Valeriana Farmades

  SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT
VALERIANA FARMADES, 50 mg, coated tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 155 mg (approx.) coated tablet contains:
Active ingredient:
Valerian dry extract to 0.8% in valerenic acids, 50 mg

3. PHARMACEUTICAL FORM
Coated tablets.

4. CLINICAL PARTICULARS
4.1.  Therapeutic indications
Mild sedative.  Aids nighttime sleep.
4.2.  Posology and method of administration
To aid sleep take 1-2 tablets half an hour before bedtime; for hyperexcitablity take 1-2 tablets during the day or in the evening before bedtime. Do not exceed the recommended dose.
4.3.  Controindications
Persons suffering from hypersensitivity to the product should not use it.
4.4.  Special warnings and precautions for use
Swallow the tablets whole, washed down with a little water or other liquid.
If symptoms do not improve after a short period of time it is advisable to seek medical advice.
4.5.  Interaction with other medicinal products and other forms of interaction
No specific documented reports of interactions with other medicinal products or interactions of another nature are known to exist.
4.6.  Pregnancy and lactation
Although the product can be freely used, it is never advisable to exceed the recommended dose.
4.7.  Effects on ability to drive and use machines
When taken at the recommended dose, no impairment is known of. However, the general precautions for central nervous system sedatives do apply.
4.8.  Undesirable effects
The product is extremely well tolerated; there are no known reports of clinical cases of undesirable effects attributable to the group of active ingredients.
4.9.  Overdose
There are no known reports of overdose; if you experience any symptoms that you think may be due to overdose, take the action recommended for central nervous system sedatives.
 
5. Pharmacological properties
5.1.  Pharmacodynamic properties
The active ingredient of valerian (Valeriana officinalis L., Fam. Valerianacee) is derived from the dried underground organs (rhizomes and roots) of the plant. Extract of valerian in toto is known to have antispasmodic and sedative properties. Experimental pharmacological studies carried out on the active ingredients of valerian extract have shown that these substances reduce spontaneous motility, reinforce hypnotic action, neutralise the effect of caffeine and improve coordination. Other experimental studies have shown that the active ingredients reduce nervousness, anxiety and aggressivity. Further documented pharmaceutical particulars include an antagonistic effect on narcosis and on the hypnotic effect of alcohol as well as a weak analgesic action.
5.2.  Pharmacokinetic properties
The pharmokinetic properties of the product were studied following oral, endovenous and intraduodenal administration: the active ingredients were found to be absorbed unaltered in form, although the quantity absorbed was modest; most specific activity in the tissues was found as products of degradation.
5.3.  Preclinical safety data
Subacute toxicity studies (4 weeks in rats, at doses from 6 to 150 mg/Kg/day by mouth) did not reveal any obvious signs of toxicity, except that growth rate and ability to utilise food were affected at the highest dosage. In the same species, the administration of 30-360 mg/Kg/day for 6 months did not reveal any signs of toxicity. No deaths, anomalies of the organs or hystological damage were found in Beagle dogs treated for 6 months with doses from 30 to 180 mg/Kg/day. Oral administration of the product in rabbits and rats did not provide any evidence of potential mutagenicity.

6. Pharmaceutical particulars
6.1.  List of excipients:
Colloidal silica, magnesium stearate, polyvinylpyrrolidone, microcrystalline cellulose, talc, magnesium oxide, polymethacrylic esters, polyethylene glycol, saccharosie, titanium dioxide, sodium carboxymethyl cellulose, cera E.
6.2.  Incompatibilities
None
6.3.  Shelf life
36 months
6.4.  Special precautions for storage
Do not store above 25°C.
6.5.  Nature and contents of container
Glass bottle containing 30 tablets.

7. MARKETING AUTHORISATION HOLDER
Bayer S.p.A., Viale Certosa 130 – 20156 Milano, Italy

8. MARKETING AUTHORISATION NUMBER
M.A.H. no. 025204037

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09.06.1989/01.06.2000

10. DATE OF (PARTIAL) REVISION OF THE TEXT
01.06.2005