VALERIANA VEMEDIA 20CPR RIV450

VALERIANA VEMEDIA 450 MG

active ingredients

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

Excellent

Compressed core: Liquid glucose (dryed by nebulization) Anidra colloidal silica Cellulose powder Sodium chroscarmellosa sodium Stearic acid Talco Coating of the tablet: Saccarosio Talco Calcium Carbonate E170 Acacia Gomma adragante Titanium dioxide E171 Glucose liquid (dryed by nebulization) Capol 600 T.S., containing white beeswax, carnauba wax and gum.

Therapeutic indications

Vegetable medicine for relief from mild nervous tensions and sleeping disorders. Valeriana Vemedia is indicated in adults and children over 12 years old.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Oral use. Population Teenagers over 12 years old, adults and elderly: For relief from mild nervous tensions: 1 tablet 3 times a day. For sleeping disorders: 1 tablet in half an hour before bedtime, if necessary with addition of 1 other tablet before 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 ingested whole, with some water. Tablets should not be chewed. Duration of use Since the treatment manifests its effectiveness gradually, the root of valerian is not suitable for acute interventional treatment of mild nervous tensions or difficulties to fall asleep. Valeriana Vemedia must be taken continuously for 2-4 weeks in order to achieve the maximum effect. If symptoms persist or worsen after 2 weeks of continued use, the patient should contact a doctor.

Conservation

Store at a temperature below 25°C.

Warnings

Pediatric population The use of Valeriana Vemedia is not recommended in children under 12 years of age, as the available data is not sufficient. This medicine contains glucose (103 mg per tablet) and sucrose (268 mg per tablet). Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose mal absorption or saccarase-isomaltase failure should not take this medicine.

Interactions

Data on drug interactions with other medicines are only available in limited number. Clinical interactions with metabolized drugs from CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 have not been observed. The association with synthesis sedatives is not recommended.

Effects

Gastrointestinal symptoms may arise, such as nausea or abdominal cramps. The frequency of such symptoms is not known. If there are other adverse reactions other than those mentioned above, the patient should consult a doctor or pharmacist. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospetta-reazione-avversa

Overdosing

The root of valerian at a dose of about 20 g caused benign symptoms (affactication, abdominal cramps, sense of thoracic constriction, feeling of stun, tremor in the hands and midriasis), which disappeared within 24 hours. If symptoms arise, treatment must be supportive.

Pregnancy Data relating to the use of valerian in pregnant women do not exist or are in limited number. Animal studies are not sufficient to demonstrate reproductive toxicity (see paragraph 5.3). Valeriana Vemedia is not recommended during pregnancy. Food It is not known whether valerian constituents or their metabolites are excreted in breast milk. The risk for infants/ infants cannot be excluded. Valeriana Vemedia is not recommended during lactation. Fertility Data relating to the effects of Valeriana Vemedia on male or female fertility are not available.

Source: Farmadati