Capsiol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KAPSIOL® CAPSIOL

Composition:

Active substances: salicylic acid, castor oil, tincture of finely chopped capsicum pepper fruits (Capsici fructus) (1 : 10) (extractant — 90% ethanol);

1 ml of the preparation contains: salicylic acid 10 mg, castor oil 100 mg, tincture of finely chopped capsicum pepper fruits (Capsici fructus) (1 : 10) (extractant — 90% ethanol) 0.1 ml;

Excipient: ethanol 96%.

Pharmaceutical form. Topical alcoholic solution.

Main physicochemical properties: clear liquid ranging in color from reddish-yellow, yellow to yellowish, with a characteristic odor.

Pharmacotherapeutic group.
Dermatological preparations. ATC code D11AX.

Pharmacological Properties.

Pharmacodynamics. Capsiol® exerts a local irritant, softening, and keratolytic effect, which promotes improved nutrition of the scalp and hair growth. Salicylic acid, included in the formulation, provides an antiseptic effect, which, together with the softening action of castor oil, facilitates removal of dandruff. Capsicum tincture penetrates into the hair follicles and stimulates the hair bulbs, promoting hair growth.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Treatment and prevention of hair loss, as well as removal and prevention of dandruff.

Contraindications.

Skin diseases of various kinds, increased skin sensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction.

Topical use of products containing salicylic acid should not be combined with oral administration of products containing acetylsalicylic acid and other nonsteroidal anti-inflammatory agents. Do not use concurrently with benzoyl peroxide and topical retinoid products. Salicylic acid may enhance skin permeability to other medicinal products. It may potentiate the adverse effects of methotrexate and the hypoglycemic effect of oral antidiabetic agents, particularly sulfonylurea derivatives.

Instructions for use.

Do not apply the medicinal product to areas with acute inflammatory processes of the skin or skin damage.

Avoid contact of the drug with the eyes. In case of contact with the eyes, rinse thoroughly with a large amount of running water.

Use during pregnancy or breastfeeding.

The use of the drug during pregnancy is contraindicated. If it is necessary to use Capsiol® during breastfeeding, breastfeeding should be discontinued.

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

Method of Administration and Dosage.

Apply the product to the scalp with massaging motions before washing the hair. Leave on the scalp for 1 hour, then thoroughly rinse off. Use Capsiol® no more frequently than once a week. The treatment course lasts 1–2 months. After 3–4 weeks, the treatment course should be repeated.

Use of single-dose vials of 10 ml. Unscrew the cap. Invert the vial and, gently shaking, first apply the solution to areas of the scalp where hair loss is particularly noticeable. Then divide the hair into sections and apply the solution directly onto the scalp along each parting.

After applying Capsiol®, hands must be thoroughly washed.

Children. Do not use in children under 12 years of age.

Overdose.

When large doses are applied, keratolytic effects and allergic reactions may intensify. Treatment is symptomatic.

Adverse Reactions.

Allergic reactions, dryness, desquamation, skin irritation, contact dermatitis, urticaria, pruritus requiring discontinuation of the drug.

With prolonged use, absorption of the drug into the systemic circulation is possible, leading to salicylate-type adverse effects: tinnitus, dizziness, epigastric pain, nausea, vomiting, acidosis, tachypnea.

If any adverse events occur, consult a physician immediately!

Reporting of adverse reactions after drug registration is highly important. It enables ongoing monitoring of the benefit-risk balance associated with the use of this medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should 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 25 °C.

Keep out of reach of children.

Do not use the medicinal product after the expiry date stated on the packaging.

Packaging. 10 mL in a bottle with a dropper cap, with 4, 8, or 12 bottles per carton; 100 mL or 200 mL in a bottle, 1 bottle per carton; 100 mL or 200 mL in a bottle with a dropper cap, 1 bottle with dropper cap per carton.

Availability. Over-the-counter.

Manufacturer. JSC "FITOFARM".

Manufacturer's Address and Place of Business.

84500, Sybirtseva St., 2, Bakhmut, Donetsk Oblast, Ukraine.

Marketing Authorization Holder. JSC "FITOFARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoi Rady Ave., Premises 18, 3rd Floor, Kyiv, 02100, Ukraine.

If adverse reactions occur or if you have any questions regarding the safety, quality, or efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOFARM" at: +38 (044) 390 52 96.

INSTRUCTION

for medical use

KApsiol®

CAPSIOL

Composition:

Active ingredients: salicylic acid, castor oil, tincture of finely chopped capsicum pepper fruits (Capsici fructus) (1 : 10) (extractant – 90% ethanol);

1 ml of the preparation contains: salicylic acid 10 mg, castor oil 100 mg, tincture of finely chopped capsicum pepper fruits (Capsici fructus) (1 : 10) (extractant – 90% ethanol) 0.1 ml;

Excipient: ethanol 96%.

Pharmaceutical form. Topical alcoholic solution.

Main physicochemical properties: clear reddish-yellow, yellow to yellowish liquid with a characteristic odour.

Pharmacotherapeutic group.
Dermatological preparations. ATC code D11AX.

Pharmacological properties.

Pharmacodynamics. Capsiol® exerts a local irritant, softening, and keratolytic effect, which promotes improved nutrition of the scalp and hair growth. Salicylic acid, an ingredient of the medicinal product, exhibits antiseptic action, which together with the softening effect of castor oil ensures removal of dandruff. Capsicum tincture penetrates into the hair follicles and stimulates hair bulbs, promoting hair growth.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Treatment and prevention of hair loss, as well as elimination and prevention of dandruff.

Contraindications.

Skin diseases of various etiologies, increased skin sensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions.

Topical use of products containing salicylic acid should not be combined with oral administration of drugs containing acetylsalicylic acid and other nonsteroidal anti-inflammatory agents. Do not use concurrently with benzoyl peroxide and topical retinoid preparations. Salicylic acid may enhance skin permeability to other medicinal products. It may potentiate the adverse effects of methotrexate, and the hypoglycemic effect of oral antidiabetic drugs, particularly sulfonylurea derivatives.

Special precautions for use.

The medicinal product should not be applied to areas of skin with acute inflammatory processes or skin damage.

Avoid getting the product into the eyes. In case of contact with eyes, rinse thoroughly with copious amounts of running water.

Use during pregnancy or breastfeeding.

Use of this medicinal product during pregnancy is contraindicated. If use of Capsiol® is necessary, breastfeeding should be discontinued.

Ability to influence reaction speed when driving or operating machinery. Unknown.

Method of Administration and Dosage

Apply the medication to the scalp using massaging motions before washing the hair. Leave on the scalp for 1 hour, then thoroughly rinse off. Use Capsiol® no more frequently than once a week. The treatment course lasts 1–2 months. After 3–4 weeks, the treatment course should be repeated.

Application of single-dose 10 ml vials. Unscrew the cap. Turn the vial upside down and, gently shaking, first apply the solution to areas of the scalp where hair loss is particularly noticeable. Then part the hair into sections and apply the solution directly to the scalp along each parting.

After applying Capsiol® medication, hands must be thoroughly washed.

Children. Do not use in children under 12 years of age.

Overdose.

When large doses are applied, keratolytic effects and allergic reactions may intensify. Treatment is symptomatic.

Adverse reactions.

Allergic reactions, dryness, peeling, skin irritation, contact dermatitis, urticaria, itching requiring discontinuation of the drug.

With prolonged use, systemic absorption of the drug may occur, leading to salicylate-like adverse effects: tinnitus, dizziness, epigastric pain, nausea, vomiting, acidosis, tachypnea.

In case of any adverse events, it is necessary to consult a physician!

Reporting of adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Do not use the medicinal product after the expiry date stated on the packaging.

Packaging. 10 mL in a bottle with dropper cap, with 4, 8 or 12 bottles per carton; 100 mL or 200 mL in a bottle, 1 bottle per carton; 100 mL or 200 mL in a bottle with dropper cap, 1 bottle with dropper cap per carton.

Availability category. Over-the-counter.

Manufacturer. JSC "FITOFARM" (responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of operations.

17 Chumatska Street, city of Boryspil, Kyiv region, Ukraine, 08303.

Marketing Authorization Holder. JSC "FITOFARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoi Rady Boulevard, premises 18, 3rd floor, Kyiv, Ukraine, 02100.

In case of adverse reactions or questions regarding the safety, quality, and efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOFARM" at +38 (044) 390 52 96.