Summary of medicine characteristics - SALVIAN CAPSULES
SALVIAN Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 300mg of Sage Leaf (Salvia officinalis L.) For list of excipients see section 6.1.
Hard capsules.Clear size 0 hard capsules.
4.1 Therapeutic indications
SALVIAN is a traditional herbal medicinal product used for the relief of excessive sweating associated with the menopause, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
Women experiencing menopausal symptoms:
For the temporary relief of excessive sweating associated with the menopause. Take 1 capsule per day swallowed with water.
Duration of use:- 2 weeks.
If symptoms do not improve after 2 weeks during the use of SALVIAN a doctor or a qualified healthcare care practitioner should be consulted.
There is no relevant use in children or adolescents under 18 years of age.
4.3 Contraindications
Hypersensitivity to Sage Leaf or to any of the excipients
4.4 Special warnings and precautions for use
There is no relevant use in children or adolescents under 18 years of age.
4.5 Interaction with other medicinal products and other forms of interaction None reported
The intake of Sage 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 Fertility, pregnancy and lactation
The safety of SALVIAN during pregnancy and lactation has not been established.
Due to the lack of data, use during pregnancy and lactation is not recommended.
Studies on the effect on fertility have not been performed.
4.7 Effects on ability to drive and use machines
SALVIAN may impair ability to drive and use machines.
Patients who are affected should not drive or operate machinery.
4.8 Undesirable effects
None known.
If adverse reactions occur, a doctor or qualified health care practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard
4.9 Overdose
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
5.3 Preclinical safety dataReverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) mutation assays with or without metabolic activation.
Adequate tests on reproductive toxicity and carcinogenicity have not been performed.
6.1 List of excipients
Hypromellose (capsule shell)
6.2 Incompatibilities
Not Applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C in the original package.
6.5 Nature and contents of container
Duma 110ml HDPE plastic container and tamper evident threaded Duma cap.
SALVIAN pack contains 30 or 60 Capsules.
6.6 Special precautions for disposal
6.6 Special precautions for disposalThere are no special precautions for disposal of SALVIAN capsules. When the container is empty the label should be removed and the container placed in a recycling bin.