Carniland^® (Drops) Instructions for Use

Marketing Authorization Holder

Medical Leasing-Consulting, LLC (Russia)

Manufactured By

Tver Pharmaceutical Factory, PJSC (Russia)

ATC Code

C01DA52 (Nitroglycerin in combination with other drugs)

Dosage Form

Carniland®

Sublingual drops: 25 ml or 50 ml dropper bottle

Dosage Form, Packaging, and Composition

Sublingual drops in the form of a transparent dark yellow-green liquid with the odor of valerian and menthol.

Excipients: ethanol (ethyl alcohol) 95% – up to 100 ml.

25 ml – orange glass dropper bottles (1) – cardboard boxes.
50 ml – orange glass dropper bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Antianginal drug

Pharmacotherapeutic Group

Anti-anginal agent

Pharmacological Action

Sedative and antispasmodic (vasodilator) agent that improves myocardial blood supply and metabolism. The composition is similar in action to the formulation known as Votchal’s drops.

Indications

• Relief of angina attacks;
• Cardialgia.

ICD codes

Dosage Regimen

Administer the drops sublingually.

Place the prescribed number of drops under the tongue and hold for absorption; do not swallow immediately.

Use 3 to 4 times per day or as needed for the relief of an acute angina attack.

The dose must be set individually for each patient, typically starting with 5-10 drops per dose.

Do not exceed the maximum single dose of 15 drops or the maximum daily dose of 60 drops unless directed by a physician.

If the therapeutic effect is insufficient or diminishes, consult a doctor for dose adjustment; tolerance to nitrates may develop with frequent use.

For cardialgia, use the same sublingual route and individual dosing.

If a dose is missed, administer it as soon as possible; if it is near the time for the next dose, skip the missed dose and resume the usual schedule.

Adverse Reactions

From the cardiovascular system: dizziness, orthostatic hypotension, “nitrate” headache, tachycardia, skin hyperemia, feeling of heat.

From the gastrointestinal tract: dry mouth, nausea. If side effects occur, it is recommended to reduce the single dose of the drug.

From the nervous system: dizziness.

Contraindications

• Hypersensitivity to nitrates;
• Shock;
• Collapse;
• Concomitant use of PDE5 inhibitors (sildenafil, vardenafil or tadalafil);
• Age under 18 years (efficacy and safety have not been established).

With caution

Intracranial hypertension, conditions accompanied by a decrease in left ventricular filling pressure, including cardiac tamponade, isolated mitral stenosis, constrictive pericarditis, uncontrolled hypovolemia, heart failure with normal or low pulmonary artery pressure, hemorrhagic stroke, subarachnoid hemorrhage, recent traumatic brain injury, toxic pulmonary edema, idiopathic hypertrophic subaortic stenosis, closed-angle glaucoma with high intraocular pressure; severe anemia, hyperthyroidism, cerebrovascular accident, shock, arterial hypotension (systolic blood pressure less than 90 mm Hg), alcoholism.

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Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Used in elderly patients as indicated.

Special Precautions

During the use of this agent, a significant decrease in blood pressure and dizziness may occur when abruptly moving to a “standing” position from a “lying” or “sitting” position; when consuming alcohol, during physical exercise, and in hot weather.

Frequent use of this agent, as with all organic nitrates, leads to the development of tolerance, requiring an increase in dose.

Influence on the ability to drive vehicles and mechanisms

During treatment, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Drug Interactions

Concomitant use with vasodilators, antihypertensive agents, ACE inhibitors, beta-blockers, slow calcium channel blockers, procainamide, tricyclic antidepressants, MAO inhibitors, PDE5 inhibitors (sildenafil, vardenafil or tadalafil), as well as ethanol, enhances the hypotensive effect.

Concomitant use with sapropterin increases the risk of arterial hypotension.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.