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IBUPROFEN 400 MG CAPLETS

Active substance(s): IBUPROFEN

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IBUPROFEN 400MG CAPLETS
Read all of this leaflet carefully before you start taking this medicine because
it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor
or pharmacist have told you.
• 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 or pharmacist. This includes any
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:
1. What Ibuprofen Caplets are and what are they used for
2. What you need to know before you take Ibuprofen Caplets
3. How to take Ibuprofen Caplets
4. Possible side effects
5. How to store Ibuprofen Caplets
6. Contents of the pack and other information

1. WHAT IBUPROFEN CAPLETS ARE AND
WHAT THEY ARE USED FOR
The active substance used in these caplets is Ibuprofen.
Ibuprofen belongs to a class of medicines called the non-steroidal anti-inflammatory
drugs (NSAIDs), which helps relieve pain, reduces inflammation and lowers
temperature when you have a fever.
These caplets are used to treat rheumatic and muscular pain, pain of non-serious
arthritic conditions, backache, neuralgia, migraine, headache, dental pain, and period
pains. They are also used for the relief of feverishness, colds and influenza.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
IBUPROFEN CAPLETS
Do not take these caplets 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).
• 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, passed blood in your
stools or passed black tarry stools)

Ibuprofen Caplets
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• 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
• are in the last 3 months of pregnancy
• have a condition which increases your tendency to bleeding.
• have had a skin rash, itchy runny nose or facial swelling when previously taking
ibuprofen, aspirin or similar medicines
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs
(Non-Steroidal anti-inflammatory drugs)
• have breathing difficulties
• are under 12 years old
• are taking other NSAID pain killers or more than 75mg aspirin a day.
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 (Systemic
Lupus Erythematosus)
• have a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease)
or suffer from bowel problems
• have kidney or liver problems
• are elderly, as it increases the frequency of adverse reactions
• are in the first 6 months of pregnancy
• have uncontrolled blood pressure or cardiovascular problems
• experience prolonged bleeding time
There is a risk of kidney problems in dehydrated children and adolescents.
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 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 heart attack, bypass surgery, peripheral artery disease (poor circulation in
the legs of feet due to narrow or blocked arteries), or any kind of stroke (including
‘mini-stroke’ or transient ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of
heart disease or stroke, or if you are a smoker.

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Women of childbearing age:
Ibuprofen belongs to a group of medicines 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 taking this medicine if you have problems becoming pregnant.
Other medicines and Ibuprofen Caplets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Ibuprofen may affect or be affected by some other medicines. For example:
• other painkillers, including non-steroidal anti-inflammatory medicines e.g.
indometacin or diclofenac, aspirin and COX-2 inhibitors e.g. celecoxib
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin
acetylsalicylic acid, warfarin, ticlopidine)
• diuretics e.g. furosemide (drugs to increase urine output)
• corticosteroids (used to treat inflammatory conditions)
• methotrexate (used to reduce inflammation)
• lithium (used as a mood stabilizer)
• zidovudine (used in retroviral disease like HIV)
• selective serotonin reuptake inhibitors (SSRIs), e.g. fluoxetine (used for
depression)
• ciclosporin or tacrolimus (given after transplant surgery, or used in psoriasis or
rheumatism)
• mifepristone (for termination of pregnancy)-do not take ibuprofen if you have
taken mifepristone in the last 12 days
• quinolone antibiotics e.g. ciprofloxacin (for infections)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril,
beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists
such as losartan) or drugs for heart disease or to stimulate your heart e.g.
glycosides such as digoxin
• cholestyramine
• sulphonyl ureas such as glibenclamide (to treat diabetes)
• aminoglycosides ( a type of antibiotic)
• voriconazole or fluconazole (types of anti-fungal drugs)
• Ginkgo biloba herbal medicine (there is a chance you may bleed more easily if
you are taking this with ibuprofen)
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 other medicines.

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Package leaflet: Information for the user

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side effects not listed in this leaflet. You can also report side effects directly via Yellow
Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this medicine.

5. HOW TO STORE IBUPROFEN CAPLETS
• Keep this medicine out of the sight and reach of children
• Blisters: Do not store above 250C. Store in the original package.
Containers: Do not store above 250C. Keep the container tightly closed.
• 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 Caplets contain
• The active substance is Ibuprofen.
• Other ingredients are: lactose, potato starch, hypromellose, sodium starch
glycolate, colloidal anhydrous silica, magnesium stearate, sucrose, talc,
titanium dioxide (E171), maize starch, pregelatinised starch
What Ibuprofen Caplets look like and the contents of the pack
• The caplets are white, sugar coated capsule shaped.
• The caplets are available in packs containing 6, 12, 24, 25, 48, 84, 96 or 250
caplets.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Limited,
Unit 3 Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom
Telephone:
0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
E-mail:
info@bristol-labs.co.uk
Ibuprofen 400mg caplets; PL 17907/0012
This leaflet was last revised in December 2015
To request a copy of this leaflet in Braille, large print or audio format, please contact
the licence holder at the address (or telephone, fax, email) above.

V11 02-12-15 D0

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3. HOW TO TAKE IBUPROFEN CAPLETS
• Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist have told you. Check with your doctor or pharmacist if you are not
sure.
• The caplets should be swallowed with a drink of water.
• Take with or after food to reduce the possibility of side effects
Adults, the elderly and adolescents of 12 to 17 years:
• Take one caplet up to 3 times a day.
• Leave at least 4 hours between doses.
• Do not take more than 3 caplets in any 24 hour period.
Your doctor may have prescribed a slightly different dose to the usual dose stated
above; you should always follow your doctor’s instructions for taking medicines.
This product is intended for short term use 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, 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 age.
If you take more Ibuprofen Caplets than you should
Contact your nearest hospital A&E (casualty department) or your doctor immediately.
Take your 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 Caplets
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 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 (or SLE)
• 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

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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 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.
Ibuprofen Caplets contain Lactose and Sucrose
• If you have been told by your doctor that you have intolerance to some sugars,
check with your doctor before taking this medicine as it contains LACTOSE and
SUCROSE.

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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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