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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