Mononit 10

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 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 comes 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 prevention of its attacks.

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

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

Warnings and precautions

Before starting to take Mononit 10, Mononit 20, Mononit 40, discuss it with your doctor or pharmacist.

Be particularly cautious when taking Mononit 10, Mononit 20, Mononit 40:

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 weakening of the medicine's effect have been reported in cases of prior use of other nitrate medicines. To avoid weakening or loss of the medicine's effect, you should avoid continuous use of high doses.
Caution is advised 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 10, Mononit 20, Mononit 40 in children and adolescents have not been established.

Mononit 10, Mononit 20, Mononit 40 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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-adrenoreceptor 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 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 advised 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 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 the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice 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 your reaction ability, even if taken as recommended. Therefore, you should not drive vehicles, operate machines, or work without stable 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 your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Usually, the recommended dose is one tablet of Mononit 10, Mononit 20, or Mononit 40 two or three times a day. Your 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.
Do not change the prescribed dose or the intervals between doses, as this may lead to reduced or discontinued medicine effectiveness.

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.

Overdose of Mononit 10, Mononit 20, Mononit 40

If you have taken more than the recommended dose of Mononit 10, Mononit 20, Mononit 40, contact your doctor or go to the nearest hospital immediately.
Symptoms of overdose are: significantly decreased blood pressure, orthostatic circulatory disorders (decreased blood pressure related to rapid standing up or sitting from a lying position), pale skin, excessive sweating, weak pulse, headache, weakness, dizziness, flushing, nausea, vomiting, and diarrhea. After significant overdose, methemoglobinemia with cyanosis, shortness of breath, and increased intracranial pressure may occur.

Missed dose of Mononit 10, Mononit 20, or Mononit 40

If you miss a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose, just take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Mononit 10, Mononit 20, or Mononit 40 treatment

Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, ask your 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 up to 1 in 10 people):

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

Common (may affect up to 1 in 10 people):

• at the beginning of treatment or after dose increase, hypotension and (or) low blood pressure may occur, orthostatic hypotension (decreased blood pressure when standing up quickly or sitting from a lying position), rapid heart rate, disorientation, dizziness, drowsiness, weakness.

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

• nausea, vomiting, sudden flushing of the skin, especially the face and neck (hot flashes), skin allergic reactions;
• significantly decreased blood pressure with increased angina pectoris symptoms;
• collapse, slow heart rate, loss of consciousness.

Rare (may affect up to 1 in 1,000 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 (reduced medicine effectiveness).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mononit 10, Mononit 20, Mononit 40

There are no special precautions for storage.
Keep the medicine out of the 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. Ask your 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 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.
Rzeszów Branch
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