Stilen

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STILEN (Stillen®)

Composition:

One film-coated tablet contains:

Active substance: 60 mg of soft leaf extract of Artemisiae Argyi (20:1), containing 0.48–1.44 mg of eupatilin and 0.15–0.45 mg of jaceosidin, extracted with 95% ethanol;

Excipients: microcrystalline cellulose; lactose monohydrate; poloxamer; sodium croscarmellose; calcium silicate; talc; magnesium stearate;

Coating: Spectrablend White SM-1320, Spectrablend Green SM-1321, Spectrablend Clear SM-1212, carnauba wax.

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated, green, oval-shaped tablets, embossed with "SLT" on one side and "DА" on the other.

Pharmacotherapeutic group. Agents for treatment of diseases associated with acidity disorders. ATC code A02X.

Pharmacological Properties.

Pharmacodynamics.

Stilen exerts a healing effect on the gastric mucosa in gastritis by enhancing regenerative processes in damaged mucosal cells. The reparative properties of Stilen are provided by flavonoids, which stimulate protein synthesis and improve local blood supply.

The anti-inflammatory activity of Stilen is mediated by pronounced antioxidant properties that prevent lipid peroxidation, block the formation of bioreactive oxygen species, inhibit the release of leukotriene D4 induced by Helicobacter pylori in vitro, and reduce activation of the inflammation-associated transcription factor NF-kB.

Stilen protects the gastric mucosa from damaging effects of various ulcerogenic agents, such as alcohol and nonsteroidal anti-inflammatory drugs (NSAIDs). Protection against alcohol-induced gastric mucosal damage occurs through inhibition of xanthine oxidase activity and oxidative stress. Prevention of gastric mucosal injury caused by NSAID use is achieved by increased release of endogenous prostaglandin E2 from peritoneal neutrophils and reduced production of prostaglandin F1ɑ. Stilen stimulates mucus secretion by gastric epithelium without affecting basal gastric juice secretion or hydrochloric acid production.

Pharmacokinetics.

Stilen is a herbal medicinal product, and pharmacokinetic studies have not been conducted.

Clinical characteristics.

Indications.

Treatment of gastric mucosal lesions (erosions, hemorrhages, hyperemia, edema) in acute and chronic gastritis, including that caused by Helicobacter pylori infection.

Prevention of gastritis induced by nonsteroidal anti-inflammatory drugs (NSAIDs).

Contraindications.

Hypersensitivity to the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Data on interaction with other medicinal products are lacking.

Special precautions for use.

The use of the medicinal product Stilen has not been studied in patients with gastritis complicated by a history of gastrectomy, concomitant duodenal ulcer, or caused by the use of NSAIDs.

According to clinical trial data, the treatment duration is two weeks, and the duration of prophylaxis is four weeks.

If there is no symptom improvement within 2 weeks of treatment, therapy should be re-evaluated.

Use with caution in patients with:

• Thrombosis (cerebral vascular thrombosis, myocardial infarction, thrombophlebitis, etc.);
• Consumption coagulopathy (disseminated intravascular coagulation);
• Severe impairment of liver, kidney, heart, lung function, or blood disorders;
• History or symptoms of drug allergy (rash, fever, itching, etc.).

Stilen contains lactose; therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Stilen contains the colouring agent tartrazine (E 102), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

Pregnancy. Contraindicated (increases uterine tone).

Breastfeeding period. It is unknown whether the medicinal product Stilen is excreted in breast milk. Therefore, it should not be used in breastfeeding women.

Ability to affect reaction speed when driving or operating machinery.

Studies on the influence of Stilen on the ability to drive vehicles or operate machinery have not been conducted.

Dosage and Administration.

The medicinal product Stilen should be administered orally, 1 tablet 3 times a day.

Children.

Due to the lack of experience with the use of the medicinal product Stilen in children, it should not be prescribed to patients under 18 years of age.

Overdose.

Studies on cases of overdose with the use of the medicinal product Stilen have not been conducted.

Adverse reactions.

In clinical studies of acute or chronic gastritis, the following adverse reactions were reported:

Gastrointestinal tract: nausea, anorexia, diarrhea, vomiting, heartburn, and epigastric pain were sometimes observed.

Nervous system: dizziness and headache were sometimes observed.

Skin and subcutaneous tissue: rash and pruritus were sometimes observed.

Hepatobiliary system: elevation of alanine aminotransferase (ALT) levels was sometimes observed.

In a clinical study on prevention of gastritis induced by nonsteroidal anti-inflammatory drugs (NSAIDs), the adverse reactions listed below were reported. Prior to the clinical study, patients were taking Stilen concurrently with NSAIDs. Therefore, it is unknown whether the adverse reactions listed below are related to NSAIDs or to Stilen use. In addition, a causal relationship with Stilen administration has not been established.

Cardiovascular system: palpitations were sometimes observed.

Gastrointestinal tract: very frequently observed were abdominal distension, epigastric pain, heartburn, nausea, diarrhea; sometimes observed were lower abdominal pain, constipation, dyspepsia, belching, increased gastrointestinal motility, gastroesophageal reflux, vomiting, and sensation of hunger.

Hepatobiliary system: increased ALT levels were frequently observed; increased serum bilirubin levels were sometimes observed.

Metabolic disorders: increased appetite was sometimes observed.

Nervous system: headache was sometimes observed.

Psychiatric disorders: insomnia was sometimes observed.

Renal and urinary system: dysuria was sometimes observed.

Respiratory system: nasopharyngitis was sometimes observed.

Laboratory findings: increased serum lactate dehydrogenase levels were sometimes observed.

There have been reports of facial swelling; however, a causal relationship with Stilen administration has not been established.

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.

30 tablets in a plastic container, 1 container in a carton.

Prescription status.

Over-the-counter.

Manufacturer.

Dong-A ST Co., Ltd., Republic of Korea.

Manufacturer's address and address of its business operations.

(2F Section B, 3F, 4F Section B) 200-23, Bokseokgongdan 1-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea.