Instructions for Persen film-coated tablets blister pack No. 40
Composition
active ingredients: 1 tablet contains dry valerian (root) water-ethanol extract (Valeriana officinalis L., radix, extractum hydroalcoholic siccum) (4-7:1) (extractant – ethanol 70% (v/v)) – 35 mg; dry lemon balm leaf extract (Melissa officinalis L., folium, extractum siccum) (3-6:1) (extractant – ethanol 50% (v/v)) – 17.5 mg; dry peppermint leaf extract (Mentha piperita L., folium, extractum siccum) (3-6:1) (extractant – ethanol 40% (v/v)) – 17.5 mg;
excipients: glucose solution, colloidal anhydrous silicon dioxide, maltodextrin, peppermint essence in powder, lactose monohydrate, microcrystalline cellulose, corn starch, crospovidone, talc, magnesium stearate;
shell: hypromellose, carmellose sodium, povidone, sucrose, colloidal anhydrous silica, calcium carbonate, brown iron oxide (E 172), titanium dioxide (E 171), glycerin, talc, montan glycol wax.
Dosage form
Film-coated tablets.
Main physicochemical properties: chocolate-brown round, biconvex, film-coated tablets.
Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C M.
Pharmacological properties
Pharmacodynamics
Persen is a herbal preparation 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 tablet contains 14 mg of glucose solution and 67 mg of sucrose, therefore the drug should not be prescribed to patients with rare hereditary forms of fructose intolerance, sucrase-isomaltase deficiency or 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 Persen® during these periods.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may affect the ability to drive and use machines, therefore, during its use, it is recommended to refrain from driving or operating 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 3 tablets 3 times a day; for insomnia - 3 tablets an hour before bedtime.
The drug is characterized by a gradual onset of action. To achieve the optimal treatment effect, it is recommended to use it for at least 14 days.
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 103 Persen® tablets, may cause minor symptoms such as fatigue, abdominal cramps, chest tightness, dizziness, hand tremors, 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.
Keep out of reach of children.
Packaging
10 tablets in a blister; 4 (10 ´ 4) blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
SOPHARMA AD, Bulgaria.
Location of the manufacturer and address of its place of business
16 Iliensko Shosse Str., Sofia 1220, Bulgaria.
