Monisol (Tablets) Instructions for Use

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

Manufactured By

Hemofarm Koncern Zorka Pharma A.D. (Serbia and Montenegro)

ATC Code

C01DA14 (Isosorbide mononitrate)

Active Substance

Isosorbide mononitrate

Dosage Forms

	Monisol	Tablets 20 mg: 30 pcs.
		Tablets 40 mg: 30 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Peripheral vasodilator. Anti-anginal drug

Pharmacotherapeutic Group

Vasodilating agent – nitrate

Pharmacological Action

Peripheral vasodilator with a predominant effect on venous vessels. Anti-anginal drug.

It reduces both preload and afterload, which decreases myocardial oxygen demand and leads to myocardial unloading.

Monisol, by dilating the coronary arteries, improves coronary blood flow; it reduces pressure in the pulmonary circulation.

Pharmacokinetics

Absorption and Distribution

After oral administration, isosorbide-5-mononitrate is well absorbed from the gastrointestinal tract.

C_max in blood plasma is reached after 1 hour. Isosorbide-5-mononitrate does not bind to plasma proteins.

Metabolism

Isosorbide-5-mononitrate is not subject to the first-pass effect through the liver.

More than 95% of the active substance is biotransformed via denitration and conjugation.

Excretion

T_1/2 is about 5 hours.

Up to 5% of isosorbide-5-mononitrate is excreted by the kidneys unchanged.

Indications

• Prevention of angina attacks;
• Rehabilitation treatment after myocardial infarction;
• Chronic heart failure (as part of combination therapy).

ICD codes

Dosage Regimen

It is established individually, based on the clinical efficacy and tolerability of the drug.

For the prevention of angina attacks, the initial dose of Monisol is 20 mg (1 tab. 20 mg or 1/2 tab. 40 mg) 2 times/day.

For chronic heart failure, 40 mg (1 tab.) 3 times/day every 8 hours.

If a headache occurs at the beginning of the treatment course, single doses of the drug can be reduced during the first 2-3 days.

Adverse Reactions

From the cardiovascular system: at the beginning of treatment, a headache may occur, which is relieved by taking analgesics and disappears with continued therapy; dizziness, arterial hypotension, tachycardia.

Contraindications

• Acute myocardial infarction accompanied by a decrease in diastolic blood pressure;
• Cardiogenic shock;
• Acute circulatory failure;
• Severe arterial hypotension;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

The use of Monisol in the first trimester of pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use Monisol during lactation, the issue of discontinuing breastfeeding should be decided.

Special Precautions

Monisol is not used to relieve angina attacks.

Monisol should be prescribed with caution to patients with glaucoma, increased intracranial pressure.

The drug should be discontinued gradually.

Alcohol consumption while taking Monisol may increase headache.

Effect on the ability to drive vehicles and operate machinery

Monisol should be prescribed with caution to patients engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Overdose

Symptoms: headache, dizziness, nausea, tachycardia, arterial hypotension.

Treatment: symptomatic therapy is performed.

Drug Interactions

Concomitant use of Monisol with other vasodilators, calcium channel blockers, antihypertensive drugs, tricyclic antidepressants enhances the hypotensive effect.

Storage Conditions

The drug should be stored at room temperature.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.