Commission Decision of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance) (2008/911/EC)

[F1Any other information necessary for the safe use U.K.

[F2Contraindication] U.K.

Hypersensitivity to the active substance.

[ F3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

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Special warnings and precautions for use U.K.

[F2The use in children under 12 years of age is not recommended due to lack of adequate data.]

If the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted. [F4For tinctures and extracts containing ethanol the appropriate labelling for ethanol, taken from the Guideline on excipients in the label and package leaflet of medicinal products for human use, must be included.]

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Interactions with other medicinal products and other forms of interaction U.K.

None reported.

[F2Fertility, pregnancy and lactation] U.K.

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended. [F4No fertility data available.]

Effects on ability to drive and use machines U.K.

No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects U.K.

Insomnia, irritability, tachycardia and headaches may occur. The frequency is not known. [F4If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.]

Overdose U.K.

No case of overdose has been reported.

[F4Pharmaceutical particulars (if necessary) U.K.

Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product) U.K.

Not applicable.] ]

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