Mononit 100 Retard

Package Leaflet: Information for the Patient

MONONIT 60 retard,60 mg, prolonged-release coated tablets
MONONIT 100 retard,100 mg, prolonged-release coated tablets
Isosorbide Mononitrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
See section 4.

Table of Contents of the Leaflet:

• 1. What is Mononit 60 retard, Mononit 100 retard, and what is it used for
• 2. Important information before taking Mononit 60 retard, Mononit 100 retard
• 3. How to take Mononit 60 retard, Mononit 100 retard
• 4. Possible side effects
• 5. How to store Mononit 60 retard, Mononit 100 retard
• 6. Contents of the pack and other information

1. What is Mononit 60 retard, Mononit 100 retard, and what is it used for

Mononit 60 retard, Mononit 100 retard comes in the form of prolonged-release coated tablets and contains isosorbide mononitrate as the active substance.
Isosorbide mononitrate belongs to a group of medicines called organic nitrates. The medicine causes vasodilation, increases blood flow through the vessels, and reduces the heart muscle's demand for oxygen.
Mononit 60 retard, Mononit 100 retard is used for the long-term treatment of angina pectoris (chest pain and feeling of pressure in the chest) and prevention of its attacks.

2. Important information before taking Mononit 60 retard or Mononit 100 retard

When not to take Mononit 60 retard, Mononit 100 retard:

• if the patient is hypersensitive (allergic) to isosorbide mononitrate, other nitrates, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has shock or circulatory collapse;
• if the patient has severe heart function disorders (cardiogenic shock);
• if the patient has severe heart muscle or pericardial diseases, causing significant limitation of heart function (such as hypertrophic cardiomyopathy, constrictive pericarditis, cardiac tamponade);
• if the patient is taking medicines for erectile dysfunction (phosphodiesterase type 5 inhibitors, e.g., sildenafil, vardenafil, tadalafil) at the same time. Isosorbide mononitrate therapy should not be interrupted to take a medicine containing a phosphodiesterase type 5 inhibitor, as this may increase the risk of angina pectoris (see "Mononit 60 retard, Mononit 100 retard and other medicines");
• if the patient has very low blood pressure (hypotension) (systolic blood pressure below 90 mmHg);
• if the patient has severe hypovolemia (reduced blood volume in the vessels);
• if the patient is taking riociguat (a medicine used to treat pulmonary hypertension) at the same time;
• if the patient has severe anemia (reduced red blood cell count, which may cause pale skin, weakness, and shortness of breath).

Warnings and precautions

Before starting to take Mononit 60 retard, Mononit 100 retard, the patient should discuss it with their doctor or pharmacist.

Special caution should be exercised when taking Mononit 60 retard, Mononit 100 retard:

• if the patient has low filling pressure in the heart, e.g., in recent myocardial infarction, impaired left ventricular function; systolic blood pressure should be avoided below 90 mmHg;
• if the patient has aortic stenosis and/or mitral stenosis;
• if the patient has a tendency to faint due to sudden body position changes, e.g., when getting up in the morning (orthostatic circulation disorders);
• if the patient has diseases with increased intracranial pressure;
• if the patient has liver function disorders;
• if the patient has glaucoma;
• if the patient has hyperthyroidism (increased thyroid function, which may cause increased appetite, weight loss, and sweating);
• if the patient has reduced activity of the enzyme glucose-6-phosphate dehydrogenase (G6PD), which may cause hemolytic anemia

Mononit 60 retard and Mononit 100 retard are not intended for the treatment of acute angina pectoris attacks and acute myocardial infarction.
Reduced efficacy of treatment and weakened effect of the medicine have been reported in cases of prior use of other nitrate medicines. To avoid weakening or loss of the medicine's effect, continuous use of high doses should be avoided.
Caution should be exercised in patients with pulmonary or coronary heart disease, as the medicine may cause transient hypoxemia (insufficient oxygen in the blood). In patients with coronary heart disease, myocardial ischemia may develop.
Children and adolescents
The safety and efficacy of Mononit 60 retard, Mononit 100 retard in children and adolescents have not been established.

Mononit 60 retard, Mononit 100 retard and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Concomitant use of the following medicines may enhance the blood pressure-lowering effect of Mononit 60 retard, Mononit 100 retard:

• other vasodilators (e.g., prazosin);
• beta-blockers (e.g., propranolol);
• diuretics;
• calcium channel blockers (e.g., verapamil);
• angiotensin-converting enzyme inhibitors (e.g., captopril);
• neuroleptics (used to treat mental disorders, e.g., chlorpromazine);
• tricyclic antidepressants (used to treat depression, e.g., amitriptyline);
• medicines used to treat erectile dysfunction, which contain phosphodiesterase type 5 inhibitors (e.g., sildenafil, vardenafil, tadalafil);
• riociguat (a medicine used to treat pulmonary hypertension). Concomitant use of the medicine with dihydroergotamine (a medicine used to treat migraine) may increase dihydroergotamine levels in the blood and thus cause increased blood pressure.

Concomitant use of nitrates and ergot alkaloids should be avoided, as they may have opposing effects.
Caution is recommended when using a medicine containing sapropterin (given to patients with high blood phenylalanine levels) with all medicines that cause vasodilation through the release of nitric oxide, e.g., glyceryl trinitrate (NTG), isosorbide dinitrate (ISDN), isosorbide 5-mononitrate (5-ISMN), and others.

Mononit 60 retard, Mononit 100 retard with food, drink, and alcohol

Tablets should be taken after a meal.
Concomitant consumption of alcohol may enhance the blood pressure-lowering effect of Mononit 60 retard, Mononit 100 retard.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Mononit 60 retard and Mononit 100 retard may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
It is not known whether isosorbide mononitrate passes into human milk. Therefore, this medicine should not be used during breastfeeding.
It is not known whether isosorbide mononitrate affects human fertility.

Driving and using machines

The medicine may significantly affect the patient's reaction, even if taken as recommended. Therefore, the patient should not drive vehicles, operate machines, or work without stable support. This applies especially to the initial treatment period, dose increase, product change, and concomitant consumption of alcohol.

Mononit 60 retard, Mononit 100 retard contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Mononit 60 retard, Mononit 100 retard

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.
Mononit 60 retard, Mononit 100 retard are intended for long-term use by patients receiving the same maintenance doses of isosorbide mononitrate as in Mononit 60 retard or Mononit 100 retard.
The recommended dose is one tablet of Mononit 60 retard or Mononit 100 retard once daily, in the morning.
Tablets should be taken after a meal, without chewing, with a small amount of liquid.

Elderly patients

No dose adjustment is necessary in elderly patients.

Use in children and adolescents

The medicine should not be used in children.

Taking a higher dose of Mononit 60 retard, Mononit 100 retard than recommended

In case of taking a higher dose of Mononit 60 retard, Mononit 100 retard than recommended, the patient should immediately consult a doctor or go to the nearest hospital.
Symptoms of overdose are: significantly decreased blood pressure, orthostatic circulation disorders (decreased blood pressure associated with sudden body position changes), pale skin, excessive sweating, weak pulse, reflex tachycardia, headache, weakness, dizziness, flushing, nausea, vomiting, and diarrhea. In case of significant overdose, methemoglobinemia with cyanosis, shortness of breath, and increased intracranial pressure may occur.

Missing a dose of Mononit 60 retard, Mononit 100 retard

In case of missing a dose, the patient should take it as soon as they remember. However, if it is close to the time for the next dose, the missed dose should not be taken, and the next dose should be taken at the usual time.
A double dose should not be taken to make up for the missed dose.

Stopping treatment with Mononit 60 retard, Mononit 100 retard

Treatment should not be stopped abruptly without consulting a doctor.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Mononit 60 retard, Mononit 100 retard can cause side effects, although not everybody gets them.
Side effects are listed according to their frequency of occurrence:
Very common (may affect up to 1 in 10 people):

• headache (usually resolves after a few days of treatment).

Common (may affect up to 1 in 100 people):

• at the beginning of treatment or after dose increase, hypotension and/or low blood pressure may occur, orthostatic hypotension (decreased blood pressure associated with sudden body position changes), tachycardia, disorientation, dizziness, somnolence, weakness.

Uncommon (may affect up to 1 in 1,000 people):

• nausea, vomiting, sudden flushing, especially of the face and neck (hot flashes), skin allergic reactions;
• significant decrease in blood pressure with increased angina pectoris symptoms;
• collapse, bradycardia, loss of consciousness.

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

• heartburn, exfoliative dermatitis.

Frequency not known (cannot be estimated from the available data):

• methemoglobinemia (abnormal hemoglobin formation);
• hemolytic anemia in patients with reduced glucose-6-phosphate dehydrogenase enzyme activity;
• angioedema (allergic reaction that may cause difficulty swallowing or breathing);
• rash, erythema, itching, urticaria (allergic reactions);
• myocardial ischemia (angina pectoris);
• transient hypoxemia (insufficient oxygen in the blood);
• tolerance to the medicine, cross-tolerance with other nitrates (weakened effect of the medicine).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, ul. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Mononit 60 retard, Mononit 100 retard

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mononit 60 retard, Mononit 100 retard contains

• The active substance of the medicine is isosorbide mononitrate. Each prolonged-release coated tablet of Mononit 60 retard contains 60 mg of isosorbide mononitrate, each prolonged-release coated tablet of Mononit 100 retard contains 100 mg of isosorbide mononitrate.
• Other ingredients are: hydroxypropyl methylcellulose, sodium carmellose, potato starch, silicon dioxide, anhydrous, stearic acid; coating:Opadry II 85F21336 [polyvinyl alcohol, macrogol 3000, titanium dioxide, talc, quinoline yellow (E 104), indigo carmine (E 132)].

What Mononit 60 retard, Mononit 100 retard looks like and contents of the pack

Mononit 60 retard: light green, elongated, biconvex, smooth coated tablets with prolonged release
Mononit 100 retard: dark green, elongated, biconvex, smooth coated tablets with prolonged release.
Pack size:
30 prolonged-release coated tablets.

Marketing authorization holder

Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw

Manufacturer

Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów
To obtain more detailed information, please contact:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00
Date of last revision of the leaflet:April 2024