Holland & Barrett St. Johns Wort Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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