I N S T R U C T I O N for medical use of the medicinal product SADIPHYTUM (SADIPHYT)

Composition:

Active substances: 1 g of the herbal mixture contains: Topinambur tubers (Helianthi tubera) 0.2 g; Stevia leaves (Steviae folia) 0.2 g; Bilberry shoots (Vaccinii myrtilli cormus) 0.2 g; Bean pods (Phaseoli valvaefructum) 0.2 g; Green tea (Theae chinensis) 0.15 g; Peppermint leaves (Menthae piperitae folia) 0.05 g.

Pharmaceutical form. Herbal mixture.

Main physicochemical properties: a mixture of heterogeneous fragments of green, dark green, greyish-green, brownish-green, yellowish-white, light brown or brownish-brown color.

Pharmacotherapeutic group. Medicinal products used in diabetes. ATC code A10X.

Pharmacological properties.

Pharmacodynamics.

The biologically active substances in the herbal mixture exert a hypoglycemic effect in mild to moderate type II diabetes mellitus, allowing in some cases a reduction in daily doses of oral antidiabetic agents; they regulate gastrointestinal tract function, stimulate pancreatic activity, normalize metabolic processes, reduce blood cholesterol levels, and exhibit anti-inflammatory, choleretic, and diuretic properties.

Clinical characteristics.

Indications.

Mild to moderate forms of type II diabetes mellitus, gastrointestinal tract disorders (enterocolitis, chronic pancreatitis, chronic cholecystitis) – as part of complex therapy.

Contraindications.

Hypersensitivity to the biologically active substances of the drug. Bronchial asthma, croup; acute exacerbation of chronic pancreatitis, acute exacerbation of chronic enterocolitis, biliary tract dyskinesia; spasmophilia.

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

Special precautions for use.

In patients with gastroesophageal reflux, heartburn may increase.

Use during pregnancy or breastfeeding. Contraindicated.

Ability to affect reaction speed when driving or operating machinery. Unknown.

Method of Administration and Dosage

Place 1 tablespoon of the herbal mixture into an enameled container, pour 300 mL (1.5 cups) of hot boiled water, cover with a lid, and steep in a water bath for 15 minutes. Cool at room temperature for 45 minutes, strain, squeeze out the residue, and add the expressed liquid to the strained infusion. Adjust the final volume of the infusion to 300 mL with boiled water. Administer warm, 3 times daily, 30 minutes before meals, for 20–30 days: for adults and children aged 14 years and older – ½ cup; for children aged 10–14 years – ⅓–¼ cup; for children aged 7–10 years – 2 tablespoons. Shake the infusion before use.

Place 2 filter bags into a glass or enameled container, pour 300 mL (1.5 cups) of boiling water, cover, and steep for at least 1 hour. It is recommended to steep in a thermos. Administer warm, 3 times daily, 30 minutes before meals, for 20–30 days: for adults and children aged 14 years and older – ½ cup; for children aged 10–14 years – ⅓–¼ cup; for children aged 7–10 years – 2 tablespoons.

After 7–10 days, the treatment course may be repeated (after consultation with a physician).

Store the prepared infusion at 8–15°C for no more than 2 days.

Children. This product should be administered to children aged 7 years and older only as directed by a physician.

Overdose. Exceeding the recommended dosage may cause chest pain due to the presence of peppermint.

Side effects.

Allergic reactions are possible (including hyperemia, rash, itching, skin swelling, urticaria, contact dermatitis).

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions. Store in the original packaging at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging. 75 g in packs with an inner packet; 3.0 g in a filter bag, 20 filter bags per pack or in a pack with an inner packet; 3.0 g in a filter bag in an individual sachet, 20 filter bags per pack.

Release category. Over-the-counter.

Manufacturer/Marketing authorization holder. JSC "Lektravy".

Address of manufacturer and location of its business activities / address of marketing authorization holder.

Ukraine, 10001, Zhytomyr Oblast, Zhytomyr, Kyivske Shose, building 21.