SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

VALDRIAN Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 400mg of Valerian root. (Valeriana officinalis L.)

For list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Hard capsules.

Clear size 0 hard capsules.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

VALDRIAN is a traditional herbal medicinal product used for the temporary relief of symptoms of 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 the temporary relief of symptoms of mild anxiety, take one capsule 3 times daily swallowed with water.

To aid sleep, take one capsule 30 minutes before bedtime with an earlier dose during the evening if necessary.

As treatment effects may not be apparent immediately, VALDRIAN should be taken 2-4 weeks continuously.

Maximum daily dose:- 4 single doses.

Duration of use:-

If symptoms worsen, or do not improve after 4 weeks, of taking VALDRIAN, a doctor or a qualified healthcare care practitioner should be consulted.

Not recommended for children or adolescents under 18 years (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 do not improve after 4 weeks of taking VALDRIAN, a doctor or a qualified healthcare care practitioner should be consulted.

The use of this product is not recommended in children and adolescents below the age of 18 years 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 interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway have not been observed.

Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

4.6    Fertility, pregnancy and lactation

The safety of VALDRIAN during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

Studies on the effect on fertility have not been performed.

4.7    Effects on ability to drive and use machines

VALDRIAN may impair ability to drive and use machines.

Patients who are affected should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingesting VALDRIAN (valerian root).

The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or qualified health care practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

4.9 Overdose

If symptoms arise, treatment should be supportive.

Valerian root at a dose of approximately 20g (equivalent to 50 VALDRIAN capsules) caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headedness, hand tremor and mydriasis), which disappeared within 24 hours

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30g of the drug) withdrawal symptoms (delirium) have been reported.

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

Extracts with ethanol and the essential oil of Valerian root have shown low toxicity in rodents during acute tests and from repeated dose toxicity over periods of 4-8 weeks.

No mutagenicity was observed in an Ames test conducted with this product.

Studies on carcinogenicity and reproductive toxicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hypromellose (capsule shell)

6.2 Incompatibilities

Not Applicable.

Shelf life

2 years.

6.4 Special precautions for storage

Store below 25°C. Store in the original package.

6.5 Nature and contents of container

Duma 110ml HDPE plastic container and tamper evident threaded Duma cap.

VALDRIAN pack contains 60 Capsules.

6.6 Special precautions for disposal

There are no special precautions for disposal of VALDRIAN capsules. When the container is empty the label should be removed and the container placed in a recycling bin.

7 MARKETING AUTHORISATION HOLDER

Bio-Health Limited Culpeper Close Medway City Estate Rochester Kent

ME2 4HU

8    MARKETING AUTHORISATION NUMBER(S)

THR 15817/0004

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 11/07/2008

DATE OF REVISION OF THE TEXT

07/03/2014