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BIOPLANTA ST JOHNS WORT TABLETS

Active substance(s): ST JOHNS WORT EXTRACT

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PATIENT INFORMATION LEAFLET
Information for the User

Bioplanta St John’s Wort tablets
The active substance is St John’s Wort dry extract 250mg
Please read this leaflet carefully before you start taking these tablets.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or qualified
healthcare practitioner.
• You must contact a qualified healthcare practitioner if your symptoms worsen or if they do not
improve after six weeks, if any of the side-effects get serious, or if you notice any
side-effects not listed in this leaflet.
In this leaflet:
1.
2.
3.
4.
5.
6.

What this product is and what it is used for
Before you take this product
How to take this product
Possible side-effects
How to store this product
Further information

1. 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.) (3.56:1) (equivalent to 875-1500mg of St John’s Wort).
Extraction solvent: Ethanol 60% v/v.

Driving and operating machinery
In rare cases St John’sWort may cause dizziness
or tiredness. If this happens to you, 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.
DO NOT TAKE THIS PRODUCT IF YOU ARE
TAKING ANY OF THE FOLLOWING MEDICINES:
All hormonal contraceptives The birth control “Pill”,

emergency contraception (also
known as 'the morning-after
pill'), hormonal implants,
creams, patches, intra-uterine
devices with hormones.

Bioplanta St John’s Wort is a traditional herbal
medicinal product used for the relief of slightly
low mood and mild anxiety. This usage is based
on traditional use only.
All medicines for
depression/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,
fovatriptan, naratriptan,
rizatriptan, sumatriptan,
zolmitriptan

Some medicines for
high blood pressure

Amlodipine, nifedipine,
felodipine, verapamil

A medicine for
regulating mood

Lithium

2. Before you take this product
DO NOT TAKE this product if:
• you are under 18 years of age.
• you are allergic to any of the ingredients
(listed in section 6).
• you are lactose intolerant (react badly to
lactose or milk).
• you are pregnant or breastfeeding.
• your skin is very sensitive to sunlight.
• you are having light therapy (phototherapy)
for any condition.
• you are suffering from depression (see below).
• you are taking any of the medicines in Section 2
as this product may affect the way they work.
Suffering from depression?
This product is for symptoms of slightly low mood
and mild anxiety. If you think you are suffering from
depression and have thoughts of self-harm, suicide
or any other symptoms of depression you should see
your doctor. Other symptoms of depression can
include feeling hopeless and helpless, loss of interest
in daily activities, appetite or weight changes, sleep
changes, loss of energy and difficulty concentrating.
Tell your doctor before using this product
if you have an intolerance to some sugars
(see section 6).
While you are taking this product:
• Avoid prolonged sunbathing or the use of sun
beds or solariums whilst taking this product.
In rare cases St John’s wort may cause your
skin to be much more sensitive to sunlight.
• Tell your doctor you are taking this product if
you have to have an operation. You should stop
taking this product 10 days before an operation.

A thyroid hormone

Thyroxine

St John's Wort PIL 2014 (5940-03) 06/05/2014 17:54 Page 2

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 diuretic)
• lansoprazole and omeprazole (proton pump
inhibitors)
• theophylline (a bronchodilator)
• gliclazide (an antidiabetic medicine)
3. How to take this product
You should speak to your doctor, pharmacist or
qualified healthcare practitioner if you are not sure
if this product is suitable for you.
Adults and the elderly
Take one tablet daily.
Swallow the tablets whole with some water or
other liquid.
Do not chew the tablets.
Don’t take more than the recommended dose.
If you take too much of this product (overdose)
If you take too much and feel ill, talk to your doctor.
Taking too much is unlikely to be harmful.
If you forget to take this product
Don’t worry about the missed dose.
Take the next tablet as usual.
If you have any questions, or are unsure about
anything, please ask your doctor, pharmacist or
qualified healthcare practitioner.
4. Possible side-effects
Like all medicines, this product can cause
side-effects, although not everybody gets them.
Minor effects
The following minor side-effects can occur when
using this product.
Digestive symptoms:
• Nausea
• Indigestion
• Diarrhoea
• Constipation
• Loss of appetite
Fatigue and restlessness
Allergic skin reactions:
• Itching (pruritis)
• Rash
• Red itchy spots (urticaria)
Stop taking the product immediately if these
allergic reactions occur.
Other side-effects:
Headaches, nerve pain or tingling (neuropathy),
anxiety, mania, dizziness.
Sunburn-like reactions on skin exposed to strong
ultra-violet light (UV) irradiation e.g sun, solarium
have been reported, particularly in fair skinned
individuals.
If you are concerned about any side-effect, or any
side-effect becomes 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 nurse. This includes any possible
side-effects not listed in this leaflet. You can also
report side-effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side-effects you can help provide
more information on the safety of this medicine.
After taking this product:
You must speak to a qualified healthcare
practitioner if your symptoms worsen, if they do
not improve after six weeks, or if any side-effect
becomes serious or side-effects not mentioned in
this leaflet occur.
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.
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 film-coated tablet of this product contains
250mg of extract (as dry extract) from St John’s
Wort aerial parts (Hypericum perforatum L.) (3.56:1) (equivalent to 875-1500mg of St John’s Wort).
Extraction solvent: Ethanol 60% v/v.
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 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.
Traditional Registration holder for this product
Bioplanta UK Ltd
Alexander House, Mere Park, Dedmere Road
Marlow, Bucks, SL7 1FX
Manufacturer of this product
Hälsa Pharma GmbH,
Immermannstrasse 9,
33619, Bielefeld, Germany
Traditional herbal registration number:
THR 34768/0001
If you would like further information about this
product, contact the local representative of the
Traditional Herbal Registration Holder:
Bioplanta UK Ltd
Alexander House, Mere Park, Dedmere Road
Marlow, Bucks, SL7 1FX.
Telephone: 0207 486 0111
Email: info@bioplanta.co.uk

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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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