SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

English Herbal Medicines Herbal Menopause Relief Napiers Herbal Menopause Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml of oral liquid contains

0.3 ml of liquid extract from Pulsatilla herb (Anemonepulsatilla L.) (1:1). Extraction solvent: ethanol 60% v/v.

0.015ml of liquid extract from Black Cohosh rhizomes and root (Cimicifuga racemosa (L.) Nutt.) (1:1). Extraction solvent: ethanol 82% v/v.

0.4 ml of liquid extract from Valerian root* (Valeriana officinalis L.) (1:1). Extraction solvent: ethanol 45% v/v.

0.65 ml of liquid extract from Scullcap herb* (Scutellaria lateriflora L.) (1:1). Extraction solvent: ethanol 21% v/v.

0.3 ml of liquid extract from Motherwort flowering herb* (Leonurus cardiaca L.) (1:1).

Extraction solvent: ethanol 21% v/v.

* Certified organically produced herbal ingredient.

Each 5 ml of oral liquid also contains approximately:

1.1 ml ethanol (alcohol),1.45g sucrose, 29.5 microlitres glucose and sorbitol. (See section 4.4 ‘Special warnings and precautions for use.’)

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Oral liquid.

Dark brown liquid.

CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of menopausal symptoms, such as hot flushes, night sweats, poor sleep, mood changes and irritability, based on traditional use only.

As there is evidence that Black Cohosh may have hormone-like actions, it should only be used by women of childbearing potential if contraception is used.

4.2    Posology and method of administration

For oral use only.

Women experiencing menopausal symptoms:

One 5ml teaspoon three times a day with water or fruit juice.

There is no relevant use in children and adolescents less than 18 years of age.

If symptoms worsen or do not improve after 12 weeks, a doctor or qualified healthcare practitioner should be consulted.

Hepatic and renal impairment

The safety of Black Cohosh has not been studied in patients with hepatic and/or renal impairment. This product should not be taken by patients who have hepatic impairment or renal impairment.

4.3 Contraindications

Hypersensitivity to any of the actives or excipients.

Patients who have active liver disease or a history of liver damage.

Women who ar e pregnant or br east feeding or in women who could b ecome pregnant (unless contraception is used).

In patients currently receiving treatment for, or who have had, a history of an estrogen dependent tumour.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

There have been rare cases of hepatic reactions associated with the use of Black Cohosh. Patients taking the product should immediately stop the use of the product and consult their doctor if they develop signs and symptoms suggestive of liver dysfunction (fatigue, loss of appetite, yellowing of the skin and eyes or severe upper stomach pain with nausea and vomiting or dark urine).

Advice should be sought from a physician if the patient has a family history of breast cancer.

Estrogens may only be taken concurrently with the product under medical supervision, as their effect may be intensified by Black Cohosh.

If menstrual disorders occur or menstruation re-appears and if the symptoms are persistent, of unknown origin, or have recently occurred, a doctor should be consulted as this may indicate the presence of other conditions which need to be medically diagnosed.

Contains alcohol - up to 880mg ethanol (alcohol) per dose equivalent to 22 ml of beer or 9.2 ml of wine.

Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver-disease, or epilepsy.

Contains glucose, sucrose and sorbitol. May be harmful to the teeth.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

There is no relevant indication in the elderly or children or adolescents under 18 years of age.

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.

For Valerian root only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interactions with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 or CYP 2E1 pathway have not been observed.

Additive effects with hypnotics and other sedatives cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of the product may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

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

Safety during pregnancy and lactation has not been established. Therefore it should be avoided during pregnancy and lactation. Additionally, because of the potential for Black cohosh to have hormone-like actions the product should also be avoided by women who could become pregnant unless contraception is used.

Studies on fertility have not been performed.

4.7 Effects on ability to drive and use machines

May impair the ability to drive and use machines. If affected do not drive or operate machines.

This product contains alcohol (see Section 2).

4.8 Undesirable effects

Gastrointestinal symptoms (eg nausea, abdominal cramps) may occur after ingesting Valerian root. The frequency is not known.

Gastrointestinal disorders (dyspepsia, diarrhoea), allergic skin reactions (urticaria, pruritus, skin rash), facial oedema and peripheral oedema, increase in liver enzymes (transaminases), weight gain have been reported with Black cohosh. The frequency is not known.

In rare cases, Black Cohosh may cause liver reactions (including hepatitis, jaundice and disturbances in liver function tests).

If other adverse reactions not mentioned above occur, a doctor or qualified health care practitioner should be consulted.

4.9 Overdose

Treatment should be symptomatic and supportive.

Valerian root at a dose of approximately 20g caused benign symptoms (fatigue, abdominal cramp, chest tightness, light headedness, hand tremor and mydriasis) which disappeared within 24 hours.

After intake of very high doses of valerian root over several years (daily consumption corresponding to approximately 30g of the drug) withdrawal symptoms (delirium) have been reported.

Overdose of this product may result in alcohol intoxication. The amount of ethanol in a full bottle (17.6 g in 100ml and 35.2 g in 200ml; equivalent to 0.73 and 1.47 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.

For Cimicifuga extracts, in a six- month study in ra ts the no- observed- effect-level (NOEL) for the isopropanolic extract (Granulate) was defined with 21.06 mg native extract/kg bodyweight.

Evidence from in-vitro and in-vivo pharmacological studies suggests that Cimicifuga extracts do not influence the latency or d evelopment of breast cancer. However, contradictory results have been obtained in other in-vitro experiments.

In Cimicifuga-treated (isopropanolic black cohosh extract equivalent to 40 mg of root and rhizome), tumour-bearing, female transgenic mice, the percentage of mice with detectable metastatic lung tumours at necropsy was increased compared to those on the control diet. However, in the same experimental model, no incr ease in p rimary breast tumour was see n. Influence on br east c ancer or ot her horm one-depending tumours cannot be completely excluded.

A genotoxicity study (AMES-test) of the ethanolic extract (4.5-8.5:1, ethanol 60% (V/V)) was performed to a concentration of 1 m g/plate. The test does not fulfil the recent criteria of such testing and the refore the relevance of these results for safety assessment is doubtful.

There are no conclusive studies on carcinogenicity and reproductive toxicity.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Liquid Glucose Syrup (sucrose)

Glycerol

Tincture Cardamon Compound (Water, Cinnamon bark, Caraway seed, Cardamom pods, Ethanol, Glyercol, Cochineal E120)

Nutmeg Oil Clove Oil Cinnamon Oil

Liquorice Liquid Extract (Liquorice root,sorbitol, ethanol and water)

Ethanol

Caramel E150

Water.

6.2    Incompatibilities

Not applicable

6.3    Shelf life

3 years

6.4    Special precautions for storage

Do not store above 25^oC. Store in the original container.

6.5    Nature and contents of container

Glass bottle with polypropylene or wadded hard plastic screw-cap: 100ml,150ml

and 200ml.

6.6    Special precautions for disposal

No special requirements

7    MARKETING AUTHORISATION HOLDER

Rutland Biodynamics Ltd,

Town Park Farm, Brooke,

Rutland, LE15 8DG.

8    MARKETING AUTHORISATION NUMBER(S)

THR 28255/0024

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

30/04/2013

10    DATE OF REVISION OF THE TEXT

30/04/2013