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2. Kira Restful Sleep

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Kira Restful Sleep

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains: 300 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (equivalent to 900-1800 mg of Valerian root)

Extraction solvent: Ethanol 70 % v/v

One coated tablet contains 218 mg of sucrose, 64 mg of glucose and 38 mg of lactose monohydrate.

For full list of excipients see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet.

White, glossy, round, biconvex.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of sleep disturbances due to symptoms of 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 1 to 2 tablets half an hour before bedtime. If necessary, an additional dose can be taken earlier in the evening. The tablets should not be chewed.

As treatment effects may not be immediately apparent, Kira Restful Sleep should be taken for 2-4 weeks continuously.

If symptoms worsen or do not improve after 4 weeks 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 Valerian or any of the excipients.

The product should not be used in children or adolescents under 18 years of age.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

This product contains sucrose, glucose and lactose monohydrate.

One coated tablet contains 218 mg sucrose, 64 mg glucose and 38 mg lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactase malabsorption should not take this medicine.

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

If symptoms worsen or do not improve after 4 weeks 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 are available. Clinical relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway ha not been observed. 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. Due to the lack of data, use during pregnancy and lactation is not recommended.

No studies on the effect on fertility have been performed.

4.7 Effects on ability to drive and use machines

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

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 qualified healthcare 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 balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

Valerian root at a dose of approximately 20 g (equivalent to about20 tablets) 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.

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

Extract:

Liquid glucose Colloidal anhydrous silica

Tablet core:

Lactose monohydrate Cellulose powdered Hydrophobic colloidal silica Magnesium stearate

Coating:

Sucrose

Talc

Hypromellose Castor oil, virgin

Povidone Macrogol 6000 Colloidal anhydrous silica Gelatin

Titanium dioxide (E 171) Carnauba wax

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25 °C

6.5 Nature and contents of container

Original packages containing 25, 30 or 60 coated tablets.

Kira Restful Sleep tablets are packed in PVC/PVDC-aluminium blisters in a cardboard box.

Not all pack sizes may be marketed.