Document: document 3 change

• document 0
• document 1
• document 2
• document 3
• document 4

---

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Superdrug Quiet Night Tablets

Holland & Barrett Herbal Classics Peaceful Night

Sainsbury’s Sleep Aid

Tesco Herbal Sleep Aid

Sominex Herbal

Nytol Herbal Tablets

Gerard House Somnus Sleep Aid

Boots Sleepeaze Herbal

HERBALSTORE Sleep Aid

Wilko Sleep Aid Tablets

HealthAid SleepAid Tablets

Asda Sleep Aid

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains:

34 mg of extract (as dry extract) from Hop strobile (Humulus lupulus L.) (4-6:1) Extraction solvent: Ethanol 70% (v/v)

30.8 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (4:1) Extraction solvent: Ethanol 60% (v/v)

15.2 mg of extract (as dry extract) of Passion Flower herb (Passiflora incarnata L.) (5-7:1)

Extraction solvent: Ethanol 50% (v/v)

Each film coated tablet also contains 10mg of glucose (See Section 4.4 Special warnings and precautions for use.’

For full list of excipients see 6.1.

PHARMACEUTICAL FORM

Film coated tablet.

Tan brown, circular biconvex.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used 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.

Adults and the elderly:

Two tablets to be taken approximately one hour before bedtime.

Not recommended for use in children or adolescents under 18 years of age (See Section 4.4. special warnings and precautions for use’)

Duration of use:

As the effects of this product may not occur immediately, it should be taken continuously for 2 - 4 weeks.

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

4.3 Contraindications

Hypersensitivity to any of the active ingredients or any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose

This product is not recommended for use by children or adolescents under 18 years of age 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

Also contains glucose. Patients with rare glucose galactose malabsorption should not take this medicine.

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 has not been observed.

Concomitant use with hypnotics and synthetic sedatives such as benzodiazepines is not recommended unless advised by a doctor.

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.

Test 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 or operate machines. If affected, do not drive or operate machines.

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea, abdominal cramps may occur after ingestion of Valerian root. The frequency is not known.

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported with Passion flower. The frequency is not known.

There are no known adverse reactions with Hops.

If other adverse effects not mentioned above occur, a doctor or a 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 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 20g caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headedness, hand tremor and mydriasis) which disappeared within 24 hours.

If symptoms arise, treatment should be supportive.

After intake of high doses of Valerian root over several years (daily consumption corresponding to approximately 10g of the drug) withdrawal symptoms (delirium have been reported).

No symptoms of overdose have been reported for Passion flower and Hops.

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

6.1 List of excipients

Extract excipients Maltodextrin

Colloidal Anhydrous Silica Liquid Glucose

Core excipients Calcium Hydrogen Phosphate Microcrystalline Cellulose Stearic Acid Magnesium Stearate

Film-coat

Polyethylene Glycol 400 Hypromellose 4500 Hydroxypropylmethyl Cellulose Iron Oxide - yellow (E172)

Iron Oxide - red (E172)

Iron Oxide - black (E172) Titanium Dioxide (E171)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Blister pack containing 6, 30, 50, 60, 90 or 120 tablets.

High Density Polyethylene container with a polypropylene child resistant closure containing 60 tablets.