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English Herbal Medicines Herbal Menopause Relief

PATIENT INFORMATION LEAFLET

ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF

or

NAPIERS HERBAL MENOPAUSE RELIEF

Please read this information carefully

before you start taking this medicine. It contains important information about this product. Keep this leaflet with this medicine. You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.

What is in this leaflet?

1.    What is ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF and what it is used for.

2.    Before you take ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF

3.    How to take ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF

4.    Possible Side Effects

5.    How to store ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF

6.    Further information

1. What is ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF and what it is used for

This product is a traditional herbal medicinal product containing liquid extracts of Pulsatilla herb; Black Cohosh rhizomes and root; Valerian root* ; Scullcap herb* and Motherwort flowering herb*.

* Certified organically produced herbal ingredient.

What ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF is used for

ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF is 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.

2. Before you take ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF

Do not take this product if you:

• are under 18 years of age

•    are taking other medication known to interact with alcohol (e.g. metronidazole).

•    are pregnant or breast feeding

•    could become pregnant and are not using contraception.

•    are allergic to any of the active ingredients or to plants of the Asteraceae/ Compositae family, or any of the excipients.

•    have or have ever had liver or kidney problems

•    are having treatment for or have ever had an oestrogen dependant tumour

•    are taking a medicine for sleep or anxiety

Tell your doctor before taking this product:

-    if you have a family history of breast cancer

-    if you are already taking a medicine containing oestrogen

Consult your doctor:

-    immediately and stop taking this product if you develop signs and symptoms of liver toxicity which are fatigue, loss of appetite, yellowing of the skin and eyes or severe upper stomach pain with nausea, vomiting or dark urine.

- if you have problems with your periods or if they have stopped and start again when taking this product and if the symptoms are persistent, of unknown origin or have recently occurred.

Taking other medicines

Tell your doctor before taking this medicine if you are taking any other medicines, including any bought without a prescription.

Important information about some of the ingredients in this product:

This product contains up to 1.1ml 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.

This product contains sucrose, sorbitol and glucose. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this product. Maybe harmful to the teeth.

This product contains Valerian root and alcohol may increase its effects. Therefore excessive consumption of alcohol should be avoided.

Driving and using machines:

This product may affect your ability to drive or use machines and contains alcohol (see above). If affected do not drive or use machines.

3. How to take ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF

Women experiencing menopausal symptoms:

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

Maximum daily dose: 15mls (3 doses)

There is no relevant indication for use in children or adolescents under 18 years old.

Do not exceed the stated dose.

If symptoms worsen or do not improve after 12 weeks, consult your doctor or qualified healthcare practitioner.

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor or pharmacist or qualified healthcare practitioner and take this leaflet with you. Overdose of this product may cause alcohol intoxication (see section 2 Important information about some of the ingredients in this product)

If you forget to take this product

Continue to take your usual dose at the usual time. Do not take a double dose to make up for the missed dose. It does not matter if you have missed a dose.

If your condition worsens or if symptoms persist for more than 12 weeks after taking the product or if side effects become serious or if side effects not mentioned in the patient information leaflet occur, consult a doctor or qualified healthcare practitioner.

4. Possible side effects

Like all medicines, this product can have side effects, although not everybody gets them.

The following possible side effects may occur:

Gastrointestinal symptoms (e.g. nausea, stomach cramps) have been reported after taking Valerian root preparations. The frequency is not known.

Gastrointestinal disorders (indigestion, diarrhoea), allergic skin reactions (hives, itching, skin rash), swelling of the face or extremities, increase in liver enzymes (transaminases) and weight gain have been reported with Black cohosh. The frequency is not known.

In rare cases, Black Cohosh may cause liver reactions (including yellowing of the skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness and disturbances in liver function tests). If these effects occur, consult your doctor immediately.

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

Making medicines safer

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

Alternatively you can get a paper Yellow Card form from your doctor’s surgery or a pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday to Friday).

5. How to store ENGLISH HERBAL MEDICINES HERBAL MENOPAUSE RELIEF

Do not use after the expiry date. Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist to dispose of medicines no longer required.

The expiry date is printed on the box and the bottle label. The expiry date refers to the last day of the month.

Do not store above 25 0C. Store in the original package.

Keep all medicines out of the reach and sight of children Keep your medicine in the original container.

6. Further Information

Active Ingredients

Each 5ml of oral liquid contains

0.3 ml of liquid extract from Pulsatilla herb (Anemone pulsatilla 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.

This product also contains the following ingredients:

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.

This product is available in 100ml, 150ml or 200ml bottle sizes. Not all pack sizes may be marketed.

Traditional Herbal Registration Number THR 28255/0024

Registration holder and Manufacturer for this product :

Rutland Biodynamics Ltd.,

Town Park Farm Brooke,

Rutland, LE15 8DG

This leaflet was last revised in February 2014

THR certification mark