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1. Bioplanta St Johns Wort Tablets
2. Bioplanta St Johns Wort Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Bioplanta St John’s Wort tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

250 mg of extract (as dry extract) from St John’s wort aerial parts (Hypericum perforatum L.)(3.5-6:1)(equivalent to 875 - 1500 mg of St John’s wort).

Extraction solvent: Ethanol 60% v/v.

Each film-coated tablet contains: Lactose monohydrate (11 mg). For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Film-coated tablet.

Round, ochre, film-coated tablets, free from ruptures.

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

For adults and the elderly, take 1 tablet daily. The tablets should be swallowed whole with a little liquid. The tablets should not be chewed.

The patient should consult a doctor if symptoms worsen or do not improve after 6 weeks.

Not for children or adolescents under 18 years.

4.3 Contraindications

Hypersensitivity to the active ingredient or any of the excipients.

Patients with known dermal photosensitivity or patients undergoing phototherapy or any photodiagnostic procedures.

This product should not be taken concomitantly with the medicines included in Section 4.5. This is because St John’s wort (Hypericumperforatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines including leading to a possible decrease in the effectiveness of those medicines.

In addition, pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants and with the triptan group of medicines.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens, or if symptoms persist for more than six weeks medical advice should be sought.

The dosing and safety of St John’s Wort have not been studied in children/ adolescents below 18 years and safety is not established.

This product is intended for relief of symptoms of slightly low mood and mild anxiety. Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.

In very rare cases, particularly in light-skinned persons, sun burn type reactions on skin areas exposed to strong sunlight may occur due to photosensitisation by St John’s wort. Persons using this product should avoid excessive sunbathing or the use of sunbeds or solariums.

This product should be discontinued at least 10 days prior to elective surgery due to the potential for interactions with medicinal products used during general and regional anaesthesia (see Section 4.5).

Each film-coated tablet also contains: Lactose monohydrate (11 mg).

Patients with rare glucose-galactose malabsorption and/or with rare hereditary problems of galactose intolerance, the Lapp lactose deficience or glucosegalactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Substances in St John’s wort (Hypericumperforatum) have been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as the transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines leading to a potential decrease in the effectiveness of those medicines. The concomitant use of ciclosporin, tacrolimus for systemic use, Amprenavir, indinavir and other protease inhibitors, irinotecan and warfarin is contraindicated.

Special care should be taken in case of concomitant use of all drug substances the metabolism of which is influenced by CYP1A2, CYP3A4, CYP2C9, CYP2C19 or P-glycoprotein (e.g. amitriptyline, fexofenadine, benzodiazepines, methadone, simvastatin, digoxin, finasteride), because a reduction of plasma concentration is possible.

Users of oral contraceptives taking St John’s wort (Hypericum perforatum) may experience intracyclic menstrual bleeding and risk of contraception failure is increased.

Clinically significant pharmacodynamic interactions have also been identified with the SSRI antidepressants, and the triptan group of medicines used to treat migraines. Due to the increased risk of undesirable effects associated with these interactions this product should not be used concomitantly with these types of medicines.

Therefore this product should not be taken concomitantly with the medicines included in Table below:

Co-administered drug	Interaction	Recommendations concerning coadministration
Anaesthetics /pre-operative medicines
Fentanyl, propofol, sevoflurane, midazolam	Reduced blood levels with risk of therapeutic failure.	Based on the elimination half-lives of hypericin and hyperforin this product should be discontinued at least 10 days prior to elective surgery.
Analgesics
Tramadol	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antianginals
Ivabradine	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Anti-arrhythmics
Amiodarone	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antibacterials
Erythromycin, clarithromycin, telithromycin	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.

Anticoagulants
warfarin, acenocoumarol	Reduced anticoagulant effect and need for increased dose	Do not take with this product.
Antidepressants
Tricyclics eg. amitriptyline, clomipramine MAOIs eg. moclobemide SSRIs eg. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, Others eg. duloxetine, venlafaxine	Increased serotonergic effects with increased incidence of adverse reactions.	Do not take with this product.
Antiepileptics
All drugs in this class including: carbamazepine phenobarbitone phenytoin primidone sodium valproate	Reduced blood levels with increased risk of frequency and severity of seizures.	Do not take with this product.
Antifungals
itraconazole, voriconazole	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antimalarials
artemether lumefantrine	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Anti-parkinsons
rasagiline	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antipsychotics
aripiprazole	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antivirals
HIV protease inhibitors: amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir,	Reduced blood levels with possible loss of HIV suppression.	Do not take with this product.

nelfinavir, ritonavir, saquinavir, tipranavir
HIV nonnucleoside reverse transcriptase inhibitors: efavirenz, nevirapine, delavirdine	Reduced blood levels with possible loss of HIV suppression	Do not take with this product.
Anxiolytics
buspirone	Increased serotonergic effects with increased incidence of adverse reactions.	Do not take with this product.
Aprepitant	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Barbiturates
butobarbital, phenobarbital	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Calcium channel blockers
amlodipine,nifedipine verapamil, felodipine	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Cardiac glycosides
digoxin	Reduced blood levels and loss of control of heart rhythm or heart failure.	Do not take with this product.
CNS Stimulants
methyl phenidate	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Cytotoxics
irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Hormonal contraceptives
Oral contraceptives Emergency Hormonal Contraception	Reduced blood levels with risk of unintended pregnancy and breakthrough bleeding.	Do not take with this product.
Hormonal implants, injections
Transdermal patches, creams etc.
Intra-uterine devices with hormones

Hormone Replacement Therapy
Hormone Replacement Therapy: Oral Trandermal patches, gels Vaginal rings	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Hormone antagonists
exemestane	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Diuretics
eplerenone	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
5HT agonists
almotriptan,eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan and zolmitriptan	Increased serotonergic effects with increased incidence of adverse reactions.	Do not take with this product.
Immunosuppressants
cyclosporin, tacrolimus	Reduced blood levels with risk of transplant rejection.	Do not take with this product.
Lipid regulating dru	gs_
simvastatin, atorvastatin	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Lithium	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Proton pump inhibitors
lansoprazole, omeprazole	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Theophylline	Reduced blood levels and loss of control of asthma or chronic airflow limitation.	Do not take with this product.
Thyroid hormones
thyroxine	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Oral hypoglycaemic drugs
gliclazide	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.

4.6 Pregnancy and lactation

Safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Gastrointestinal disorders including dyspepsia, anorexia, nausea, diarrhoea, constipation; allergic skin reactions such as rash, urticaria, pruritis; fatigue and restlessness have been reported. The frequency is not known.

Fair-skinned individuals may react with intensified sunburn-like symptoms under intense sunlight or strong ultra-violet (UV) irradiation.

Other adverse reactions that have been reported include headaches, neuropathy, anxiety, dizziness and mania.

If other adverse reactions not mentioned above occur, a doctor, pharmacist or a qualified healthcare practitioner should be consulted.

4.9 Overdose

There are no data on human overdose with St John’s wort.

After the intake of up to 4.5g dry extract per day for 2 weeks and additionally 15g dry extract just before hospitalization seizures and confusion have been reported.

Where a large overdose has occurred, phototoxic reactions may occur. The skin of the patient should be protected for one week from UV irradiation and sunlight. Outdoor activities should be restricted and clothes and/or sun block preparations used to protect the skin from sunlight. Symptomatic and supportive measures should be taken as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Herbal medicinal product for the treatment of depressive disorders.

ATC code: N06AP01

The active constituents of St John’s wort have not been definitively established. However, the phloroglucinol constituent, hyperforin, and the hypericin group of constituents, are thought to play an important role in its activity.

5.2    Pharmacokinetic properties

The active ingredients of St John's wort can interact with other medicinal agents in two ways. Firstly, active ingredients in St John’s wort that themselves are metabolised in the liver by the CYP3A4 isoenzyme, increase (induce) the activity of this enzyme so that it accelerates the elimination of other medicinal agents which are degraded by the same pathway. This leads to a consequent reduction in the plasma concentration and effectiveness of these other substances. Secondly, the active ingredients in St John’s wort, like other type SRI or SSRI medicinal agents with an antidepressant action, can raise the concentration of serotonin in certain parts of the central nervous system so that this neurotransmitter can sometimes reach toxic levels, particularly when drugs containing St John’s wort are combined with other antidepressants

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extract:

Lactose monohydrate Calcium hydrogen phosphate dihydrate Cellulose, powdered Silica, colloidal anhydrous

Tablet core:

Cellulose, powdered Magnesium Stearate Silica, colloidal anhydrous Sodium starch glycolate (type A)

Stearic acid

Film-coating:

Eudragit E 100 Hypromellose Macrogol 6000 Talc

Titanium dioxide E 171

Iron oxide hydrate E 172 (= yellow iron oxide)

6.2 Incompatibilities

Not applicable

07/05/2014