Nytol Herbal Simply Sleep One-A-Night Tablets

Kalms Night One-A-Night

Nytol Herbal Simply Sleep One-A-Night Tablets

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.

Film coated tablet

White, ovaloid

A traditional herbal medicinal product used for the temporary relief of sleep disturbances, based on traditional use only.

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).

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

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.

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 co- medication 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.

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.

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

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.

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.

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

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

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

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)

Not applicable.

3 years.

Do not store above 25°C.

Store in the original package.

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

Not all pack sizes may be marketed.

No special requirements.

G. R. Lane Health Products Limited

Sisson Road

Gloucester

GL2 0GR

United Kingdom

Tel: +44 (0)1452 524012

Fax: +44 (0)1452 507930

Email: [email protected]

THR 01074/0002

05/03/2010

26/08/2016