Max strength GNC Live Well ST. Johns Wort capsules,Max strength Holland & Barrett ST. Johns Wort capsules,Max strength Natures Garden ST. Johns Wort capsules,Max strength Lifecycle ST. Johns Wort capsules – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Holland & Barrett Max Strength St. John’s Wort Capsules

GNC Live Well Max Strength St. John’s Wort Capsules

Lifecycle Max Strength St. John’s Wort Capsules

Nature’s Garden St. John’s Wort Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains 284mg of extract (as dry extract) from St. John’s Wort aerial parts (Hypericum perforatum L.) (equivalent to 1422mg – 1991mg of St. John’s Wort) . Extraction solvent: ethanol 60% v/v.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Capsule, hard

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

d

y

Hormonal contraceptives

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

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

5.3 Preclinical safety data

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.

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

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25ºC.

Store in the original packaging.

6.5 Nature and contents of container

1. 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. 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 and other handling

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 21710/0003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

11/08/2016

10 DATE OF REVISION OF THE TEXT

11/08/2016