VEMEDIA PHARMA, Valeriana 20 450 mg VEMEDIA PHARMA

“Composition
Active ingredients
Each film-coated tablet contains: 450 mg dry extract (SED 3-6:1) of Valeriana officinalis root (equivalent to 1350-2700 mg of Valeriana officinalis root). Extraction solvent: 70% ethanol (v/v).

Excipients
Tablet core: liquid glucose (spray-dried), colloidal anhydrous silica, powdered cellulose, sodium croscarmellose, stearic acid, talc. Tablet shell: sucrose, talc, calcium carbonate E170, gum arabic, tragacanth gum, titanium dioxide E171, liquid glucose (spray-dried), Capol 600 TC containing white beeswax, carnauba wax and shellac.

Method of administration and dosage
Oral administration. Dosage Adolescents over 12 years of age, adults and the elderly: To relieve mild nervous tension: 1 tablet 3 times a day.
For sleep disorders: 1 tablet half an hour to an hour before bedtime, if necessary, adding another tablet earlier in the evening.
Maximum daily dose: 4 tablets. 1 tablet contains 450 mg of dry extract, which corresponds to 1350-2700 mg of valerian root.
Method of administration The tablets should be swallowed whole with a small amount of water.
The tablets should not be chewed.
Duration of use Since the treatment shows its effectiveness gradually, valerian root is not suitable for acute interventional treatment of mild nervous tension or problems with falling asleep.
Valeriana Vemedia must be taken continuously for 2-4 weeks to achieve maximum effect.
If symptoms persist or worsen after 2 weeks of continuous use, the patient should seek medical advice.

Warnings
Paediatric population. Valeriana vemedia is not recommended for use in children under 12 years of age, as there is insufficient data on this subject.
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
Limited data are available on drug interactions. No clinically significant interactions have been observed with drugs metabolized by cytochrome CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1. Combination with synthetic sedatives is not recommended.

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

Storage
Store below 25°C.”

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