This information is intended for use by health professionals

1. Name of the medicinal product

Natrasleep

2. Qualitative and quantitative composition

Each film coated tablet contains:

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

33.4 mg of extract (as dry extract) from Hops strobile (Humulus lupulus L.) (4-8:1) Extraction solvent : Methanol 40% (v/v)

Each film coated tablet contains 11.69 mg of glucose

For full list of excipients, see 6.1.

3. Pharmaceutical form

Film coated tablet

Light brown speckled oval biconvex tablet.

4. Clinical particulars
4.1 Therapeutic indications

A traditional herbal medicinal product used to aid sleep based on traditional use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly One to three tablets half an hour before bedtime.

As treatment effects may not be apparent immediately, the tablets should be taken 2 - 4 weeks continuously.

Children and adolescents under 18 years

Not recommended for children and adolescents under 18 years (See Section 4.4 Special warnings and precautions for use).

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

4.3 Contraindications

Hypersensitivity to the active ingredients or to any of the excipients

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

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

This product contains glucose. One tablet contains 11.69 mg 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 CYP2D6, CYP 3AA4/5, CYP1A2 or CYP2E1 pathway have not been observed.

Additive effects with hypnotics and other sedatives 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.

In the absence of sufficient data the use in pregnancy and 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 use machines. Patients who are affected should not drive or use machines.

4.8 Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur after ingestion of valerian root.

The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor, pharmacist or qualified healthcare practitioner should be consulted.

4.9 Overdose

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

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. Pharmaceutical particulars
6.1 List of excipients

Extract:

Glucose Syrup (dried)

Maltodextrin

Colloidal anhydrous silica

Tablet core:

Calcium Phosphate Dibasic

Croscarmellose Sodium

Microcrystalline Cellulose

Magnesium Stearate

Silicon Dioxide

Film coat:

Hypromellose

Talc

Green Dispersion (contains Hypromellose , Copper Chlorophyllin (E141), Vegetable Carbon Black (E153) and Titanium Dioxide (E171))

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years

6.4 Special precautions for storage

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

6.5 Nature and contents of container

30 tablets in a securitainer.

32 tablets in a blister pack.

50 tablets in a blister pack.

64 tablets in an HDPE container.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Marketing authorisation holder

Omega Pharma Ltd.

1st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

8. Marketing authorisation number(s)

THR 02855/0087

9. Date of first authorisation/renewal of the authorisation

08/04/2013

10. Date of revision of the text

08/04/2013