RECUTAN

APPROVED by the Order of the Ministry of Health of Ukraine

07.2018 No. 1309

Certificate of State Registration No. UA 8838/01/01 AMENDMENTS MADE by the Order of the Ministry of Health of Ukraine ___________ No. ________ INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT REKUTANÒ (RECUTAN)

Composition:

Active substance: liquid extract of chamomile flowers (Chamomillae flores extractum liquidum) (extractant 50% (v/v) ethanol) (1:1) – up to 100 ml;

Excipients: polysorbate-80, ethanol 50%.

Pharmaceutical form. Liquid.

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

Pharmacotherapeutic group. Dermatological preparations. ATC code D11AX.

Pharmacological properties.

Pharmacodynamics.

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

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Used as a single agent or as part of combination therapy in inflammatory diseases of the oral cavity (stomatitis, gingivitis, glossitis, periodontosis), in diseases of the upper respiratory tract (pharyngitis, tonsillitis, including after tonsillectomy); in proctology—for hemorrhoids; in gynecology—topically for inflammatory processes and cervical erosion; for prophylactic vaginal irrigation before cesarean section. The medicinal product is used as mouthwashes, inhalations, enemas, and baths.

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

Contraindications. Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions. Interaction with medicinal products is currently unknown.

Special precautions for use.

The undiluted preparation must not be used. Recommended doses should not be exceeded when using the preparation. Patients with a history of hypersensitivity to plants of the Asteraceae/Compositae family (ragweed, chrysanthemums, calendula, daisy) are more prone to developing allergic reactions when using preparations containing chamomile extract.

Ethanol (when used orally). This medicinal product contains no more than 3.0 g/dose of ethanol (alcohol). It is harmful for patients suffering from alcoholism. Caution should be exercised when administering to breastfeeding women, children, patients with liver disorders, and patients with epilepsy.

Use during pregnancy or breastfeeding.

The medicinal product should not be used during pregnancy. During breastfeeding, the preparation should be used only as prescribed by a physician.

Ability to influence reaction rate while driving or operating machinery.

It should be noted that a single dose of the preparation contains 5% ethanol; therefore, when the preparation is taken orally, patients should refrain from driving vehicles or operating machinery.

Dosage and Administration

For oral cavity diseases – for rinsing: 2 teaspoons (10 ml) of the preparation are dissolved in a glass (200 ml) of water. In periodontitis, tampons are soaked in this solution and placed into the gingival pockets for 10–15 minutes daily for 3–7 days.

For upper respiratory tract diseases – daily inhalations are performed using the following solution: 2 teaspoons (10 ml) of the preparation are dissolved in a glass (200 ml) of water, administered for 10 days.

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

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

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

Shake well before use.

Children

There is no experience with the use of this preparation in children.

Overdose. No data available.

Side effects.

Allergic reactions are possible in individuals with increased sensitivity to chamomile (hyperemia, skin itching, rash, urticaria, Quincke's edema, anaphylactic shock).

Shelf life. 2 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 glass or polymer bottles or jars, placed in a carton.

Availability. Over-the-counter.

Manufacturer. JSC "Halychpharm".

Manufacturer's address and location of business activity.

6/8 Opryshkivska Street, Lviv, 79024, Ukraine.