NYTOL HERBAL SIMPLY SLEEP ONE-A-NIGHT Film coated tablet Ref.[7373] Active ingredients: Valerian

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).

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.

Shelf life: 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.