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Holland & Barrett Moodease St Johns Wort One-A-Day Tablets

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Document: leaflet BOOTS_THR 23056-0007 change

315 mm


Information for the user


Max Strength Mood Lift St John's Wort Tablets 425 mg St John's Wort extract


145 mm    I    I    145 mm


Read all of this leaflet carefully because it contains important information for you.

This medicine is a traditional herbal medicinal product available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

•    You must contact a pharmacist or doctor if your symptoms worsen or do not improve after 6 weeks

What this medicine is for

This traditional herbal medicinal product contains St John's Wort extract which has traditionally been used to relieve the symptoms of slightly low mood and mild anxiety. This medicine is recommended for these conditions based on traditional use only.

Before you take this medicine

This medicine can be taken by adults aged 18 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

XDo not take:

•    If you are under 18 years

•    If you are allergic to any of the ingredients (see “What is in this medicine”)

   If you have been diagnosed with depression or think you may be depressed (see "Other important information")

   If your skin is very sensitive to sunlight

•    If you are having light treatment

   If you are about to have an operation (see "Other important information")

•    If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains glucose and sucrose)

•    If you are pregnant or breastfeeding


Other important information

Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily activities, changes in appetite or weight, changes in sleeping patterns or habits, loss of energy and difficulty in concentrating. If your doctor has told you that you have depression, do not take this medicine. It does not relieve the symptoms of depression. If you think you have depression talk to your doctor before taking this medicine.

If you need to go into hospital for an operation, tell the doctor that you are taking this medicine. Stop taking this medicine at least 10 days before your operation so that it does not affect the anaesthetic or pain medicines that you need.

Avoid excessive sunbathing or the use of sunbeds/solariums while you are taking this medicine.

Driving and using machines: This medicine may cause you to feel dizzy or sleepy. If you are affected do not drive or use machines.

If you take other medicines

You should not take this medicine if you are taking certain medicines (see below).

If you are not sure that your medicine is on this list, or you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor or medicine you have bought for yourself.

XDo not take this medicine if you are taking any of the following medicines:

•    All hormonal contraceptives - the birth control ‘Pill’, emergency contraception (also known as "the morning after pill"), hormonal implant, creams, patches, intra-uterine devices with hormones

•    All medicines for depression/anxiety - amitriptyline, clomipramine, moclobemide, citalopram, fluoxetine, 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


•    AIT medicines for HIv infections - amprenavir, afazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delaviridine

•    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 migraine - 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 medicine at the same time, unless a doctor has said it is safe to do so:

•    Fentanyl, propofol, sevoflurane, midazolam (anaesthetics/pre-operative medicines)

•    Tramadol (an analgesic)

•    Erythromycin, clarithromycin, telithromycin (antibiotics)

•    Itraconazole and voriconazole (antifungals)

•    Artemether and lumefantrine (antimalarials)

•    Rasagiline (for Parkinson’s disease)

•    Aripiprazole (an antipsychotic medicine)

•    Buspirone (an anxiolytic)

•    Aprepitant (used to treat post-operative vomiting)

•    Butobarbital and phenobarbital (barbiturates)

•    Methyl phenidate (a central nervous system stimulant)

•    Exemestane (a hormone antagonist for breast cancer)

•    Eplerenone (a diuretic or water tablet)

•    Lansoprazole and omeprazole (proton pump inhibitors for heartburn)

•    Theophylline (a bronchodilator for breathing problems)

•    Gliclazide (for diabetes)


315 mm


/How to take this medicine

I Check the foil is not broken before use. If it is, do not take that tablet.

Age

How many to take

How often to take

Adults aged 18 years and over

One

Once daily


Swallow the tablet whole with water or liquid. Do not chew the tablet.

Do not give to children or adolescents under 18 years.

Do not take more than the amount recommended above.

If symptoms worsen or do not improve after 6 weeks talk to your doctor.

If you take too many tablets: Talk to a pharmacist or doctor.

Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these side effects, stop taking the tablets. See a doctor:

•Allergic reactions (skin rash, hives, red itchy skin)

These other effects may happen. If they bother you talk to a pharmacist:

•    Stomach problems, e.g. indigestion, loss of appetite, feeling sick (nausea), diarrhoea, constipation

•    Fatigue, restlessness

•    Sunburn-like reactions in skin exposed to strong sunlight or strong ultra-violet (UV) irradiation e.g. solarium, particularly in fair skinned individuals

•    Headaches, nerve pain or tingling, dizziness, mania (raised excitability), anxiety

If any side effect becomes severe, lasts more than a few days, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Reporting 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 help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at _ wyw.mhra.aqv_.uk/yellowcard.


How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the base of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

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). This is equivalent to 1490 - 2550 mg of St John's Wort. The extraction solvent is ethanol 60% v/v.

As well as the active ingredient, the tablets also contain maltodextrin, colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate (type A), magnesium stearate.

The tablet coating contains hypromellose, sucrose, talc, calcium carbonate (E170), tragacanth, acacia, glucose, beeswax white, carnauba wax, shellac, titanium dioxide (E171), yellow iron oxide (E172), vanillin.

The pack contains 30 or 90 coated tablets.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by Wiewelhove GmbH Gildestrasse 39 49477 Ibbenburen Germany. Traditional Herbal Registration held by Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Bucks SL7 1FX

Leaflet prepared December 2015

If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA.


Other formats


To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)


Please be ready to give the following information:


Product name: Boots Max Strength Mood Lift St John's Wort Tablets

Reference number: THR 23056/0007

This is a service provided by the Royal National Institute

of Blind People.


56-17-7311 _.3901/03


ARTWORK ONLY


ARTWORK TEXT SIZE


Main Headings:

13pt

Sub Headings:

11 pt

Body Copy:

9pt


PACK MOCK OP

Product Name: Max Strength Mood Lift St John's Wort Tablets

Product Licence No.: THR 23056/0007

Wording Ref: Internally Approved vl dated 10/12/2015 (BIC211347, A)

Status: Internally Approved

Pack Deta i Is: FVC/PVDC- aluminium blisters in a carton.

Pack Size:

30, 90.

Version No.

Date Issued

Reason For Change

1

10/12/2015

update to QRD text (ADR statement and the 'morning after PIL' description)

2

08/07/2016

Correction to sugars warning during

the renewal process


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Trident Reference No:

BTC211347

Zen Ref:

TR1058969

Category:

Healthcare

Sub-Category:

Vitamins Et Supplements

Brand:

Premium

Pack Type:

Leaflet

Variant:

BTS Max Strength Mood Lift St John's

Wort Tablets - Leaflet

Action:

B

Date:

14/07/16

Country:

UK

Component Code:

3901/03

Item Code:

56-17-731

CAD Ref No:

N/A

Printer:

N/A

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: N/A

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

100110101(820)

Technical Et Non Printing Items Cutter ^ Guides


Colours

PANTONE 280 C

1


TRIDENT

Connaught House, Connaught Road, Xingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.


STUDIO USE ONLY Michael Wood head    vi.o

Sm»Art check results: G=1; 0=0; R=0; - MW - 14/07/16 09:21:57



Information for the user


Max Strength Mood Lift St John's Wort Tablets 425 mg St John's Wort extract


Read all of this leaflet carefully because it contains important information for you.

This medicine is a traditional herbal medicinal product available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

•    You must contact a pharmacist or doctor if your symptoms worsen or do not improve after 6 weeks

What this medicine is for

This traditional herbal medicinal product contains St John's Wort extract which has traditionally been used to relieve the symptoms of slightly low mood and mild anxiety. This medicine is recommended for these conditions based on traditional use only.

Before you take this medicine

This medicine can be taken by adults aged 18 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

XDo not take:

•    If you are under 18 years

•    If you are allergic to any of the ingredients (see “What is in this medicine”)

   If you have been diagnosed with depression or think you may be depressed (see "Other important information")

   If your skin is very sensitive to sunlight

•    If you are having light treatment

   If you are about to have an operation (see "Other important information")

•    If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains glucose and sucrose)

•    If you are pregnant or breastfeeding


Other important information

Symptoms of depression include feelings of helplessness and hopelessness, loss of interest in daily activities, changes in appetite or weight, changes in sleeping patterns or habits, loss of energy and difficulty in concentrating. If your doctor has told you that you have depression, do not take this medicine. It does not relieve the symptoms of depression. If you think you have depression talk to your doctor before taking this medicine.

If you need to go into hospital for an operation, tell the doctor that you are taking this medicine. Stop taking this medicine at least 10 days before your operation so that it does not affect the anaesthetic or pain medicines that you need.

Avoid excessive sunbathing or the use of sunbeds/solariums while you are taking this medicine.

Driving and using machines: This medicine may cause you to feel dizzy or sleepy. If you are affected do not drive or use machines.

If you take other medicines

You should not take this medicine if you are taking certain medicines (see below).

If you are not sure that your medicine is on this list, or you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor or medicine you have bought for yourself.

XDo not take this medicine if you are taking any of the following medicines:

•    All hormonal contraceptives - the birth control ‘Pill’, emergency contraception (also known as "the morning after pill"), hormonal implant, creams, patches, intra-uterine devices with hormones

•    All medicines for depression/anxiety - amitriptyline, clomipramine, moclobemide, citalopram, fluoxetine, 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


•    AIT medicines for HIv infections - amprenavir, afazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, efavirenz, nevirapine, delaviridine

•    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 migraine - 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 medicine at the same time, unless a doctor has said it is safe to do so:

•    Fentanyl, propofol, sevoflurane, midazolam (anaesthetics/pre-operative medicines)

•    Tramadol (an analgesic)

•    Erythromycin, clarithromycin, telithromycin (antibiotics)

•    Itraconazole and voriconazole (antifungals)

•    Artemether and lumefantrine (antimalarials)

•    Rasagiline (for Parkinson’s disease)

•    Aripiprazole (an antipsychotic medicine)

•    Buspirone (an anxiolytic)

•    Aprepitant (used to treat post-operative vomiting)

•    Butobarbital and phenobarbital (barbiturates)

•    Methyl phenidate (a central nervous system stimulant)

•    Exemestane (a hormone antagonist for breast cancer)

•    Eplerenone (a diuretic or water tablet)

•    Lansoprazole and omeprazole (proton pump inhibitors for heartburn)

•    Theophylline (a bronchodilator for breathing problems)

•    Gliclazide (for diabetes)


/How to take this medicine

I Check the foil is not broken before use. If it is, do not take that tablet.

Age

How many to take

How often to take

Adults aged 18 years and over

One

Once daily


Swallow the tablet whole with water or liquid. Do not chew the tablet.

Do not give to children or adolescents under 18 years.

Do not take more than the amount recommended above.

If symptoms worsen or do not improve after 6 weeks talk to your doctor.

If you take too many tablets: Talk to a pharmacist or doctor.

Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these side effects, stop taking the tablets. See a doctor:

•Allergic reactions (skin rash, hives, red itchy skin)

These other effects may happen. If they bother you talk to a pharmacist:

•    Stomach problems, e.g. indigestion, loss of appetite, feeling sick (nausea), diarrhoea, constipation

•    Fatigue, restlessness

•    Sunburn-like reactions in skin exposed to strong sunlight or strong ultra-violet (UV) irradiation e.g. solarium, particularly in fair skinned individuals

•    Headaches, nerve pain or tingling, dizziness, mania (raised excitability), anxiety

If any side effect becomes severe, lasts more than a few days, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Reporting 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 help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at _ wyw.mhra.aqv_.uk/yellowcard.


How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the base of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

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). This is equivalent to 1490 - 2550 mg of St John's Wort. The extraction solvent is ethanol 60% v/v.

As well as the active ingredient, the tablets also contain maltodextrin, colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium, sodium starch glycolate (type A), magnesium stearate.

The tablet coating contains hypromellose, sucrose, talc, calcium carbonate (E170), tragacanth, acacia, glucose, beeswax white, carnauba wax, shellac, titanium dioxide (E171), yellow iron oxide (E172), vanillin.

The pack contains 30 or 90 coated tablets.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by Wiewelhove GmbH Gildestrasse 39 49477 Ibbenburen Germany. Traditional Herbal Registration held by Schwabe Pharma (UK) Ltd Alexander House Mere Park Dedmere Road Marlow Bucks SL7 1FX

Leaflet prepared December 2015

If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA.


Other formats


To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)


Please be ready to give the following information:


Product name: Boots Max Strength Mood Lift St John's Wort Tablets

Reference number: THR 23056/0007

This is a service provided by the Royal National Institute

of Blind People.


56-17-7311 _.3901/03


ARTWORK ONLY


ARTWORK TEXT SIZE


Main Headings:

13pt

Sub Headings:

11 pt

Body Copy:

9pt


PACK MOCK OP

Product Name: Max Strength Mood Lift St John's Wort Tablets

Product Licence No.: THR 23056/0007

Wording Ref: Internally Approved vl dated 10/12/2015 (B1C211347, A)

Status: Internally Approved

Pack Deta i Is: FVC/PVDC- aluminium blisters in a carton.

Pack Size:

30, 90.

Version No.

Date Issued

Reason For Change

1

10/12/2015

update to QRD text (ADR statement and the 'morning after PIL' description)

2

08/07/2016

Correction to sugars warning during

the renewal process


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


Category:

Healthcare

Sub-Category:

Vitamins Et Supplements

Brand:

Premium

Pack Type:

Leaflet

Variant:

BTS Max Strength Mood Lift St John's

Wort Tablets - Leaflet

Action:

B

Date:

14/07/16

Country:

UK

Component Code:

3901/03

Item Code:

56-17-731

CAD Ref No:

N/A

Printer:

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: N/A

(smallest bar)

Edgemark Position:

N/A

Pharmacode No/NE:

100110101(820)

Technical Et Non Printing Items Cutter ^ Guides


Colours

PANTONE 280 C

1


STUDIO USE ONLY    vl.O