Active substance(s): ST JOHNS WORT DRY EXTRACT / VALERIAN ROOT ETHANOLIC DRY EXTRACT 3-6:1
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:
What DiaCalm tablets are and what they are used for
Before you take DiaCalm tablets
How to take DiaCalm tablets
Possible side effects
How to store DiaCalm tablets
Contents of the pack and other information
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.
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)
- you are being treated with some of the medicines mentioned in section “Taking other
- 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 (alAll hormonal contraceptives
so known as the morning after pill), hormonal implants, creams, patches, intra-uterine devices with
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
All medicines for thinning the
All medicines for epilepsy
primidone, sodium valproate
All immunosuppressant medicines
All medicines for HIV infections Amprenavir, atazanavir, darunavir, fosamprenavir,
indinavir, lopinavir, nelfinavir, ritonavir, saquinavir,
tipranavir, efavirenz, nevirapine, delavirdine
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, rizatriptan, sumatriptan, zolmitriptan
Some medicines for high blood
Amlodipine, nifedipine, verapamil, felodipine
A medicine for regulating mood Lithium
A thyroid hormone
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
Do not use DiaCalm tablets if you are pregnant or breast-feeding.
Driving and using machines
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
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 take more than the leaflet tells you to.
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 missed dose. 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.
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.
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.
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 www.mhra.gov.uk/yellowcard 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
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
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:
Liquid glucose; spray dried
Silica, colloidal anhydrous
Stearic acid 50
Silica, colloidal anhydrous
Calcium carbonate E 170
Acacia, spray dried
Liquid glucose, spray dried
Titanium dioxide E 171
Iron(III)-oxide hydrate E 172 (= yellow iron oxide)
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.
Diapharm GmbH & Co. KG
Manufacturer of this product
Diapharm GmbH & Co. KG
Würzburger Str. 3
Traditional herbal registration number: THR 42340/0021
If you would like further information about this product, please contact:
Diapharm GmbH & Co. KG
Würzburger Str. 3
Telephone: +49 (0)251-609350
This leaflet was last revised in September 2017.
For a large print, Braille or audio version update of this leaflet, call [to be updated].
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.