Discussion in Working Party on Community monographs and Community list (MLWP)

January 2011 March 2011

Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation

31 March 2011

End of consultation (deadline for comments).Comments should be provided using this template to hmpc.secretariat@ema.europa.eu

15 August 2011

Rediscussion in Working Party on Community monographs and Community list (MLWP)

Adoption by Committee on Herbal Medicinal Products (HMPC)

Well-established use

Traditional use

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended

Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen (cola)

i)    Herbal substance Not applicable.

ii)    Herbal preparations

a)    Powdered herbal substance

b)    Liquid extract (DER 1:1), extraction solvent ethanol 60% V/V

c)    Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 60% V/V

Well-established use

Traditional use

Powdered herbal substance in solid dosage forms for oral use.

Powdered herbal substance as herbal tea for oral use.

Herbal preparations in liquid dosage forms for oral use.

The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Well-established use

Traditional use

Traditional herbal medicinal product for symptoms of fatigue and sensation of weakness.

The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.

Well-established use

Traditional use

Posology

Adults and elderly

a)    Powdered herbal substance: 1-3 g, 3 times daily.

Herbal tea: 1-3 g of powdered herbal substance in 150 ml of water as a decoction,

3 times daily.

b)    Liquid extract: 0.6-1.2 ml, 3 times daily.

c)    Tincture: 1-4 ml, 3 times daily.

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

Duration of use

If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Method of administration

Oral use.

Well-established use

Traditional use

Hypersensitivity to the active substance(s).

Gastric and duodenal ulcers, cardiovascular disorders such as hypertension and arrhythmia,

hyperthyroidism.

Well-established use

Traditional use

The use in children and adolescents under 18 years of age has not been established due to lack of adequate data.

Not recommended before bedtime as it may cause sleep disturbances.

If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

For 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.

Well-established use

Traditional use

Patients taking MAO-inhibitor drugs should use Colae semen with caution.

Caffeine containing preparations reduce sedative action and increase side effects caused by sympathomimetic drugs.

Well-established use

Traditional use

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Well-established use

Traditional use

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

Well-established use

Traditional use

None known.

If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.

4.9. Overdose

Well-established use

Traditional use

No case of overdose has been reported.

5. Pharmacological properties

5.1. Pharmacodynamic properties

Well-established use

Traditional use

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

5.2. Pharmacokinetic properties

Well-established use

Traditional use

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

Caffeine crosses the placenta and is distributed in breast milk.

5.3. Preclinical safety data

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product.

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

Well-established use

Traditional use

Not applicable.