Hughes Health Red Peony Menopause Tincture
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hughes Health Red Peony Menopause Tincture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of oral liquid contains 1 ml of tincture from dried Red Peony (Paeonia lactiflora Pallas) root (1:3). Extraction solvent: Ethanol 25% v/v.
Each 1 ml of oral liquid also contains approximately 197 mg Ethanol (alcohol) equivalent to 5 ml of beer or 2 ml of wine.
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Oral drops A brown liquid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the symptomatic relief of hot flushes associated with the menopause, based on traditional use only.
4.2 Posology and method of administration
For oral use only
Adult Females
For the symptomatic relief of hot flushes associated with the menopause: Take 20 drops (1 ml) in a small amount of water, three times a day.
There is no relevant use in children and adolescents under 18 years of age.
If symptoms persist, worsen or do not improve during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
Contraindications
4.3
Patients with known hypersensitivity to Paeonia lactiflora, or any of the excipients.
Pregnancy and lactation (see Section 4.6).
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Contains alcohol - up to 197 mg ethanol per dose (equivalent to 5 ml of beer or 2 ml of wine).
Harmful for those suffering from alcoholism. To be taken into account in high risk groups such as patients with liver-disease, or epilepsy.
There is no relevant use in children and adolescents under 18 years of age.
If menstrual disorders occur or menstruation re-appears and if symptoms are persistent, of unknown origin, or have recently occurred, a doctor should be consulted.
A study in animals has shown delayed absorption of phenytoin when administered with Peony root. The clinical significance of these findings is unknown. Patients taking phenytoin should consult their doctor before using this product.
4.5 Interaction with other medicinal products and other forms of interaction
No studies have been carried out to determine if drug interactions occur with this product.
Contains alcohol, and should therefore be avoided in patients taking other medication known to interact with alcohol (e.g. metronidazole).
4.6 Fertility, 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.
No studies on the effect on fertility have been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect of this product on the ability to drive or use machinery have been performed. This product contains alcohol (see Section 2).
4.8 Undesirable effects
Stomach upsets.
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or qualified healthcare 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 balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www. mhra. gov. uk/y ell owcard.
4.9 Overdose
No case of overdose has been reported.
Overdose of this product may result in alcohol intoxication: the amount in a full bottle: (9.9g in 50ml and 19.8g in 100ml: equivalent to 0.5 and 1.0 large glasses of wine respectively) may result in intoxication and should be treated accordingly.
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, genotoxicity and carcinogenicity have not been performed
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Ethanol (from tincture)
6.2 Incompatibilities
None known
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Amber glass bottle fitted with glass pipette, butyl-rubber bulb and HDPE plastic cap. Plastic cap includes a tamper-evident collar that shears on first opening.: 50ml and 100ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
K Hughes & Co Limited,
118 Trew,
Mount Road,
Dungannon,
County Tyrone,
BT71 7EF
8 MARKETING AUTHORISATION NUMBER(S)
THR 42358/0001
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 DATE OF REVISION OF THE TEXT