Instructions for Stylen film-coated tablets 60 mg container No. 30
Composition
1 film-coated tablet contains:
active ingredient: 60 mg of Artemisiae Argyi wormwood leaf extract, mild (20:1), containing 0.48–1.44 mg of eupatyline and 0.15–0.45 mg of jayseosidine, extractant ethanol 95%;
excipients: microcrystalline cellulose; lactose monohydrate; poloxamer; croscarmellose sodium; calcium silicate; talc; magnesium stearate;
Coating: Spectrablend white CM-1320, Spectrablend green CM-1321, Spectrablend transparent CM-1212, carnauba wax.
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, green in color and oval in shape, embossed with “SLT” on one side and “DA” on the other.
Pharmacotherapeutic group
Means for the treatment of diseases associated with acidity disorders. ATX code A02X.
Pharmacological properties
Pharmacodynamics.
Stylen has a healing effect on the gastric mucosa in gastritis by enhancing regenerative processes in the affected cells of the mucous membrane. The reparative properties of the drug Stylen are provided by flavonoids, which stimulate protein synthesis and improve local blood supply.
The anti-inflammatory activity of Stylene is realized through pronounced antioxidant properties that prevent lipid peroxidation, block the formation of bioreactive oxygen species, inhibit the release of leukotriene D4 caused by Helicobacter pylori in vitro, and reduce the activation of the transcription factor NF-kB, associated with inflammation.
Stylen protects the gastric mucosa from the damaging effects of various ulcerogens, such as alcohol and nonsteroidal anti-inflammatory drugs (NSAIDs). Protection of the gastric mucosa from alcohol-induced damage is achieved by inhibiting the activity of xanthine oxidase and oxidative stress. Prevention of gastric mucosal damage during the use of NSAIDs is ensured by increased release of endogenous prostaglandin E2 from peritoneal neutrophils and reduced production of prostaglandin F1ɑ. Stylen stimulates mucus secretion by the gastric epithelium, without affecting the basal secretion of gastric juice and the production of hydrochloric acid.
Pharmacokinetics.
Stylene is a herbal medicine and pharmacokinetic testing has not been conducted with it.
Indication
Treatment of lesions of the gastric mucosa (erosion, hemorrhage, hyperemia, edema) in acute and chronic gastritis, including those caused by Helicobacter pylori infection.
Prevention of gastritis caused by taking NSAIDs.
Contraindication
Hypersensitivity to the components of the drug.
Interaction with other medicinal products and other types of interactions
There are no data on interactions with other drugs.
Application features
The use of the drug Stylen has not been studied in patients with gastritis that was complicated by a history of gastrotomy, accompanied by a concomitant duodenal ulcer, and was caused by the use of NSAIDs.
According to clinical studies, the duration of treatment is two weeks, and the duration of prevention is four weeks.
If no improvement in symptoms is observed after 2 weeks of use, therapy should be reviewed.
Use with caution in patients with:
thrombosis (cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.);
consumption coagulopathy (disseminated intravascular coagulation);
severe liver, kidney, heart, lung function disorders and blood diseases;
symptoms of drug allergy (rash, fever, itching, etc.) or with a history of drug allergy symptoms.
Stylen contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
Stylene contains the dye tartrazine (E 102), which may cause allergic reactions.
Use during pregnancy or breastfeeding
Pregnancy. Contraindicated (increases uterine tone).
Breastfeeding. It is not known whether Stylen passes into breast milk. Therefore, it should not be used by women who are breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies on the effects on the ability to drive vehicles and other mechanisms have been conducted.
Method of administration and doses
The drug Stylen should be taken orally, 1 tablet 3 times a day.
Children.
Due to the lack of experience with the use of Stylen in children, it should not be prescribed to patients under 18 years of age.
Overdose
No studies of overdose cases with the use of the drug Stylen have been conducted.
Side effects
In clinical studies of acute or chronic gastritis, the following adverse reactions were reported:
Nervous system: dizziness and headache were sometimes observed.
Skin and subcutaneous tissue disorders: Rash and itching were occasionally observed.
Hepatobiliary system: sometimes an increase in alanine aminotransferase (ALT) levels was observed.
In a clinical study of the prevention of gastritis caused by NSAIDs, the following adverse reactions were reported. Before the clinical study, patients were taking Stylen concomitantly with NSAIDs. Therefore, it is not known whether the following adverse reactions are related to NSAIDs or to Stylen. In addition, a causal relationship with Stylen has not been established.
Cardiovascular system: sometimes palpitations were observed.
Gastrointestinal: very often abdominal bloating, upper abdominal pain, heartburn, nausea, diarrhea; sometimes lower abdominal pain, constipation, dyspepsia, belching, increased gastrointestinal motility, gastroesophageal reflux, vomiting and feeling of hunger were observed.
Hepatobiliary system: increased ALT levels were often observed; increased serum bilirubin levels were sometimes observed.
Metabolic disorders: increased appetite has occasionally been observed.
Nervous system: headache was sometimes observed.
On the part of the psyche: insomnia was sometimes observed.
Renal and urinary disorders: dysuria was occasionally observed.
Respiratory system: nasopharyngitis was occasionally observed.
Laboratory parameters: sometimes an increase in serum lactate dehydrogenase levels was observed.
There have been reports of facial swelling, although a causal relationship with taking the drug Stylen has not been established.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
30 tablets in a plastic container, 1 container in a pack.
Vacation category
Without a prescription.
Producer
Dong-A ST Co., Ltd., Republic of Korea.
Location of the manufacturer and address of the place of implementation of its activities.
(2F Section B, 3F, 4F Section B) 200-23, Baekseokgon-daeng 1-ro, Sobuk-gu, Cheonan-si, Chungcheongnam-do, Republic of Korea.
