Package Leaflet: Information for The User

Cimirelief®

Black Cohosh rhizome and root extract 2.5 mg

In this leaflet:

1.    What Cimirelief® Tablets are and what they are used for

2.    Before you take Cimirelief® Tablets

3.    How to take Cimirelief® Tablets

4.    Possible side effects

5.    How to store Cimirelief® Tablets

6.    Further information

1. What Cimirelief® Tablets are and what they are used for

This product is a traditional herbal medicinal product containing Black Cohosh rhizome and root extract. Cimirelief® Tablets are used for the relief of symptoms of the menopause such as hot flushes, sweating, sleep disturbances, restlessness, nervous irritability or temporary mood changes. This usage is based on traditional use only.

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

2. Before you take Cimirelief® Tablets

Do not take Cimirelief® Tablets if you:

•    are allergic (hypersensitive) to Black Cohosh or to any of the other ingredients in this medicine (see section 6: Product description)

•    have, or have ever had liver or kidney disease (e.g. hepatitis, jaundice or cirrhosis)

•    are pregnant or breast-feeding

•    are of childbearing potential and do not use contraception

•    are having or have ever had treatment for breast cancer or any other hormone-dependent tumour.

Tell your doctor before taking this product if

you:

•    have a family history of oestrogen dependent tumours

•    are currently taking another medicine that contains oestrogen

•    cannot tolerate some sugars because each tablet of Cimirelief® Tablets contain 187 mg of lactose.

While you take this medicine see your doctor if:

• menstrual disorders occur or menstruation re-appears and if the symptoms are persistent, of unknown origin, or have recently occurred. This may indicate the presence of other conditions which need to be medically diagnosed.

• you get fatigue, loss of appetite, yellowing of the skin or eyes or severe upper stomach pain with nausea and vomiting or dark urine (symptoms suggestive of liver dysfunction). You should immediately stop the use of the product and seek medical advice.

3. How to take Cimirelief® Tablets

Adults:

For women experiencing menopausal symptoms, take one tablet twice each day, morning and evening.

Remember to always take this medicine with a glass of water. The tablets should be swallowed whole. Do not chew the tablets. You do not need to take the tablets with meals.

Do not exceed the stated dose.

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

If your symptoms persist or worsen

You must speak to a doctor or qualified healthcare practitioner if your symptoms worsen, if they do not improve after twelve weeks, if side effects not mentioned in this leaflet occur or if you notice any re-appearance or changes in menstrual bleeding.

If you take too much of this product

If you take too much and feel ill, talk to your doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take Cimirelief® Tablets

Continue to take your usual dose at the usual time. It does not matter if you have missed a dose.

If you have any questions about taking this medicine or you are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4. Possible side effects

Like all medicines, Cimirelief® Tablets can cause side effects, although not everybody gets them.

Possible side effects:

•    gastrointestinal disorders (upper abdominal disorders, diarrhoea)

•    allergic skin reactions (nettle rash, itching, skin rash)

•    swelling of the face or extremities

•    increase in liver enzymes (transaminases)

•    weight gain

The frequency is not known.

In rare cases, Black Cohosh may cause liver reactions (yellowing of eyes or skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness).

You must not take any more of these tablets if you get any of these symptoms. You must see your doctor immediately.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cimirelief® Tablets

Keep the tablets out of the reach and the sight of children.

Do not use the tablets after the expiry date on the carton and the blister strip. The expiry date is the last day of that month. Return any out-of-date tablets to your pharmacist who will dispose of them for you.

Do not store above 30°C. Store in the original package.

What Cimirelief® Tablets look like and contents of the pack

Cimirelief® Tablets are white to beige and round.

Cimirelief® Tablets come in blister packs of 60, 100 or 200 tablets.

Traditional Herbal Registration Holder and Manufacturer

Traditional Herbal Registration Holder:

Schaper & Brummer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter, Germany

Manufacturer:

Schaper & Brummer GmbH & Co. KG, Bahnhofstr. 35, 38259 Salzgitter, Germany

Distributor:

tml:health Hamilton House PO Box 8014 Reading RG6 9DB

info@cimirelief.co.uk

This leaflet was last revised in November 2014.

For a large print, Braille or audio version of this leaflet, please contact:

Schaper & Brummer GmbH & Co.KG, Bahnhofstrasse 35, 38259 Salzgitter, Germany.

THR 26548/0003 certification mark

® Registered Trade Mark

6. Further Information

What Cimirelief® Tablets contain

The active ingredient in each tablet is:

2.5 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt) (6 - 11: 1).

Extraction solvent: isopropyl alcohol 40 % v/v.

The other ingredients are

Cellulose powder Lactose monohydrate Magnesium stearate Potato starch.

Each tablet contains 197 mg lactose monohydrate, corresponding to 187 mg lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

9766/014/00