TESCO ST JOHNS WORT TABLETS

Active substance: HYPERICUM DRY EXTRACT 3.5-6:1

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Moodease PIL (2011)

8/1/11

12:44

Page 1

2: Before you take this product

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

Patient Information Leaflet

Moodease

DO NOT TAKE this product if:
G
you are under 18 years of age
G
you are pregnant or breastfeeding
G
you are allergic to any of the ingredients (listed in section 6)
G
you are lactose intolerant (react badly to lactose or milk)
G
your skin is exceptionally sensitive to sunlight (photosensitive)
G
you are having light treatment (phototherapy) for any condition
G
you are suffering from depression (see below)



St John’s Wort

film-coated tablets
Extract 250mg

Please read this leaflet carefully before you start taking these tablets.
It contains some important information about Moodease™ St John’s Wort.
Keep this leaflet with the tablets.
You may want to read it again or show it to your doctor, pharmacist or qualified
healthcare practitioner.

What is in this leaflet
1: What this product is and what it is used for ........................................page 1
2: Before you take this product ............................................................page 2-4
3: How to take this product ......................................................................page 4
4: Possible side-effects ............................................................................page 5
5: How to store this product ....................................................................page 5
6: Further information ..............................................................................page 6

1: What this product is and what it is used for
This product is a traditional herbal medicinal product containing St John’s Wort. Each filmcoated tablet of this product contains 250mg of extract (as dry extract) from St John’s Wort
aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 875-1500mg of St John’s
Wort). Extraction solvent: Ethanol 60% v/v.
Moodease™ 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.

1

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

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.

Some medicines for cancer

Irinotecan, dasatinib, erlotinib, imatinib,
sorafenib, sunitinib, etoposide, mitotane

Some medicines for heart disease

Digoxin, ivabradine, amiodarone

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.

Some medicines for migraines

Almotriptan, eletriptan, frovatriptan,
naratriptan, rizatriptan, sumatriptan,
zolmitriptan

Some medicines for high blood
pressure

Amlodipine, nifedipine, felodipine, verapamil

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 opposite.

A medicine for regulating mood

Lithium

A thyroid hormone

Thyroxine

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 section 6).
While you are taking this product:
G
avoid excessive sunbathing or the use of sunbeds/solariums
G
stop using it at least 10 days prior to undergoing any surgery

2

3

Moodease PIL (2011)

8/1/11

12:44

Page 2

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

4: Possible side-effects

6: Further information

Like all medicines, this product can have side-effects, although the frequency is not
known. These side-effects are listed below.
G

Each film-coated tablet of this product contains 250mg of extract (as dry extract) from
St John’s Wort aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 8751500mg of St John’s Wort). Extraction solvent: Ethanol 60% v/v.

digestive upsets such as
indigestion, loss of appetite,
nausea, diarrhoea, constipation

G

fatigue and restlessness

G

allergic skin reactions
such as rash, hives or itching

This product also contains the following ingredients:
Extract: Lactose monohydrate, calcium hydrogen phosphate dihydrate, cellulose
powdered, silica colloidal anhydrous.
Tablet core: Cellulose powdered, stearic acid, sodium starch glycolate (type A), silica
colloidal anhydrous, magnesium stearate.

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

Film-coating: Eudragit E 100, hypromellose, Macrogol 6000, talc, titanium dioxide
(E171), iron oxide hydrate (E172) (yellow iron oxide).

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

If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this product.
Each film-coated tablet contains 11mg of lactose monohydrate.

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

Each pack contains 30 film-coated tablets.

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 Freephone 0808 100 3352 (available
10am –2pm Monday – Friday).

3: 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.

Registration holder for this product
Schwabe Pharma (UK) Ltd, Alexander House, Mere Park, Dedmere Road, Marlow, Bucks,
SL7 1PD
Manufacturer of this product
Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, Germany

After taking this product
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 in this leaflet occur.

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 you have any questions, or are unsure about anything, please ask your doctor,
pharmacist or qualified healthcare practitioner.

Certification Mark. Traditional Herbal Registration number: THR 23056/0011
If you would like further information about this product, please contact:
Goldshield Limited (Reg No: 3561477)
No.1 Croydon (NLA Tower), 12-16 Addiscombe Road, Croydon CR0 0XT

5: 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.

Telephone: 080 8168 0712. Email: info@goldshield.co.uk
This leaflet was prepared in January 2011

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

4

5

6

Moodease PIL (2011) tracked

8/1/11

12:46

Page 1

Delete: Section 7
Insert: Section 6

Delete: After taking this product
Insert: How to take this product

2: Before you take this product

Moodease
St John’s Wort

film-coated tablets
Extract 250mg

DO NOT TAKE this product if:
G
you are under 18 years of age
G
you are pregnant or breastfeeding
G
you are allergic to any of the ingredients (listed in section 6)
G
you are lactose intolerant (react badly to lactose or milk)
G
your skin is exceptionally sensitive to sunlight (photosensitive)
G
you are having light treatment (phototherapy) for any condition
G
you are suffering from depression (see below)

Insert:
qualified

Please read this leaflet carefully before you start taking these tablets.
It contains some important information about Moodease™ St John’s Wort.
Keep this leaflet with the tablets.
You may want to read it again or show it to your doctor, pharmacist or qualified
healthcare practitioner.

What is in this leaflet
1: What this product is and what it is used for ........................................page 1
2: Before you take this product ............................................................page 2-4
3: How to take this product ......................................................................page 4
4: Possible side-effects ............................................................................page 5
5: How to store this product ....................................................................page 5
6: Further information ..............................................................................page 6

1: What this product is and what it is used for
This product is a traditional herbal medicinal product containing St John’s Wort. Each filmcoated tablet of this product contains 250mg of extract (as dry extract) from St John’s Wort
aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 875-1500mg of St John’s
Wort). Extraction solvent: Ethanol 60% v/v.
Moodease™ 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.

Delete: Cyclosporin
Insert: Ciclosporin

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

Patient Information Leaflet



Insert: /anxiety

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

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.

Some medicines for cancer

Irinotecan, dasatinib, erlotinib, imatinib,
sorafenib, sunitinib, etoposide, mitotane

Some medicines for heart disease

Digoxin, ivabradine, amiodarone

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.

Some medicines for migraines

Almotriptan, eletriptan, frovatriptan,
naratriptan, rizatriptan, sumatriptan,
zolmitriptan

Some medicines for high blood
pressure

Amlodipine, nifedipine, felodipine, verapamil

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 opposite.

A medicine for regulating mood

Lithium

A thyroid hormone

Thyroxine

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 section 6).
While you are taking this product:
G
avoid excessive sunbathing or the use of sunbeds/solariums
G
stop using it at least 10 days prior to undergoing any surgery

Insert new sub-heading and
move paragraphs to section 2
1

2

3

Moodease PIL (2011) tracked

8/1/11

Delete: or pharmacist

12:46

Page 2

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

3: 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.

Insert:
qualified

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 you have any questions, or are unsure about anything, please ask your doctor,
pharmacist or qualified healthcare practitioner.
Insert:
qualified

Delete: ............side-effects. However, side-effects are uncommon with St
John’s Wort. These are listed below.

Delete heading:
Uncommon side effects (affecting fewer
than 1 in 100 people

Insert new sub-heading and
move paragraph to section 4

Insert: .........side-effects, although the frequency is not known.
These side-effects are listed below.

4: Possible side-effects

6: Further information

Like all medicines, this product can have side-effects, although the frequency is not
known. These side-effects are listed below.
G

digestive upsets such as
indigestion, loss of appetite,
nausea, diarrhoea, constipation

G

allergic skin reactions
such as rash, hives or itching

Each film-coated tablet of this product contains 250mg of extract (as dry extract) from
St John’s Wort aerial parts (Hypericum perforatum L.) (3.5-6:1) (equivalent to 8751500mg of St John’s Wort). Extraction solvent: Ethanol 60% v/v.
This product also contains the following ingredients:
Extract: Lactose monohydrate, calcium hydrogen phosphate dihydrate, cellulose
powdered, silica colloidal anhydrous.

Insert: and restlessness

fatigue and restlessness

G

Delete paragraph:
If these persist for more than a few days, or become
troublesome, stop taking this product. These side-effects
are often only temporary.

Tablet core: Cellulose powdered, stearic acid, sodium starch glycolate (type A), silica
colloidal anhydrous, magnesium stearate.

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

Other side-effects

Insert: and

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

Film-coating: Eudragit E 100, hypromellose, Macrogol 6000, talc, titanium dioxide
(E171), iron oxide hydrate (E172) (yellow iron oxide).
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this product.
Each film-coated tablet contains 11mg of lactose monohydrate.

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

Each pack contains 30 film-coated tablets.

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 Freephone 0808 100 3352 (available
10am –2pm Monday – Friday).

Registration holder for this product
Schwabe Pharma (UK) Ltd, Alexander House, Mere Park, Dedmere Road, Marlow, Bucks,
SL7 1PD
Manufacturer of this product
Wiewelhove GmbH, Gildestrasse 39, 49477 Ibbenbüren, Germany

After taking this product
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 in this leaflet occur.

Certification Mark. Traditional Herbal Registration number: THR 23056/0011
If you would like further information about this product, please contact:
Goldshield Limited (Reg No: 3561477)
No.1 Croydon (NLA Tower), 12-16 Addiscombe Road, Croydon CR0 0XT

5: 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.

Telephone: 080 8168 0712. Email: info@goldshield.co.uk
This leaflet was prepared in January 2011

Store the tablets in a cool dry place. Do not store the tablets in a place where the
temperature goes above 25oC.
Keep the tablets out of the reach and sight of children.

Delete: May 2010
Insert: January 2011

Keep your tablets in the blister pack until it is time to take them.
4

Insert
if any side-effet becomes serious.

5

6

Expand view ⇕

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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