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HYPERICON COATED TABLETS

Active substance(s): ST JOHNS WORT EXTRACT

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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
Please read this leaflet carefully before you start taking these coated tablets.




Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or qualified healthcare
practitioner.
You must contact a doctor or a qualified healthcare practitioner if your symptoms worsen, if they do not improve after 6
weeks, if any of the side effects gets serious, or if you notice any side effects not listed in this leaflet.

In this leaflet:

While you are taking this product:

1. What Hypericon is and what it is used for



avoid excessive sunbathing or the use of sunbeds or solariums.



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

2. Before you take Hypericon
3. How to take Hypericon
4. Possible side effects
5. How to store Hypericon

Taking other medicines

6. Further information

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:

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).

All hormonal contraceptives – The birth control 'Pill', emergency
contraception, hormonal implants, creams, patches, intra-uterine
devices with hormones

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.

All medicines for depression/anxiety – Amitriptyline, clomipramine, moclobemide, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine

2. BEFORE YOU TAKE HYPERICON

All hormonal replacement therapy (HRT) treatments – HRT
tablets, patches, gels, vaginal rings
All medicines for thinning the blood (anticoagulants) – Warfarin,
acenocoumarol

Do not take this product







if you are under 18 years of age.



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.

if you are allergic to any of the ingredients (see section 6).
if you are pregnant or breast-feeding.

All immunosupressant medicines – Ciclosporin, tacrolimus

if you are suffering from depression (see below).
if your skin is exceptionally sensitive to sunlight (photosensitive).

All medcines for HIV infections – Amprenavir, atazanavir, darunavir, 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, amiodarone

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).

Mock-up of the package leaflet

All medicines for epilepsy – Carbamazepine, phenobarbitone,
phenytoin, primidone, sodium valproate

Some medicines for migraine – Almotriptan, eletriptan, frovatriptan, 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 (anaesthetics/pre-operative medicines)



tramadol (an analgesic)

0004 (19/01/2011)

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St. John's wort coated tablets (Hypericon)

SWISS CAPS GMBH











erythromycin, clarithromycin and telithromycin (antibiotics)







exemestane (a hormone antagonist)

itraconazole and voriconazole (antifungals)
artemether and lumefantrine (antimalarials)

THR 18397/0006

If any of the side effects become serious or if you notice
any other side effects not mentioned above, consult your
doctor or pharmacist.'
You can help to make medicines safer by reporting any sideeffects 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 Freephone 0808 100 3352
(available 10am - 2pm Monday - Friday).

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)

5. HOW TO STORE HYPERICON
Keep out of the reach and sight children.

lansoprazole and omeprazole (proton pump inhibitors)

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.

theophylline (a bronchodilator)

Do not store above 30°C.

eplerenone (a diuretic)

gliclazide (an antidiabetic medicine)

Store in the original packaging.

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.

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

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.

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)

Adults and the elderly
Hypericon also contains the following ingredients

Take 1 tablet daily.
Swallow the tablet whole with a little liquid. Do not chew the
tablets.

Herbal preparation
Maltodextrin, precipitated silicon dioxide

Do not exceed the stated dose.

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

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.

Coated tablet shell
Shellac, Povidone, Glycerol diacetate alkanoate (C16-C18), 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

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.

Swiss Caps GmbH,
Grassingerstraße 9, D-83043 Bad Aibling, Germany
Traditional herbal registration number: 18397/0006
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.

Mock-up of the package leaflet

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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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