Passiflora tincture

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PUZHYRNIA TINCTURE

Composition:

Active substance: 1 vial contains 25 ml or 100 ml of tincture of motherwort herb (Leonuri cardiacae herba) (1:5) (extraction solvent – 70% ethanol (v/v)).

Pharmaceutical form. Tincture for internal use.

Main physicochemical properties: clear greenish-brown liquid.

Sediment formation may occur during storage.

Pharmacotherapeutic group.

Sedative and hypnotic agents. ATC code N05CM.

Pharmacological properties.

In terms of its action, hawthorn tincture is similar to valerian preparations. The sedative effect occurs due to enhancement of the inhibition process or reduction of the excitation process in the central nervous system. It does not exhibit hypnotic effects, but facilitates the onset of physiological sleep and deepens it. It does not cause signs of habituation or psychological dependence.

Clinical characteristics.

Indications.

Functional disorders of the cardiovascular system activity (hyperkinetic type neurocirculatory dystonia), early stages of arterial hypertension, increased emotional excitability, irritability, mild forms of sleep disturbances.

Contraindications.

Increased individual sensitivity to the components of the drug.

Pronounced arterial hypotension (reduced arterial pressure), bradycardia.

Interaction with other medicinal products and other types of interactions.

Valerian tincture may potentiate the pharmacological effects of sedatives, hypnotics, analgesics, antihypertensive drugs, and cardiac glycosides, as well as enhance the effect of alcohol.

Inform your doctor about the concurrent use of any other medicinal products.

Special precautions for use.

Prolonged use of the medicine is not recommended due to the presence of ethanol.

Motherwort tincture is a traditional medicinal product used according to indications supported by long-standing use.

Use during pregnancy or breastfeeding.

Since the product contains ethanol, the tincture is not recommended for oral use in women during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

When taking Motherwort tincture, patients should refrain from driving vehicles or operating potentially hazardous machinery.

Dosage and Administration.

Take "Pustyrnyk Tincture" orally after meals.

Adults are recommended to take 30–50 drops of the tincture 3–4 times daily until a stable therapeutic effect is achieved. For children aged 12 years and older, the dosage is calculated as 1 drop per year of life.

If the bottle does not have a dropper cap, use a medical glass pipette to measure the dose; the dosage remains unchanged.

Patients should consult a physician if symptoms do not improve during treatment or if adverse reactions occur that are not listed in the instructions for medical use.

The duration of treatment is determined individually for each patient, taking into account the nature and severity of the pathological process, the course of the disease, individual tolerance to the drug, and the stability of the achieved therapeutic effect.

Children.

Since ethanol is an ingredient of the preparation, the tincture is not recommended for oral use in children under 12 years of age.

Overdose.

Overdose may result in dizziness, drowsiness, and decreased arterial blood pressure.

Treatment. In case of overdose, discontinue the drug immediately and initiate prompt symptomatic and supportive therapy according to the patient's clinical condition.

Increased sensitivity to the drug may occur.

Side effects.

In cases of individual hypersensitivity, local allergic reactions may occur (including redness and swelling of the skin, rash, itching), as well as dizziness, drowsiness, fatigue, and decreased mental and physical performance.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after marketing authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 4 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

25 or 100 ml in glass bottles.

25 ml or 100 ml in a glass bottle; 1 bottle in a cardboard box.

Supply classification.

Over-the-counter.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of business activity.

16 Barvinkova Street, Lubny, Poltava region, 37500, Ukraine.