DIABLACK COHOSH TABLETS - patient leaflet, side effects, dosage

Patient leaflet - DIABLACK COHOSH TABLETS

1: what this product is and what it is used for

This product is a traditional herbal medicinal product containing Black Cohosh root extract. Each film-coated tablet of this product contains 6.5 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5–8.5:1) (equivalent to 29.25–55.25 mg of Black Cohosh). Extraction solvent: Ethanol 60 % v/v.

DiaBlack Cohosh Tablets is a traditional herbal medicinal product used for the relief of symptoms of the menopause, such as hot flushes, night sweats, and temporary changes in mood (such as nervous irritability and restlessness), based on traditional use only.

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

2: Before you take this product

DO NOT TAKE this product if you:

have ever had or are suffering from liver or kidney problems (e.g. hepatitis, jaundice or cirrhosis)
have or have ever had treatment for breast cancer or any other hormone-dependent tumour
are of childbearing potential or do not use contraception
are lactose-intolerant (react badly to lactose or milk)
are pregnant or breastfeeding
are allergic to any of the ingredients (see section 6)
are under 18 years of age

Tell your doctor before taking this product if you:

have a persistent history of menstrual disorders
are currently taking a medicine containing -estrogen

You must speak to a qualified healthcare practitioner if you symptoms worsen, if they do not improve after 12 weeks, or if you notice any re-appearance or changes in menstrual bleeding.

3: how to take this product

For oral use only

Adults

For women experiencing menopausal symptoms, take 1 tablet daily.

Tablets should be taken at the same time of day if possible (morning or evening). Swallow the tablets whole with some water or other liquid. Do not chew the tablets.

Do not take more than the leaflet tells you to.

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take this product

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

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

4: possible side effects

Like all medicines, this product can have side-effects. They are listed below.

Uncommon side-effects (affecting fewer than 1 in 1000 people)

digestive upsets such as If these persist for more than a few days, or be-

come troublesome, stop taking this product. These common side-effects are often only temporary.

Stop taking this product immediately if you experience any allergic skin reaction.

such as nettle rash, itching

of the skin

Other side-effects

Black Cohosh may rarely cause liver problems. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness) stop taking immediately and seek medicinal advice. Tell your doctor or pharmacist, if you notice any other side-effect.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or qualified healthcare practitioner This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5: how to store this product

Do not use your tablets after the expiry date. Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

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

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

Keep your tablets in the blister pack until it is time to take them.

6: contents of the pack and other information

Each film-coated tablet of this product contains 6.5 mg of extract (as dry extract) from Black Cohosh rhizome and root (Cimicifuga racemosa (L.) Nutt.) (4.5–8.5:1) (equivalent to 29.25–55.25 mg of Black Cohosh). Extraction solvent: Ethanol 60 % v/v.

This product also contains the following ingredients:

Tablet core:

Cellulose powdered, lactose monohydrate, silica colloidal anhydrous, magnesium stearate, maize starch, cellulose microcrystalline, sodium starch glycolate (type A).

Film-coating:

Hypromellose, macrogol 4000, titanium dioxide (E 171)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each film-coated tablet contains 142mg of lactose monohydrate.

Each pack contains 30, 60, 90 or 100 film-coated tablets.

Registration holder

Schwabe Pharma (UK) Ltd.

Alexander House, Mere Park, Dedmere Road,

Marlow SL7 1FX

Manufacturer of this product

Diapharm GmbH & Co. KG or Wiewelhove GmbH

Wurzburger Str. 3 Dornebrink 19

26121 Oldenburg	49479 Ibbenburen
Germany	Germany

Traditional herbal registration number: THR 23056/0020

THR"

Certification Mark

If you would like further information about this product, please contact: