SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Quiet Life Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

75 mg Hops strobiles (Humulus lupulus L.)

58 mg Passion Flower herb (Passiflora incarnata L.)

34 mg Motherwort herb (Leonurus cardiaca L.)

9.625 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.)(equivalent to 39 - 48mg of Valerian root)

Extraction solvent: Ethanol 60%v/v

5.8 mg of extract (as dry extract) from Wild Lettuce (Lactuca virosa L.) (equivalent to 29 mg of Wild Lettuce leaf)

Extraction solvent: Water

4.49 mg Nicotinamide

0.71 mg Thiamine Hydrochloride

0.57 mg Riboflavin

Each coated tablet contains 89 mg of sucrose.

(See Section 4.4 ‘Special warnings and precautions for use’)

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Coated tablet.

Pink circular, biconvex, sugar coated tablet.

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 and for the temporary relief of sleep disturbances, based on traditional use only.

4.2    Posology and method of administration

For oral short term use only.

For temporary relief of symptoms associated with stress such as mild anxiety;

Adults and the elderly: Take 2 tablets twice per day with water after meals plus 3 tablets at bedtime.

For temporary relief of sleep disturbances;

Adults and the elderly: Take 2 tablets 30 to 60 minutes before bedtime. One additional tablet can be taken earlier during the evening if necessary.

Not more than seven tablets to be taken in 24 in hours.

Not recommended for use in children or adolescents under 18 years old. (See Section 4.4 ‘Special warnings and precautions for use’)

Duration of use:

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

4.3    Contraindications

Hypersensitivity to the active substances or to any of the excipients.

4.4    Special warnings and precautions for use

Do not exceed the stated dose

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency 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 a 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. 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 sedative cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of Quiet Life 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 during 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 any tools or machines.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps may occur after ingestion of Valerian root preparations. 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.

4.9 Overdose

Valerian root at a dose of approximately 20 g caused benign symptoms (fatigue, abdominal cramp, chest tightness lightheadedness, had 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 30g 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.

Extract:

Maltodextrin Colloidal anhydrous silica Dicalcium Phosphate

Core:

Acacia, Spray-dried Icing Sugar Magnesium Stearate Silicon Dioxide Sodium Starch Glycolate Stearic Acid

Coating:

Acacia, Spray-dried Calcium Carbonate (Light) Carnauba Wax Mastercote Pink SP0415G Talc

Shellac Varnish Sucrose

Titanium Dioxide Yellow Beeswax

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25 °C.

Store in original package

6.5 Nature and contents of container

50, 100 and 200 tablets in amber glass bottles (USP Type III glass) fitted with white HDPE tamper evident caps.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

G. R. Lane Health Products Limited

Sisson Road

Gloucester

GL2 0GR

United Kingdom

Tel: +44 (0)1452 524012

Fax: +44 (0)1452 507930

Email: info@laneshealth.com

8    MARKETING AUTHORISATION NUMBER(S)

THR 01074/0233

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/02/2013

10 DATE OF REVISION OF THE TEXT

08/11/2016