Natrasleep
SUMMARY OF PRODUCT CHARACTERISTICS
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
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