HELIOS SLEEP 30C PILLULES - summary of medicine characteristics

Helios Sleep 30c Pillules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each pillule contains

Avena sativa 30c

Coffea arabica 30c

Passiflora incarnata 30c

Valeriana officinalis 30c

Also contains sucrose 40mg

For a full list of excipients see section 6.1

3 PHARMACEUTICAL FORM

Pillules

White, hard, roughly spherical, approximately 4mm in diameter.

4.1 Therapeutic indications

A homeopathic medicinal product used within the homeopathic tradition for the temporary relief of sleep disturbances.

4.2 Posology and method of administration

For oral use only

One pillule to be sucked as required 10 minutes before retiring to bed.

For consumers having difficulty sucking the pillule, it may be crushed or dissolved in half a teaspoonful of previously boiled, cooled water and then administered.

Do not take within 15 minutes of eating or drinking.

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

If symptoms worsen, or persist for more than 7 days, a doctor or qualified healthcare practitioner should be consulted

4.3 Contraindications

Hypersensitivity to Avena sativa, Coffea Arabica, Passiflora incarnata,Valeriana officinalis preparations 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.

If symptoms worsen, or persist for more than 7 days, a doctor or qualified healthcare practitioner should be consulted.

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

4.5 Interaction with other medicinal products and other forms of interaction None known.

4.6 Fertility, pregnancy and lactation

Pregnancy: There is no evidence of the safety of the product in human pregnancy, nor is there any evidence from animal studies. Although no adverse events have been observed, the use of this product during pregnancy should be avoided unless under the guidance of a doctor.

Lactation: There is no evidence to suggest that the product should not be used during lactation.

Studies on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May cause drowsiness. If affected, consumers should not drive or operate machinery

4.8 Undesirable effects

There are no known adverse effects. If adverse effects occur, a doctor or qualified healthcare practitioner should be consulted.

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

None reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group

The ATC code is V03. All other therapeutic groups.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

6.2 Incompatibilities

None known

6.3 Shelf life

5 years

6.4 Special precautions for storage

Store below 30°C away from direct sunlight.

6.5 Nature and contents of container

4g round plastic tubular dispenser consisting of a polypropylene body, polypropylene dispensing head and polystyrene cap. The main polypropylene body contains an inner polystyrene tube.

Pack size: 4g Pillules (100 approx)

6.6 Special precautions for disposal

There are no special precautions.

7 MARKETING AUTHORISATION HOLDER

Helios Homeopathy Limited

89–97 Camden Road

Tunbridge Wells

Kent

TN1 2QR

U.K.

Tel 01892 537 254

Fax 01892 546850

Email JohnM@helios.co­.uk

8 MARKETING AUTHORISATION NUMBER(S)

NR 27776/0005