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Lifecycle St. Johns Wort Capsules

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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 (State in normal font)

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.

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

Duration of use:

If symptoms worsen or persist after 6 weeks of using the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

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

This product should not be used in patients with known dermal photosensitivity or those undergoing phototherapy or any photodiagnostic procedures.

This product should not be taken concomitantly 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, propofo

sevoflurane,

midazolam

, 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 electiv 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

Do not take with this product

failure

Antibacterials

Erythromycin

Clarithromycin

telithromycin

Reduced blood levels with

risk of therapeutic failure

Do not take with this product

Anticoagulants (blood thinning medicines)

Warfarin,

acenocoumarol

Reduced anticoagulan effect

and need for increase dose

Do not take with this product

Antidepressants

Tricyclics eg Amitiptyline Clomipramine

MAOIs eg

Moclobemide

SSRIs eg

Citalopram, escitalopram Fluoxetin Fluvoxamine Paroxetin, sertrali

Others eg

Duloxetin

Venlafaxine

Increased serotonergic effect with increased incidence of adverse reactions

s Do not take with this product

Co-administered

drug

Interaction

Recommendations

concerning

co-administration

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, 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 leve with

risk of therapeutic failure

Do not take with th product

Cardiac glycosides

Digoxin

Reduced blood leve and loss

of control of heart

Do not take with th product

rhythms or heart failure

CNS Stimulants

Methyl phenidate

Reduced blood leve and loss

of control of heart rhythms or heart failure

Do not take with th product

Cytotoxics

Irinotecan, dasatinib, erlotinib, imatinib, Sorafenib, sunitinib,

Etoposide, mitotane

Reduced blood leve with

risk of therapeutic failure

Do not take with th product

Hormonal contraceptives

Oral contraceptives

Emergency hormonal contraception

Hormonal implants injections

Transdermal patches creams etc.

Intra-uterine devices with hormones

Reduced blood leve with

risk of unintended pregnancy and breakthrough bleeding.

Do not take with th product

Hormone Replacement Therapy

Oral

Trandermal patches, Gels Vaginal rings

Reduced blood leve with

risk of therapeutic failure

Do not take with th product

Hormone antagonists

Exemestane

Reduced blood leve with riskof therapeutic failure

Do not take with th product

Diuretics

eplerenone

Reduced blood leve with

risk of therapeutic failure

Do not take with th 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 thi product

Immunosuppressants

Cyclosporine

tacrolimus

Reduced blood levels wit risk of therapeutic failure

Do not take with thi product

Lipid regulating drugs

Simvastatin

atorvastatin

Reduced blood levels wit] risk of transplant rejectioi

Do not take with thi product

Lithium

Reduced blood levels wit] risk of therapeutic failure

Do not take with thi product

Proton pump inhibitors

Lansoprazole,

omeprazole

Reduced blood levels wit] risk of therapeutic failure

Do not take with thi product

Theophylline

Reduced blood levels and loss of control of asthma < chronic airflow limitation

Do not take with thi product

Thyroid hormones

throxine

Reduced blood levels wit] risk of therapeutic failure

Do not take with thi product

Oral hypoglycaemic drugs

gliclazide

Reduced blood levels wit risk of therapeutic failure

Do not take with thi product

4.6 Pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

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

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

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

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC amended. Studies on acute toxicity and repeated dose toxicity did not show 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 quercetin and are irrelevant to human safety No signs of mutagenicity have been detected in further in vitro and in vivo test systems.

Tests on reproductive toxicity revealed equivocal results.

Test on the carcinogenic potential have not been performed.

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

Dark amber PET bottles - Three years

Green Polyethylene terephthalate (PET) bottles - Three 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

NBTY Europe 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

09/11/2010

10 DATE OF REVISION OF THE TEXT

10/01/2013