Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: G. R. Lane Health Products Limited, Sisson Road, Gloucester, GL2 0GR, United Kingdom, Tel: +44 (0)1452 524012, Fax: +44 (0)1452 507930, Email: info@laneshealth.com
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.
Not applicable.
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