PERSEN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PERSEN® (PERSENÒ)

Composition:

Active substances: 1 tablet contains aqueous-ethanolic dry extract of valerian root (Valeriana officinalis L., radix, extractum hydroalcoholic siccum) (4–7:1) (extraction solvent – 70% ethanol (v/v)) – 35 mg; dry extract of lemon balm leaf (Melissa officinalis L., folium, extractum siccum) (3–6:1) (extraction solvent – 50% ethanol (v/v)) – 17.5 mg; dry extract of peppermint leaf (Mentha piperita L., folium, extractum siccum) (3–6:1) (extraction solvent – 40% ethanol (v/v)) – 17.5 mg.

Excipients: glucose solution, anhydrous colloidal silicon dioxide, maltodextrin, powdered peppermint essence, lactose monohydrate, microcrystalline cellulose, corn starch, crospovidone, talc, magnesium stearate.

Coating: hypromellose, sodium carmellose, povidone, sucrose, anhydrous colloidal silicon dioxide, calcium carbonate, iron oxide brown (E 172), titanium dioxide (E 171), glycerin, talc, montanglycol wax.

Pharmaceutical form. Coated tablets.

Main physicochemical characteristics: chocolate-brown, round, biconvex coated tablets.

Pharmacotherapeutic group.
Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

Persen® is a herbal preparation with mild sedative effects.

The combination exerts a weak sedative effect and is indicated for the relief of mild transient nervous tension (as a daily sedative agent in cases of mental stress, excitability, and irritability).

Valerian exerts a sedative effect. It positively influences well-being in symptoms of irritability such as restlessness, excitement, and tension due to nervous overstrain. In insomnia, it promotes faster onset of sleep.

Melissa also exerts sedative and spasmolytic effects.

Peppermint is traditionally used in combination with valerian in sedative preparations.

The medicinal product is used in neuroses when administration of potent sedatives is inappropriate. The indications for its use are based solely on long-standing usage experience.

Pharmacokinetics.

Data are lacking.

Clinical characteristics.

Indications.

Neuroses accompanied by the following symptoms:

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

Contraindications.

Hypersensitivity to valerian, lemon balm, peppermint, or to any other component of the medicinal product. Severe arterial hypotension, bronchial asthma. Depression or other conditions associated with central nervous system depression.

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 via CYP 2D6, CYP 3A4/5, CYP 1A2, or CYP 2E1 have not been observed.

Concomitant use with synthetic sedative agents (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

The drug 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 using preparations containing peppermint leaves, as this may worsen their condition.

Preparations containing peppermint leaves should be administered with particular caution to patients with cholelithiasis or other diseases of the bile ducts and gallbladder.

The drug contains lactose and therefore should not be used in patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

One tablet contains 14 mg of glucose solution and 67 mg of sucrose; therefore, the drug should not be administered to patients with rare hereditary fructose intolerance, sucrase-isomaltase deficiency, or glucose-galactose malabsorption syndrome.

Alcoholic beverages should be avoided during treatment with this drug.

Use during pregnancy or breastfeeding

The efficacy and safety of using the drug during pregnancy or breastfeeding have not been established; therefore, Perun® is not recommended during these periods.

Ability to influence reaction speed when driving or operating machinery

The drug may affect the ability to drive or operate machinery. Therefore, during treatment, it is recommended to refrain from driving vehicles or operating other machinery until individual sensitivity is determined.

Method of Administration and Dosage

Adults and children aged 12 years and older:
For mental strain, excitability, or irritability, it is recommended to take 3 tablets three times daily. For insomnia: 3 tablets one hour before bedtime.

The tablets should be swallowed whole with water. May be taken regardless of food intake.

The effect of the medication develops gradually. To achieve optimal therapeutic effect, it should be used for at least 14 days.

The duration of treatment is not limited. No dependence has been observed even with prolonged use. No withdrawal syndrome occurs after discontinuation.

If no improvement is observed within 14 days from the start of treatment, a physician should be consulted.

Children

There is no data available on the use of this medicinal product in children under 12 years of age; therefore, its use is not recommended in this patient group.

Overdose

Symptoms:
A single dose of approximately 20 g of valerian root, equivalent to about 103 tablets of Persen® medication, may cause mild symptoms such as fatigue, abdominal cramps, chest tightness, dizziness, hand tremor, and pupil dilation. These symptoms resolve within 24 hours. Overdose of medications containing valerian may also cause headache, drowsiness, lethargy, general weakness, abdominal pain, nausea, decreased hearing and visual acuity, bradycardia/tachycardia, reduced attention span, and enhanced sedative effect.

There have been no reports of overdose cases with lemon balm leaf or peppermint.

Treatment:
Symptomatic therapy (gastric lavage, administration of activated charcoal).

Adverse reactions.

Gastrointestinal disorders: frequency cannot be determined – nausea, abdominal cramps; possible exacerbation of heartburn.

Very rarely somnolence, asthenic manifestations (weakness, reduced mood and work capacity, suppression of emotional responses), dizziness, depression have been observed. If other adverse effects occur (e.g. hypersensitivity reactions including rash, pruritus, urticaria, skin redness and swelling), consult a physician.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

10 tablets in a blister; 4 blisters (10 × 4) in a cardboard box.

Availability.

Over-the-counter.

Manufacturer.

SOPHARMA AD, Bulgaria.

Manufacturer's address.

16 Iliensko Shosse Str., Sofia 1220, Bulgaria.