Fristom

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FRISTOM (FREESTOM)

Composition:

Active substances: 1 tablet contains 30 mg of concentrated ethanolic extract of Corydalis tuber in the form of corydaline and Pharbitis seed in the form of chlorogenic acid (5:1) (extractant ethanol 50%) (9.5 – 11.5 : 1);

Excipients: microcrystalline cellulose (PH101); lactose monohydrate; sodium croscarmellose; calcium silicate; magnesium stearate; purified water, ethanol; film coating Opadry® 7000A white (hypromellose, titanium dioxide (E 171), ethylcellulose, diethyl phthalate); film coating Opadry® 80W64830 pink (polyvinyl alcohol, titanium dioxide (E 171), talc, lecithin, iron oxide red (E 172), xanthan gum, iron oxide yellow (E 172), iron oxide black (E 172)); film coating Opaglos® 97W19196 transparent (sodium croscarmellose, maltodextrin, dextrose monohydrate, lecithin, sodium citrate).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: oval film-coated tablets, pink in color.

Pharmacological Properties.

Pharmacodynamics.

Fristom is a herbal medicinal product for the treatment of functional dyspepsia. The medicinal product Fristom is an alcoholic extract from a mixture of 5 parts of petasites rhizomes and 1 part of ipomoea seeds.

Mechanism of action

Fristom improves gastric content evacuation, enhances gastric accommodation, and reduces visceral hypersensitivity in patients with functional dyspepsia. It is the only medicinal product for the treatment of functional dyspepsia with such a triple mechanism of action, acting via 5-HT4 and 5-HT1A agonism, α2-adrenergic agonism, and D2 antagonism.

Pharmacokinetics.

No data available.

Clinical characteristics.

Indications.

In complex therapy of functional dyspepsia.

Contraindications.

Fristom is contraindicated in the following cases:

• In patients with hypersensitivity to any component of the medicinal product Fristom.
• Patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not use the medicinal product Fristom, as it contains lactose.

Interaction with other medicinal products and other forms of interaction.

Despite limited clinical experience with concomitant use of the medicinal product Fristom with other medicinal products, attention should be paid to potential drug interactions, and caution should be exercised when using Fristom together with the following medicinal products:

• when used concomitantly with anticholinergic agents, the effectiveness of the medicinal product Fristom may be reduced due to inhibition of gastrointestinal motility;
• ipomoea seeds, one of the active substances in the medicinal product Fristom, must not be used together with croton oil.

Special precautions for use.

The medicinal product Fristom should be used with caution, as its mechanism of action may enhance the effects of acetylcholine.

The use of the medicinal product Fristom in the treatment of functional dyspepsia is possible only after consultation with a physician.

During clinical studies, the duration of treatment with the medicinal product Fristom was 8 weeks. If there is no improvement in symptoms after 4 weeks of taking Fristom, alternative therapy should be considered.

This medicinal product contains lactose and therefore should not be administered to patients with rare hereditary disorders of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Use during pregnancy or breastfeeding.

The safety of using the medicinal product Fristom during pregnancy and breastfeeding has not been established.

Ability to influence reaction rate when driving vehicles or operating machinery.

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

Dosage and Administration.

Adult patients should take 1 tablet 3 times daily before meals.

Children.

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

Overdose.

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

Adverse Reactions

During Phase III clinical trials with the medicinal product Fristom, the following systemic adverse reactions were reported.

Nervous system disorders: dizziness was occasionally observed (0.4%).

Gastrointestinal disorders: constipation (2.2%), diarrhea (1.7%), increased amylase levels (0.4%) were occasionally observed.

Cardiovascular system disorders: tachycardia was occasionally observed (0.4%).

Endocrine disorders: increased blood prolactin levels were occasionally observed (1.7%).

Skin and subcutaneous tissue disorders: pruritus (1.3%), rash (0.9%), urticaria (0.4%), skin pain (0.04%) were occasionally observed.

Hepatobiliary disorders: increased alanine aminotransferase levels (1.3%), increased gamma-glutamyl transferase levels (0.9%), increased aspartate aminotransferase levels (0.4%), increased blood lactate dehydrogenase levels (0.4%) were occasionally observed.

Investigations: increased blood creatine phosphokinase levels were occasionally observed (0.4%).

According to the results of a 4-year post-marketing surveillance study conducted in Korea involving 605 patients, the incidence of adverse reactions was 7.11% (43/605 patients, 47 cases). Among these, the incidence of adverse reactions for which a causal relationship with the investigational medicinal product could not be excluded was 3.97% (24/605 patients, 25 cases), including diarrhea – 1.65% (10/605 patients, 10 cases), constipation – 1.65% (10/605 patients, 10 cases), pruritus and urticaria – 0.33% (2/605 patients, 2 cases), dizziness – 0.17% (1/605 patient, 1 case). No serious or unexpected adverse reactions were recorded during this study.

Based on the evaluation combining data from post-marketing surveillance and spontaneous adverse reaction reports received between 1989 and 2015, the following adverse reactions were identified:

Gastrointestinal disorders: dyspepsia, abdominal pain, nausea, bloating.

Psychiatric disorders: insomnia.

Metabolism and nutrition disorders: electrolyte imbalance.

However, the obtained data do not confirm a causal relationship between the active substances and the listed adverse reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30 °C. Keep out of reach of children.

Incompatibilities.

No data available.

Packaging.

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

Prescription status.

Over-the-counter.

Manufacturer.

Dong-A ST Co., Ltd. / Dong-A ST Co., Ltd.

Manufacturer's address and location of operations.

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