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Relieves symptoms of low mood and anxiety

image descriptionKarmaMood Maximum Strength St John’s Wort Tablets

St John’s Wort extract 425mg

(equivalent to 1490-2550mg of St John’s Wort)

30 tablets and 60 tablets

Traditionally used for:

  • Low mood
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A traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety, exclusively based upon long-standing use as a traditional remedy. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal active
St John’s Wort (Hypericum perforatum L.)
Strength
425mg of dried aerial parts extract (equivalent to 1490-2550mg of St John’s Wort)
Dose
One tablet daily

A licensed herbal medicine means a safe, high quality product

KarmaMood Maximum Strength St John’s Wort Tablets have been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:

  • KarmaMood is a regulated herbal product and meets specific standards of safety and quality
  • KarmaMood is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines

The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer you reassurance about these products. KarmaMood’s registration under the THRS scheme provides you with the reassurance that it has been assessed by the MHRA and meets the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that KarmaMood has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

Each pharmaceutical grade coated tablet is foiled blister packed to retain its freshness and maintain its potency.

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products. Please click Trust Schwabe to see why we’re the leaders in traditional herbal medicine, worldwide.

KarmaMood Maximum Strength contains St John’s Wort, a wild flowering herb with distinctive yellow blooms. The petals and leaves of the plant contain a number of unique substances such as hypericin and hyperforin.

Also available from…

Boots, Holland & Barrett, Superdrug, Ocado and other leading independent pharmacies and health food stores nationwide.

As seen on TV!

About St John's Wort

St John’s Wort, a wild flowering herb, has been used by herbalists for centuries.

Visit herbfacts.co.uk

About low mood

All of us have the odd “off” day from time to time, but some find a low mood hard to shake – but natural remedies can often help.

Karma Guide

Download your FREE ‘Beat The Blues’ guide.

Feeling Blue?

Useful advice for coping with depression and low mood. Visit Feeling-blue.co.uk

Take a health check

Check your mood using this simple questionnaire and get some useful tips on what might help.

What this product is and what is it used for

This product is a traditional herbal medicinal product containing St John’s Wort. Each coated tablet of this product contains 425mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 1490-2550mg of St John’s Wort). Extraction solvent: Ethanol 60%v|v.

KarmaMood Maximum Strength St John’s Wort is a traditional herbal medicinal product used for the relief of slightly low mood and mild anxiety. This usage is based on traditional use only.

Before you take this product

DO NOT TAKE this product if:

  • you are under 18 years of age
  • you are pregnant or breastfeeding
  • you are allergic to any of the ingredients (listed in further information below)
  • your skin is exceptionally sensitive to sunlight (photosensitive)
  • you are having light treatment (phototherapy) for any condition
  • you are suffering from depression (see below)

Suffering from depression?

Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily activities, appetite or weight changes, sleep changes, loss of energy and difficulty concentrating. If your doctor has told you that you are suffering from depression do not use this product. If you think that you may be suffering from depression you should tell your doctor.

Tell your doctor before using this product if you have an intolerance to some sugars (see further information below).

While you are taking this product:

  • avoid excessive sunbathing or the use of sunbeds/solariums
  • stop using it at least 10 days prior to undergoing any surgery

Driving and operating machinery

In rare cases St John’s Wort may make you feel dizzy or sleepy. If affected do not drive or use machines.

Taking this product with other medicines

St John’s Wort can affect the way some medicines work and reduce their effectiveness. Medicines that can be affected by St John’s Wort include prescription medicines, and those that you may have bought yourself without a prescription.

Therefore it is important that you do not take St John’s Wort if you are using any of the medicines listed in the table below.

DO NOT TAKE THIS PRODUCT IF YOU ARE TAKING ANY OF THE FOLLOWING MEDICINES

  • All hormonal contraceptives
    The birth control ‘Pill’, emergency contraception, hormonal implants, creams, patches, intra-uterine devices with hormones.
  • All medicines for depression
    Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine.
  • All hormonal replacement therapy (HRT) treatments
    HRT tablets, patches, gels, vaginal rings
  • All medicines for thinning the blood (anticoagulants)
    Warfarin, acenocoumarol
  • All medicines for epilepsy
    Carbamazepine, phenobarbitone, phenytoin, primidone, sodium valproate
  • All immunosuppressant medicines
    Cyclosporin, tacrolimus
  • All medicines for HIV infections
    Amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delavirdine
  • Some medicines for cholesterol
    Simvastatin, atorvastatin
  • Some medicines for cancer
    Irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane
  • Some medicines for heart disease
    Digoxin, ivabradine, amiodarone
  • Some medicines for migraines
    Almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
  • Some medicines for high blood pressure
    Amlodipine, nifedipine, felodipine, verapamil
  • A medicine for regulating mood
    Lithium
  • A thyroid hormone
    Thyroxine

St John’s Wort may also affect the following medicines. Therefore do not take this product with these medicines unless a doctor or pharmacist has said it is safe to do so:

  • fentanyl, propofol, sevoflurane, and midazolam (anaesthetics/pre-operative medicines)
  • tramadol (an analgesic)
  • erythromycin, clarithromycin and telithromycin (antibiotics)
  • itraconazole and voriconazole (antifungals)
  • artemether and lumefantrine (antimalarials)
  • rasagiline (an anti-Parkinson’s medicine)
  • aripiprazole (an antipsychotic medicine)
  • buspirone (an anxiolytic)
  • aprepitant (used to treat post-operative vomiting)
  • butobarbital and phenobarbital (barbiturates)
  • methyl phenidate (a central nervous system or CNS stimulant)
  • exemestane (a hormone antagonist)
  • eplerenone (a diuretic)
  • lansoprazole and omeprazole (proton pump inhibitors)
  • theophylline (a bronchodilator).
  • gliclazide (an antidiabetic medicine)

How to take this product

Adults and the elderly

Take 1 tablet daily. Swallow the tablets whole with some water or other liquid. Do not chew the tablets.

Do not exceed the stated dose

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or 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 have any questions, or are unsure about anything, please ask your doctor, pharmacist or healthcare practitioner.

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after six weeks, if any side-effect becomes serious or if side-effects not mentioned occur.

Possible side-effects

Like all medicines, this product can have side-effects. However, side-effects are uncommon with St John’s Wort. These are listed below.

  • digestive upsets such as indigestion, loss of appetite, nausea, diarrhoea, constipation
  • fatigue and restlessness
  • allergic skin reactions such as rash, hives or itching

Stop taking this product immediately if you experience an allergic reaction.

Other side-effects

These include headaches, nerve pain or tingling (neuropathy), anxiety, dizziness, mania. Also sunburn-like reactions in skin exposed to strong ultraviolet (UV) irradiation (e.g. sun, solarium) have been reported, particularly in fair-skinned individuals.

If you notice any other side-effect not mentioned above or any side-effect becomes serious, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side-effects you can help provide more information on the safety of this medicine.

How to store this product

Do not use your tablets after the expiry date. Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

Store the tablets in a cool dry place. Do not store the tablets in a place where the temperature goes above 25°C.

Keep the tablets out of the reach and sight of children.

Keep your tablets in the blister pack until it is time to take them.

Further information

Each coated tablet of this product contains 425mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 1490-2550mg of St John’s Wort). Extraction solvent: Ethanol 60%v|v.

This product also contains the following ingredients:

Tablet core: Maltodextrin, silica colloidal anhydrous, microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate (Type A), magnesium stearate.

Coating: Hypromellose, sucrose, talc, calcium carbonate E170, tragacanth, acacia, liquid glucose (dry substance), titanium dioxide E171, iron oxide hydrate E172 (yellow iron oxide), vanillin, beeswax white, carnauba wax, shellac.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each tablet contains 6mg of glucose and 234mg of sucrose.

Each pack contains 30, 60 or 90 coated tablets.

Registration holder for this product

Schwabe Pharma (UK) Ltd
Alexander House, Mere Park,
Dedmere Road, Marlow, Bucks SL7 1FX

Manufacturer of this product

Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, Germany

Traditional Herbal Registration number: THR 23056/0007

If you would like further information about this product, please contact:

Schwabe Pharma (UK) Ltd,
Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL7 1FX
Telephone:01628 401 980
Email:info@schwabepharma.co.uk

This information was revised in 11/2015.

1 Name of the medicinal product

  • Karmamood Maximum Strength St John’s Wort Tablets
  • Boots Mood Lift Max Strength St John’s Wort Tablets
  • Higher Nature St John’s Wort Mood Uplift Tablets
  • Simply Supplements Mood Boost Max Strength St John’s Wort Tablets
  • Holland & Barrett Moodease St John’s Wort One-a-Day Tablets

2 Qualitative and quantitative composition

Each coated tablet contains: 425 mg of extract (as dry extract) from St John’s wort aerial parts (Hypericum perforatum L.)(3.5-6:1)(equivalent to 1490 – 2550 mg of St John’s wort). Extraction solvent: Ethanol 60% v/v. Excipients: 1 tablet contains 234 mg of sucrose and 6 mg of glucose. For full list of excipients, see section 6.1

3 Pharmaceutical form

Coated tablet. Round, yellow, coated tablets, free from ruptures.

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. For adults and the elderly, take 1 tablet daily. The tablets should be swallowed whole with a little liquid. The tablets should not be chewed. If symptoms worsen, or do not improve after 6 weeks, a doctor or a qualified healthcare practitioner should be consulted. The use in children or adolescents under 18 years is not recommended (See ‘Section 4.4 Special Warnings and Precautions for Use’).

4.3 Contraindications

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 any of 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, CYP2C19, CYP2C9 and CYP3A4 as well as transport protein Pglycoprotein. 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 symptoms worsen, or do not improve after 6 weeks, a doctor or a qualified healthcare practitioner should be consulted. The use in children or adolescents less than 18 years old is not recommended due to lack of adequate data 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 light-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) Each film-coated tablet also contains: 6 mg of glucose and 234 mg of sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

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 concentration is possible. Users of oral contraceptives taking St John’s wort (Hypericum perforatum) may experience intrecyclic 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 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. amitriptyline, clomipramine MAOIs eg. moclobemide SSRIs eg. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, Others eg. duloxetine, venlafaxine 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
Oral Hormone Replacement Therapy, Trandermal 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 incidence of adverse reactions. Do not take with this product.
Immunosuppressants
cyclosporin, tacrolimus Reduced blood levels with risk of transplant rejection. Do not take with this product.
Lipid regulating drugs
simvastatin, atorvastatin 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.

4.6 Fertility, pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Gastrointestinal disorders including dyspepsia, anorexia, nausea, diarrhoea, 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. 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 are 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 hospitalization 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 one week 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

Pharmacotherapeutic group: Herbal medicinal product for the treatment of depressive disorders. ATC code: N06AP01 The active constituents of St John’s wort have not been definitively established. However, the phloroglucinol constituent, hyperforin, and the hypericin group of constituents, are thought to play an important 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

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation. Adequate tests on reproductive toxicity have not been performed. Tests on carcinogenicity have not been performed.

6 Pharmaceutical particulars

6.1 List of excipients

Tablet core:

  • Maltodextrin
  • Silica, colloidal anhydrous
  • Cellulose, microcrystalline
  • Croscarmellose sodium
  • Sodium starch glycolate (Type A)
  • Magnesium stearate

Coating:

  • Hypromellose
  • Sucrose
  • Talc
  • Calcium carbonate E170
  • Tragacanth
  • Acacia
  • Liquid glucose (dry substance)
  • Titanium dioxide E171
  • Iron oxide hydrate E172 (=yellow iron oxide)
  • Vanillin
  • Beeswax white
  • Carnauba wax
  • Shellac

6.2 Incompatibilities

Not applicable

6.3 Shelf life

The shelf life is 3 years

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Original packages contain 30, 60 or 90 Karmamood Maximum Strength St John’s Wort coated tablets. Not all pack sizes may be marketed. Also original packages containing 30 (Boots Max Strength Mood Lift St John’s Wort Tablets, Higher Nature St John’s Wort Mood Uplift Tablets, Simply Supplements Mood Boost Max Strength St John’s Wort Tablets, Holland & Barrett Moodease St John’s Wort One-a-Day tablets) or 90 (Boots Max Strength Mood Lift St John’s Wort Tablets) coated tablets. The coated tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet.

6.6 Special precautions for disposal

No special requirements

7 Registration holder

Schwabe Pharma (UK) Limited Alexander House Mere Park Dedmere Road Marlow Buckinghamshire SL7 1FX

8 Registration number

THR 23056/0007

9 Date of first registration

20th February 2008

Date of revision/renewal of the text

25th November 2016

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