VALERIAN DISPERT 125 MG COATED TABLETS

VALERIAN DISPERT 125 MG COATED TABLETS

Therapeutic indications

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

Dosage and method of use

Dosage 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: same as 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 paragraph 6.1. Use in children under 12 years of age is not recommended, as no data are available on the efficacy and safety of the drug in pediatrics. 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

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.

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 125 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 .