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DIACALM TABLETS

Active substance(s): ST JOHNS WORT DRY EXTRACT / VALERIAN ROOT ETHANOLIC DRY EXTRACT 3-6:1

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1.3 – Product Information

May 2013

1.3.1 – Package leaflet

Page 5 / 11
DiaCalm coated tablets THR 42340/0021

Module 1.3.1 Package Leaflet
DiaCalm tablets
Valerian root extract 56 mg and St. John’s Wort herb extract 120 mg
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take DiaCalm
tablets carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor if your symptoms worsen or do not improve after 4 weeks.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
What DiaCalm tablets are and what they are used for
2.
Before you take DiaCalm tablets
3.
How to take DiaCalm tablets
4.
Possible side effects
5.
How to store DiaCalm tablets
6.
Further information

1.

WHAT DIACALM TABLETS ARE AND WHAT THEY ARE USED FOR

This product is a traditional herbal medicinal product containing extracts of:
• St. John’s Wort herb
• Valerian root
For full details see section 6.
DiaCalm tablets is a traditional herbal medicinal product used to relieve slightly low mood,
mild anxiety and sleep disturbances due to mild anxiety, based on traditional use only.

2.

BEFORE YOU TAKE DIACALM TABLETS

Do not take DiaCalm tablets if
- you are allergic (hypersensitive) to Valerian, St. John’s Wort or any of the other
ingredients of DiaCalm tablets (see section 6)
- you are under 18 years of age
- your skin is exceptionally sensitive to sunlight (photosensitive)
- you are having light treatment (phototherapy) for any condition
- you are suffering from depression (see below)

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you are being treated with some of the medicines mentioned in section “Taking other
medicines” below.
you are already taking a medicine for sleep or anxiety

Take special care with DiaCalm tablets
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.
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
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,
All hormonal contraceptives
hormonal implants, creams, patches, intra-uterine devices with hormones.
All medicines for depresAmitriptyline, clomipramine, moclobemide, citalsion/anxiety
opram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine
All hormonal replacement therHRT tablets, patches, gels, vaginal rings
apy (HRT) treatments
Warfarin, acenocoumarol
All medicines for thinning the
blood (anticoagulants)
All medicines for epilepsy
Carbamazepine,
phenobarbitone,
phenytoin,
primidone, sodium valproate
Ciclosporin, tacrolimus
All immunosuppressant medicines
All medicines for HIV infections Amprenavir, atazanavir, darunavir, fosamprenavir,
indinavir, lopinavir, nelfinavir, ritonavir, saquinavir,
tipranavir, efavirenz, nevirapine, delavirdine
Simvastatin, atorvastatin
Some medicines for cholesterol
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,

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

rizatriptan, 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)
Taking DiaCalm tablets with food and drink
The tablets can be taken with or without food. The effects of this product may be increased by
alcohol. Excessive use of alcohol should therefore be avoided.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Safety during pregnancy and breast-feeding has not been established. Therefore, taking
DiaCalm tablets during pregnancy and breast-feeding is not recommended.
Driving and using machines
In rare cases DiaCalm tablets may cause tiredness; if affected do not drive or operate machinery.
Important information about some of the ingredients of DiaCalm tablets
This medicine contains glucose and sucrose (sugars). If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicinal
product.

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3.

HOW TO TAKE DIACALM TABLETS

Always take DiaCalm tablets exactly according to the instruction of this package leaflet. You
should check with your doctor or pharmacist if you are not sure.
Adults and the elderly
To help relieve symptoms of slightly low mood and mild anxiety:
One tablet to be taken one to three times daily.
To relieve sleep disturbances due to mild anxiety:
One tablet to be taken half an hour before going to sleep.
The tablets should be swallowed whole with some liquid, e.g. a glass of water. They can be
taken with or without food.
The maximum daily dose is 3 tablets
Do not exceed the stated dose.
Use in children
DiaCalm tablets should not be used in children or adolescents under 18 years old.
Duration of treatment
If your condition worsens, or if symptoms persist for more than 4 weeks you should consult
your doctor or qualified healthcare practitioner.
If you take more DiaCalm tablets than you should
If you take more tablets than you should and feel unwell, consult your doctor or qualified
healthcare practitioner as soon as possible.
If you forget to take DiaCalm tablets
Do not take a double dose to make up for a forgotten tablet. Leave out that tablet and take the
next tablet at the right time.
If you stop taking DiaCalm tablets
No adverse reactions to stopping DiaCalm tablets have been reported.
If you have any further questions on the use of this product, ask your doctor, pharmacist or
qualified healthcare practitioner.

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4.

POSSIBLE SIDE EFFECTS

Like all medicines, DiaCalm tablets can cause side effects, although not everybody gets them.
The frequency is not known.
-

Gastrointestinal symptoms like indigestion, loss of appetite, nausea, diarrhoea, abdominal
cramps and constipation.
Allergic skin reactions such as nettle rash, itching of the skin, hives. Stop taking this
product immediately if you experience any allergic reactions.
Tiredness
Restlessness
Other side effects 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.

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

5.

HOW TO STORE DIACALM TABLETS

Keep the tablets out of the reach and sight of children.
Do not use DiaCalm tablets after the expiry date. The expiry date is printed on the box and the
blister pack. The expiry date refers to the last day of that month.
Do not store above 30° C.
Store the tablets in the original packaging.
Keep your tablets in the blister pack until is time to take them..
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

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6.

FURTHER INFORMATION

What DiaCalm tablets contains
-

The active substances are:
Each coated tablet contains:
56 mg of extract (as dry extract) from Valerian Root (Valeriana officinalis L.) (3-6:1), Extraction solvent: ethanol 70% (v/v)
120 mg of extract (as dry extract) from St. John's Wort Herb (Hypericum perforatum L.) (3.56:1), Extraction solvent: ethanol 60% (m/m)

-

The other ingredients are:
Extract:
Liquid glucose; spray dried
Maltodextrin
Silica, colloidal anhydrous
Tablet core:
Cellulose, microcrystalline
Cellulose, powdered
Croscarmellose sodium
Stearic acid 50
Silica, colloidal anhydrous
Talc
Coating:
Sucrose
Talc
Calcium carbonate E 170
Acacia, spray dried
Liquid glucose, spray dried
Titanium dioxide E 171
Tragacanth
Iron(III)-oxide hydrate E 172 (= yellow iron oxide)
Carnauba wax
Iron(II, III)-oxide 80 E 172 (= black iron oxide)

What DiaCalm tablets look like and contents of the pack
Green, round tablets, biconvex, smooth and glossy surface.
The coated tablets are sealed into binary blisters made of PVC / PVDC and aluminium with
normally 10 tablets each.
Original packs of 30, 60, 90, or 100 coated tablets. Not all pack sizes may be marketed.

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Registration holder and manufacturer of this product
Diapharm GmbH & Co. KG
Hafenweg 18-20
48155 Münster
Germany

Traditional herbal registration number: THR 42340/0021

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

This leaflet was last approved in {09/2011}.

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 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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