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NATURES BEST ST JOHNS WORT TABLETS

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT



2

Lamberts St John s Wort Tablets
Nature s Best St John s Wort Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 370 mg of extract (as dry extract) from St John s
Wort aerial parts (Hypericum perforatum L.) (5-7:1) (equivalent to 1850mg
2590mg of St John s Wort.)
Extraction solvent: Ethanol 60% V/V
For full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Film-coated tablets
Clear Coated Brown Speckled Oval Shaped Tablet.

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: The recommended dosage is 1 tablet daily.
The tablet should be swallowed whole with a little water or other liquid. The
tablets should not be chewed.
This product is not recommended for children or adolescents under 18 years of
age (See Section 4.4. Special Warnings and precautions for use)

If symptoms worsen during the use of the product or persist for more than 6
weeks, a doctor or a qualified healthcare practitioner should be consulted.

4.3

Contraindications
Hypersensitivity to the active substance or any of the excipients.
Patients with known dermal photosensitivity or patients undergoing phototherapy
or other 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,
CYP2C19 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 stated dose.
If the condition worsens during the use of the product or if symptoms persist for
more than 6 weeks, consult a doctor or qualified healthcare practitioner.
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 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 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 sunbeds 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).

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, CYP2C9, CYP2C19 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-glycopprotein (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

Anaesthetics/pre-operative medicines
Fentanyl,
Reduced blood
propofol,
levels with risk of
sevoflurane,
therapeutic failure.
midazolam

Analgesics
Tramadol

Antianginals
Ivabradine

Anti-arrhythmics
Amiodarone

Recommendations concerning coadministration

Based on the
elimination half-lives
of hypericin and
hyperforin this
product should be
discontinued at least
10 days prior to
elective surgery.

Reduced blood
levels with risk of
therapeutic failure.

Do not take with this
product.

Reduced blood
levels with risk of
therapeutic failure.

Do not take with this
product.

Reduced blood

Do not take with this

levels with risk of
therapeutic failure.
Antibacterials
Erythromycin,
clarithromycin
telithromycin
Anticoagulants
Warfarin,
acenocoumarol

Antidepressants
Tricyclics eg.
amitriptyline,
clomipramine
MAOIs eg.
moclobemide
SSRIs eg.
citalopram,
escitalopram,
fluoxetine,
fluvoxamine,
paroxetine,
sertraline
Others eg.
duloxetine,
venlafaxine
Antiepileptics
All drugs in
this class
including:
carbamazepine
phenobarbitone
phenytoin
primidone
sodium valproate
Antifungals
Itraconazole,
voriconazole

Antimalarials
Artemether,
lumefantrine

product.

Reduced blood
levels with risk of
therapeutic failure.

Do not take with this
product.

Reduced
anticoagulant
effect and need for
increased dose.

Do not take with this
product.

Increased
serotonergic effects
with increased
incidence of adverse
reactions.

Do not take with
this product.

Reduced blood levels
with increased risk of
frequency and
severity of seizures.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure

Do not take with
this product.

Anti-parkinsons
Rasagiline

Antipsychotics
Aripiprazole

Antivirals
HIV protease
inhibitors:
amprenavir,
atazanavir,
darunavir,
fosamprenavir,
indinavir,
lopinavir,
nelfinavir,
ritonavir,
saquinavir,
tipranavir
HIV nonnucleoside
reverse
transcriptase
inhibitors:
efavirenz,
nevirapine,
delavirdine
Anxiolytics
Buspirone

Aprepitant

Barbiturates
Butobarbital,
phenobarbital

Calcium channel blockers

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Reduced blood levels
with possible loss of HIV
suppression.

Do not take with
this product.

Increased
serotonergic effects
with increased
incidence of adverse
reactions.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.
Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Amlodipine,
nifedipine,
verapamil,
felodipine

Cardiac glycosides
Digoxin

CNS Stimulants
Methyl
phenidate

Cytotoxics
Irinotecan,
dasatinib,
erlotinib,
imatinib,
sorafenib,
sunitinib,
etoposide,
mitotane

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Reduced blood levels
and loss of control of
heart rhythm or heart
failure.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Hormonal contraceptives
Oral
Reduced blood levels
contraceptives
with risk of
Emergency
unintended pregnancy
Hormonal
and breakthrough
Contraception
bleeding.
Hormonal
implants,
injections
Transdermal
patches,
creams etc.
Intra-uterine devices
with hormones
Hormone Replacement Therapy
Hormone
Reduced blood levels
Replacement
with risk of
Therapy:
therapeutic failure.
Oral Transdermal
patches, gels, Vaginal

Do not take with
this product.

Do not take with
this product.

rings

Hormone antagonists
Exemestane

Diuretics
Eplerenone

5HT agonists
Almotriptan,
eletriptan,
frovatriptan,
naratriptan,
rizatriptan,
sumatriptan
and
zolmitriptan

Immunosuppressants
Ciclosporin,
tacrolimus

Lipid regulating drugs
Simvastatin,
atorvastatin

Lithium

Proton pump inhibitors
Lansoprazole,
omeprazole

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Increased
serotonergic effects
with increased
incidence of adverse
reactions.

Do not take with
this product.

Reduced blood levels
with risk of transplant
rejection.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Reduced blood levels
with risk of
therapeutic failure.

Do not take with
this product.

Theophylline

Thyroid hormones
Thyroxine

Reduced blood levels
and loss of control of
asthma or chronic
airflow limitation.

Do not take with
this product.

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

Pregnancy and lactation
Safety of the product during pregnancy and lactation has not been established. In
the absence of sufficient data the use in pregnancy and lactation is not
recommended.

4.7

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

4.8

Undesirable effects
Gastrointestinal disorders including dyspepsia, anorexia, nausea, diarrhoea or
constipation; allergic skin reactions such as rash, urticaria, pruritis; fatigue and
restlessness have been reported. 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 healthcare practitioner should be consulted.

4.9

Overdose
No case of overdose has been reported.
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.
When 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
The active constituents of St. John s wort have not been definitively
established.
However, hypericin, pseudohypericin, hyperforin and the flavonoids are
considered to play a role in its activity.

5.2

Pharmacokinetic properties
The active ingredients of St John s wort can interact with other medicinal
agents in two ways. Firstly, active ingredients in St John s wort that
themselves are metabolised in the liver by the CYP3A4 isoenzyme, increase
(induce) the activity of this enzyme so that it accelerates the elimination of
other medicinal agents which are degraded by the same pathway. This leads to
a consequent reduction in the plasma concentration and effectiveness of these
other substances. Secondly, the active ingredients in St John s wort, like other
type SRI or SSRI medicinal agents with an antidepressant action, can raise the
concentration of serotonin in certain parts of the central nervous system so that
this neurotransmitter can sometimes reach toxic levels, particularly when
drugs containing St John s wort are combined with other antidepressants.

5.3

Preclinical safety data
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 muagenicity
could be detected in further in-vitro and in-vivo test systems.
Tests on reproductive toxicity revealed equivocal results.
Tests on carcinogenic potential have not been performed.
Phototoxicity:
After oral application of dosages of 1800mg of an extract per day for 15 days the
skin sensitivity against UVA was increased, and the minimum dose for
pigmentations was significantly reduced. In the recommended dosage, no signs of
phototoxicity are reported.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Excipients in the extract
Maltodextrin
Silica colloidal anhydrous

Tablet Core
Maltodextrin
Microcrystalline cellulose
Croscarmellose Sodium
Stearic Acid
Magnesium Stearate
Silica Colloidal Anhydrous
Tablet Coating
Hypromellose
Glycerol

6.2

Incompatibilities
Not applicable

6.3

Shelf life
2 years

6.4

Special precautions for storage
Do not store above 25 C. Store in the original package.

6.5

Nature and contents of container
Tablets are packed into PVC/PVDC aluminium foil blister strips of 15 tablets in
the following pack size; 30, 60, 90 Tablets and packed into a Carton.
Not all pack sizes may be marketed

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Lamberts Healthcare Limited
1, Lamberts Road,
Tunbridge Wells
Kent
TN2 3EH

8

MARKETING AUTHORISATION NUMBER(S)
THR 34425/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/03/2011

10

DATE OF REVISION OF THE TEXT
17/03/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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