Recutane

Ukraine
Brand name Recutane
Form solution
Active substance / Dosage
Prescription type over-the-counter (OTC)
ATC code
Registration number UA/5120/01/01
Recutane solution

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT REKUTAN (RECUTAN)

Composition:

Active substance: 1 ml of solution contains flower heads of chamomile (Flores Chamomillae) liquid extract (1:1) – 1 g;

Excipients: polysorbate, ethanol 50%.

Pharmaceutical form. Solution.

Main physicochemical properties: dark brown liquid with a chamomile odor. Formation of sediment is permissible.

Pharmacotherapeutic group. Dermatologicals. ATC code D11AX.

Pharmacological properties.

Pharmacodynamics.

Rekutan has certain effects due to the chemical substances contained in the chamomile flower extract, particularly anti-inflammatory (inhibits exudative processes), wound-healing (stimulates tissue regeneration), and also exerts some antiseptic action. Rekutan does not produce local irritant effects. Prolonged use of the medicinal product does not cause negative effects on the body.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

As a monotherapy or as part of combination therapy in inflammatory diseases of the oral cavity (stomatitis, gingivitis, glossitis, periodontosis); in upper respiratory tract diseases (pharyngitis, tonsillitis, including post-tonsillectomy); in proctology for hemorrhoids; in gynecology—topically for inflammatory conditions and cervical erosion; for prophylactic vaginal preparation before cesarean section surgery. The drug is administered as rinses, inhalations, enemas, and sitz baths.

Orally for chronic gastritis, colitis, enterocolitis, and peptic ulcer of the stomach and duodenum.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other types of interactions.

Drug interactions are currently unknown.

Special precautions for use.

Do not use the undiluted medicinal product. The recommended doses must be observed when using the product. Patients with a history of hypersensitivity to plants of the Asteraceae/Compositae family (ragweed, chrysanthemums, calendula, daisy) are more prone to develop allergic reactions when using preparations containing chamomile extract.

Ethanol (when administered orally). This medicinal product contains 3800 mg/dose of ethanol (alcohol). It is harmful for patients suffering from alcoholism. Caution is advised when administering to breastfeeding women, patients with liver disorders, and patients with epilepsy. The alcohol contained in this medicinal product may affect the action of other drugs. The amount of alcohol present in this medicinal product may impair the ability to drive or operate machinery.

Use during pregnancy or breastfeeding.

Rekutan should not be administered during pregnancy.

During breastfeeding, the product should be used only under medical supervision.

Effect on ability to drive or operate machinery.

When administered orally, it should be noted that a single dose of the product contains 1.66% ethanol. Therefore, patients should refrain from driving or operating machinery while taking this product.

Method of Administration and Dosage

For oral cavity diseases – for rinsing: dissolve 2 teaspoons (10 ml) of the drug in a glass (200 ml) of water. For periodontitis, soak pledgets in this solution and insert them into the gingival pockets daily for 10–15 minutes over a period of 3–7 days.

For upper respiratory tract diseases – for daily inhalations: prepare a solution by dissolving 2 teaspoons (10 ml) of the drug in a glass (200 ml) of water; use for 10 days.

For stomach and duodenal diseases (chronic gastritis, colitis, enterocolitis, peptic ulcer of the stomach and duodenum), take the extract orally as a solution: adults should take 1 teaspoon (5 ml of the drug in ½ glass (100 ml) of warm water) 20 minutes before meals, 2–4 times daily.

For hemorrhoids, use as enemas and sitz baths: 2 teaspoons (10 ml) of the drug per glass (200 ml) of warm water, 2–3 times daily.

For vaginal douching – 2–3 tablespoons (30–45 ml) of the drug in 1 liter of warm water, 2–3 times daily for 3–4 weeks.

Children. There is no experience with the use of the drug in children.

Overdose.

There is no data regarding overdose of the drug.

Side effects.

In case of individual hypersensitivity to chamomile, allergic reactions may occur (hyperemia, rash, skin itching, urticaria, Quincke's edema, anaphylactic shock).

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. 100 ml in a bottle in a box.

Availability category. Over-the-counter.

Manufacturer.

Limited Liability Company "Research Plant "GNCLS".

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's location and address of business activity. Ukraine, Kharkiv region, city of Kharkiv, Vorobiova street, building 8.

(Limited Liability Company "Research Plant "GNCLS")

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenko street, building 22.

(LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA")