Phytorelax
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PHYTORELAX
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 350 mg of Valerian root (Valeriana officinalis L.)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
Colourless and transparent hard capsules containing clear brownish powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety and to aid sleep, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only
Adults and the elderly:
For mild anxiety: Take 2 capsules two or three times a day.
To aid sleep: Take 2 capsules half an hour before going to bed.
Maximum daily dose: 6 capsules
As treatment effects may not be apparent immediately, the capsules should be taken 2-4 weeks continuously.
Duration of use:
If symptoms worsen or persist after 4 weeks of using the product, a doctor or qualified healthcare practitioner should be consulted.
Not recommended for use in children or adolescents under 18 years of age (see Section 4.4. Special warnings and precautions for use)
4.3 Contraindications
Hypersensitivity to Valerian root or to any of the excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or persist after 4 weeks of using the product, a doctor or qualified healthcare practitioner should be consulted.
The use in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has not been observed.
Combination with synthetic sedatives is not recommended.
The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption should therefore be avoided.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. Due to the lack of sufficient data, use during pregnancy and lactation is not recommended.
Studies on the effects on fertililty have not been performed.
4.7 Effects on ability to drive and use machines
PHYTORELAX may impair ability to drive and use machines. Affected patients should not drive or operate machinery.
4.8 Undesirable effects
Gastrointestinal symptoms (e.g nausea, abdominal cramps) may occur.
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9 Overdose
Valerian root at a dose of approximately 20 g caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis) which disappeared within 24 hours. If symptoms arise, treatment should be supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended
5.3 Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity and genotoxicity in vitro and in vivo.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule shell : Hypromellose
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 25°C. Store in the original package
6.5 Nature and contents of container
Brown, poly (vinyl chloride) container with a security caps made of low density polyethylene.
Container with 45 or 150 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Laboratoires ARKOPHARMA Lid de Carros Le Broc - 1ere avenue,
2709 m06510 CARROS France
Trading as
Laboratoires ARKOPHARMA
Lid de Carros Le Broc - 1ere avenue, 2709 m
06510 CARROS
FRANCE
8 MARKETING AUTHORISATION NUMBER(S)
THR 12297/0020
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 26/03/2013
10 DATE OF REVISION OF THE TEXT
26/03/2013