Valeriana Dispert 45 mg Valerian Dry Extract 30 Coated Tablets

VALERIAN DISPERT 45 MG COATED TABLETS

Therapeutic indications

Mild sedative, also to promote night rest.

Dosage and method of use

Dosage Children: 1-2 coated tablets twice a day, adults: 1-3 coated tablets three times a day. Method of administration The coated tablets should be swallowed without chewing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Generally contraindicated during pregnancy and breastfeeding.

Side effects

There are no known side effects that can be attributed to the use of the medicine under the recommended conditions and for short periods of time. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance 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

Do not exceed the recommended dose. Consult your doctor if symptoms persist for more than 2 weeks or if they worsen during treatment. Valeriana DISPERT contains lactose : Patients suffering from rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Valeriana DISPERT contains sucrose : Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. Keep the medicine out of the reach of children.

Pregnancy and breastfeeding

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

Expiration and conservation

Do not store above 30°C.

Interactions with other drugs

No interactions have been reported. The patient is however invited to ask his doctor for advice if he is taking other medicines.

Overdose

Valerian root at a dose of approximately 20 g causes mild symptoms (fatigue, abdominal cramps, feeling of slight dizziness, 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 : dry extract of Valerian root 45 mg prepared with ethanol 70% v/v (Valerian root: extract ratio equal to 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, lake, hypromellose, talc, light magnesium oxide, gum arabic, sucrose, povidone K25, macrogol 6000, titanium dioxide, carmellose sodium, white wax, carnauba wax .