Informations for option: Diamenocalm Tablets, show other option

Select option:

1. Diamenocalm Tablets
2. Diamenocalm Tablets

1.3 - Product Information 1.3.1 - Labelling

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

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

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 ta	king any of the following medicines
All hormonal contraceptives	The birth control “Pill”, emergency contraception, hormonal implants, creams, patches, intra-uterine devices with hormones.
All medicines for depres-sion/anxiety	Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine
All hormonal replacement therapy (HRT) treatments	HRT tablets, patches, gels, vaginal rings
All medicines for thinning the blood (anticoagulants)	Warfarin, acenocoumarol
All medicines for epilepsy	Carbamazepine, phenobarbitone, phenytoin, primidone, sodium valproate
All immunosuppressant medicines	Ciclosporin, tacrolimus
All medicines for HIV infections	Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delavirdine
Some medicines for cholesterol	Simvastatin, atorvastatin
Some medicines for cancer	Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane
Some medicines for heart disease	Digoxin, ivabradine, amiodarone
Some medicines for migraines	Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan,

	sumatriptan, zolmitriptan
Some medicines for high blood pressure	Amlodipine, nifedipine, verapamil, felodipine
A medicine for regulating mood	Lithium
A thyroid hormone	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.

4: Possible side-effects

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

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.

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 Munster 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

Wurzburger Str. 3

26121 Oldenburg

Germany

Telephone: +49 (0)441 - 98344-0 Email: info@diapharm.de

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).