Instructions for Persen Forte hard capsules blister No. 20
Composition
active ingredients: 1 capsule contains valerian (root) hydro-ethanolic dry extract (Valeriana officinalis L., radix, extractum hydroalcoholic siccum) (4-7:1) (extractant – ethanol 70% (v/v)) – 87.5 mg; lemon balm leaf extract (Melissa officinalis L., folium, extractum siccum) (3-6:1) (extractant – ethanol 50% (v/v)) – 17.5 mg; peppermint leaf extract (Mentha piperita L., folium, extractum siccum) (3-6:1) (extractant – ethanol 40% (v/v)) – 17.5 mg;
excipients: glucose solution, maltodextrin, colloidal anhydrous silicon dioxide, peppermint essence in powder, light magnesium oxide, lactose monohydrate, talc, magnesium stearate;
capsule shell: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172).
Dosage form
The capsules are hard.
Main physicochemical properties: size 2 capsules, with a brown-red cap and body, containing brown-colored powder or compressed powder with inclusions.
Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C M.
Pharmacological properties
Pharmacodynamics.
Persen® forte is a herbal medicine with a mild sedative effect.
The combination has a weak sedative effect and is indicated for the elimination of mild transient nervous tension (as a daily sedative for mental stress, excitement, irritability).
Valerian has a sedative effect. It has a positive effect on well-being with symptoms of irritability, such as restlessness, excitement and tension due to nervous overload. In case of insomnia, it helps to fall asleep faster.
Melissa also has a sedative and antispasmodic effect.
Peppermint is traditionally used in combination with valerian in sedative preparations.
The drug is used for neuroses when taking strong sedatives is inappropriate. Indications for its use are determined exclusively on the basis of long-term experience of use.
Pharmacokinetics.
Data is missing.
Indication
Neuroses accompanied by the following symptoms:
jitters;
trouble;
tension caused by stress;
sleep disorders.
Contraindication
Hypersensitivity to valerian, lemon balm, peppermint or other components of the drug. Severe arterial hypotension, bronchial asthma. Depression or other conditions accompanied by suppression of the central nervous system.
Interaction with other medicinal products and other types of interactions
Data on interactions with other drugs are limited. Before using the drug simultaneously with other drugs, you should consult a doctor.
No clinically significant interactions with active substances metabolized by CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 have been identified.
Concomitant use with synthetic sedatives (benzodiazepines) without consulting a doctor is not recommended.
With simultaneous use, the effects of other sedatives and hypnotics, antispasmodics, analgesics, anxiolytics, and alcohol may be enhanced.
Application features
The drug should be used with caution in patients who have severe liver dysfunction or have had severe liver disease in the past.
Patients with gastroesophageal reflux (heartburn) should avoid using preparations containing peppermint leaves, as it may worsen their condition.
Patients with gallstone disease or other diseases of the bile ducts and gallbladder should be prescribed preparations containing peppermint leaves with extreme caution.
The drug contains lactose, so it should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
1 capsule contains 35 mg of glucose solution, therefore the drug should not be prescribed to patients with glucose-galactose malabsorption syndrome.
While using the drug, you should refrain from drinking alcoholic beverages.
Use during pregnancy or breastfeeding
The efficacy and safety of the drug during pregnancy or breastfeeding have not been established, therefore it is not recommended to use the drug during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may affect the ability to drive a car and use machinery, therefore, during its use, it is recommended to refrain from driving or using other machinery until individual sensitivity is determined.
Method of administration and doses
Adults and children over 12 years of age: for mental stress, excitement or irritability, it is recommended to take 2 capsules 2 times a day; for insomnia - 2 capsules an hour before bedtime.
The capsules should be swallowed whole with water, regardless of meals.
The duration of treatment is not limited. Even with prolonged use of the drug, addiction is not observed. There is no withdrawal syndrome after discontinuation of treatment.
If no improvement is observed 14 days after the start of treatment, you should consult a doctor.
Children
There are no data on the use of the drug in children under 12 years of age, therefore its use in this category of patients is not recommended.
Overdose
Symptoms. A single dose of about 20 g of valerian roots, equivalent to approximately 42 capsules of Persen® forte, may cause minor symptoms such as fatigue, abdominal cramps, chest tightness, dizziness, hand tremor, and dilated pupils. These symptoms resolve within 24 hours. Overdose of valerian-containing drugs may also cause headache, drowsiness, lethargy, general weakness, abdominal pain, nausea, decreased hearing and vision, bradycardia/tachycardia, decreased concentration, and increased sedative effect.
There are no reports of overdoses of lemon balm and peppermint leaves.
Treatment: symptomatic therapy (gastric lavage, use of activated charcoal).
Side effects
On the part of the digestive tract: frequency cannot be estimated - nausea, abdominal cramps; possible exacerbation of heartburn.
Very rarely, drowsiness, asthenic manifestations (weakness, decreased mood and performance, suppression of emotional reactions), dizziness, depression were observed. If other side effects occur (for example, hypersensitivity reactions, including rash, itching, urticaria, redness and swelling of the skin), you should consult a doctor.
Expiration date
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 (10 ´ 2) blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Adifarm EAD.
Location of the manufacturer and its business address
Boulevard Simeonovskoe Shose, 130, Sofia, 1700, Bulgaria.
