SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Menoforce Sage tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet contains 51 mg of dried tincture from fresh Sage (Salvia officinalis L.) leaves (1:17-18).

Extraction solvent: Ethanol 68% V/V.

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Tablet

It is an olive-green to yellowish-brown, slightly dotted, oblong, biconvex, bevelled tablet with a slightly aromatic odour.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of excessive sweating associated with menopausal hot flushes, including night sweats based on traditional use only.

4.2    Posology and method of administration

For oral use only.

Women experiencing menopausal symptoms: 1 tablet daily.

Children and adolescents under 18 years.

There is no relevant use in children and adolescents under 18 years.

4.3 Contraindications

Do not use in cases of known hypersensitivity to Sage preparations or to any of the excipients.

4.4 Special warnings and precautions for use

If the condition worsens consult a healthcare practitioner.

This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

The intake of Sage leaf preparations might influence the effect of medicinal products acting via GABA receptor (e.g. barbiturates, benzodiazepines), even if not seen clinically. Therefore the concomitant use with such medicinal products is not recommended.

4.6 Pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established, therefore the use of this product during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

May impair ability to drive and use machines. Affected patients should not drive or operate machinery.

Undesirable effects

No undesirable effects are reported.

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

Overdose

No case of overdose has been reported with Menoforce Sage tablets

Overdose has been reported with a sense of heat, tachycardia, vertigo and epileptic form convulsions (seizures) after intake corresponding to more than 15 g sage leaves (equivalent to between 11 and 19 doses).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

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

5.3 Preclinical safety data

Tests on reproductive toxicity and carcinogenicity have not been performed with Menoforce Sage tablets

Genotoxicity data available for an extract of Salvia officinalis and for the essential oil of Salvia officinalis in two separate investigations demonstrated negative Ames test results. This is supported by other published data and suggests that the risk of genotoxicity or mutagenicity resulting from the use of Salvia officinalis extracts is negligible.

6.1 List of excipients

Microcrystalline cellulose

Sucrose laurate Hydrogenated cottonseed oil

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years unopened.

Use within 4 months of opening.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Amber glass bottles (Type III glass) sealed with coated aluminium foil and closed with pilfer proof screw caps fitted with a polyethylene liner

Pack sizes:    30 tablets

90 tablets

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.