315 mm

Information for the user

145 mm    I    I    145 mm

Mood Lift St John's Wort Tablets St John's Wort extract 250 mg

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^ou have depression, or think you may have depression (see

er important information’’’

np<

•    If your skin is very sensitive to sunlight

•    If you are having light treatment

•    If you have an intolerance to some sugars, unless your doctor tells you to (this medicine containslactose)

•    Ifyou are pregnant or breastfeedjng

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.

KDo 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

» All medicines 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, 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 (anaesfnetics/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

4How totake thismedicine "

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

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 fake 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 www.mhra.aov.uk/vellowcard.

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 film-coated tablet contains 250 mg of extract (as dry extract) from St John's wort aerial parts (Hypericum perforatum L.) (3.5-6:1). This is equivalent to 875 -1500 mg of St John's wort. The extraction solvent is ethanol 60% v/v.

As well as the active ingredient, the extract also contains lactose monohydrate, calcium hydrogen phosphate dihydrate, powdered cellulose, colloidal anhydrous silica.

The tablet core contains powdered cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate (type A), stearic acid.

The tablet coating contains Eudragit E100, hypromellose, macrogol 6000, talc, titanium dioxide (E171), iron oxide (E172).

The pack contains 30 yellow film-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 Mood Lift St John's Wort Tablets Reference number: THR 23056/0011 This is a service provided by the Royal National Institute of Blind People.

4Q99/D3!

ARTWORK ONLY

ARTWORK TEXT SIZE

Main Headings:    13pt

Sub Headings:    11 pt

Body Copy:    9pt

PACK MOCK OP

Technical Et Non Printing Items Cutter ^ Guides

Product Name:

Boots Mood Lift St John's Wort Tablets

Product Licence No.: THR 23056/0011

Wording Ref:    MHRA approved,VI dated 08/07/2014 (BTC156255action E

Status:    Internally Approved

Pack Details:    PVC/ PVDC - aluminium blisters in a carton.

Reason For Change

12/01/2016

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

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.

Colours

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 PROM TRIDENT.

STUDIO USE ONLY Joshua James    vi.o

Sm»Art check results: G=1;0=0; R=0; -JJ -13/01/1615:01:02

Information for the user

Mood Lift St John's Wort Tablets St John's Wort extract 250 mg

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^ou have depression, or think you may have depression (see

er important information’’’

np<

•    If your skin is very sensitive to sunlight

•    If you are having light treatment

•    If you have an intolerance to some sugars, unless your doctor tells you to (this medicine containslactose)

•    Ifyou are pregnant or breastfeedjng

4How totake thismedicine "

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

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 fake 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 www.mhra.aov.uk/vellowcard.

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.

KDo 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 ’    '    '    '    '    '    he

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

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 film-coated tablet contains 250 mg of extract (as dry extract) from St John's wort aerial parts (Hypericum perforatum L.) (3.5-6:1). This is equivalent to 875 -1500 mg of St John's wort. The extraction solvent is ethanol 60% v/v.

As well as the active ingredient, the extract also contains lactose monohydrate, calcium hydrogen phosphate dihydrate, powdered cellulose, colloidal anhydrous silica.

The tablet core contains powdered cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate (type A), stearic acid.

The tablet coating contains Eudragit E100, hypromellose, macrogol 6000, talc, titanium dioxide (E171), iron oxide (E172).

The pack contains 30 yellow film-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.

» All medicines 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, 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 (anaesfhetics/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)

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 Mood Lift St John's Wort Tablets Reference number: THR 23056/0011 This is a service provided by the Royal National Institute of Blind People.

4Q99/D3!

ARTWORK ONLY

ARTWORK TEXT SIZE

Main Headings:    13pt

Sub Headings:    11 pt

Body Copy:    9pt

PACK MOCK OP

Technical Et Non Printing Items Cutter ^ Guides

Product Name:

Boots Mood Lift St John's Wort Tablets

Product Licence No.: THR 23056/0011

Wording Ref:    MHRA approved,VI dated 08/07/2014 (BTC156255action E

Status:    Internally Approved

Pack Details:    PVC/ PVDC - aluminium blisters in a carton.

Reason For Change

12/01/2016

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

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.

Colours

STUDIO USE ONLY    vl.O