St. John's wort coated tablets (Hypericon) SWISS CAPS GMBH THR 18397/0006

PACKAGE LEAFLET: INFORMATION FOR THE USER Hypericon coated tablets St John's wort extract 180mg

In this leaflet:

1.    What Hypericon is and what it is used for

2.    Before you take Hypericon

3.    How to take Hypericon

4.    Possible side effects

5.    How to store Hypericon

6.    Further information

1. WHAT HYPERICON IS AND WHAT IT IS USED FOR

This product is a traditional herbal medicinal product containing St John's wort. Each coated tablet of this product contains 180mg extract (as dry extract) from St John's wort (Hypericum perforatum L.) flowering herb (4-6:1). Extraction solvent: Ethanol 60% (m/m).

Hypericon is a traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety. This usage is based on traditional use only.

2. BEFORE YOU TAKE HYPERICON

Do not take this product

•    if you are under 18 years of age.

•    if you are allergic to any of the ingredients (see section 6).

•    if you are pregnant or breast-feeding.

•    if you are suffering from depression (see below).

•    if your skin is exceptionally sensitive to sunlight (photosensitive).

•    if you are having light treatment (phototherapy) or any testing procedures that use light (photodiagnostic procedures).

•    if you are due to have an operation in the next 10 days. Suffering from depression

This product is intended for relief of symptoms of slightly low mood and mild anxiety.

If you think you are suffering from depression and have thoughts of self-harm, suicide or any other symptoms of depression you should see your doctor.

Other symptoms of depression can include feelings of helplessness and hopelessness, lost of interest in daily activities, appetite or weight changes, sleep changes, loss of energy and difficulty concentrating.

Take special care with Hypericon

Tell your doctor before using this product if you have an intolerance to some sugars (see section 6).

While you are taking this product:

•    avoid excessive sunbathing or the use of sunbeds or solari-ums.

•    stop using it at least 10 days prior to undergoing any surgery

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. 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/anxiety - Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine, fluvoxa-mine, 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 immunosupressant medicines - Ciclosporin, tacrolimus

All medcines for HIV infections - Amprenavir, atazanavir, daru-navir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delaviridine

Some medicines for cholesterol - Simvastatin, atorvastatin

Some medicines for cancer - Irinotecan, dastinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane

Some medicines for heart disease - Digoxin, ivabradine, amioda-rone

Some medicines for migraine - Almotriptan, eletriptan, frovatrip-tan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

Some medicines for high blood pressure - Amlodipine, nifedipine, felodipine, verapamil

A medicine for regulating blood - Lithium

A thyroid hormone - Thyroxine

Do not take this product with the following medicines unless a doctor has said it is safe to do so:

•    fentanyl, propofol, sevoflurane and midazolam (anaesthe-tics/pre-operative medicines)

•    tramadol (an analgesic)

•    erythromycin, clarithromycin and telithromycin (antibiotics)

•    itraconazole and voriconazole (antifungals)

•    artemether and lumefantrine (antimalarials)

•    rasagiline (an anti-Parkinsons medicine)

•    aripiprazole (an antipsychotic medicine)

•    buspirone (an anxiolytic)

•    aprepitant (used to teat 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)

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, if you feel dizzy or sleepy, do not drive or use machines.

3. HOW TO TAKE HYPERICON

You should speak to your doctor, pharmacist or qualified healthcare practitioner if you are not sure if this product is suitable for you.

Adults and the elderly

Take 1 tablet daily.

Swallow the tablet whole with a little liquid. Do not chew the tablets.

Do not exceed the stated dose.

You must contact a doctor or qualified healthcare practitioner if

•    your condition worsens or does not improve after six weeks.

•    side effects mentioned in the leaflet become serious or if other side effects occur.

This product is not to be taken by children and adolescents less than 18 years old.

If you take more of Hypericon than you should: Speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forgot to take Hypericon: Continue to take your usual dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Hypericon can cause side effects, although not everybody gets them.

•    Gastrointestinal disorders (e.g. indigestion, loss of apetite, nausea, diarrhoea and constipation)

•    Fatigue and restlessness

•    Allergic skin reactions (e.g. rash, hives or itching of the skin). If you experience allergic skin reactions, stop taking this product and consult your doctor.

Also sunburn-like reactions on skin exposed to strong sunlight or strong ultra-violet (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 side effects become serious or if you notice any other side effects not mentioned above, consult your doctor or pharmacist.'

5.    HOW TO STORE HYPERICON

Keep out of the reach and sight children.

Do not use Hypericon after the expiry date which is stated on the box and the blister. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original packaging.

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 to protect the environment.

6.    FURTHER INFORMATION What Hypericon contains

Each coated tablet contains 180 mg extract (as dry extract) from St John's wort (Hypericum perforatum L.) flowering herb (4-6:1). Extraction solvent: Ethanol 60% (m/m)

Hypericon also contains the following ingredients

Herbal preparation

Maltodextrin, precipitated silicon dioxide Tablet core

Crospovidone, croscarmellose sodium, maize starch, calcium hydrogen phosphate dihydrate, calcium stearate, precipitated silicon dioxide

Coated tablet shell

Shellac, Povidone, Glycerol diacetate alkanoate (Ci₆-Ci₈), Talc, Sucrose, Spray-dried acacia, Titanium dioxide E171, Calcium carbonate, Heavy kaolin, Macrogol 6000,

Quinoline yellow E104, Indigotine E132

What Hypericon looks like and contents of the pack

The coated tablet is round, light green-coloured.

Each pack contains 30, 50, 60 or 100 coated tablets. Not all pack sizes my be marketed.

Traditional herbal registration holder and manufacturer

Swiss Caps GmbH,

GrassingerstraBe 9, D-83043 Bad Aibling, Germany Traditional herbal registration number: 18397/0006    ¹    i)'¹'

For any information about this medicinal product, please contact the local representative of the Traditional Herbal Registration Holder:

Swiss Caps UK Ltd.

Suite 1 Old Coach House Robin Hoods Well Skelbrooke

Doncaster DN6 8LS - UK Tel.: 44 (0) 1302 33 82 20 Fax: 44 (0) 1302 33 82 21

This leaflet was last approved in January 2011.

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