SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Vitabiotics Valerian Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains 400 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 2000mg -2400mg of valerian root)

Extraction solvent Ethanol 70% v/v For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film coated tablet.

Oval, biconvex, green film coated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of sleep disturbances and mild anxiety 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 one tablet twice a day.

For sleep disturbances: Take 1 to 2 tablets half an hour before bedtime.

Not for children or adolescents under 18 years (see Section 4.4. Special warnings and precautions for use).

Tablets should be swallowed whole with some water or other liquid. The tablets should not be chewed.

As treatment effects may not be apparent immediately, tablets should be taken for at least 2-4 weeks continuously.

Maximum dose: 4 tablets per day.

Duration of use

If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens during the use of the product consult a doctor or qualified healthcare practitioner.

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. Additive effects with hypnotics and other sedative drugs 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

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data the use in pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May impair the ability to drive and use machines. If affected, do not drive or operate machines.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a pharmacist 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.

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

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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Tablet Core Maltodextrin Microcrystalline cellulose Sodium croscarmellose Stearic Acid Magnesium Stearate Colloidal Anhydrous Silica

Film coating Polydextrose Hypromellose Titanium Dioxide (E171)

Curcumin

Copper Chlorophyllin Medium Chain Triglycerides

6.2 Incompatibilities

None known.

6.3 Shelf life

2 Years

6.4 Special precautions for storage

Do not store above 25 °C. Store in the original packaging.

6.5 Nature and contents of container

Tablets are packed into PVC/PVDC blister strips in the following pack sizes; 30, 60, 90 tablets and packed into a carton.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Vitabiotics 1 Aspley Way London NW2 7HF

8    MARKETING AUTHORISATION NUMBER(S)

THR 00387/0057

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/04/2012

10    DATE OF REVISION OF THE TEXT

10/04/2012