SEDASEN FORTE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEDASEN FORTE (SEDASEN FORTE)

Composition:

Active substances: 1 capsule contains valerian dry extract (Valeriana officinalis L.) (3-8:1) (extraction solvent – ethanol 80%) 125 mg, peppermint dry extract (Mentha piperita L.) (4-6:1) (extraction solvent – ethanol 50%) 25 mg, lemon balm (lemon mint) dry extract (Melissa officinalis L.) (6-8:1) (extraction solvent – ethanol 70%) 25 mg;

Excipients: anhydrous lactose, talc;

Capsule shell composition: titanium dioxide (E 171), Ponceau 4R (E 124), Patent Blue V (E 131), Quinoline Yellow (E 104), Sunset Yellow FCF (E 110), gelatin.

Pharmaceutical form. Capsules.

Main physicochemical characteristics: hard gelatin capsules size №1 or №2 with white body and green cap. The contents of the capsules are powder or granules ranging from light brown to brown in color with a characteristic odor. A yellowish or greyish tint, as well as the presence of dark and white specks, may be present.

Pharmacotherapeutic group. Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

Sedasen Forte is a combined herbal preparation whose action is due to the synergistic effects of its components.

Biologically active substances of valerian (complex esters of borneol and isovaleric acid, valeropotriates, alkaloids valerin and chotinin) reduce excitability of the central and autonomic nervous systems, possess pronounced sedative and hypnotic effects, exert spasmolytic and choleretic actions, enhance secretory activity of the gastrointestinal mucosa, and potentiate the effects of other hypnotic and sedative agents. In addition, the complex of biologically active substances of valerian exerts a beneficial neuroregulatory effect on myocardial function (slows heart rate and dilates coronary vessels).

Peppermint possesses a broad spectrum of pharmacological activity. Peppermint leaves contain 1–3% essential oil composed of menthol (up to 70%) and its esters, ketone menthone, oleic and ursolic acids, and flavonoids. When administered orally, these components of peppermint exert moderate spasmolytic, sedative, hypnotic, and choleretic effects, reduce nausea, mildly stimulate secretion of digestive glands, and dilate coronary vessels.

The main active ingredients of lemon balm (melissa) — components of essential oil (0.06–1%): citral (up to 62%), geraniol, menaloöl, perillal, caryophyllene — exhibit sedative, anticonvulsant, hypotensive, antiarrhythmic, spasmolytic, and antiemetic effects. In addition, active components of melissa improve digestive processes, exert a mild choleretic effect, normalize reduced appetite, promote restoration of intestinal saprophytic flora, and stimulate secretion of digestive enzymes.

The drug does not cause dependence. It is indicated for use in neuroses when administration of potent sedatives is inappropriate. The indications for its use are based solely on long-term clinical experience.

Pharmacokinetics.

Data are lacking.

Clinical characteristics.

Indications.

Neuroses accompanied by the following symptoms:

• nervous excitement;
• restlessness;
• stress-induced tension;
• sleep disturbances.

Contraindications.

Hypersensitivity to any component of the medicinal product, pronounced arterial hypotension, bronchial asthma. Depression or other conditions associated with suppression of central nervous system activity.

Interaction with other medicinal products and other forms of interaction.

Data regarding interactions with other medicinal products are limited. Consult a physician before using this product concomitantly with other medicinal products. Clinically significant interactions with active substances metabolized by cytochrome CYP2D6, CYP3A4/5, CYP1A2, CYP2E1 have not been described. Concomitant use with synthetic sedatives (benzodiazepines) is not recommended without medical consultation. Concomitant use may enhance the effects of other sedatives, hypnotics, spasmolytics, analgesics, anxiolytics, and alcohol.

Special precautions for use

Do not exceed the recommended doses of the medicinal product.

The medicinal product should be used with caution in patients with severe hepatic impairment or a history of severe liver disease.

Patients with gastroesophageal reflux (heartburn) should avoid medicinal products containing peppermint leaves, as this may worsen their condition.

Medicinal products containing peppermint leaves should be administered with particular caution to patients with cholelithiasis or other biliary tract disorders.

The medicinal product contains lactose; therefore, if you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicinal product.

The medicinal product contains Ponceau 4R (E 124) and Brilliant Blue FCF (E 110), which may cause allergic reactions.

Specific sensitivity to the smell of valerian may occur.

Alcoholic beverages should be avoided during the use of this medicinal product.

Use during pregnancy or breastfeeding

The efficacy and safety of the medicinal product during pregnancy or breastfeeding have not been established; therefore, Sedasen Forte is not recommended for use during these periods.

Ability to affect reaction speed when driving or operating machinery

The medicinal product may affect the ability to drive or operate machinery. Therefore, during its use, it is recommended to refrain from driving or operating machinery until individual sensitivity is determined.

Dosage and Administration.

For adults and children aged 12 years and older: in cases of mental strain, excited state, or increased irritability – 2 capsules twice daily; for insomnia – 2 capsules one hour before bedtime. The capsules should be swallowed whole with water, regardless of food intake. The effect of the drug develops gradually. For optimal therapeutic effect, continuous use for at least 2 weeks is recommended. The treatment duration is not limited. No habituation is observed even with prolonged use of Sedasen Forte. No withdrawal symptoms occur after discontinuation. If no improvement is observed within 14 days from the start of treatment, medical advice should be sought.

Children.

Sedasen Forte capsules are not recommended for children under 12 years of age.

Overdose.

Symptoms. A single intake of approximately 20 g of valerian root may cause mild symptoms such as increased fatigue, abdominal spasms, chest tightness, dizziness, hand tremor, and pupil dilation, which resolve within 24 hours. Overdose with valerian-containing preparations may also lead to headache, drowsiness, lethargy, general weakness, abdominal pain, nausea, reduced hearing and visual acuity, bradycardia or tachycardia, decreased concentration, and enhanced sedative effect.

There are no reports of overdose with lemon balm leaf or peppermint.

Treatment. There is no specific antidote; treatment is symptomatic (gastric lavage, administration of activated charcoal).

Side effects.

Gastrointestinal tract: nausea, abdominal cramps, possible exacerbation of heartburn.

Central nervous system: drowsiness, lethargy, asthenic manifestations (weakness, lowered mood, emotional blunting), decreased work capacity and concentration, dizziness, depression.

General reactions: hypersensitivity reactions, including rash, itching, urticaria, skin redness and swelling. In such cases, consult a physician.

Shelf life.

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

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

20 hard gelatin capsules in a plastic container, placed in a cardboard box.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and place of business.

21027, Vinnytsia, str. 600-richchia, 25, Ukraine.

Tel.: + 38(0432)52-30-36.

E-mail: [email protected]

www.sperco.ua