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PATIENT INFORMATION LEAFLET

Food Supplement Company Herbal Mood Relief tablets

St John’s Wort extract 334 mg

What is in this leaflet?

1.    What Food Supplement Company Herbal Mood Relief is and what it is used for

2.    Before you take Food Supplement Company Herbal Mood Relief

3.    How to take Food Supplement Company Herbal Mood Relief

4.    Possible Side Effects

5.    How to store Food Supplement Company Herbal Mood Relief

6.    Further Information

1. What Food Supplement Company Herbal Mood Relief is and what it is used for

What Food Supplement Company Herbal Mood Relief is

This product is a traditional herbal medicinal product containing St John’s Wort extract. Each film-coated tablet contains 334 mg of extract (as dry extract ) from St John’s Wort aerial parts {Hypericum, perforatum. L. ) (5-7:1) (equivalent to 1670mg -2338mg of St John’s Wort). Extraction solvent: Ethanol 60% v/v.

What Food Supplement Company Herbal Mood Relief is used for

Food Supplement Company Herbal Mood Relief is a traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety. This is based on traditional use only.

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, thoughts of self harm or suicide. 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 before taking this product.

2. Before you take Food Supplement Company Herbal Mood Relief

/ Do not take this product if:

•    Your skin is exceptionally sensitive to sunlight (photosensitive)

•    You are having light treatment (phototherapy) for any condition

•    You are suffering from depression (see above)

•    You are pregnant or breastfeeding 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 A Driving and operating machinery

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

Taking 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 without a prescription.

Therefore it is important that you do not take St John’s Wort if you are using any of the medicines in the following list. All hormonal contraceptives: The birth control ‘Pill’, emergency contraception, hormonal implants, creams, patches, intra-uterine devices with hormones.

All medicines for depression/anxiety: 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: Ciclosporin, 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, zolmittiptan 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 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 )

3. Howto take Food Supplement Company Herbal Mood Relief

Adults and the elderly

Take 1 or 2 tablets a day. 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 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 your condition worsens or if symptoms persist for more than 6 weeks after taking this product or if side effects become serious or if side effects not mentioned in the patient information leaflet occur, consult a doctor or a qualified healthcare practitioner. If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4. Possible Side Effects

Like all medicines, this product can have side effects. The following side effects have been reported:

-    gastrointestinal disorders such as indigestion, loss of appetite, nausea, diarrhoea, constipation: fatigue and restlessness.

-    allergic skin reactions such as rash, hives or itching of the skin. If you experience allergic skin reactions, stop taking the product and consult your doctor.

Also sunburn-like reactions on skin exposed to strong sunlight or strong ultraviolet (UV) irradiation e.g. solarium have been reported, particularly in fair skinned individuals. Other side effects that have been reported include headaches, nerve pain or tingling, anxiety, dizziness and mania.

If any of the above side effects become serious or if other side effects not mentioned above occur, a doctor or pharmacist should be consulted.

5. Howto store Food Supplement Company Herbal Mood Relief

x Do not use your tablets after the expiry date. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment. The expiry date is printed on the box and the blister pack. The expiry date refers to the last day of that month.

/ Do not store above 25°C. Store in the original packaging.

! 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.

6. Further Information

Each film-coated tablet contains 334 mg of extract (as dry extract) from St John’s Wort aerial parts (Hypericumperforatum L.) (5-7:1) (equivalent to 1670mg - 2338mg of St John’s Wort). Extraction solvent: Ethanol 60% v/v.

This product also contains the following ingredients:

Tablet core: Dicalcium Phosphate, Microcrystalline Cellulose, Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, Stearic Acid

Tablet coating: Hypromellose, Iron Oxide Yellow (El72), Titanium Dioxide (E171), Purified Talc.

What these tablets look like

Food Supplement Company Herbal Mood Relief tablets are pale yellow oval biconvex film coated tablets. This product is available in 30, 60, 90 pack sizes. Not all pack sizes may be marketed.

Traditional Herbal Registration Number: THR 02231/0002 Registration holder for this product:

The Herbal Research Company Limited, 27 Old Gloucester Street, London WC1N 3XX

Manufacturer of this product: Honeywood Ltd Edmonds Close, Denington Industrial Estate, Wellingborough, Northants, NN8 2QY If you would like further information about this product please contact:

FSC Food Supplement Company, Lancaster Road, Carnaby, Bridlington, East Yorkshire Y015 3QY.

Email: info@beehealth.com Tel. +44(0)1262 607890 and Fax. +44(0)1262 424012

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.yellowcard.gov.uk. Alternatively you can get a paper yellow card form from your GP’s surgery or pharmacy, or call free phone 0808 100 3352 (available 10am - 2pm Monday to Friday).

For a large print, Braille or audio version of this leaflet call 01262 607890 This leaflet was last revised in September 2010.