SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Bonuit® Sleep Aid tablets

Holland & Barrett Valerian Plus tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

125 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (3-6:1) (equivalent to 375 - 750 mg of Valerian root).

Extraction solvent: Ethanol 70% v/v,

and

250mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (5-7:1) (equivalent to 1250 - 1750 mg of Passion flower herb).

Extraction solvent: Ethanol 50% v/v

Also contains 187 mg of sucrose and 32 mg of glucose. (See Section 4.4 Special warnings and precautions for use.’)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet.

Light-yellow, round, biconvex, smooth glossy surface.

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.

For adults and the elderly, take one to two tablets half an hour before bedtime. If necessary, an additional tablet can be taken earlier in the evening. 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, the product should be taken for at least 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 less than 18 years old is not recommended (See ‘Section 4.4 Special Warnings and Precautions for Use.’)

4.3 Contraindications

Hypersensitivity to Valerian, Passion Flower or any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

This product contains sucrose and glucose.

1 sugar-coated tablet contains max. 187 mg of sucrose and a max. 32 mg glucose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine

If the condition worsens, or if symptoms persist for more than four weeks, a doctor or qualified healthcare practitioner should be consulted.

The use in children or adolescents less than 18 years old is not recommended due to lack of adequate data

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 metabolized by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway has 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 this product 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 during pregnancy or lactation is not recommended.

Studies on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May impair the ability to drive and operate machines. Affected patients should not drive or operate machines.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps, may occur. The frequency is not known. One case of hypersensitivity (vasculitis) and one case of tachycardia have been reported with Passion Flower. 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 continual 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

Valerian root at a dose of approximately 20 g (equivalent to 10 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.

No cases of overdose have been reported for Passion Flower.

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

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation.

Adequate tests on reproductive toxicity and carcinogenicity have not been performed.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Tablet core Maltodextrin

Silica, colloidal anhydrous Cellulose, powdered Croscarmellose sodium Magnesium stearate Stearic acid Talc

Liquid glucose, spray dried

Coating

Sucrose

Talc

Calcium carbonate E170

Acacia

Tragacanth

Titanium dioxide E 171

Liquid glucose, spray dried

Iron oxide hydrate E 172 (=yellow iron oxide)

Hypromellose

Capol 600 T.S. containing:

Beeswax, white Carnauba wax Shellac

6.2    Incompatibilities

Not applicable

6.3    Shelf life

4 years

6.4    Special precautions for storage

Do not store above 30°C. Store in the original packaging.

6.5 Nature and contents of container

Original packages containing 14, 15, 28 and 30 Bonuit Sleep Aid coated tablets. Not all pack sizes may be marketed. Also original packages containing 30 Holland & Barrett Valerian Plus coated tablets

The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow

Buckinghamshire SL7 1FX

8    MARKETING AUTHORISATION NUMBER(S)

THR 23056/0009

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/08/2016

10    DATE OF REVISION OF THE TEXT

08/08/2016