Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing St johns wort may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
CARE ST JOHN'S WORT TABLETS Adults and the elderly: Take 2 tablets once a day. The tablets should be swallowed whole with a little water or other liquid. The tablets should not be chewed. Do not take more than the label tells you to. See your doctor or qualified healthcare practitioner if symptoms worsen, or persist for more than 6 weeks. Not suitable for children or adolescents under the age of 18 years. If you take more of this product than you should Speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you. If you forget to take this product Continue to take your usual dose at the usual time, it does not matter if you have missed a dose. If you are unsure about anything or have any questions about this product, consult your doctor, pharmacist or qualified healthcare practitioner.
Like all medicines, this product can cause side effects, although not everybody gets them. The following side effects have been reported:
THIS PRODUCT Do not store above 25°C. Store in the original package in order to protect from light and moisture. Keep out of the sight and reach of children. Do not use this product after the expiry date which is stated on the base of the bottle after EXP. The expiry date refers to the last day of that month. MHRA Header Boxshould not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of Medicines medicines no longer required. These measures will help protect the environment. Point Sizes Used Colours Used Fonts Used Care St John's Wort Low Mood Relief Min Max 6. CONTENTS OF THE PACK AND OTHER INFORMATION Product Title Tablets Helvetica LT Std 9pt 9pt Process Black What Care St John's Wort Tablets contain
3. How to take Care St John's Wort Tablets 1. WHAT CARE ST JOHN'S WORT TABLETS ARE AND WHAT THEY ARE USED FOR Care St. John's Wort Low Mood Relief Tablets are a traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety, based on traditional use only. Each film coated tablet contains 300mg of extract (as dry extract) from St. John's Wort aerial parts (Hypericum perforatum L.) (5-7:1) (equivalent to 1500-2100mg of St. John's Wort herb). Extraction solvent: Ethanol 60% v/v. 2. BEFORE YOU TAKE CARE ST JOHN'S WORT TABLETS Do not take this product:
Process Black
Point Sizes Used Min Max
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
9pt
Care St John's Wort Low Mood Relief Tablets St John's Wort extract 300mg
PCP Header Box Operator
Approved by Date
GKE
Artwork No. 901442 CRN
13872 (Ref 13871 60's)
Suffix
Reason for Change
New product introduction
C
Issued by Date MHRA/IMB submission required
Yes
9pt 9pt Helvetica LT Std 60's/120's
20214001
160 x 256mm
10
Pack Size
IG Code
Dimensions
Proof No.
Date
31.10.2017 Leaflet Component
Process Black
Point Sizes Used Min Max Fonts Used Colours Used
Care St John's Wort Low Mood Relief Tablets Product Title
MHRA Header Box
St John's Wort may also affect the following medicines. Therefore do not take Care St John's Wort Low Mood Relief Tablets with these medicines unless a doctor has said it is safe to do so:
Care St John's Wort Low Mood Relief Tablets comes as tablet. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Care St John's Wort Low Mood Relief Tablets is st johns wort.
Medicines with the same active substance, strength and form include: Boots Max Strength St John's Wort Mood Lift Tablets, Boots St John's Wort Mood Lift Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Care St John's Wort Low Mood Relief Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
A traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety, based on traditional use only.
For oral short term use only.
For adults and the elderly, take 2 tablets once daily. The tablets should be swallowed whole with a little liquid. The tablets should not be chewed
This product is not recommended for use in children or adolescents under 18 years (See section 4.4 'Special warnings and precautions for use')
A doctor or qualified healthcare practitioner should be consulted if symptoms worsen or do not improve after 6 weeks.
Hypersensitivity to the active ingredient or any of the excipients.
Patients with known dermal photosensitivity or patients undergoing phototherapy or any photodiagnostic procedures.
Concomitant use with ciclosporin, tacrolimus for systemic use, amprenavir, indinavir and other protease inhibitors, irinotecan and warfarin (see section 4.5 'Interactions with other medicinal products and other forms of interaction'). This is because St John's Wort (Hypericum perforatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 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.
Do not exceed the stated dose.
If the condition worsens, or if symptoms persist for more than six weeks medical advice should be sought.
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 relief of symptoms of slightly low mood and mild anxiety. Patients with signs and symptoms of depression should seek medical advice 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 sun-beds 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).
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 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 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 SSRI antidepressants, and the triptan group of medicines used to treat migraines. Due to 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 the table below.
Co-administered drug
Interaction
Recommendations concerning co-administration.
Anaesthetics / pre-operative medicines
Fentanyl,
Propofol
Sevoflurane
Midazolam
Reduced blood levels with risk of therapeutic failure
Based on the elimination half lives of hypericin and hyperforin, this product should be discontinued at least 10 days 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.
Anti-arrhythmics
Amiodarone
Reduced blood levels with risk of therapeutic failure
Do not take with this product.
Antibacterials
Erythromycin
Clarithromycin
Telithromycin
Reduced blood levels with risk of therapeutic failure
Do not take with this product.
Anticoagulants
Warfarin
Acenocoumarol
Reduced anticoagulant effect and need for increased dose.
Do not take with this product.
Antidepressants
Tricyclics eg
Amitryptyline
Clomipramine
MAOI's eg
Moclobemide
SSRI's eg
Citalopram
Escitalopram
Fluoxetine
Fluvoxamine
Paroxetine
Sertraline
Others eg
Duloxetine
Venlaflaxine
Increased serotonergic effects with increased incidence of adverse reactions.
Do not take with this product.
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 of HIV suppression.
Do not take with this product.
HIV non-nucleoside reverse transcriptase inhibitors: Efavirenz, Nevirapine, Delavirdine
Reduced blood levels with possible loss of 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.
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 rhythm or heart failure.
Do not take with this product.
CNS Stimulants
Methyl phenidate
Reduced blood levels with risk of therapeutic 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 and breakthrough bleeding.
Do not take with this product.
Hormone Replacement Therapy
Hormone Replacement Therapy:
Oral
Transdermal 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 of therapeutic failure
Do not take with this product.
Diuretics
Eplerenone
Reduced blood levels with risk of therapeutic failure
Do not take with this product.
5HT agonists
Almotriptan, Eletriptan, Frovatriptan, Naratriptan, Rizatriptan, Sumatriptan, and Zolmitriptan
Increased serotonergic effects with increased risk of adverse reactions
Do not take with this product.
Immunosuppressants
Ciclosporin,
Tacrolimus
Reduced blood levels with risk of transplant rejection
Do not take with this product.
Lipid regulating drugs
Simvastatin
Atovastatin
Reduced blood levels with risk of therapeutic failure
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
Thyroxine
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.
Safety of the product 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.
No studies on the ability to drive and use machines have been performed.
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 or qualified healthcare practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance 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 or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.
Symptomatic and supportive measures should be taken as appropriate.
After intake or 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. After ingestion of massive overdoses, the patient should be protected from sunlight and other UV-light sources for 1 -2 weeks. Outdoor activities should be restricted and clothes and/or sun block preparations used to protect the skin from sunlight.
Ask anything about Care St John’s Wort Low Mood Relief Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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