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Ibuprofen 200mg Tablets

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Document: leaflet BOOTS_PL 17907-0077 change

140 mm


PACKAGE LEAFLET: INFORMATION TOR THE USER 'PlKKj

IBUPROFEN 200MG TABLETS

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

Women of childbearing age:



Always take this medicine exactly as ^escribed in this leaflet or as your doctor or pharmacist have told you.

[• Keep this leaflet. You may need to read it i again.

!• Ask your pharmacist if you need more | information or advice.

!• If you get any side effects, talk to your ] doctor or pharmacist. This includes any i possible side effects not listed in this leaflet.

| See section 4.

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

What is in this leaflet:

h .What Ibuprofen Tablets are and what they | are used for

12.What you need to know before you take

| Ibuprofen Tablets

'3.How to take Ibuprofen Tablets

l4.Possible side effects

|5.How to store Ibuprofen Tablets

i6.Contents of the pack and other information

<1. What Ibuprofen Tablets are and what they are used for

iThe active substance used in these tablets is |lbuprofen.

ilbuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) which helps relieve pain, reduces [inflammation and lowers temperature when lyou have a fever.

[These Tablets are used for the relief of rheumatic or muscular pain, back ache, ineuralgia, migraine, headache, dental pain, [period pains, feverishness, and the symptoms of cold and influenza.

2. What you need to know before you take Ibuprofen Tablets

Do not take these Tablets if you:

[• Have ever been told you are allergic to [ ibuprofen, aspirin, other non-steroidal ! anti-inflammatory drugs, or to any of the [ other ingredients (listed in Section 6) i» Have had perforation or a bleeding [ stomach after taking non-steroidal ' anti-inflammatory medicines (you may have ! been sick and it contained blood or dark [ particles that looked like coffee grounds, i passed blood in your stools or passed [ black tarry stools)

'• Have a stomach ulcer, perforation or ! bleeding, or have had one twice or more in [ the past

!• Suffer from severe heart, liver or kidney [ problems

i» Are in the last 3 months of pregnancy !• Have had skin rash, itchy runny nose or ' facial swelling when previously taking ! ibuprofen, aspirin or similar medicines.

[• Have had gastrointestinal bleeding or i perforation when previously taking NSAIDs [ (Non-Steroidal Anti-inflammatory Drugs)

*    Have breathing difficulties.

!• Are under 12 years of age

[• Are taking aspirin at a daily dose above i 75mg

[• Have a condition which increases your i tendency to bleeding

Warnings and precautions

Talk to your doctor or pharmacist if you:

!• Suffer from asthma, or have a past history [ of asthma

!• Have aseptic meningitis or other connective [ tissue diseases such as SLE (Sytemic i Lupus Erythematosus)

!• Are in the first 6 months of pregnancy

'• Have a history of gastrointestinal disease

! (ulcerative colitis, Crohn’s disease) or suffer

[ from bowel problems

i» Have kidney or liver problems

[• Are elderly, as it increases the frequency of

' adverse reactions

!• Have uncontrolled blood pressure or

[ cardiovascular problems

i» Experience prolonged bleeding time

ffhere is a risk of kidney problems in dehydrated children and adolescents.

pther 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 recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking [Ibuprofen if you:

!• have heart problems including heart failure,

[ angina (chest pain), or if you have had a i 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 (including ’mini-stroke’

[ or transient ischaemic attack “TIA”). i» have high blood pressure, diabetes, high [ cholesterol, have a family history of heart !_ .disease or stroke, or if_you are a smoker


Ibuprofen belongs to a group of medicines i which may impair fertility in women. This | effect is reversible on stopping the medicine. ' It is unlikely that Ibuprofen, used occasionally,! will affect your chances of becoming    [

pregnant, however, tell your doctor before    i

taking this medicine if you have problems    j

becoming pregnant.    '

Other medicines and Ibuprofen Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any j other medicines.    [

Ibuprofen may affect or be affected by some j other medicines. For example:    I

•    Other painkillers, including non-steroidal [

anti-inflammatory medicines e.g.    i

indometacin or diclofenac, and COX-2 j inhibitors e.g. celecoxib

•    Medicines that are anti-coagulants (i.e. thin I

blood/prevent clotting e.g. aspirin    j

acetylsalicylic acid, warfarin, ticlopidine) i

•    Diuretics e.g. furosemide (drugs to increase j urine output)

•    Corticosteroids (used to treat inflammatory j

conditions)    j

•    Methotrexate (used to reduce inflammation) I

•    Lithium (used as a mood stabiliser)    j

•    Zidovudine (used in retroviral disease like i

HIV)    I

•    Selective serotonin reuptake inhibitors

(SSRIs), e.g. fluoxetine (used for    I

depression)    j

•    Ciclosporin or tacrolimus (given after transplant surgery, or used in psoriasis or j rheumatism)

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

•    Quinolone antibiotics e.g. ciprofloxacin (for j infections)

•    Medicines that reduce high blood pressure j

(ACE-inhibitors such as captopril,    [

beta-blockers such as atenolol medicines, I angiotensin-ll receptor antagonists such as [ losartan) or drugs for heart disease or to stimulate your heart e.g. glycosides such j as digoxin

•    Cholestyramine    I

•    Sulphonyl ureas such as glibenclamide (to [ treat diabetes)

•    Aminoglycosides (a type of antibiotic) j

•    Voriconazole or fluconazole (types of

anti-fungal drugs)    |

•    Ginkgo biloba herbal medicine (there is a [

chance you may bleed more easily if you I are taking this with ibuprofen)    [

Some other medicines may also affect or be ■ affected by the treatment of Ibuprofen. You j should therefore always seek the advice of your doctor or pharmacist before you use ! Ibuprofen with other medicines.    [

Pregnancy, breast-feeding and fertility

•    Do NOT take this medicine if you are in the [ last 3 months of pregnancy.

•    Speak to your doctor or pharmacist before j

taking this medicine if you are in the first 6 ' months of pregnancy, are breast feeding or! are planning to breastfeed.    [

•    Always ask your doctor or pharmacist for advice before taking any other medicine, j

Ibuprofen Tablets contain Lactose and Sucrose

•    If you have been told by your doctor that j

you have intolerance to some sugars, ' check with your doctor before taking this ! medicine as it contains LACTOSE and    1

SUCROSE.

3. How to take Ibuprofen Tablets

Always take this medicine exactly as described in this leaflet or as your doctor or j pharmacist have told you. Check with your [ doctor or pharmacist if you are not sure. !

•    The Tablets should be swallowed with a

drink of water.    j

•    Take with or after food to reduce the

possibility of side effects.    !

Adults, the elderly and adolescents of 12 to 17 years:

•    Take one or two Tablets up to 3 times a I

day.    [

•    The dose should not be repeated more i

frequently than every 4 hours.    j

•    Do not take more than 6 Tablets in any

24 hour period.    j

This product is intended for short term use j only. You should take the lowest dose for the shortest time necessary to relieve your    !

symptoms.    [

Adults and the elderly: if this medicinal product is required for more than [ 10 days, or if symptoms persist or worsen, i consult your doctor.    |

Adolescents: If this medicinal product is ' required for more than 3 days, or if symptoms! persist or worsen, consult your doctor.    [

Do not give to children under 12 years of i age.____________________________|


If you take more Ibuprofen Tablets than you should

Contact your nearest hospital A&E (casualty department) or your doctor immediately. Take Vour medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

If you forget to take a dose of Ibuprofen Tablets

If necessary, take the missed dose when you remember.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may sometimes cause side effects, although not everybody gets them.

If you experience any of the following serious side effects then STOP taking this medicine immediately and contact your doctor or pharmacist:

•    Peptic ulceration or perforation. Symptoms could include severe abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/motions) or passing black tarry stools

•    Inflammation of the brain lining. Symptoms could include stiff neck, headache, feeling or being sick, fever or feeling disorientated

•    Severe allergic reactions. Symptoms could include fainting, faster heart rate, swelling of the face, tongue and throat

•    Worsening of asthma and wheezing or difficulty breathing

•    Severe forms of skin reactions including peeling and blistering of the skin, mouth and genitals (Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis)

Other possible side effects Uncommon (may affect up to 1 in 100 people)

•    Allergic reactions such as hives, skin rashes and itching

•    Abdominal pain, indigestion, heartburn and feeling sick

•    Headache

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

•    Diarrhoea, wind, constipation or being sick Very rare (may affect up to 1 in 10,000 people)

•    Reduction in blood cells, which can make the skin pale or yellow, cause fever, sore throat, mild mouth ulcers, flu-like symptoms, exhaustion or weakness, easy bruising, or bleeding from the skin or nose

•    High blood pressure, heart failure or chest pain

•    Nervousness, visual disturbance, ringing in the ears and dizziness

•    Liver problems. Symptoms could include yellowing of the skin or the whites of the eyes

•    Kidney problems. Symptoms could include swelling of the ankles

Not Known (frequency cannot be estimated from the available data)

•    Skin eruptions

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website at:

www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.


5.    How to store Ibuprofen Tablets

•    Keep this medicine out of the sight and reach of children.

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

•    Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Ibuprofen Tablets contain

•    The active substance is Ibuprofen.

•    Other ingredients are lactose, potato starch, methylcellulose, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, sucrose, talc, titanium dioxide (E171), pregelatinised maize starch, maize starch and carnauba wax.

What Ibuprofen Tablets looks like and contents of the pack

•    The Tablets are white, sugar coated capsule shaped.

•    The Tablets are available in packs containing 12 or 16 Tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation Holder Bristol Laboratories Ltd, Unit 3, Canal Side, Northbridge Road, Berkhamsted, Hertfordshire HP4 1 EG United Kingdom

Leaflet prepared March 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 free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product Name: Ibuprofen 200mg Tablets Reference Number: 17907/0077 This is a service provided by the Royal National Institute of Blind People


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