SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Kalms Night One-A-Night

Nytol Herbal Simply Sleep One-A-Night Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 385 mg of extract (as dry extract) from Valeriana officinalis L., radix (equivalent to 1.54 - 1.93 g of Valerian root).

Extraction solvent: Ethanol 60% V/V.

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Film coated tablet White, ovaloid

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 use.

Adults and the elderly: One tablet to be taken 30-60 minutes before bedtime.

One additional tablet can be taken earlier during the evening if necessary.

As treatment effects may not be apparent immediately, Kalms Night One-a-Night should be taken for 2-4 weeks continuously.

Duration of use:

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

The use in children or adolescents under 18 years of age is not recommended (see Section 4.4. Special warnings and precautions of use).

Contraindications

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

4.4 Special warnings and precautions for use

Do not exceed stated dose.

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 persist or worsen after 4 weeks of using the medicinal product, a doctor or 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 sedatives cannot be excluded and therefore comedication is not recommended as a general precaution.

The effect of Kalms Night One-a-Night may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

4.6    Pregnancy and lactation

Safety during pregnancy and lactation has not been established. As a precautionary measure, because of lack of data, use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

May impair ability to drive and use machines. If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

Gastrointestinal symptoms (e.g. nausea, abdominal cramps) may occur. 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 (equivalent to 8 to 13 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, 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 10 g of the drug) withdrawal symptoms (delirium) have been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16 c (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.

List of excipients

Extract excipients Maltodextrin

Colloidal anhydrous silica Tablet Core

Croscarmellose Sodium Magnesium Stearate

Prosolv SMCC50 (Silicified Microcrystalline Cellulose)

Talc

Silicon Dioxide Tablet Coating

Opadry (TM) 07F28588 White (Hypromellose, Talc, Titanium Dioxide, PEG, Saccharin Sodium)

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

14, 21, 28, 42 or 56 tablets stored in PVC/Aclar®-aluminium/polyethylene laminate blister packs.

Not all pack sizes may be marketed.

Special precautions for disposal

No special requirements.