PERSEN® FORTE

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

Composition:

Active substances: 1 capsule contains aqueous-ethanolic dry extract of valerian root (Valeriana officinalis L., radix, extractum hydroalcoholicum siccum) (4-7:1) (extraction solvent – ethanol 70% v/v) – 87.5 mg; dry extract of lemon balm leaf (Melissa officinalis L., folium, extractum siccum) (3-6:1) (extraction solvent – ethanol 50% v/v) – 17.5 mg; dry extract of peppermint leaf (Mentha piperita L., folium, extractum siccum) (3-6:1) (extraction solvent – ethanol 40% v/v) – 17.5 mg;

Excipients: glucose solution, maltodextrin, colloidal anhydrous silicon dioxide, powdered peppermint essence, light magnesium oxide, lactose monohydrate, talc, magnesium stearate;

Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Pharmaceutical form. Hard capsules.

Main physicochemical properties: size 2 capsules with brown-red cap and body, containing brown powder with specks or compressed powder.

Pharmacotherapeutic group.

Sedatives and hypnotics. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

Persen® forte is a herbal medicinal product with mild sedative properties.

The combination exerts a mild sedative effect and is indicated for the relief of mild transient nervous tension (as a daily sedative during mental stress, states of excitement, 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 drug is used in neuroses when administration of potent sedatives is inappropriate. The indications for its use are based solely on long-standing experience of use.

Pharmacokinetics.

Data not available.

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 types of interactions.

Data regarding interactions with other medicinal products are limited. Prior to concomitant use with other medicinal products, consult a physician.

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 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

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

Patients with gastroesophageal reflux (heartburn) should avoid using preparations containing peppermint leaf, as this may worsen their condition.

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

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

One capsule contains 35 mg of glucose solution; therefore, the drug should not be administered to patients with 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, the use of this medicinal product is not recommended during these periods.

Ability to affect 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 machinery until individual sensitivity to the drug is determined.

Method of Administration and Dosage

Adults and children aged 12 years and older:
For mental strain, excited state, or irritability, it is recommended to take 2 capsules twice daily.
For insomnia – 2 capsules one hour before bedtime.

Capsules should be swallowed whole with water, regardless of food intake.

The medicinal product has a gradual onset of action. To achieve optimal therapeutic effect, it should be used for at least 14 days.

The duration of treatment is not limited. No habituation has been observed even with prolonged use. Withdrawal syndrome does not occur after discontinuation of treatment.

If no improvement in condition 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 the drug 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 42 capsules of Persen® Forte, may cause mild symptoms such as fatigue, abdominal cramps, chest tightness, dizziness, hand tremor, and pupil dilation. These symptoms resolve within 24 hours. In cases of overdose with valerian-containing products, additional symptoms may include 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 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 spasms; possible exacerbation of heartburn.

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

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 capsules in a blister; 2 blisters (10 × 2) in a cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

Adifarm EAD.

Manufacturer's address and place of business.

Boulevard Simeonovsko shose 130, Sofia, 1700, Bulgaria.