Mononit 20

Package Leaflet: Information for the Patient

MONONIT 10,10 mg, coated tablets
MONONIT 20,20 mg, coated tablets
MONONIT 40,40 mg, coated tablets
Isosorbide mononitrate

Read the 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Mononit 10, Mononit 20, Mononit 40 and what is it used for
• 2. Important information before taking Mononit 10, Mononit 20, Mononit 40
• 3. How to take Mononit 10, Mononit 20, Mononit 40
• 4. Possible side effects
• 5. How to store Mononit 10, Mononit 20, Mononit 40
• 6. Contents of the pack and other information

1. What is Mononit 10, Mononit 20, Mononit 40 and what is it used for

Mononit 10, Mononit 20, Mononit 40 is available in the form of 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 need for oxygen.
Mononit 10, Mononit 20, Mononit 40 is used for the long-term treatment of angina pectoris (chest pain and feeling of pressure in the chest) and to prevent its attacks.

2. Important information before taking Mononit 10, Mononit 20, Mononit 40

When not to take Mononit 10, Mononit 20, Mononit 40:

• if the patient is allergic (hypersensitive) 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 that significantly limit heart function (such as hypertrophic cardiomyopathy, constrictive pericarditis, cardiac tamponade);
• if the patient is taking medicines for erectile dysfunction (such as 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 10, Mononit 20, Mononit 40 and other medicines");
• if the patient has very low blood pressure (hypotension) (systolic blood pressure below 90 mmHg);
• if the patient has severe hypovolemia (decreased 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 (decreased red blood cell count, which may cause pale skin, weakness, and shortness of breath).

Warnings and precautions

Before starting to take Mononit 10, Mononit 20, Mononit 40, the patient should discuss it with their doctor or pharmacist.

Special caution should be exercised when taking Mononit 10, Mononit 20, Mononit 40:

• 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 circulatory 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 decreased activity of the enzyme glucose-6-phosphate dehydrogenase (G6PD), which may cause hemolytic anemia.

Mononit 10, Mononit 20, and Mononit 40 are not intended for the treatment of acute angina pectoris attacks and acute myocardial infarction.
Decreased 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.
Care should be taken in patients with lung diseases 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 10, Mononit 20, Mononit 40 in children and adolescents have not been established.

Mononit 10, Mononit 20, Mononit 40 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 10, Mononit 20, Mononit 40:

• other vasodilators (e.g., prazosin);
• beta-blockers (e.g., propranolol);
• diuretics;
• calcium antagonists (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 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.
Care should be taken when concomitantly 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 10, Mononit 20, Mononit 40 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 10, Mononit 20, Mononit 40.

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 10, Mononit 20, Mononit 40 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 breast 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 ability, even if taken as recommended. Therefore, the patient should not drive vehicles, operate machines, or work without constant support. This is especially true during the initial treatment period, dose increase, product change, and concomitant alcohol consumption.

Mononit 10, Mononit 20, and Mononit 40 contain 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 10, Mononit 20, and Mononit 40

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Usually, the recommended dose is one tablet of Mononit 10, Mononit 20, or Mononit 40, taken two or three times a day. The doctor may increase the dose if necessary.
The maximum daily dose is 120 mg of isosorbide mononitrate.
Tablets should be taken after a meal, without chewing, with a small amount of liquid.
To maintain the medicine's effectiveness, when taking two doses a day, the second tablet should be taken 8 hours after the first tablet, and when taking three doses a day, tablets should be taken every 6 hours.
The prescribed dose or time intervals between doses should not be changed, as this may lead to weakened or discontinued effect of the medicine.

Elderly patients

In elderly patients, there is no need to adjust the dose.

Use in children and adolescents

The medicine should not be used in children.

Taking a higher dose of Mononit 10, Mononit 20, Mononit 40 than recommended

In case of taking a higher dose of Mononit 10, Mononit 20, Mononit 40 than recommended, the patient should immediately consult their doctor or go to the nearest hospital.
Symptoms of overdose are: significantly decreased blood pressure, orthostatic circulatory disorders (decreased blood pressure related to sudden body position changes), pale skin, excessive sweating, weak pulse, reflex tachycardia, headache, weakness, dizziness, flushing of the skin, nausea, vomiting, and diarrhea. After significant overdose, methemoglobinemia with cyanosis, shortness of breath, and increased intracranial pressure may occur.

Missing a dose of Mononit 10, Mononit 20, or Mononit 40

In case of missing a dose, the patient should take it as soon as they remember. However, if it is almost 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 Mononit 10, Mononit 20, or Mononit 40

The patient should not stop the treatment without consulting their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Mononit 10, Mononit 20, Mononit 40 can cause side effects, although not everybody gets them.
The following side effects have been observed during treatment with the medicine:
Very common (may affect at least 1 in 10 people):

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

Common (may affect less than 1 in 10 people):

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

Uncommon (may affect less than 1 in 100 people):

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

Rare (may affect less than 1 in 1000 people):

• heartburn, exfoliative dermatitis.

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

• methemoglobinemia (abnormal hemoglobin formation);
• hemolytic anemia (in patients with decreased activity of the enzyme glucose-6-phosphate dehydrogenase);
• angioedema (allergic reaction that may cause difficulty swallowing or breathing);
• rash, erythema, pruritus, 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 any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. 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 10, Mononit 20, Mononit 40

There are no special precautions for storing the medicine.
The medicine should be stored out of sight and reach of children.
Do not use the 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mononit 10, Mononit 20, Mononit 40 contains

• The active substance of the medicine is isosorbide mononitrate. Each Mononit 10 coated tablet contains 10 mg of isosorbide mononitrate, each Mononit 20 coated tablet contains 20 mg of isosorbide mononitrate, and each Mononit 40 coated tablet contains 40 mg of isosorbide mononitrate.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, talc, magnesium stearate; coating: eudragit RL 30D, talc, titanium dioxide, macrogol 6000, methylsilicone oil.

What Mononit 10, Mononit 20, Mononit 40 looks like and contents of the pack

Mononit 10: white, round, biconvex coated tablets with "M10" engraved on both sides.
Mononit 20: white, round, biconvex coated tablets with "M20" engraved on both sides.
Mononit 40: white, round, biconvex coated tablets with "M40" engraved on both sides.
Pack sizes:
Mononit 10: 60 coated tablets.
Mononit 20: 30 or 60 coated tablets.
Mononit 40: 30 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
Tel.: +48 22 280 00 00
Date of last revision of the leaflet:April 2024