ROTOKAN

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ROTOKAN

Composition:

1 vial contains:

Active substances: liquid extract (1:1) from medicinal plant raw materials: flowers of chamomile (flores chamomillae), flowers of marigold (flores calendulae), yarrow herb (herba millefolii) (2:1:1) – 55 ml or 110 ml;

Excipients: ethanol (96%), purified water.

Pharmaceutical form. Liquid extract.

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

Pharmacotherapeutic group.

Agents affecting the digestive system and metabolism. Preparations 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, exerts anti-inflammatory, antimicrobial, and spasmolytic effects, reduces capillary permeability, enhances and accelerates regeneration processes of mucous membranes (improves trophic processes), and has moderate hemostatic properties.

The preparation exerts a positive effect on the trophism of the gastric mucosa and has a spasmolytic action.

Rotokan exerts 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.

Hypersensitivity to any component of the medicinal product.

For oral administration – increased blood coagulation, predisposition to thrombosis.

Interaction with other medicinal products and other types of interactions.

Not known. If simultaneous use of any other medicinal products is required, medical advice should be sought.

Special precautions for use.

Do not use the drug for longer than the recommended duration without consulting a physician. If symptoms do not begin to improve, or if the condition worsens or adverse reactions occur, consult a doctor for advice regarding further use of the drug.

Do not exceed the recommended doses during use.

In peptic ulcer disease and gastritis with increased acidity, use the drug in combination with antacids and spasmolytics.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, the medicinal product should be used only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction speed when driving or operating machinery.

Not studied.

Method of Administration and Dosage

Before use, adults and children aged 12 years and older should dissolve 1 teaspoon (5 ml) of Rotokan in 1 glass of warm water.

For periodontitis, treat locally after removal of dental deposits and instrumental processing of pathological periodontal pockets. Insert thin pledgets thoroughly moistened with the prepared solution into the periodontal pockets for 20 minutes. The procedure should be performed daily or every other day (4–6 times).

In cases of stomatitis and other diseases of the oral mucosa, apply the prepared solution as applications for 15–20 minutes or as mouth rinses using the same solution for 1–2 minutes. Administer 2–3 times daily for 2–5 days.

In gastroenterology, Rotokan is taken orally and used in micro-enemas.

For oral administration: take 1/2–1/3 glass of the solution prepared by dissolving 1 teaspoon of Rotokan in 1 glass of warm boiled water, 30 minutes before meals or 40–60 minutes after meals, 3–4 times daily.

For micro-enemas: use 1 teaspoon of the drug in 50–100 ml of warm boiled water (after bowel cleansing), 1–2 times daily. The treatment course lasts 15–20 days. The duration of drug use depends on the achieved therapeutic effect and the course of the disease.

Children.

Rotokan is not recommended for children under 12 years of age.

Overdose.

Cases of overdose have not been reported.

An increase in adverse reactions is possible.

In case of oral overdose, acute alcohol intoxication may occur, with symptoms similar to those of ethanol poisoning.

Treatment: gastric lavage, symptomatic therapy.

Side effects.

In individuals with increased sensitivity, allergic reactions are possible, such as skin swelling, redness, rash, itching, urticaria, angioneurotic edema, anaphylactic shock.

If any adverse reactions occur, discontinue use of Rotokan and consult a physician regarding further use.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

55 ml or 110 ml in bottles No. 1.

Availability. Over-the-counter.

Manufacturer.

JSC "Lubnifarm".

Manufacturer's address and location of business activities.

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