Fitocan-gncls

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PHYTOCAN-GNCLS

Composition:

Active substances: 1 vial contains liquid extract (1:1) from medicinal plant raw materials: chamomile flowers (Flos Matricariae), marigold flowers (Flos Calendulae), yarrow herb (Herba Millefolii) (2:1:1) (extraction agent: ethanol 40%) containing total flavonoids calculated as rutin – not less than 0.1% – 50 ml or 100 ml;

Excipients (besides extraction agent): none.

Pharmaceutical form. Liquid.

Main physicochemical characteristics: dark brown liquid with an orange tint, with a characteristic odor. Formation of sediment during storage is permissible.

Pharmacotherapeutic group. Medicinal products used in dentistry. ATC code A01AD11.

Pharmacological properties.

Pharmacodynamics. A combined herbal preparation whose action is determined by the physiologically active substances contained in its composition. It exerts anti-inflammatory, antimicrobial, and spasmolytic effects, reduces capillary permeability, enhances and accelerates regenerative processes of mucous membranes (improves trophic processes), and has certain hemostatic properties. It also produces wound-healing and antioxidant effects.

Clinical characteristics.

Indications. In dental practice for inflammatory diseases of the oral mucosa (aphthous and other stomatitis, ulcerative-necrotic gingivostomatitis).

As part of combination therapy in the treatment of gastrointestinal tract disorders (chronic gastritis, duodenitis, functional dyspepsia, chronic colitis).

Contraindications. Increased blood coagulation, predisposition to thrombosis. Hypersensitivity to the components of the medicinal product or to other plants of the Asteraceae family (Compositae).

Interaction with other medicinal products and other types of interactions. Unknown.

If simultaneous use of any other medicinal products is necessary, a physician must be consulted regarding this possibility.

Special precautions for use.

Do not use the medication for longer than the recommended duration without consulting a physician. If symptoms do not begin to improve, or if the patient's condition worsens or adverse effects occur, consult a physician regarding further use of the medication. When taken orally, do not exceed the recommended doses. In patients with peptic ulcer disease or gastritis with increased acidity, the medication should be used concomitantly with antacids and spasmolytics.

This medicinal product contains 0.98% v/v ethanol (alcohol), i.e. 789.25 mg per 2.5 ml dose (½ measuring cup). It is harmful for patients suffering from alcoholism. Caution is advised when administering to children, patients with liver disorders, and patients with epilepsy.

Use during pregnancy or breastfeeding. The medication is contraindicated during pregnancy. During breastfeeding, the medication may be used only if, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the infant.

Ability to affect reaction speed when driving or operating machinery. The medicinal product contains ethanol; therefore, during treatment, it is recommended to avoid driving vehicles or operating machinery.

Administration and Dosage

Before use, dissolve 1 teaspoon (5 ml) of the medication in 1 glass (200 ml) of warm water for adults and children aged 12 years and older.

For stomatitis and other diseases of the oral mucosa: apply the prepared solution as applications for 15–20 minutes or as mouth rinses for 1–2 minutes. Use 2–3 times daily for 2–5 days.

In gastroenterology: use orally and in microenemas.

Oral administration: take ½–⅓ glass of the solution, prepared by dissolving 1 teaspoon of the medication in 1 glass of warm boiled water, 30 minutes before meals or 40–60 minutes after meals, 3–4 times daily.

For microenemas: 1 teaspoon of the medication in 50–100 ml of warm boiled water (after bowel cleansing), 1–2 times daily. Treatment course lasts 15–20 days.

Duration of medication use is determined individually by a physician and depends on the therapeutic effect achieved and the course of the disease.

Children. Do not use in children under 12 years of age.

Overdose. Cases of overdose have not been reported. Overdose may enhance adverse reactions.

When taken orally, overdose is accompanied by acute alcohol intoxication, with symptoms similar to those of ethanol poisoning.

Treatment: gastric lavage, symptomatic therapy.

Side effects.

Immune system/ skin and subcutaneous tissue disorders: allergic reactions, skin swelling, skin rashes, urticaria, itching and other hypersensitivity reactions, skin redness, angioneurotic edema, anaphylactic reactions (including shock).

Gastrointestinal disorders: bitter taste in mouth, epigastric burning sensation, abdominal pain.

If any adverse reactions occur, the use of the medicinal product must be discontinued immediately and a physician should be consulted regarding further therapy with the product.

Shelf life. 3 years.

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

Packaging. 50 ml or 100 ml in a bottle closed with a tamper-evident cap, in a cardboard box.

Availability category. Over-the-counter (without prescription).

Manufacturer.

Limited Liability Company "Research Plant 'GNCLS'".

Limited Liability Company "Pharmaceutical Company 'Zdorovya'".

Manufacturer's address and place of business.

8 Vorobiova Street, Kharkiv, Kharkiv Region, 61057, Ukraine.

(Limited Liability Company "Research Plant 'GNCLS')

22 Shevchenko Street, Kharkiv, Kharkiv Region, 61013, Ukraine.

(Limited Liability Company "Pharmaceutical Company 'Zdorovya').