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Dosage form: & nbspcapsules
Composition:

Composition of one capsule:

active ingredients: valerian rhizomes with roots extract (dry) - 125,000 mg; lemon balm extract (dry) - 25,000 mg; peppermint leaves extract (dry) - 25,000 mg;

Excipients: magnesium oxide - 6,000 mg; lactose monohydrate - 85,500 mg; magnesium hydrosilicate - 8,100 mg; magnesium stearate - 2,200 mg; silicon dioxide colloidal anhydrous - 3,200 mg; shell capsule, titanium dioxide E171 - 1.3690%; iron oxide red E172 0,7527%; quinoline yellow E104 - 0.0153%; Eclipse yellow E110 (sunset yellow) 0.0368%; azorubin E122 - 0.0438%; methyl parahydroxybenzoate E128 - 0.2945%; propyl parahydroxybenzoate E126 - 0.1241%; gelatin - 97.3638%.

Description:

Capsules number 2 (body and lid) are reddish brown; contents of capsules - granules or compressed mass from greenish brown to brown color with impregnations.

Pharmacotherapeutic group:herbal sedative
ATX: & nbsp
  • Other sleeping pills and sedatives
  • Pharmacodynamics:

    The drug has a soothing and antispasmodic effect.

    Extract of rhizomes with valerian roots has a calming effect.

    Melissa Leaf Extract - soothing and spasmolytic, peppermint leaves peppermint extract and moderate soothing effect.

    Indications:Insomnia (difficulty falling asleep), associated with increased nervous excitability.
    Contraindications:

    - Hypersensitivity to the components of the drug;

    - deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

    - arterial hypotension;

    - Cholangitis, cholelithiasis and other bile duct diseases;

    - pregnancy;

    - the period of breastfeeding;

    - children under 12 years.

    Carefully:

    Patients with gastroesophageal reflux disease (GERD).

    Dosing and Administration:

    Inside, washing down capsules with a small amount of water, regardless of food intake.

    With insomnia adults and children over 12 years should take 1-2 capsules 1 hour before bedtime.

    Do not take the drug continuously for more than 1.5-2 months. The course of treatment is 2-4 weeks.

    To increase the duration of treatment, it is necessary to consult a doctor.

    When discontinuation of treatment, withdrawal syndrome does not occur.

    Side effects:

    Allergic reactions are possible (hyperemia, skin rash, peripheral edema, allergic dermatitis), bronchospasm, with prolonged use - constipation.

    Overdose:

    A single intake of 20 grams of rhizomes with valerian roots (approximately 39 capsules of Persen® Night) can cause a feeling of fatigue, stomach cramps, a feeling of contraction in the chest, dizziness, trembling of the hands, dilated pupils that can disappear on their own within 24 hours.

    When overdosing, it is advisable to wash the stomach and consult a doctor.

    Interaction:

    The drug enhances the effect of hypnotics and other drugs that depress the central nervous system (CNS), antihypertensive drugs (in particular, the central action), pain medications, which requires dose adjustment.

    Special instructions:

    In patients with GERD, symptoms may worsen.

    If during the use of the drug the symptoms of insomnia persist or become heavier, you should consult your doctor.

    Do not use the drug continuously for more than 1.5-2 months.

    Effect on the ability to drive transp. cf. and fur:

    During drug treatment, care should be taken when carrying out potentially dangerous activities requiring increased concentration and speed of psychomotor reactions (vehicle management, working with moving mechanisms, dispatcher and operator work).

    Form release / dosage:

    Capsules.

    Packaging:

    Primary packaging: 10 capsules per blister of aluminum and

    Polyvinyl chloride / thermoelast / polyvinylidene chloride foil.

    Secondary packaging: 1, 2, 4, 6 or 8 blisters in a cardboard box together with instructions for use.

    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013803 / 01
    Date of registration:29.07.2008 / 20.11.2015
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    LEK d.d. Slovenia
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp23.02.2016
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