BIOPLANTA ST JOHNS WORT TABLETS
Active substance(s): ST JOHNS WORT EXTRACT
PATIENT INFORMATION LEAFLET
2. Before you take this product
Bioplanta St John’s Wort tablets St John's Wort extract 250mg
DO NOT TAKE this product if:
you are under 18 years of age.
you are pregnant or breastfeeding.
you are allergic to any of the ingredients (listed in section 6).
you are lactose intolerant (react badly to lactose or milk).
your skin is exceptionally sensitive to sunlight (photosensitive).
you are having light treatment (phototherapy) for any condition.
you are suffering from depression (see below).
Please read this leaflet carefully before you start taking these tablets. It
contains some important information about Bioplanta St John’s Wort
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.
What this product is and what it is used for …………..Page 1
Before you take this product………………………………….Pages 2-4
How to take this product………………………………………..Page 4
Possible side-effects……………………………………………….Page 5
How to store this product………………………………………Page 5
Further information……………………………………………….Page 6
What this product is and what it is used for
This product is a traditional herbal medicinal product containing St John’s
Wort. Each film-coated tablet of this product contains 250mg of extract (as
dry extract) from St John’s Wort aerial parts (Hypericum perforatum L.)
(3.5-6:1) (equivalent to 875-1500mg of St John’s Wort). Extraction solvent:
Ethanol 60% v/v.
Bioplanta St John’s Wort is a traditional herbal medicinal product used
for the relief of slightly low mood and mild anxiety, based on traditional
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 that you may be suffering from depression you should tell your doctor.
Tell your doctor before using this product if you have an intolerance to some sugars (see
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
Driving and operating machinery
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 a prescription.
Therefore it is important that you do not take St John’s Wort if you are using any of the medicines
listed in the table opposite.
DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING ANY OF THE FOLLOWING
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:
All hormonal contraceptives
All medicines for depression/
All hormonal replacement therapy
All medicines for thinning the
All medicines for epilepsy
The birth control ‘Pill’, emergency
contraception (also known as 'the
morning after pill'), hormonal
implants, creams, patches, intrauterine devices with hormones.
fluvoxamine, paroxetine, sertraline,
HRT tablets, patches, gels, vaginal
Some medicines for high blood
A medicine for regulating mood
phenytoin, primidone, sodium
Amprenavir, atazanavir, darunavir,
fosamprenavir, indinavir, lopinavir,
nelfinavir, ritonavir, saquinavir,
tipranavir, efavirenz, nevirapine,
Irinotecan, dasatinib, erlotinib,
imatinib, sorafenib, sunitinib,
Digoxin, ivabradine, amiodarone
Amlodipine, nifedipine, felodipine,
A thyroid hormone
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
fentanyl, propofol, sevoflurane, and midazolam (anaesthetics/preoperative 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. Swallow the tablets whole with some water or other liquid.
Do not chew the tablets. Do not take more than the label/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 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.
4. Possible side-effects
6. Further information
Each film-coated tablet of this product contains 250mg of extract (as dry
extract) from St John’s Wort aerial parts (Hypericum perforatum L.) (3.5-6:1)
(equivalent to 875-1500mg of St John’s Wort). Extraction solvent: Ethanol
Like all medicines, this product can have side-effects, although the frequency is not
known. These side-effects are listed below
digestive upsets such as indigestion, loss of appetite, nausea, diarrhoea
fatigue and restlessness
allergic skin reactions such as rash, hives or itching
Stop taking this product immediately if you experience an
These include headaches, nerve pain or tingling (neuropathy), anxiety, dizziness and
mania. Also sunburn-like reactions in skin exposed to strong ultra-violet (UV) irradiation
(e.g. sun, solarium) have been reported, particularly in fair-skinned individuals.
If you notice any other side-effect not mentioned above or any side-effect becomes
serious, tell your doctor or pharmacist.
Reporting of side-effects
If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any
possible side-effects not mentioned in this 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 medicine.
This product also contains the following ingredients:
Extract: Lactose monohydrate, calcium hydrogen phosphate dihydrate,
cellulose powdered, silica colloidal anhydrous.
Tablet core: Cellulose powdered, stearic acid, sodium starch glycolate (type
A), silica colloidal anhydrous, magnesium stearate.
Film-coating: Eudragit E 100, hypromellose, Macrogol 6000, talc, titanium
dioxide (E171), iron oxide hydrate (E172) (yellow iron oxide).
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 11mg of lactose monohydrate.
Each pack contains 28, 30, 56, 60, 90 or 120 film-coated tablets.
Not all pack sizes may be marketed.
After taking this product
You must speak to a qualified healthcare practitioner if your symptoms worsen, if they
do not improve after six weeks, if any side-effect becomes serious or if side-effects not
mentioned in this leaflet occur.
Registration holder for this product
Bioplanta UK Ltd (a wholly owned subsidiary of Schwabe Pharma (UK) Ltd),
Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL7 1FX
Manufacturer of this product
Hälsa Pharma GmbH,
33619, Bielefeld, Germany
5. How to store this product
Traditional Herbal Registration number: THR 34768/0001
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 the tablets above 25°C.
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.
If you would like further information about this product, please contact:
Bioplanta UK Ltd, Alexander House, Mere Park, Dedmere Road, Marlow,
Bucks, SL7 1FX.
Telephone: 01628 401980. Email: email@example.com
Leaflet last revised 11/2017.
For a large print, Braille or audio version update of this leaflet, call
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.