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DIAMENOCALM TABLETS

Active substance(s): DRY EXTRACT OF CIMICIFUGA RHIZOME / ST JOHNS WORT DRY EXTRACT

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1.3 – Product Information

May 2013

1.3.1 – Labelling

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DiaMenoCalm, coated tablets - THR 42340/0016

Module 1.3.1 Package Leaflet

Patient Information Leaflet
DiaMenoCalm Tablets
St. John’s Wort extract 300 mg and Black Cohosh root extract 6.4 mg
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about DiaMenoCalm Tablets.
Keep this leaflet with the tablets.
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 this product is and what it is used for
2: Before you take this product
3: How to take this product
4: Possible side-effects
5: How to store this product
6: Further information

1: What this product is and what it is used for
This product is a traditional herbal medicinal product containing extracts of:
• St. John’s Wort
• Black Cohosh root
For full details see section 6.
DiaMenoCalm Tablets is a traditional herbal medicinal product used for the relief of symptoms of the
menopause, including hot flushes, night sweats, slightly low mood and mild anxiety based on traditional use only.
As there is evidence that Black cohosh may have hormone-like actions, this product should only be
used by women of childbearing potential if contraception is used.

2: Before you take this product
DO NOT TAKE this product if:
• you are under 18 years of age
• you are pregnant or breastfeeding
• you are of child bearing potential and do not use adequate contraception
• you are allergic to any of the ingredients (see section 6)
• your skin is exceptionally sensitive to sunlight (photosensitive)
• you are having light treatment (phototherapy) for any condition
• you are suffering from depression (see below)
• you have ever had or are suffering from liver or kidney disease (e.g. hepatitis, jaundice or cirrhosis)
• you have ever had or are suffering from an oestrogen dependent tumour

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Tell your doctor before using this product if you:
• are currently taking any medicines containing oestrogens
• think you may be suffering from depression (see below)
• have a persistent history of menstrual disorders
• have been told by your doctor that you have an intolerance to some sugars. This product contains lactose monohydrate, sucrose and glucose (see section 6).
While you are taking this product:
• avoid excessive sunbathing or the use of sunbeds/solariums
• stop using it at least 10 days prior to undergoing any surgery
Suffering from depression?
Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily
activities, appetite or weight changes, sleep changes, loss of energy and difficulty concentrating. If
your doctor has told you that you are suffering from depression do not use this product. If you think
you may be suffering from depression you should tell your doctor.
Driving and operate machinery
In rare cases St. John’s Wort may make you feel dizzy or sleepy. If affected do not drive or use machines.
Taking this product with other medicines
St. John’s Wort can affect the way some medicines work and reduce their effectiveness. Medicines
that can be affected by St. John’s Wort include prescription medicines and those that you may have
bought yourself without prescription.
Therefore it is important that you do not take with this product if you are using any of the medicines
listed in the table.
Do not take this product if you are taking any of the following medicines
The birth control “Pill”, emergency contraception, hormoAll hormonal contraceptives
nal implants, creams, patches, intra-uterine devices with
hormones.
All medicines for depresAmitriptyline,
clomipramine,
moclobemide,
citalopram,
escitalopram,
fluoxetine,
fluvoxamine,
paroxetine,
sertraline,
sion/anxiety
All hormonal replacement therapy
(HRT) treatments
All medicines for thinning the
blood (anticoagulants)
All medicines for epilepsy
All immunosuppressant medicines
All medicines for HIV infections

Some medicines for cholesterol
Some medicines for cancer
Some medicines for heart disease
Some medicines for migraines

duloxetine, venlafaxine
HRT tablets, patches, gels, vaginal rings
Warfarin, acenocoumarol
Carbamazepine, phenobarbitone, phenytoin, primidone, sodium
valproate
Ciclosporin, tacrolimus
Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir,
lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz,
nevirapine, delavirdine

Simvastatin, atorvastatin
Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib,
etoposide, mitotane
Digoxin, ivabradine, amiodarone
Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan,

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Some medicines for high blood
pressure
A medicine for regulating mood
A thyroid hormone

sumatriptan, zolmitriptan
Amlodipine, nifedipine, verapamil, felodipine

Lithium
Thyroxine

St. John’s Wort may also affect the following medicines. Therefore do not take this product with
these medicines unless a doctor has said it is safe to do so:
• fentanyl, propofol, sevoflurane and midazolam (anaesthetics/pre-operative medicines)
• tramadol (an analgesic)
• erythromycin, clarithromycin and telithromycin (antibiotics)
• itraconazole and voriconazole (antifungals)
• artemether and lumefantrine (antimalarials)
• rasagiline (an anti-parkinson’s medicine)
• aripiprazole (an antipsychotic medicine)
• buspirone (an anxiolytic)
• aprepitant (used to treat post-operative vomiting)
• butobarbital and phenobarbital (barbiturates)
• methyl phenidate (a central nervous system or CNS stimulant)
• exemestane (a hormone antagonist)
• eplerenone (a diuretic)
• lansoprazole and omeprazole (proton pump inhibitors)
• theophylline (a bronchodilator)
• gliclazide (an antidiabetic medicine)

3: How to take this product
Adults and the elderly
Take 1 tablet daily. The tablet should be taken at the same time of day if possible (morning or evening). Swallow the tablets whole with a little liquid. Do not chew the tablets.
Do not exceed the stated dose.
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 your usual dose at the usual time; it does not matter if you have missed a dose.
If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or
qualified healthcare practitioner.
After taking this product
You must speak to a doctor or qualified healthcare practitioner if your symptoms worsen, if they do
not improve after six weeks, or if you notice any re-appearance or changes in menstrual bleeding.

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4: Possible side-effects
Like all medicines, this product can have side-effects. These are listed below.

• gastrointestinal disorders e.g.
indigestion, loss of appetite, nausea, diarrhoea, constipation
• fatigue and restlessness
• facial swelling, swelling of the
feet, ankles or lower leg
• weight gain

If these persist for more than a few days, or
become troublesome, stop taking this product.
These side-effects are often only temporary.

• allergic skin reactions
Stop taking this product immediately if you
such as nettle rash, itching of the experience any allergic skin reaction.
skin, hives
Other side-effects
These include headaches, nerve pain or tingling, anxiety, dizziness, mania. Also, sunburn like reactions in skin exposed to strong sunlight or strong ultra-violet (UV) irradiation (e.g. solarium) have been reported, particularly in fair-skinned individuals,
when taking St. John’s Wort.
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 medical advice.
If you notice any other side-effect not mentioned above or if any side effect becomes serious, tell your
doctor or pharmacist.

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.
Store the tablets in a cool dry place.
Do not store the tablets in a place where the temperature goes above 25° C.
Store tablets 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.

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6: Further information
Each coated tablet of this product contains 300 mg of extract (as dry extract) from St. John’s Wort
aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 1050 – 1800 mg of St. John’s Wort).
Extraction solvent: Ethanol 60% m/m and 6.4 mg of extract (as dry extract) from Black Cohosh roots
and rhizome (Cimicifuga racemosa (L.) Nutt.) (4.5-8.5:1) (equivalent to 28.80-54.40 mg of Black
Cohosh rhizome). Extraction solvent: Ethanol 60% v/v

This product also contains the following ingredients:
Extract: Maltodextrin, silica colloidal anhydrous, powdered cellulose, lactose monohydrate
Tablet core: Silica colloidal anhydrous, croscarmellose sodium, microcrystalline cellulose, sodium
starch glycollate (type A), magnesium stearate
Coating: Hypromellose, sucrose, talcum, calcium carbonate E 170, tragacanth, acacia, liquid glucose
(dry substance), titanium dioxide E 171, iron oxide hydrate E 172, vanillin, beeswax white, carnauba
wax, shellac
If you have been told by your doctor that you have an intolerance to some sugar, contact your doctor
before taking this product. Each coated tablet contains 19 mg of lactose monohydrate, 234 mg of sucrose and 6 mg of glucose.
Each pack contains 30, 60, 90 or 100 coated tablets.
Not all pack size may be marketed.
Registration holder and manufacturer of this product
Diapharm GmbH & Co. KG
Hafenweg 18-20
48155 Münster
Germany
Traditional herbal registration number: THR 42340/0016

Certification Mark
If you would like further information about this product, please contact:
Diapharm GmbH & Co. KG
Würzburger Str. 3
26121 Oldenburg
Germany
Telephone: +49 (0)441 - 98344-0
Email: info@diapharm.de

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This leaflet was prepared in November 2010.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at
www.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP’s surgery
or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday to Friday).

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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