Cedoflor (Tincture) Instructions for Use

Marketing Authorization Holder

Red Star KhPZ, PJSC (Ukraine)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Dosage Form

Cedoflor

Tincture: bottle or jar 100 mL.

Dosage Form, Packaging, and Composition

100 mL – bottles (1) – cardboard packs.
100 mL – jars (1) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

Sedative herbal preparation.

Biologically active substances of hawthorn fruits (flavonoids, organic acids, etc.) reduce the excitability of the central nervous system, improve coronary and cerebral circulation, help normalize heart rhythm, and eliminate dizziness.

Melilotus officinalis herb has a sedative effect.

Coriandrum sativum fruits have a sedative effect in cases of increased nervous excitability.

Indole alkaloids avenin, B vitamins and other substances contained in oats grain have a stabilizing effect on the nervous system and possess a pronounced calming effect.

Lemon balm herb has antidepressant, calming, and tonic effects.

The complex of biologically active substances of motherwort herb (including alkaloids, glycosides), in addition to a pronounced sedative effect, has a hypotensive effect and reduces heart rate.

The sedative effect of the drug develops from the first day of use.

Hop fruits contain essential oil, resins, flavonoids and biologically active substances which cause the sedative effect.

Indications

Neuroses of various etiologies; mild form of neurasthenia accompanied by irritability, anxiety, fear, increased fatigue, absent-mindedness; nervous excitement; sleep disorders or insomnia (mild forms); neurocirculatory dystonia of the hypertensive and cardiac type; asthenic syndrome.

ICD codes

Dosage Regimen

Take orally, 30 minutes before meals.

Dilute 5 mL of the tincture in a small amount of water.

Administer 3 times per day.

The standard course of treatment is 21 days.

If necessary, repeat the course after a break determined by a physician.

Do not exceed the recommended single or daily dosage.

For sleep disorders, take the last dose in the evening before bedtime.

Use a measuring cup or spoon for accurate dosing; do not estimate doses.

Consult a physician to adjust the duration of therapy or for repeated courses.

Discontinue use and seek medical advice if adverse reactions occur.

Adverse Reactions

From the cardiovascular system very rarely – significant decrease in blood pressure, bradycardia.

From the nervous system dizziness, drowsiness (when taken in high doses), fatigue, headache due to the pronounced sedative effect of motherwort – decreased mental and physical performance.

From the digestive system: nausea, vomiting, pain in the epigastric region, heartburn.

Allergic reactions in case of hypersensitivity to the components of the drug, urticaria, itching, pinpoint rash and spotted red rashes may occur.

Contraindications

Pronounced arterial hypotension, bradycardia, blood clotting disorders, internal bleeding, depression and other diseases accompanied by depression of the central nervous system; pregnancy, lactation period (breastfeeding), age under 18 years; hypersensitivity to the components of the medicinal product.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindication – age under 18 years.

Special Precautions

It is not recommended to take simultaneously with alkaloid salts.

Should not be used together with antiarrhythmic drugs.

Drug Interactions

Enhances the effect of hypnotics, sedatives and other drugs that depress the central nervous system.

Enhances the effect of hypnotics and other drugs that depress the central nervous system.

When taken simultaneously with cardiac glycosides, the effect of the latter is enhanced.

Some enhancement of the effect of direct and indirect anticoagulants is possible.

The tincture containing this combination may enhance the pharmacological effects of analgesics, antihypertensive drugs, and also enhances the effect of alcohol.

Storage Conditions

Store at 2°C (36°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.