Vemedia Valerian 20 Coated Tablets 450mg

Each coated tablet contains: 450 mg of dry extract (DER 3-6: 1) of Valeriana officinalis L., root (equal to 1350-2700 mg of valerian root). Extraction solvent: 70% ethanol (V / V). Excipients with known effect Each coated tablet contains 103 mg of glucose and 268 mg of sucrose. For the full list of excipients, see section 6.1.

Excipients

Tablet core : Liquid glucose (dried by spray) Silica, colloidal anhydrous Cellulose powder Croscarmellose sodium Stearic acid Talc Tablet coating : Sucrose Talc Calcium carbonate E170 Acacia Gum tragacanth Titanium dioxide E171 Liquid glucose (dried by spray) Capol 600 TS, containing white beeswax, carnauba wax and shellac.

Therapeutic indications

Herbal medicine for the relief of mild nervous tension and sleep disturbances. Valeriana Vemedia is indicated in adults and children over 12 years of age.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Dosage

Oral use. Posology Adolescents over 12 years of age, adults and the elderly : For the relief of mild nervous tension: 1 tablet 3 times a day. For sleep disorders: 1 tablet between half an hour and an hour before bedtime, if necessary with the addition of 1 other tablet earlier in the evening. Maximum daily dose: 4 tablets. 1 tablet contains 450 mg of dry extract, equal to 1350-2700 mg of valerian root. Method of administration The tablets should be swallowed whole with a little water. The tablets should not be chewed. Duration of use Since the treatment takes effect gradually, valerian root is not suitable for the acute interventional treatment of mild nervous tension or difficulty falling asleep. Valeriana Vemedia must be taken continuously for 2-4 weeks in order to achieve maximum effect. If symptoms persist or worsen after 2 weeks of continued use, the patient should seek medical attention.

Warnings and Precautions

Pediatric population Valeriana Vemedia is not recommended for use in children below 12 years of age as insufficient data are available in this regard. This medicine contains glucose (103 mg per tablet) and sucrose (268 mg per tablet). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Interactions

Data on drug interactions with other medicinal products are only available in limited numbers. No clinically relevant interactions were observed with drugs metabolised by cytochrome CYP 2D6, CYP 3A4 / 5, CYP 1A2 or CYP 2E1. Combination with synthetic sedatives is not recommended.

Side effects

Gastrointestinal symptoms may arise, for example nausea or abdominal cramps. The frequency of these symptoms is unknown. If other adverse reactions other than those mentioned above occur, the patient should consult a doctor or pharmacist. 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 system at http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospetta-reazione-avversa

Pregnancy and breastfeeding

Pregnancy There are no or limited amount of data from the use of valerian in pregnant women. Animal studies are insufficient to demonstrate reproductive toxicity (see section 5.3). Valerian Vemedia is not recommended during pregnancy. Breastfeeding It is unknown whether constituents of valerian or their metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded. Valeriana Vemedia is not recommended while breastfeeding. Fertility There are no data on the effects of Valeriana Vemedia on male or female fertility.