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Bioplanta St Johns Wort Tablets

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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.    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 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 (Hypericumperforatum L.) (3.56:1) (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. This usage is based on traditional use only.

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.

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.

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

A thyroid hormone

Thyroxine

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

THFT


Certification

Mark


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 (Hypericumperforatum 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

Halsa 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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