Stefimol
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STYFIMOL (STYFIMOL)
Composition:
Active substances: 1 capsule contains 100 mg of Garcinia cambogia extract (Garcinia cambogia), corresponding to 50 mg of hydroxycitric acid, 0.1 mg of chromium picolinate, 50 mg of L-tyrosine (tyrosine), 15 mg of levocarnitine (L-carnitine), and 0.037 mg of dry extract of brown algae (Fucus vesiculosus L.), calculated as iodine;
Excipients: microcrystalline cellulose; light magnesium carbonate; lactose monohydrate; talc; calcium stearate; corn starch;
Hard gelatin capsule contains: gelatin, indigotine (E 132), quinoline yellow (E 104), titanium dioxide (E 171).
Pharmaceutical form. Hard capsules.
Main physicochemical characteristics: hard gelatin capsules with a light green cap and a dark green body. The capsule contents consist of light brown granular powder.
Pharmacotherapeutic group. Agents used in obesity, excluding dietary products. ATC code A08A.
Pharmacological properties.
Pharmacodynamics.
The main component of the medicinal product is Garcinia cambogia extract (Garcinia cambogia). This plant has been used for dietary and therapeutic purposes in Southeast Asia for centuries. The primary constituent of this extract is hydroxycitric acid, which inhibits lipogenesis, reduces the formation of cholesterol and fatty acids, increases glycogen production in the liver, suppresses appetite, and enhances heat production in the body by activating thermogenic processes.
Chromium picolinate regulates glucose uptake by the body's cells and supports maintenance of normal physiological blood glucose levels. It regulates carbohydrate and lipid metabolism, particularly cholesterol metabolism.
A thermosynergistic blend based on L-carnitine and L-tyrosine is used. The unique property of L-carnitine is its ability to enhance cellular membrane permeability to fatty acids. L-carnitine increases lipid utilization for energy production and slows the rate of fat molecule synthesis in subcutaneous adipose depots. With L-carnitine administration, sustained loss of adipose tissue begins, the efficiency of fat oxidation in the body significantly increases, production of free radicals decreases, and ATP content rises.
L-tyrosine is a precursor of the neurotransmitters norepinephrine and dopamine. Catecholamine biosynthesis begins with tyrosine. Administration of L-tyrosine improves catecholamine metabolism. One of the main target tissues for catecholamines in the body is adipose tissue.
Epinephrine and norepinephrine stimulate lipolysis in adipose tissue via β1-adrenergic receptors, which, through the cAMP system, activate (by phosphorylation) hormone-sensitive triacylglycerol lipase. Epinephrine also induces lipolysis of triacylglycerols in muscle cells via the cAMP system. Tyrosine reduces appetite, promotes melatonin production, improves thyroid and adrenal gland function. Biosynthesis of thyroid hormones begins with iodination of tyrosine. These hormones stimulate metabolic processes in the body. Tyrosine participates in regulation of emotional state: it helps alleviate feelings of anxiety and overcome depression.
Brown seaweed extract: due to its iodine content, improves thyroid gland function, activates metabolic processes, and promotes lipid breakdown in adipose tissue.
Clinical characteristics.
Indications.
The medicinal product is used:
- in case of increased body weight;
- in case of predisposition to obesity;
- when using diets to reduce appetite.
Contraindications.
Hypersensitivity to components of the medicinal product, including iodine.
Interaction with other medicinal products and other types of interactions.
When prescribing the medicinal product Stifimol, it is advisable to use multivitamins concomitantly. They should be taken no earlier than 2 hours after administration of Stifimol.
Concomitant use of other iodine-containing preparations and medicinal products used for thyroid gland treatment should be avoided.
Special precautions for use.
Should be used with caution after consultation with a physician in patients with thyroid pathology, cardiovascular diseases, and gastrointestinal disorders. In thyroid diseases, the iodine content in the medicinal product Stymol, which amounts to 37 mcg per 1 capsule, should be taken into account.
The medicinal product contains lactose; therefore, it should not be used in patients with hereditary galactose intolerance, glucose-galactose malabsorption, or lactase deficiency.
Use during pregnancy or breastfeeding.
Due to the lack of clinical data, the medicinal product should not be prescribed during pregnancy or breastfeeding.
Ability to influence reaction rate while driving or operating machinery. Data are lacking.
Dosage and Administration.
For adults, administer 1 capsule of the medicinal product 2-3 times daily, before meals, with a glass of water.
Treatment duration: 4-6 weeks. Repeat courses may be prescribed after an interval of 2-3 months.
Children.
The medicinal product is not recommended for use in children due to lack of clinical data on efficacy and safety in this population.
Overdose.
Symptoms: in case of overdose, adverse reactions affecting the thyroid gland (hyperthyroidism or hypothyroidism), cardiovascular system (elevated blood pressure, tachycardia), and gastrointestinal tract (diarrhea) may occur. If symptoms of overdose occur, discontinue use of the medicinal product.
Treatment: symptomatic.
Adverse reactions.
The medicinal product is well tolerated at recommended doses and rarely causes adverse effects, which are usually related to individual intolerance to one of the components of the product. In case of individual hypersensitivity to the components of the drug, the following reactions are possible:
From the immune system: hypersensitivity reactions, including allergic and anaphylactic reactions, angioedema (Quincke's edema), skin rashes, pruritus, urticaria.
From the endocrine system: iodine-induced hyperthyroidism and hypothyroidism.
From the cardiovascular system: increased arterial pressure, tachycardia.
From the gastrointestinal tract: diarrhea.
Shelf life. 2 years.
Storage conditions.
Store in original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 capsules per blister; 10 blisters per carton.
Prescription status. Over-the-counter.
Manufacturer. JSC "KYIV VITAMIN PLANT".
Manufacturer's address and location of its business activities.
04073, Ukraine, Kyiv, Kopylivska St., 38.
Web-site: www.vitamin.com.ua.
INSTRUCTION
for medical use of the medicinal product
STYFIMOL
(STYFIMOL)
Composition:
Active substances: 1 capsule contains Garcinia cambogia extract (Garcinia cambogia) 100 mg, equivalent to 50 mg of hydroxycitric acid; chromium picolinate 0.1 mg; L-tyrosine (tyrosine) 50 mg; levocarnitine (L-carnitine) 15 mg; dry extract of brown algae (Fucus vesiculosus L.), calculated as iodine 0.037 mg;
Excipients: microcrystalline cellulose; light magnesium carbonate; lactose monohydrate; talc; calcium stearate; corn starch;
Hard gelatin capsule contains: gelatin, indigotine (E 132), quinoline yellow (E 104), titanium dioxide (E 171).
Pharmaceutical form. Hard capsules.
Main physicochemical properties: hard gelatin capsules with a light green cap and a dark green body. Capsule contents: granulated light brown powder.
Pharmacotherapeutic group. Agents used in obesity, excluding dietary products. ATC code A08A.
Pharmacological properties.
Pharmacodynamics.
The main component of the medicinal product is Garcinia cambogia extract. This plant has been used for dietary and therapeutic purposes in Southeast Asia for centuries. The primary constituent of this extract is hydroxycitric acid, which inhibits lipogenesis, reduces cholesterol and fatty acid synthesis, increases glycogen production in the liver, suppresses appetite, and enhances heat production in the body by activating thermogenesis.
Chromium picolinate regulates glucose uptake by the body's cells and helps maintain normal physiological blood glucose levels. It regulates carbohydrate and lipid metabolism, particularly cholesterol metabolism.
A thermosynergistic mixture based on L-carnitine and L-tyrosine is used. The unique property of L-carnitine is its ability to increase cell membrane permeability for fatty acids. L-carnitine enhances lipid utilization for energy production and slows down fat molecule synthesis in subcutaneous fat depots. Administration of L-carnitine leads to sustained loss of adipose tissue, significantly increases the efficiency of fat oxidation in the body, reduces the production of free radicals, and increases ATP content. L-tyrosine is a precursor of the neurotransmitters norepinephrine and dopamine. Catecholamine biosynthesis begins with tyrosine. Administration of L-tyrosine improves catecholamine metabolism. One of the main target tissues for catecholamines in the body is adipose tissue. Adrenaline and noradrenaline stimulate lipolysis in adipose tissue via β1-adrenergic receptors, which activate (by phosphorylation) hormone-sensitive triacylglycerol lipase through the cAMP system. Adrenaline also induces lipolysis of triacylglycerols in muscle cells via the cAMP system. Tyrosine reduces appetite, promotes melatonin production, improves thyroid and adrenal gland function. Biosynthesis of thyroid hormones begins with iodination of tyrosine. These hormones stimulate metabolic processes in the body. Tyrosine participates in regulation of emotional state: it helps reduce anxiety and overcome depression.
Brown algae extract: due to its iodine content, it improves thyroid gland function, activates metabolic processes, and promotes lipid breakdown in adipose tissue.
Clinical characteristics.
Indications.
The medicinal product is indicated:
- in cases of increased body weight;
- in predisposition to obesity;
- when using diets to reduce appetite.
Contraindications.
Hypersensitivity to any component of the medicinal product, including iodine.
Interaction with other medicinal products and other types of interactions.
When taking Styfimol, it is advisable to take multivitamins simultaneously. Multivitamins should be taken no earlier than 2 hours after taking Styfimol.
Concomitant use of other iodine-containing products and medicinal agents used for thyroid treatment should be avoided.
Special precautions.
Use with caution and only after consultation with a physician in patients with thyroid pathology, cardiovascular diseases, and gastrointestinal disorders. In patients with thyroid disorders, the iodine content in Styfimol (37 μg per capsule) should be taken into account.
The medicinal product contains lactose and therefore should not be used in patients with hereditary galactose intolerance, glucose-galactose malabsorption, or lactase deficiency.
Use during pregnancy or breastfeeding.
Due to lack of clinical data, the medicinal product should not be used during pregnancy or breastfeeding.
Ability to affect reaction rate when driving or operating machinery. No data available.
Method of administration and dosage.
For adults: 1 capsule 2–3 times daily, taken before meals with a full glass of water.
Treatment duration: 4–6 weeks. Repeat courses may be prescribed after a 2–3 month interval.
Children.
The medicinal product is not recommended for children due to lack of efficacy and safety data in this population.
Overdose.
Symptoms: in case of overdose, adverse reactions may occur affecting the thyroid gland (hyperthyroidism or hypothyroidism), cardiovascular system (increased arterial pressure, tachycardia), and gastrointestinal tract (diarrhea). If symptoms of overdose occur, discontinue use of the medicinal product.
Treatment: symptomatic.
Adverse reactions.
The medicinal product is well tolerated at recommended doses and rarely causes adverse effects, which are usually associated with individual intolerance to one of the components of the drug.
In case of individual hypersensitivity to the components of the drug, the following reactions are possible:
From the immune system: hypersensitivity reactions, including allergic and anaphylactic reactions, Quincke's edema, skin rashes, pruritus, urticaria.
From the endocrine system: iodine-induced hyperthyroidism and hypothyroidism.
From the cardiovascular system: increased arterial pressure, tachycardia.
From the gastrointestinal tract: diarrhea.
Shelf life. 2 years.
Storage conditions.
Store in original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
10 capsules per blister; 10 blisters per carton.
Prescription status. Over-the-counter.
Manufacturer. JSC "KYIV VITAMIN PLANT".
Manufacturer's address and location of its business activities.
04073, Ukraine, Kyiv, Kopylivska St., 38.
Web-site: www.vitamin.com.ua.