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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett St. John’s Wort Capsules GNC Live Well St. John’s Wort Capsules Lifecycle St. John’s Wort Capsules Nature’s Garden St. John’s Wort Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 142mg of extract (as dry extract) from St. John’s Wort aerial parts (Hypericum perforatum L.) (equivalent to 711mg - 995mg of St. John’s Wort) Extraction solvent: ethanol 60% v/v.

Extraction solvent: ethanol 60% v/v.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Capsule, hard

White, hard, two piece capsules with green brown powder fill.

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 use only.

Adults and the elderly - Take 1 capsule 3 times daily. Swallow the whole capsule with water.

The use in children or adolescents under 18 years is not recommended (see section 4.4 ‘Special Warnings and Precautions for use’).

Duration of use:

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

4.3 Contraindications

Hypersensitivity to St. John’s Wort or to any of the excipients.

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

Concomitant use with any of the medicines specified in section 4.5. This is because St. John’s wort (Hypericum perforatum) has been shown to induce the cytochrom P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as the transport protein P-gycoprotein. This results in pharmacokinetic interaction with a large number of medicines including a possible decrease in the effectiveness of those medicines.

Pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants and the triptan group of medicines

4.4 Special warnings and precautions for use

If the condition worsens, or if symptoms persist for more than 6 weeks a doctor or qualified healthcare practitioner should be consulted.

This product is intended for the relief of symptoms of slightly low mood and mild anxiety. Patients with signs and symptoms of depression should consult a doctor for appropriate treatment.

In very rare cases, particularly in fair-skinned individuals, sunburn type reactions may occur on skin areas exposed to strong sunlight due to photosensitisation by St. John’s wort. Patients taking this product should avoid excessive sunbathing or the use of sunbeds or solariums.

The 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

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

Do not exceed the stated dose.

4.5 Interaction with other medicinal products and other forms of interaction

Substances in St. John’s wort (Hypericum perforatum) 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 concentrations is possible

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

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

This product should not be taken concomitantly with the medicines included in the Table below

Co-administered drug	Interaction	Recommendations concerning co-administration
Anaesthetics/pre-operative medicines
Fentanyl, propofc sevoflurane, midazolam	l Reduced blood levels with risk of therapeutic failure	Based on the elimination half -life of hypericin and hyperforin this product should be discontinued at least 10days 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

HIV protease inhibitors: Amprenavir, atazanavir, Darunavir, fosamprenavir Indinavir, lopinavir, Nelfinavir, ritonavir, Saquinavir, tipranavir	Reduced blood levels with possible loss o HIV suppression	Do not take with this product
HIV non-nucleoside reverse transcriptas inhibitors: efavirenz, nevirapine, delavirdine	Reduced blood levels with possible loss o e 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

Co-administered drug	Interaction	Recommendations concerning co-administration
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 rhythms or heart failure	Do not take with this product
CNS Stimulants
Methyl phenidate	Reduced blood levels and loss of control of heart rhythms or heart 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 a breakthrough bleeding.	Do not take with this product
Hormone Replacement T	lerapy
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 therapeutic failure	Do not take with this product
Diuretics
eplerenone	Reduced blood levels with risk of therapeutic failure	Do not take with this product

Co-administered drug	Interaction	Recommendations concerning co-administration
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
Cyclosporine tacrolimus	Reduced blood levels with risk of therapeutic failure	Do not take with this product
Lipid regulating drugs
Simvastatin atorvastatin	Reduced blood levels with risk of transplant rejection.	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
throxine	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 during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

No studies on the effects on fertility have been performed.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Gastrointestinal disorders (e.g. dyspepsia, anorexia, nausea, diarrhoea, constipation), allergic skin reactions (e.g. rash, urticaria, pruritus) fatigue and restlessness may occur. 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 health care practitioner should be consulted

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continual monitoring of the benefit/risk 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

There is 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 hospitalisation 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 1-2 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

Reverse mutation assays (Ames test) on bacteria indicated that the product was mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation. However, this could be attributed to quercetin/kaempferol and is therefore not considered relevant.

Adequate tests on reproductive toxicity and carcinogenicity have not been performed.

5.3 Preclinical safety data To be finalised

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline cellulose Magnesium stearate Silica colloidal hydrated

Excipients in the extract:

Maltodextrin

Silica colloidal anhydrous

Capsule Shell: Hypromellose Titanium dioxide (E 171)

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original packaging.

6.5 Nature and contents of container

1.    Dark amber Polyethylene terephthalate (PET) bottles with a chiffon black hinge cap (low density Polyethylene) with a paper backed aluminium foil liner which acts as a tamper evident seal under the cap.

2.    Green Polyethylene terephthalate (PET) bottles with a chiffon green hinge cap (Polypropylene), with an inner seal liner designed to lift ‘n’ peel. The inner seal acts as a tamper evident seal under the cap. The Inner seal liner is made up of polyester film, polymer adhesive layer, polyester tab, polyolefin foam, aluminium foil and sealable polyester film

Pack size: 50 capsules and 100 capsules

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Holland & Barrett International Limited Samuel Ryder House,

Barling Way,

Nuneaton,

Warwickshire,

CV10 7RH United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

THR 21710/0002

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

11/08/2016

10    DATE OF REVISION OF THE TEXT

11/08/2016