Composition, form of production and packaging
? The tablets covered with a cover of dark brown color, round, biconcave.
1 tab.
Valerian extract 50 mg dry
lemon balm extract 25 mg
peppermint extract of dry 25 mg
Excipients: talc, magnesium stearate, crospovidone, corn starch, silicon dioxide colloid, microcrystalline cellulose, lactose.
Sheath composition: hydroxypropylcellulose (Hypromellose, Pharmacoat), talc, sodium carboxymethylcellulose, povidone, sucrose, silicon dioxide colloid, calcium carbonate, titanium dioxide, brown dye 75, glycerol (glycerin), E Hoechst wax (Capol 600).
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (4) - packs of cardboard.
10 pieces. - blisters (6) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
Sedative preparation of plant origin. Has a sedative and spasmolytic effect.
Extract rhizomes with the roots of valerian causes a moderately pronounced sedative effect.
Melissa extract and peppermint extract have a sedative and spasmolytic effect.
PHARMACOKINETICS
Data on pharmacokinetics are not available.
INDICATIONS
- increased nervous excitability;
- Insomnia;
Irritability.
DOSING MODE
Is taken orally, washed down with water, regardless of food intake.
Adults and children over 12 years of age with increased nervous excitability, irritability are prescribed 2-3 tablets each. 2-3 times / day; for insomnia - for 2-3 tablets. for 30 min-1 h before bedtime.
The maximum daily dose is 12 tablets.
With the cessation of treatment, withdrawal syndrome does not develop.
Do not use the drug continuously for more than 1.5-2 months.
SIDE EFFECT
Allergic reactions: hyperemia, skin rash, peripheral edema, allergic dermatitis.
From the respiratory system: bronchospasm.
From the digestive system: with prolonged use - constipation.
CONTRAINDICATIONS
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- deficiency of sugar / isomaltase, intolerance to fructose;
- arterial hypotension;
- Cholangitis, cholelithiasis and other diseases of bile ducts;
- Pregnancy;
- the period of lactation (breastfeeding);
- children's age till 12 years;
- Hypersensitivity to the components of the drug.
Caution should be given to patients with gastroesophageal reflux disease (GERD).
PREGNANCY AND LACTATION
The use of the drug during pregnancy and during lactation is contraindicated.
APPLICATION FOR CHILDREN
Contraindicated use of the drug in childhood to 12 years.
SPECIAL INSTRUCTIONS
In patients with GERD, symptoms may worsen.
If during the use of the drug symptoms persist or become heavier, the patient should consult a doctor.
Do not use the drug continuously for more than 1.5-2 months.
Impact on the ability to drive vehicles and manage mechanisms
AT the period of drug treatment should be used with caution in the performance of potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (vehicle management, working with moving mechanisms, dispatcher, operator).
OVERDOSE
Symptoms: a single intake of 20 grams of rhizomes with valerian roots (approximately 103 tablets of the drug Persen В® ) can cause a feeling of fatigue, stomach cramps, a feeling of contraction in the chest, dizziness, hand tremors, dilated pupils that can pass on their own within 24 hours.
Treatment: recommended gastric lavage; if necessary, conduct symptomatic therapy.
In cases of overdose, the patient should consult a doctor.
DRUG INTERACTION
With the simultaneous use of the drug with other drugs that depress the central nervous system (including hypnotics, antihypertensive agents of central action, analgesics), it is possible to increase the effect on the central nervous system (dosage correction may be required).
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
RU1608519242
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
