes; therefore, avoid using alcohol concurrently (see section “Driving and use of machinery”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine, considering that adequate studies in pregnant or breastfeeding women have not been conducted.
Driving and use of machinery
Monoket may impair reaction abilities and reduce reflexes while driving vehicles and operating machinery. This effect may be enhanced by alcohol consumption.
Monoket contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact him before taking this medicine.

3. How to take Monoket

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor.
The tablets should be taken after meals with some liquid, without chewing them.
The tablet can be divided into equal parts.
To split the tablet, place it on a hard surface with the score side facing upwards. Gently press your thumb on the tablet; it will break into two equal parts (see figure).

Unless otherwise prescribed by your doctor, the recommended dose is as follows:
Monoket 20 mg tablets

1–2 tablets 3 times a day.

Monoket 40 mg tablets

1 tablet 2–3 times a day. If you experience headache or low blood pressure, your doctor will instruct you to start treatment with lower doses (half a tablet of MONOKET in the morning and evening).

If you take more Monoket than you should
If you accidentally take too much Monoket, you may experience the following symptoms:

low blood pressure (value less than and/or equal to 90 mmHg)
paleness
sweating
weak pulse
increased heart rate (tachycardia)
dizziness, including dizziness upon standing
headache (cephalalgia)
weakness (asthenia)
nausea
vomiting
diarrhoea
drowsiness
hot flushes
increased levels in the blood of a substance called methaemoglobin (methaemoglobinaemia) and bluish discoloration of the skin and mucous membranes (cyanosis).

If you have taken an excessive dose of Monoket, contact your doctor immediately or go to the nearest hospital.
If you forget to take Monoket
Do not take a double dose to make up for the forgotten tablet.
If you stop treatment with Monoket
If you have any questions about using this medicine, consult your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Following the instructions contained in this leaflet reduces the risk of 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 your treatment with gradually increasing doses. Headache usually disappears during continued treatment.

Common (may affect up to 1 in 10 people)

Nausea. At the beginning of treatment or when the dose is increased, you may experience:
Dizziness (including postural dizziness, which worsens with position);
Drowsiness;
Increased heart rate (reflex tachycardia);
Drop in blood pressure upon sudden change from sitting to standing position (orthostatic hypotension);
Weakness (asthenia), which usually disappear during continued treatment.

Uncommon (may affect up to 1 in 100 people)

Worsening of chest pain (angina pectoris);
Severe drop in blood pressure (circulatory collapse), sometimes accompanied by slow and irregular heartbeat (brady-arrhythmia) and fainting (syncope);
Vomiting;
Diarrhoea;
Skin allergic reactions (e.g. rash);
Flushing. If you experience this effect, inform your doctor, who may start your treatment with gradually increasing doses.

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 the available data)

Low blood pressure (hypotension);
Skin inflammation with skin peeling (exfoliative dermatitis);
Reduced or lost therapeutic effect of this medicine or other organic nitrates (development of tolerance).

Additionally, the following side effects may occur, for which frequency is not known.
Effects related to the respiratory system

Condition in which blood is not adequately oxygenated (temporary hypoxia).

Effects related to the heart

"Paradoxical effect" with worsening of heart condition (increased ischemia, increased damage, onset of heart failure, hypoxia);
Bluish discoloration of the skin and mucous membranes (cyanosis). This effect may be due to increased levels in the blood of a substance called methaemoglobin (methaemoglobinaemia).

Effects related to the skin

Excessive sweating;
Swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in breathing and swallowing (angioedema).

Effects related to blood vessels

Pallor;
Ischaemia (reduced blood supply to an organ).

Effects related to the nervous system

Agitation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via 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 Monoket

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after the word
EXP. The expiry date refers to the last day of that month.
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 Monoket contains
MONOKET 20 mg tablets

The active substance is: isosorbide-5-mononitrate 20 mg
The other components are: lactose, microcrystalline cellulose, maize starch, talc, stearic acid aluminum salt, hydrated colloidal silica.

MONOKET 40 mg tablets

The active substance is: isosorbide-5-mononitrate 40 mg
The other components are: lactose, microcrystalline cellulose, maize starch, talc, stearic acid aluminum salt, hydrated colloidal silica, E 110 aluminum lake.

Description of the appearance of Monoket and contents of the pack
Monoket 20 mg tablets
Monoket 20 mg is supplied as tablets, packaged in blisters in a carton containing 50 tablets.
Monoket 40 mg tablets
Monoket 40 mg is supplied as tablets, packaged in blisters in a carton containing 30 tablets.

Marketing Authorization Holder and Manufacturers
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy

Manufacturers
CHIESI FARMACEUTICI S.p.A, Via S. Leonardo 96, 43122 Parma - Italy
Fine Foods & Pharmaceuticals N.T.M. S.p.A. Via Grignano 43, 24041 Brembate (BG) - Italy

Patient Information Leaflet

Monoket 60 mg modified-release tablets

Isosorbide-5-mononitrate
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.
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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Monoket is and what it is used for

Monoket contains the active substance isosorbide-5-mononitrate, which belongs to a group of medicines called "organic nitrates".
"Organic nitrates" are vasodilator medicines used in heart diseases; they relax blood vessels, thereby improving blood flow carrying nutrients to the heart.

Monoket is indicated:

for the maintenance treatment of heart disease characterized by obstruction of the coronary arteries, the blood vessels supplying blood to the heart (coronary insufficiency);
for the prevention of angina attacks—chest pain caused by heart disease—which may occur after a heart attack, possibly accompanied by weakening of the heart (heart failure), either alone or in combination with medicines that increase the heart's contractile force (cardiotonics) and medicines used to treat high blood pressure (diuretics).

Monoket is not indicated for sudden attacks of chest pain (acute angina pectoris attacks).

2. What you should know before taking Monoket

Do not take Monoket if:

you are allergic to isosorbide-5-mononitrate, organic nitrates, or any of the other ingredients of this medicine (listed in section 6);
you are currently having a heart attack;
you have a marked drop in blood pressure (which may occur in many serious conditions such as circulatory collapse, cardiogenic shock, hypovolemia);
you suffer from thickening of the heart muscle with obstruction to normal blood flow (obstructive hypertrophic cardiomyopathy);
you have a disease affecting the lining of the heart, known as pericardium (particularly constrictive pericarditis, cardiac tamponade);
you suffer from high blood pressure in the blood vessels of the lungs (primary pulmonary hypertension);
you are taking medicines for erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil) (see section “Other medicines and Monoket”);
you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and Monoket”).

Warnings and precautions
Talk to your doctor before taking Monoket.
In particular, inform your doctor:

if you suffer from an eye disease caused by increased pressure of the fluid inside the eye (glaucoma);
if you suffer from severe reduction in hemoglobin in the blood, the substance that carries oxygen in the blood (marked anemia);
if you suffer from overactivity of a gland called the “thyroid”, leading to increased levels in the blood of certain hormones known as “thyroid hormones” (hyperthyroidism);
in case of head injury (cranial trauma);
in case of bleeding in the brain due to rupture of a blood vessel (cerebral hemorrhage);
if you have narrowing (stenosis) of a heart valve;
if you are prone to low blood pressure upon sudden change from sitting to standing position (orthostatic hypotension);
if you suffer from increased blood pressure in the brain (intracranial hypertension);
if you have kidney disease (renal failure);
if you suffer from slow intestinal transit and reduced ability to move food through the intestine, as this may reduce the effect of the medicine;
if you suffer from diseases of the blood vessels of the heart (coronary artery disease), as this may lead to insufficient oxygen supply to the heart due to a temporary decrease in oxygen content in the blood (transient hypoxemia).

Following treatment with high doses and/or prolonged treatment:

you may develop a bluish discoloration of the skin and mucous membranes (cyanosis);
you may experience reduced or lost effect of this medicine. Reduced effectiveness may also occur after prior treatment with another organic nitrate (a medicine similar to Monoket).

IN ALL THESE CASES, CONSULT YOUR DOCTOR, WHO MAY PRESCRIBE AN
APPROPRIATE THERAPY.

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

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 to treat erectile dysfunction (e.g. sildenafil, vardenafil, and tadalafil). Concomitant use of Monoket with these medicines may be life-threatening;
riociguat, a medicine used to treat pulmonary hypertension.

Additionally, inform your doctor if you are taking:

dihydroergotamine (a medicine mainly used to treat headache), as concomitant administration with Monoket may increase blood levels and the effect of dihydroergotamine.

Monoket with food, drinks, and alcohol
Consuming alcohol at the same time may impair reaction abilities and reduce reflexes; therefore, avoid using alcohol together with this medicine (see section “Driving and use of machines”).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine, as there are no adequate studies conducted in pregnant or breastfeeding women.

Driving and use of machines
Monoket may impair reaction abilities and reduce reflexes while driving or operating machinery. This effect may be worsened by alcohol consumption.

Monoket contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.

3. How to take Monoket

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor.
The tablets should be taken with some liquid, without chewing; to facilitate swallowing, the tablet may be divided into 3 parts.
Unless otherwise prescribed by your doctor, the recommended dose is 1 tablet in the morning.
If you experience headache or low blood pressure, your doctor may advise you to start treatment with lower doses and gradually increase the dose.
If you experience chest pain with a sensation of pressure, particularly in the morning, your doctor may prescribe you to take 2/3 of a tablet (40 mg) in the morning and 1/3 of a tablet (20 mg) in the evening.

If you take more Monoket than you should
If you accidentally take an excessive dose of Monoket, you may experience the following symptoms:

low blood pressure (value less than and/or equal to 90 mmHg)
paleness
sweating
weak pulse
increased heart rate (tachycardia)
dizziness, including dizziness upon standing up (orthostatic dizziness)
headache (cephalalgia)
weakness (asthenia)
nausea
vomiting
diarrhoea
drowsiness
hot flushes
increased blood levels of a substance called methaemoglobin (methaemoglobinaemia) and bluish discoloration of the skin and mucous membranes (cyanosis).

If you have taken an excessive dose of Monoket, contact your doctor immediately or go to the nearest hospital.
If you forget to take Monoket
Do not take a double dose to make up for a missed tablet.
If you stop taking Monoket
If you have any doubts about using this medicine, contact your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following the instructions contained in this leaflet reduces the risk of 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 your treatment with gradually increasing doses. Headache usually disappears during continued treatment.

Common (may affect up to 1 in 10 people)

Nausea. At the beginning of treatment or when the dose is increased, the following may occur:
Dizziness (including postural dizziness, which worsens with position);
Drowsiness;
Increased heart rate (reflex tachycardia);
Drop in blood pressure upon sudden change from sitting to standing position (orthostatic hypotension);
Weakness (asthenia), which usually disappear during continued treatment.

Uncommon (may affect up to 1 in 100 people)

Worsening of chest pain (angina pectoris);
Severe drop in blood pressure (circulatory collapse), sometimes accompanied by slow and irregular heartbeat (bradyarrhythmia) and fainting (syncope);
Vomiting;
Diarrhea;
Allergic skin reactions (e.g. rash);
Flushing. If you experience this effect, inform your doctor, who may start your treatment with gradually increasing doses.

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 the available data)

Low blood pressure (hypotension);
Skin inflammation with skin peeling (exfoliative dermatitis);
Reduction or loss of therapeutic effect of this medicine or other organic nitrates (development of tolerance).

In addition, the following side effects may occur, for which the frequency is not known.

Effects on the respiratory system

Condition in which the blood is not adequately oxygenated (temporary hypoxaemia).

Effects on the heart

"Paradoxical effect" with worsening of heart condition (increased ischemia, increased damage, onset of heart failure, hypoxia);
Bluish discoloration of the skin and mucous membranes (cyanosis). This effect may be due to increased levels in the blood of a substance called methaemoglobin (methaemoglobinaemia).

Effects on the skin

Excessive sweating;
Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema).

Effects on blood vessels

Pallor;
Ischaemia (reduced blood supply to an organ).

Effects on the nervous system

Agitation.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at 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 Monoket

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after the word
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Monoket contains

The active substance is: isosorbide-5-mononitrate 60 mg
The other components are: hypromellose, lactose, methylcellulose, macrogol, copovidone, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Monoket and contents of the pack
Monoket 60 mg is available as tablets presented in blisters, packed in a carton containing 30 divisible tablets.
Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy
Manufacturer
CHIESI FARMACEUTICI S.p.A., Parma plant, Via S. Leonardo 96 – Italy
Fine Foods and Pharmaceuticals NTM S.p.A., Via Grignano, 43 - 24041 Brembate – BG - Italy