Deprivit
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DEPRIVIT (DEPRIVIT)
Composition:
Active substance: 1 tablet contains 60 mg of 0.5% St. John's wort extract (Hypericum perforatum), corresponding to 0.3 mg of hypericin;
Excipients: microcrystalline cellulose; lactose monohydrate; sodium croscarmellose; colloidal anhydrous silicon dioxide; talc; magnesium stearate;
Coating: film-coating mixture Opadry II Green (polyvinyl alcohol, polyethylene glycol (macrogol), patent blue V (E 133), quinoline yellow (E 104), titanium dioxide (E 171), iron oxide yellow (E 172), talc).
Pharmaceutical form. Film-coated tablets.
Main physicochemical characteristics: round, biconvex tablets with a green film coating.
Pharmacotherapeutic group. Antidepressants. ATC code N06A X.
Pharmacological Properties.
Pharmacodynamics.
A herbal antidepressant. The St. John's wort extract, containing active substances hypericin, pseudohypericin and hyperforin, exerts a balancing effect on the central and autonomic nervous systems.
The medicinal product Deprivit has a positive effect in cases of apathy accompanied by such symptoms as malaise, loss of appetite and insomnia. It positively influences mood, cognitive and physical abilities, and increases work capacity.
Clinical characteristics.
Indications.
Depressed mood, feelings of chronic fatigue, emotional exhaustion, weakness; reduced work capacity.
Contraindications.
Hypersensitivity to the components of the medicinal product; photosensitization, including after taking St. John's wort preparations (in history); concomitant use or use within the previous 2 weeks of monoamine oxidase inhibitors, severe depression accompanied by suicidal thoughts.
Concomitant use: indinavir or other antiretroviral medicinal products; cyclosporine, digoxin, theophylline, irinotecan, tacrolimus, simvastatin, fexofenadine, tricyclic antidepressants (amitriptyline, nortriptyline), antiepileptic agents (carbamazepine, phenobarbital, phenytoin), selective serotonin reuptake inhibitors (citalopram, fluvoxamine, sertraline, paroxetine), as well as triptans (sumatriptan, naratriptan, zolmitriptan); oral anticoagulants (warfarin and other coumarin derivatives). Use of oral contraceptives, injectable contraceptives, and implants (due to the risk of reduced efficacy of contraceptive methods).
Interaction with other medicinal products and other types of interactions.
When St. John's wort preparations are used concomitantly or immediately after therapy with monoamine oxidase inhibitors, or when monoamine oxidase inhibitors are used immediately after St. John's wort therapy, an increased risk of adverse effects is possible. Concomitant use with other antidepressants (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram) and triptan derivatives (sumatriptan, naratriptan, zolmitriptan) may also increase the risk of adverse reactions (nausea, vomiting, agitation, feelings of fear). In addition to the specified drugs, Deprevit may interact with other medicinal products whose metabolism involves the cytochrome P450 enzyme system. The effect on enzymes may persist even after discontinuation of treatment with products containing St. John's wort extract. Therefore, the interaction of the medicinal product Deprevit with other drugs may continue for up to two weeks after discontinuation of its use.
St. John's wort preparations may increase the activity of many enzymes involved in the metabolism of other medicinal products. As a result of such interactions, plasma concentration and therapeutic effect of some medicinal products may be reduced.
It may reduce the effect of indirect anticoagulants (warfarin, phenprocoumon), cyclosporine, digoxin, indinavir, amitriptyline, nortriptyline, theophylline (concomitant use is possible only under medical supervision with mandatory monitoring of blood parameters and prothrombin time at the beginning and end of treatment). Concomitant use with oral hormonal contraceptives may reduce their effectiveness and lead to intermenstrual bleeding.
Special precautions.
During treatment with the medicinal product Deprevit, exposure to intense ultraviolet radiation (prolonged sunbathing, UV lamps, solarium) should be avoided.
The medicinal product contains lactose and therefore is not recommended for patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.
Alcoholic beverages should be avoided during treatment with this medicinal product.
The medicinal product should be used with caution in patients with arterial hypertension.
Patients should be informed that prior to initiating treatment, consultation with a physician is mandatory, as symptoms for which the medicinal product is indicated may be caused by another, more serious pathology.
Use during pregnancy or breastfeeding.
The medicinal product should not be used during pregnancy or breastfeeding due to lack of safety data for use during these periods.
Ability to influence reaction speed when driving or operating machinery.
Not established; however, caution should be exercised when performing potentially hazardous activities requiring increased attention and speed of psychomotor reactions, as the medicinal product may cause dizziness.
Dosage and Administration.
Take orally during meals, without chewing, with sufficient amount of liquid.
For adults and children aged 12 years and older: 1 tablet three times daily. A satisfactory therapeutic effect may be observed after 10–14 days of treatment. Regular administration of the medicinal product for several weeks or months is required to achieve full therapeutic effect. If symptoms persist for more than 4–6 weeks, discontinue use of the medicinal product and consult a physician.
Children. Safety and efficacy of treatment in children under 12 years of age have not been established; therefore, the medicinal product should not be used in this age group.
Overdose.
Cases of hypericum overdose have not been reported. If a patient has taken a dose exceeding the recommended amount, UV exposure and sunbathing should be avoided during periods of high solar activity (May–August) for 1–2 weeks.
Adverse reactions.
Rarely, the following adverse reactions may occur during the use of the medicinal product, which usually resolve quickly.
From the nervous system: dizziness, headache.
From the psyche: anxiety, restlessness; in patients with bipolar depression, the risk of developing a manic state increases.
From the gastrointestinal tract: gastrointestinal disturbances, dry mouth.
From the skin and subcutaneous tissue: in individuals with increased sensitivity to sunlight, exposure to the sun may cause burns.
From the immune system: allergic reactions, including skin redness, itching.
General disorders: increased fatigue, elevated arterial pressure.
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. 10 tablets per blister, 3 blisters per carton.
Release category. Over-the-counter.
Manufacturer: PJSC "KYIV VITAMIN PLANT".
Manufacturer's location and address of its business activity.
04073, Ukraine, Kyiv, Kopilivska Street, 38.
Web-site: www.vitamin.com.ua.
INSTRUCTIONS
for medical use of the medicinal product
DEPRIVIT
(DEPRIVIT)
Composition:
Active substance: 1 tablet contains St. John's wort extract 0.5% (Hypericum perforatum) 60 mg, corresponding to hypericin 0.3 mg;
Excipients: microcrystalline cellulose; lactose monohydrate; sodium croscarmellose; colloidal anhydrous silicon dioxide; talc; magnesium stearate;
Coating: film-coating mixture Opadry II Green (polyvinyl alcohol, polyethylene glycol (macrogol), brilliant blue (E 133), quinoline yellow (E 104), titanium dioxide (E 171), yellow iron oxide (E 172), talc).
Pharmaceutical form. Film-coated tablets.
Main physicochemical properties: round, biconvex tablets coated with a green film.
Pharmacotherapeutic group. Antidepressants. ATC code N06A X.
Pharmacological properties.
Pharmacodynamics.
A herbal antidepressant. The St. John's wort extract, containing active substances hypericin, pseudohypericin, and hyperforin, exerts a harmonizing effect on the central and autonomic nervous systems.
The medicinal product Deprivit has a positive effect in apathy accompanied by symptoms such as malaise, loss of appetite, and insomnia. It positively influences mood, mental and physical performance, and increases work capacity.
Clinical characteristics.
Indications.
Depressed mood, feelings of chronic fatigue, emotional exhaustion, weakness; decreased work capacity.
Contraindications.
Hypersensitivity to the components of the medicinal product; photosensitization, including after taking St. John's wort preparations (in history); use of monoamine oxidase inhibitors simultaneously and/or within the preceding 2 weeks; severe depression associated with suicidal thoughts.
Concomitant use: indinavir or other antiretroviral medicinal products; cyclosporine, digoxin, theophylline, irinotecan, tacrolimus, simvastatin, fexofenadine, tricyclic antidepressants (amitriptyline, nortriptyline), antiepileptic drugs (carbamazepine, phenobarbital, phenytoin), selective serotonin reuptake inhibitors (citalopram, fluvoxamine, sertraline, paroxetine), as well as triptans (sumatriptan, naratriptan, zolmitriptan); anticoagulant drugs (warfarin and other coumarin derivatives). Use of oral contraceptives, injectable contraceptives, and implants (due to the risk of reduced effectiveness of contraceptive agents).
Interaction with other medicinal products and other types of interactions.
When St. John's wort preparations are used simultaneously or immediately after treatment with monoamine oxidase inhibitors, or when monoamine oxidase inhibitors are used immediately after St. John's wort therapy, an enhancement of adverse effects may occur. When used concomitantly with other antidepressants (fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram) and triptan derivatives (sumatriptan, naratriptan, zolmitriptan), an increased risk of adverse reactions (nausea, vomiting, agitation, fear) is also possible. In addition to the above-mentioned drugs, Deprivit may interact with other medicinal products whose metabolism involves the cytochrome P450 enzyme system. The effect on enzymes may persist even after discontinuation of treatment with St. John's wort extract-containing products. Therefore, interaction between Deprivit and other drugs may still occur within two weeks after stopping its use.
St. John's wort preparations may increase the activity of many enzymes involved in the metabolism of other medicinal products. As a result of such reactions, plasma concentration and therapeutic effect of certain medicinal products may be reduced.
It may reduce the effect of indirect anticoagulants (warfarin, phenprocoumon), cyclosporine, digoxin, indinavir, amitriptyline, nortriptyline, theophylline (concomitant use is possible only upon physician's prescription with mandatory monitoring of blood parameters and prothrombin time at the beginning and end of treatment). Concomitant use with oral hormonal contraceptives may weaken their effect and lead to intermenstrual bleeding.
Special precautions.
During treatment with Deprivit, intense ultraviolet radiation (prolonged sunbathing, UV lamps, solarium) should be avoided.
The medicinal product contains lactose; therefore, it is not recommended for patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.
Alcoholic beverages should be avoided during treatment with the medicinal product.
The medicinal product should be used with caution in patients with arterial hypertension.
Patients must be informed that they should consult a physician before starting treatment, as symptoms for which the medicinal product is indicated may be a consequence of another, more severe pathology.
Use during pregnancy or breastfeeding.
The medicinal product should not be used during pregnancy or breastfeeding due to lack of safety data during these periods.
Ability to influence reaction speed when driving or operating machinery.
Not established, but caution should be exercised when performing potentially hazardous activities requiring increased attention and psychomotor reaction speed, as the medicinal product may cause dizziness.
Method of administration and dosage.
Oral administration during meals, without chewing, taken with sufficient liquid.
Adults and children aged 12 years and older: 1 tablet three times daily. A satisfactory therapeutic effect may be observed after 10–14 days of treatment. Regular administration over several weeks or months is required to achieve full therapeutic effect. If symptoms persist for more than 4–6 weeks, the use of the medicinal product should be discontinued and medical advice sought.
Children. Safety and efficacy in children under 12 years of age have not been established; therefore, the medicinal product should not be used in this age group.
Overdose.
Cases of overdose with St. John's wort preparations have not been reported. If a patient has taken a dose higher than recommended, exposure to UV radiation and sunbathing should be avoided during periods of high solar activity (May–August) for 1–2 weeks.
Adverse reactions.
Rarely, the following adverse reactions may occur during the use of the medicinal product, which usually resolve quickly.
From the nervous system: dizziness, headache.
From the psyche: anxiety, restlessness; in patients with bipolar depression, the risk of developing a manic state increases.
From the gastrointestinal tract: gastrointestinal disturbances, dry mouth.
From the skin and subcutaneous tissue: in individuals with increased sensitivity to sunlight, exposure to the sun may cause burns.
From the immune system: allergic reactions, including skin redness, itching.
General disorders: increased fatigue, elevated arterial pressure.
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. 10 tablets per blister, 3 blisters per carton.
Release category. Over-the-counter.
Manufacturer. PJSC "KYIV VITAMIN PLANT".
Location of the manufacturer and address of its business activity.
04073, Ukraine, Kyiv, Kopilivska Street, 38.
Web-site: www.vitamin.com.ua.