VALERIANA DISPERT * 20CPR 125MG

VALERIANA DISPERT * 20CPR 125MG

Therapeutic indications

Herbal medicine for the treatment of mild and temporary states of nervous tension and temporary difficulty in falling asleep (see Section 4.4 Special warnings and precautions for use).

Dosage and method of use

Posology Adults and children over 12 years Single dose: 4 coated tablets. For nervous tension: up to 3 times a day. As an aid to sleep, a single dose half an hour to an hour before bedtime and, if necessary, a dose earlier in the evening. Elderly: as for adults. Method of administration Oral use. The tablets should be swallowed without chewing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use in children under 12 years of age is not recommended, as there are no data on the efficacy and safety of the drug in pediatrics. Generally contraindicated in pregnancy and lactation.

Side effects

There are no known undesirable effects to be attributed to the use of the medicine under the recommended conditions and for short periods of time. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Consult your doctor if symptoms persist for more than 2 weeks or if they worsen during treatment. Valerian DISPERT contains lactose : Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Valerian DISPERT contains sucrose : Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

Pregnancy and breastfeeding

As no data on use during pregnancy and lactation are available, its use is generally not recommended as a precaution. No adverse effects have been reported following the common use of valerian root as a medicinal product, but adequate experimental data are lacking in this regard.

Expiration and retention

Do not store above 30 ° C.

Interactions with other drugs

No interactions were reported. However, the patient is advised to ask the doctor for advice if he is taking other medications.

Overdose

Valerian root at a dose of about 20 g causes mild symptoms (fatigue, abdominal cramps, feeling lightly dizzy, chest tightness, hand tremors and mydriasis) which disappear within 24 hours. If symptoms appear, appropriate treatment should be instituted.

Active principles

One coated tablet contains: Active ingredient : 125 mg Valerian root dry extract prepared with 70% v / v ethanol (valerian root: extract ratio 3–6: 1). Excipients with known effects: lactose and sucrose. For the full list of excipients, see section 6.1.

Excipients

Dextrin, microcrystalline cellulose, lactose monohydrate, macrogol 4000, colloidal anhydrous silica, magnesium stearate, lacquer, hypromellose, talc, light magnesium oxide, gum arabic, sucrose, povidone K25, macrogol 6000, titanium dioxide, carmellose sodium, white wax, carnauba wax .