SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Gerard House St John’s Wort Tablets HERBALSTORE St John’s Wort Tablets Healthaid St John’s Wort

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains:

161 mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericum perforatum L.) (5-7:1) (equivalent to 806 - 1128 mg St John’s Wort).

Extraction solvent: Ethanol 60 % v/v

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Grey capsule shaped biconvex, clear film coated tablets

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.

Adults and the elderly: Take 1 -2 tablets a day.

The tablets should be swallowed whole with a little water. The tablets should not be chewed.

If symptoms worsen or do not improve after 6 weeks, a doctor or a qualified healthcare practitioner should be consulted.

This product is not recommended for use in children or adolescents under 18 years of age (see section 4.4 Special warnings and precautions for use).

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 (Hypericum perforatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, 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 recommended dose.

If symptoms worsen or do not improve after six weeks, a doctor or a qualified healthcare practitioner should be consulted.

The use of this product in children or adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.

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 fair-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 sun beds 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).

This product contains lactose monohydrate patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose 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 and CYP3A4 as well as the transport protein P-gylcoprotein. 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 CYPIA2, CYP3A4, CYP2C9, CYP3A4 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 co-administration
Anaesthetics/pre-operative medicines
Fentanyl, propofol, sevoflurane, midazolam	Reduced blood levels with risk of therapeutic failure.	Based on the elimination halflives 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, phenobarbiton,e 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, nelfinavir, ritonavir, saquinavir, tipranavir	Reduced blood levels with possible loss of HIV suppression.	Do not take with this product.
HIV non-nucleoside 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,	Reduced blood levels with risk of	Do not take with this product.

felodipine	therapeutic failure.
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, hormonal implants, injections, transdermal patches, creams etc. Intra-uterine devices with hormones	Reduced blood levels with risk of unintended pregnancy and breakthrough bleeding.	Do not take with this product.
Hormone Replacement Therapy
Hormone Replacement Therapy: Oral, transdermal 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, 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 drugs
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 Fertility, 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.

Studies on the effects on fertility have not been performed.

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. However, in rare cases St John’s Wort may make the patient feel dizzy or sleepy. Affected patients should not drive or use machines.

4.8 Undesirable effects

Gastrointestinal disorders (e.g. dyspepsia, anorexia, nausea, diarrhoea, constipation); allergic skin reactions (e.g. rash, urticarial, pruritus); fatigue and restlessness may occur. The frequency is not known.

Other ADRs reported include headaches, neuropathy, anxiety, dizziness, and mania. 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 qualified healthcare practitioner should be consulted.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No cases of overdose have been reported.

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

When a large overdose has occurred, phototoxic reactions may occur. The skin of the patient should be protected for one - two weeks 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

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended

5.3 Preclinical safety data

Studies on acute toxicity and repeated dose toxicity did not shoe signs of toxic effects.

The weak positive results of an ethanolic extract in the AMES-test (salmonella typhimurium TA 98 and TA 100, with and without metabolic activation) could be assigned to querecetin and are irrelevant to human safety. No signs of mutagenicity could be detected in further in-vivo test systems.

Test on reproductive toxicity revealed equivocal results.

Tests on carcinogenicity potential have not been performed.

Phototoxicity

After oral application of dosages of 1800 mg per day for 15 days, the skin sensitivity against UVA was increased and the minimum dose for pigmentation was significantly reduced. In the recommended dosage, no signs of phototoxicity are reported.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Excipients of the herbal preparation:

Maltodextrin

Colloidal anhydrous silica

Tablet core:

Lactose Monohydrate Microcrystalline cellulose Sodium starch glycolate (Type A)

Colloidal anhydrous silica Magnesium stearate Stearic acid

Film Coating:

Hypromellose Purified Talc

6.2 Incompatibilities Not applicable

6.3 Shelf life 24 months

6.4    Special precautions for storage

Do not store above 25°C. Store in the original package

6.5    Nature and contents of container

30, 60 or 90 tablets in Tristar Ultra Laminate blister pack with aluminium foil.

Not all pack sizes may be marketed

6.6    Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Brunel Healthcare Manufacturing Limited

William Nadin Way

Swadlincote

Derbyshire

DE11 0BB

8    MARKETING AUTHORISATION NUMBER(S)

THR 20894/0064

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

16/04/2014

10 DATE OF REVISION OF THE TEXT

31/07/2015