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Ibuprofen 200 Mg Liquid Capsules

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Document: leaflet BOOTS_PL 14338-0001 change

139.7 mm



Information for the user


Ibuprofen 200 mg Liquid Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


This medicine is 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

•    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 must talk to a doctor if you do not feel better or if you feel worse

What this medicine is for

This medicine contains Ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory medicines, which act to relieve pain and reduce swelling. It can be used to relieve headaches, rheumatic and muscular pain, backache, migraine, period pain, dental pain and neuralgia. It can also be used to reduce fever and relieve the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and adolescents (aged 12-18 years old). However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

X Do not take:

•    If you have a stomach ulcer, perforation or bleeding stomach, or have had one twice or more in the past

•    If you have had perforation or a bleeding stomach

after taking a non-steroidal anti-inflammatory medicine (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)

   If you are allergic to ibuprofen or any other ingredients of the product, aspirin or other non-steroidal anti-inflammatory medicines (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)

•    If you are taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines

•    If you have severe heart, kidney or liver failure

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

•    If you are in the last 3 months of pregnancy.

Other important information

Risk of heart attack or stroke:

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the stated dose or duration of treatment.


f Talk to your pharmacist or doctor:

•    If you have asthma, a history of asthma or other allergic disease, bowel problems, ulcerative colitis, Crohn's disease

•    If you have other kidney, heart or liver problems (see “Do not take”)

•    If you are allergic to any other painkillers

•    If you are taking any other painkillers or receiving regular treatment from your doctor

•    If you have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)

•    If you are elderly - you may get more side effects (see back of leaflet)

•    If you are between 12 and 18 years old and you are dehydrated - you may get kidney problems

•    If you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke pnduding 'mini-stroke' or transient ischaemic attack "TIA") - see Risk of heart attack or stroke' under Other important information

•    If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker

Pregnancy and Breastfeeding

Do not take this medicine if you are in the last 3 months of pregnancy. Talk to you doctor before taking this product if you are in the first 6 months of pregnancy or are breastfeeding.

These capsules belong to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine.

It is unlikely that if you only take these capsules occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

Other information

Information about some of the ingredients: The colour ponceau 4R (E124) in this medicine may cause allergic reactions.

If you take other medicines

Before you take these capsules, make sure that you tell your doctor or pharmacist about ANY other medicines you might be using at the same time. Ibuprofen may affect or be affected by some other medicines. For example:

•    Other painkillers

•    Aspirin 75 mg (to prevent heart attacks and strokes) -the protection may be reduced when you take ibuprofen

•    Medicines to thin your blood (e.g. warfarin, tidopidine)

•    Mifepristone (for termination of pregnancy) - do not take ibuprofen if you have taken mifepristone in the last 12 days

•    Water tablets (diuretics)


Medicines to treat high blood pressure (e.g. ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan), medicines for heart problems Corticosteroids (for pain and swelling)

Lithium (for bipolar disorder)

Methotrexate (for cancer, psoriasis, or rheumatism) Zidovudine (for HIV infection)

Quinolone antibiotics (for infections)

Medicines for depression

Cidosporin or tacrolimus (given after transplant

surgery, or for psoriasis or rheumatism)

Some other medicines may also affect or be affected by the treatment of ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with any other medicines, including herbal and homeopathic remedies.

/How to take this medicine

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


Age

How many to take

How often to take them

Adults and adolescents

One or two capsules

Every 4 hours, if you need to. Don't take more than 6

capsules in 24 hours.

Take the lowest amount for the shortest possible time to relieve your symptoms


Swallow each capsule with water. Do not chew.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If your symptoms worsen at any time, talk to your doctor. Adults: If your symptoms do not go away within 10 days, talk to your doctor.

Adolescents (aged 12-18 years old): If your symptoms do not go away within 3 days, talk to your doctor.

If you forget to take the capsules: Take them as soon as you remember. Do not make up for the missed capsules by taking more than the amount recommended in the table.

' If you take too many capsules: Talk to a doctor straight away. Take your medicine and this leaflet with you.

Possible side effects

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

If you are elderly you may be more likely to have some of these side effects.

1 If you get any of these serious side effects, stop taking the capsules. See a doctor at once:

You are sick and it contains blood or dark particles that look like coffee grounds

Pass blood in your stools or pass black tarry stools Stomach problems including pain, indigestion or heartburn Allergic reactions such as skin rash (which can sometimes be severe and include peeling and blistering of the skin), swelling of the face, neck or throat, worsening of asthma, difficulty in breathing

Meningitis (e.g. stiff neck, fever, disorientation)

If you get any of the following side effects see your pharmacist or doctor:

Uncommon side effects (may affect up to 1 in 100 people) Headache, feeling sick


•    Skin rash, hives, itching

Rare side effects: (may affect up to 1 in 1,000 people)

•    Diarrhoea, wind, constipation, being sick

Very rare side effects: (may affect less than 1 in 10,000 people)

•    Stomach ulcer or perforation, worsening of bowel problems such as ulcerative colitis or Crohn’s disease

•    Kidney problems, which may lead to kidney failure (you may pass more or less urine than normal, have blood in your urine or cloudy urine, or feel breathless, very tired or weak, have no appetite, or have swollen ankles)

•    Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)

•    Tiredness or severe exhaustion, changes in the blood which may cause unusual bruising or unexplained bleeding and an increase in the number of infections that they get (e.g. sore throats, mouth ulcers, flu-like symptoms including fever)

Side effects with an unknown frequency:

•    Fluid retention, which may cause swelling of the limbs

•    High blood pressure, heart failure, stroke

There may be a small increased risk of heart attack or stroke if you take large amounts of this medicine for a long time.

If you get any symptoms, stop taking the capsules and see your doctor.

Reporting of 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 report side effects directly via the Yellow Card Scheme at: www.mhra.aov.ukA/ellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C. Store in the original package.

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

Use by the date on the end flap of the carton.

What is in this medicine

Each soft gelatin capsule contains Ibuprofen 200 mg, which is the active ingredient.

As well as the active ingredient, the capsules also contain macrogol 600, potassium hydroxide, gelatine, sorbitol, purified water, titanium dioxide, isopropyl alcohol, propylene glycol, hypromellose and ponceau 4R (E124).

The pack contains 16 oval pink capsules with '1200' printed in white.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Banner Pharmacaps Europe PO Box 5037 5004 EA Tilburg The Netherlands

Leaflet Prepared September 2016

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 flee of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product Name: Boots Ibuprofen 200 mg Liquid Capsules Reference Number: 14338/0001

This is a service provided by the Royal National Institute of Blind People.

______________________C6J73QAJ1.


ARTWORK ONLY


Trident Reference No: BTC244238

Zen Ref:

TR1175168

Category:

Healthcare

Sub-Category:

Analgesics

Brand:

Core

Pack Type:

Leaflet

Variant:

ibuprofen 200mg Liquid Capsules Leaflet

Action:

A

Date:

22/09/16

Country:

UK

Component Code:

C6J73QAJ1

Item Code:

47-63-866

CAD Ref No:

209.55mmx 139.7mm

Printer:

N/A

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: (smallest bar)

N/A

Edgemark Position:

N/A

Pharmacode No/NE:

0111001100(1463)

Technical ft Non Printing Items Cutter | Guides


ARTWORK TEXT SIZE


Colours

PAMONE280 C

=


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.


Main Headings:    11 pt

Sub Headings:    9pt

Body Copy:    7pt

PACK MOCK UP

Product Name: Ibuprofen 200mg Liquid Capsules

Product Licence No.: 14338/0001

Wording Ref: MHRAapproved v1 dated 11/01/2016 [BTC203864, D]

Status:

Internally approved

Pack Details

Foil blisters

Pack Size:

16

Version No.

Date Issued

Reason For Change

1

16/09/2016

Update to pregnancy information


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Information for the user



Ibuprofen 200 mg Liquid Capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


This medicine is 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

•    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 must talk to a doctor if you do not feel better or if you feel worse

What this medicine is for

This medicine contains Ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory medicines, which act to relieve pain and reduce swelling. It can be used to relieve headaches, rheumatic and muscular pain, backache, migraine, period pain, dental pain and neuralgia. It can also be used to reduce fever and relieve the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and adolescents (aged 12-18 years old). However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

X Do not take:

•    If you have a stomach ulcer, perforation or bleeding stomach, or have had one twice or more in the past

•    If you have had perforation or a bleeding stomach

after taking a non-steroidal anti-inflammatory medicine (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)

   If you are allergic to ibuprofen or any other ingredients of the product, aspirin or other non-steroidal anti-inflammatory medicines (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)

•    If you are taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines

•    If you have severe heart, kidney or liver failure

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

•    If you are in the last 3 months of pregnancy.

Other important information

Risk of heart attack or stroke:

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the stated dose or duration of treatment.


f Talk to your pharmacist or doctor:

•    If you have asthma, a history of asthma or other allergic disease, bowel problems, ulcerative colitis, Crohn's disease

•    If you have other kidney, heart or liver problems (see “Do not take”)

•    If you are allergic to any other painkillers

•    If you are taking any other painkillers or receiving regular treatment from your doctor

•    If you have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)

•    If you are elderly - you may get more side effects (see back of leaflet)

•    If you are between 12 and 18 years old and you are dehydrated - you may get kidney problems

•    If you have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke pnduding 'mini-stroke' or transient ischaemic attack "TIA") - see Risk of heart attack or stroke' under Other important information

•    If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker

Pregnancy and Breastfeeding

Do not take this medicine if you are in the last 3 months of pregnancy. Talk to you doctor before taking this product if you are in the first 6 months of pregnancy or are breastfeeding.

These capsules belong to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine.

It is unlikely that if you only take these capsules occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

Other information

Information about some of the ingredients: The colour ponceau 4R (E124) in this medicine may cause allergic reactions.

If you take other medicines

Before you take these capsules, make sure that you tell your doctor or pharmacist about ANY other medicines you might be using at the same time. Ibuprofen may affect or be affected by some other medicines. For example:

•    Other painkillers

•    Aspirin 75 mg (to prevent heart attacks and strokes) -the protection may be reduced when you take ibuprofen

•    Medicines to thin your blood (e.g. warfarin, tidopidine)

•    Mifepristone (for termination of pregnancy) - do not take ibuprofen if you have taken mifepristone in the last 12 days

•    Water tablets (diuretics)


Medicines to treat high blood pressure (e.g. ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan), medicines for heart problems Corticosteroids (for pain and swelling)

Lithium (for bipolar disorder)

Methotrexate (for cancer, psoriasis, or rheumatism) Zidovudine (for HIV infection)

Quinolone antibiotics (for infections)

Medicines for depression

Cidosporin or tacrolimus (given after transplant

surgery, or for psoriasis or rheumatism)

Some other medicines may also affect or be affected by the treatment of ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with any other medicines, including herbal and homeopathic remedies.

/How to take this medicine

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


Age

How many to take

How often to take them

Adults and adolescents

One or two capsules

Every 4 hours, if you need to. Don't take more than 6

capsules in 24 hours.

Take the lowest amount for the shortest possible time to relieve your symptoms


Swallow each capsule with water. Do not chew.

Do not give to children under 12 years.

Do not take more than the amount recommended above.

If your symptoms worsen at any time, talk to your doctor. Adults: If your symptoms do not go away within 10 days, talk to your doctor.

Adolescents (aged 12-18 years old): If your symptoms do not go away within 3 days, talk to your doctor.

If you forget to take the capsules: Take them as soon as you remember. Do not make up for the missed capsules by taking more than the amount recommended in the table.

' If you take too many capsules: Talk to a doctor straight away. Take your medicine and this leaflet with you.

Possible side effects

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

If you are elderly you may be more likely to have some of these side effects.

1 If you get any of these serious side effects, stop taking the capsules. See a doctor at once:

You are sick and it contains blood or dark particles that look like coffee grounds

Pass blood in your stools or pass black tarry stools Stomach problems including pain, indigestion or heartburn Allergic reactions such as skin rash (which can sometimes be severe and include peeling and blistering of the skin), swelling of the face, neck or throat, worsening of asthma, difficulty in breathing

Meningitis (e.g. stiff neck, fever, disorientation)

If you get any of the following side effects see your pharmacist or doctor:

Uncommon side effects (may affect up to 1 in 100 people) Headache, feeling sick


•    Skin rash, hives, itching

Rare side effects: (may affect up to 1 in 1,000 people)

•    Diarrhoea, wind, constipation, being sick

Very rare side effects: (may affect less than 1 in 10,000 people)

•    Stomach ulcer or perforation, worsening of bowel problems such as ulcerative colitis or Crohn’s disease

•    Kidney problems, which may lead to kidney failure (you may pass more or less urine than normal, have blood in your urine or cloudy urine, or feel breathless, very tired or weak, have no appetite, or have swollen ankles)

•    Yellowing of the skin or eyes, pale stools or upper abdominal pain (these may be signs of liver problems)

•    Tiredness or severe exhaustion, changes in the blood which may cause unusual bruising or unexplained bleeding and an increase in the number of infections that they get (e.g. sore throats, mouth ulcers, flu-like symptoms including fever)

Side effects with an unknown frequency:

•    Fluid retention, which may cause swelling of the limbs

•    High blood pressure, heart failure, stroke

There may be a small increased risk of heart attack or stroke if you take large amounts of this medicine for a long time.

If you get any symptoms, stop taking the capsules and see your doctor.

Reporting of 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 report side effects directly via the Yellow Card Scheme at: www.mhra.aov.ukA/ellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Do not store above 25°C. Store in the original package.

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

Use by the date on the end flap of the carton.

What is in this medicine

Each soft gelatin capsule contains Ibuprofen 200 mg, which is the active ingredient.

As well as the active ingredient, the capsules also contain macrogol 600, potassium hydroxide, gelatine, sorbitol, purified water, titanium dioxide, isopropyl alcohol, propylene glycol, hypromellose and ponceau 4R (E124).

The pack contains 16 oval pink capsules with '1200' printed in white.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Banner Pharmacaps Europe PO Box 5037 5004 EA Tilburg The Netherlands

Leaflet Prepared September 2016

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 flee of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product Name: Boots Ibuprofen 200 mg Liquid Capsules Reference Number: 14338/0001

This is a service provided by the Royal National Institute of Blind People.

______________________C6J73QAJ1.


ARTWORK ONLY


Category:

Healthcare

Sub-Category:

Analgesics

Brand:

Core

Pack Type:

Leaflet

Variant:

ibuprofen 200mg Liquid Capsules Leaflet

Action:

A

Date:

22/09/16

Country:

UK

Component Code:

C6J73QAJ1

Item Code:

47-63-866

CAD Ref No:

209.55mmx 139.7mm

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:

0111001100(1463)

Technical ft Non Printing Items Cutter | Guides


ARTWORK TEXT SIZE


Colours

PANTONE 280 C

=


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.


Main Headings:    11 pt

Sub Headings:    9pt

Body Copy:    7pt

PACK MOCK OP

Product Name: Ibuprofen 200mg Liquid Capsules

Product Licence No.: 14338/0001

Wording Ref: MHRAapproved v1 dated 11/01/2016 [BTC203864, D]

Status:

Internally approved

Pack Details

Foil blisters

Pack Size:

16

Version No.

Date Issued

Reason For Change

1

16/09/2016

Update to pregnancy information


STUDIO USE ONLY    v1.0