SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

NEUROTONE

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

45mg Hops strobiles (Humulus lupulus L.)

45mg Scullcap herb (Scutellaria lateriflora L.)

100mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.)(5:1) Extraction solvent: Ethanol 60% v/v

Each tablet contains: 188 mg of sucrose For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated Tablet, white

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only

Adults and the elderly: Take one or two tablets three times a day.

As treatment effects may not be apparent immediately, Neurotone should be taken 24 weeks continuously.

Duration of use:

If symptoms persist or worsen after 4 weeks of using the product, a doctor or qualified healthcare practitioner should be consulted.

The use in children or adolescents under 18 years of age is not recommended (see Section 4.4. Special warnings and precautions for use

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed stated dose

The use of this product in children or adolescents under 18 years of age is not recommended because data is not sufficient and medical advice should be sought.

This product contains Sucrose. One coated tablet contains a maximum of 188 mg of sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

If symptoms persist or worsen after 4 weeks of using the product, a doctor or qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions with other medicinal products available. Clinically relevant interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has 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 Neurotone may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

4.6 Fertility, pregnancy and lactation

The safety of the product 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 fertility have not been performed.

4.7 Effects on ability to drive and use machines

Neurotone may impair the ability to drive and use machines. Patients who are affected should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal symptoms (eg nausea, abdominal cramps) may occur after ingestion of Valerian root preparations. The frequency is not known.

There are no known adverse reactions with the other active ingredients.

If the other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

Valerian root at a dose of approximately 20g (equivalent to 40 tablets) caused benign symptoms (fatigue, abdominal cramps, chest tightness, light headedness, 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 approx. 30g of the drug) withdrawal symptoms (delirium) have been reported.

No cases of overdose have been reported for the other active ingredients. Symptomatic and supportive measures should be taken as appropriate.

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.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients Extract excipients

Maltodextrin

Tablet core

Sucrose

Starch

Purified Talc Magnesium Stearate

Tablet Coating Titanium Dioxide (E171) Sucrose

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

100ml HDPE polythene tablet container and tamper evident cap closure Pack contains 60 tablets or Pack contains 30 tablets

Special precautions for disposal

There are no special precautions for disposal

MARKETING AUTHORISATION HOLDER

Kerbina Limited T/A Bio-Health Limited Culpeper Close Medway City Estate Rochester Kent

ME2 4HU

20/03/2013