Patient Information Leaflet

MONONIT 60 Retard, 60 mg, prolonged-release coated tablets
MONONIT 100 Retard, 100 mg, prolonged-release coated tablets
Isosorbide mononitrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
See section 4.

Contents of this leaflet:

What Mononit 60 Retard and Mononit 100 Retard are and what they are used for
Important information before taking Mononit 60 Retard or Mononit 100 Retard
How to take Mononit 60 Retard and Mononit 100 Retard
Possible side effects
How to store Mononit 60 Retard and Mononit 100 Retard
Contents of the pack and other information

1. What Mononit 60 Retard and Mononit 100 Retard are and what they are used for

Mononit 60 Retard and Mononit 100 Retard are available as prolonged-release coated tablets and contain isosorbide mononitrate as the active substance.
Isosorbide mononitrate belongs to a group of medicines called organic nitrates. The medicine causes blood vessels to dilate, increases blood flow through vessels, and reduces the heart muscle's oxygen demand.
Mononit 60 Retard and Mononit 100 Retard are used in the long-term treatment of angina pectoris (chest pain and pressure) and for preventing angina attacks.

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

Do not take Mononit 60 Retard or Mononit 100 Retard:

if you are allergic (hypersensitive) to isosorbide mononitrate, other nitrates, or any of the other ingredients of this medicine (listed in section 6);
if you have shock or circulatory collapse;
if you have severe heart function disorders (cardiogenic shock);
if you have severe heart muscle or pericardium diseases causing significant impairment of heart function (e.g. hypertrophic cardiomyopathy, constrictive pericarditis, cardiac tamponade);
if you are simultaneously taking medicines used to treat erectile dysfunction (phosphodiesterase-5 inhibitors such as sildenafil, vardenafil, tadalafil). Do not interrupt isosorbide mononitrate therapy to take a phosphodiesterase-5 inhibitor, as this may increase the risk of angina pain (see "Mononit 60 Retard, Mononit 100 Retard and other medicines");
if you have very low blood pressure (hypotension) (systolic blood pressure below 90 mm Hg);
if you have severe hypovolemia (reduced blood volume in vessels);
if you are simultaneously taking riociguat (a medicine used to treat pulmonary hypertension);
if you have severe anemia (reduced number of red blood cells, which may manifest as skin pallor, weakness, and shortness of breath).

Warnings and precautions
Before starting treatment with Mononit 60 Retard or Mononit 100 Retard, discuss this with your doctor or pharmacist.

Exercise particular caution when using Mononit 60 Retard or Mononit 100 Retard:

if you have low ventricular filling pressure, e.g. in acute myocardial infarction or impaired left ventricular function; avoid reducing systolic blood pressure below 90 mm Hg;
if you have aortic or mitral valve stenosis;
if you are prone to fainting related to sudden body uprighting, e.g. upon waking in the morning (orthostatic circulatory disorders);
if you have conditions associated with increased intracranial pressure;
if you have impaired liver function;
if you have a condition of the eye called glaucoma;
if you have hyperthyroidism (overactive thyroid gland, which may manifest as increased appetite, weight loss, and sweating);
if you have reduced activity of the glucose-6-phosphate dehydrogenase (G6PD) enzyme, which may manifest as hemolytic anemia.

Mononit 60 Retard and Mononit 100 Retard are not intended for the treatment of acute angina attacks or acute myocardial infarction.
Reduced treatment effectiveness and diminished drug action have been reported with prior use of other nitrates. To avoid diminished or lost efficacy, avoid continuous use of high doses.
Exercise caution in patients with lung diseases or ischemic heart disease, as the medicine may cause transient hypoxia (inadequate oxygen content in blood). In patients with ischemic heart disease, myocardial ischemia may develop.

Children and adolescents
The safety and efficacy of Mononit 60 Retard and Mononit 100 Retard in children and adolescents have not been established.

Mononit 60 Retard, Mononit 100 Retard and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Concomitant use of the following medicines may enhance the blood pressure-lowering effect of Mononit 60 Retard and Mononit 100 Retard:

other vasodilating medicines (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 psychiatric disorders, e.g. chlorpromazine);
tricyclic antidepressants (used to treat depression, e.g. amitriptyline);
medicines used to treat erectile dysfunction containing phosphodiesterase-5 inhibitors (e.g. sildenafil, vardenafil, tadalafil);
riociguat (used to treat pulmonary hypertension).

Concomitant use with dihydroergotamine (used to treat migraine) may increase dihydroergotamine blood levels and thereby raise arterial blood pressure.

Avoid concomitant use of nitrates and ergot alkaloids, as they may have opposing effects.
Caution is recommended when using medicines containing sapropterin (administered to patients with high blood levels of phenylalanine) together with any medicines causing vasodilation via nitric oxide release, 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
Take tablets after meals.
Concomitant alcohol consumption may intensify the blood pressure-lowering effect of this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Mononit 60 Retard and Mononit 100 Retard may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
It is unknown whether isosorbide mononitrate passes into human milk. Therefore, use of this medicine during breastfeeding is not recommended.
It is unknown whether isosorbide mononitrate affects human fertility.

Driving and operating machinery
This medicine may significantly affect your reaction ability, even when used as directed. Therefore, you should not drive, operate machinery, or work without stable support, especially during the initial treatment period, dose increases, product changes, or concomitant alcohol consumption.

Mononit 60 Retard, Mononit 100 Retard contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

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

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Mononit 60 Retard and Mononit 100 Retard are intended for long-term use in patients receiving
maintenance doses of isosorbide mononitrate equivalent to the amounts contained in
Mononit 60 Retard or Mononit 100 Retard.
The recommended dose is 1 tablet of Mononit 60 Retard or Mononit 100 Retard once daily in the morning.
The tablets should be taken after a meal, without chewing, with a small amount of liquid.
Elderly patients
Dosage adjustment is not required in elderly patients.
Use in children and adolescents
This medicine should not be used in children.
If you take more Mononit 60 Retard, Mononit 100 Retard than recommended
If you take more than the recommended dose of Mononit 60 Retard or Mononit 100 Retard,
seek immediate medical advice from a doctor or go to the nearest hospital.
Symptoms of overdose include: marked decrease in blood pressure, orthostatic circulatory disturbances
(decline in blood pressure associated with sudden upright posture), pallor, excessive sweating,
weakly palpable pulse, reflex tachycardia, headache, weakness, dizziness, skin flushing, nausea,
vomiting, and diarrhea. Following a significant overdose, methemoglobinemia may occur,
accompanied by cyanosis, dyspnea, tachypnea, and increased intracranial pressure.
If you miss a dose of Mononit 60 Retard, Mononit 100 Retard
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; instead, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Mononit 60 Retard, Mononit 100 Retard
Do not stop treatment suddenly without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects are listed below according to the following frequency of occurrence:

Very common (may affect at least 1 in 10 people):

headache (usually resolves within a few days of treatment).

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

at the beginning of treatment or after increasing the dose, hypotension and/or low blood pressure, fainting due to a sudden drop in blood pressure when rapidly standing up or sitting up from a lying position (orthostatic hypotension), rapid heart rate, disorientation, dizziness, drowsiness, weakness.

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

nausea, vomiting, sudden flushing of the skin, especially of the face and neck (hot flushes), skin allergic reactions;
significant drop in blood pressure accompanied by worsening retrosternal pain (angina symptoms);
collapse, slowed heart rate, loss of consciousness.

Very rare (may affect less than 1 in 10,000 people):

heartburn, exfoliative dermatitis.

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

methemoglobinemia (abnormal hemoglobin structure);
hemolytic anemia in patients with reduced activity of glucose-6-phosphate dehydrogenase enzyme;
angioedema (an allergic reaction which may cause difficulty in swallowing or breathing);
rash, erythema, itching, urticaria (allergic reactions);
myocardial ischemia (angina pectoris);
transient hypoxia (insufficient oxygen in the blood);
development of drug tolerance, cross-tolerance with other nitrates (reduced drug effect).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

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

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
"Expiry date". The expiry date refers to the last day of the stated 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 60 Retard, Mononit 100 Retard contains

The active substance 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: hydroxypropylmethylcellulose, sodium carmellose, potato starch, colloidal anhydrous silicon dioxide, stearic acid; coating: Opadry II 85F21336 [polyvinyl alcohol, polyethylene glycol 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 prolonged-release coated tablets
Mononit 100 Retard: dark green, elongated, biconvex, smooth prolonged-release coated tablets
Pack size:
30 prolonged-release coated tablets
Marketing Authorisation 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
For further information, please contact:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00