IBUPROFEN 400MG TABLETS

Active substance: IBUPROFEN

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Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Ibuprofen Tablets are and what they are
used for
2. Before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Further Information
WHAT IBUPROFEN TABLETS ARE AND WHAT

1. THEY ARE USED FOR

The name of your medicine is Ibuprofen 400mg
Tablets. They contain the active ingredient called
Ibuprofen.
Ibuprofen belongs to the group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
These drugs are painkillers and reduce inflammation.
Ibuprofen 400mg Tablets are used for:
• Rheumatic or muscular pain
• Pain of non-serious arthritic conditions
(characterized by pain and stiffness in your body)
• Back pain
• Neuralgia (painful disorder of the nerves)
• Headache including migraine
• Toothache
• Period pain
• Feverishness
• Symptoms of cold & influenza

2. BEFORE YOU TAKE IBUPROFEN TABLETS
Do not take Ibuprofen tablets if you:
• are allergic to ibuprofen or any of the other
ingredients (see section 6).
• have (or have had two or more episodes of) a
stomach ulcer, perforation or bleeding.
• have had asthma, 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).
• suffer from severe liver, kidney or heart failure.
• are in the last 3 months of pregnancy.
Take special care with Ibuprofen tablets if you:
• have or have had asthma
• have kidney, liver or bowel problems.
• are suffering from blurred vision or diminished
vision or changes in colour vision
• have heart problems, have had a previous stroke
or think that you may be at risk of these
conditions (for example if you have high blood
pressure, diabetes or high cholesterol or a
CP.IBU.400.T.RC.V2P8







smoker). Medicines such as Ibuprofen may be
associated with a small increased risk of heart
attack (“myocardial infarction”) or stroke.
Any risk is more likely with high doses and
prolonged treatment. Do not exceed the
recommended dose or duration of treatment (no
more than 10 days).
have a history of gastrointestinal disease (such
as ulcerative colitis, Crohn’s disease).
are in the first 6 months of pregnancy.
are trying to become pregnant (Ibuprofen belongs
to a group of medicines (NSAIDs) which may
impair fertility in women. The effect is reversible
upon stopping the medicine. It is unlikely that
ibuprofen, used occasionally with affect your
chances of becoming pregnant, however, tell your
doctor before taking this medicine if you have
problems becoming pregnant).
have Systemic Lupus Erythematosus (a condition
of the immune system affecting connective tissue
resulting in joint pain, skin change and disorders
of other organs).

Taking other medicines
You should tell your doctor if you are taking or have
taken any of the following medicines as they may
interact with your Ibuprofen Tablets.
Do not use the medicine if you are:
• taking other NSAID pain killers or aspirin with a
daily dose above 75mg.
Talk to your doctor or pharmacist if you are
taking:
• blood thinning drugs (anti coagulants e.g.
warfarin)
• drugs to prevent clotting (anti platelet drugs e.g.
aspirin)
• drugs to help you passing water (diuretics)
• drugs to treat high blood pressure (e.g. captopril,
atenolol, losartan).
• drugs to treat mania and depression (lithium and
SSRI).
• corticosteroids (to treat allergic or inflammatory
disorders)
• drugs to treat HIV treatment (e.g. Zidovudine)
• drugs used for the temporary suppression of your
immune system (e.g. methotrexate, ciclosporin,
tacrolimus)
• antibiotics (e.g. ciprofloxacin and
aminoglycosides such as gentamycin).
• mifepristone (for pregnancy termination).
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without prescription.
Pregnancy and breast-feeding
This medicine belongs to a group of medicines which
may impair fertility in women. This effect goes away
when the medicine is stopped. It is unlikely that this
medicine, used occasionally, will affect your chances
of becoming pregnant.
Do not take Ibuprofen 400mg tablets if you are in the
last 3 months of pregnancy. Speak to your
pharmacist or doctor before taking this product if you
are in the first 6 months of pregnancy or are breast
feeding.

3. HOW TO TAKE IBUPROFEN TABLETS
Always take Ibuprofen Tablets exactly as your doctor
or pharmacist has told you. You should check with
your doctor or pharmacist if you are not sure. Swallow
the tablets with water during or after meals.
The usual dose is:
Adults, the elderly and children over 12 years:
The starting dose is 1 tablet 3 times a day, as
required. Leave at least four hours between doses
and do not take more than three tablets in any 24
hour period. The risk of side effects is greater in the
elderly, so your doctor will give you the lowest dose
possible, and take special care of you.
Children below 12 years: Not recommended.
Ibuprofen Tablets are for short term use only. Take
the lowest dose for the shortest time necessary to
relieve your symptoms. Do not take Ibuprofen for
longer than 10 days.
If you take more Ibuprofen Tablets than you
should
If you or someone you know accidentally takes a lot
more than the stated dose (an overdose), you should
contact a doctor immediately or go to the nearest
A&E department.
If you forget to take Ibuprofen Tablets
If you forget to take a dose, take it as soon as you
remember unless it is almost time for your next dose.
Do not take a double dose to make up for a forgotten
tablet.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happens, STOP TAKING
Ibuprofen Tablets and tell your doctor immediately or
go to the nearest hospital emergency department:
• Signs of intestinal bleeding such as bright red
faeces (stools/motions), black tarry stools,
vomiting blood or dark particles that look like
coffee grounds
• Signs of serious allergic reaction such as:
- Difficulties in breathing or unexplained wheezing
- Dizziness or faster heartbeat
- Severe forms of skin reactions such as
itchiness, skin rash with redness, peeling,
flaking or blistering (e.g. Steven-Johnson
Syndrome, Erythema Multiforme, Epidermal
Necrolysis)
- Swelling of your face, tongue or throat
• Signs of kidney problems such as:
-Passing less or more urine
-Cloudy/ foamy urine or blood in the urine
-Pain in the back and/or swelling (particularly in
the legs)
• Signs of aseptic meningitis. You may have a
stiff neck, headache, feeling sick, being sick, fever
or confusion. Patients with autoimmune
disorders (lupus, mixed connective tissue
disease) may be more likely to be affected
STOP TAKING the medicine and tell your doctor if
you experience any of the following uncommon
side effects (affects 1 to 10 patients in 1,000)
• Indigestion, heartburn or feeling sick
• Pains in your stomach (abdomen) or other
abdominal problems
Other side effects include: Uncommon (affects 1
to 10 patients in 1,000)
• Allergic reactions such as skin rashes with itching,
peeling
• Headache
• Dizziness
• Feeling sleepy or having problems sleeping

• Feeling depressed
Rare (affects 1 to 10 patients in 10,000)
• Diarrhoea, flatulence (wind), constipation, being
sick
Very rare (affects less than 1 user in 10,000)
• Blood disorders resulting in unexplained bruising
or bleeding, fever, sore throat, mouth ulcers,
flu-like symptoms and severe exhaustion
• Nervousness
• Visual problems including inflammation of the eye
nerve
• Ringing in the ears (tinnitus), feeling like you are
spinning (vertigo)
• Heart failure or pains in the chest (angina
pectoris)
• High blood pressure
• Liver problems including hepatitis (swelling of the
liver) and jaundice (skin and whites of the eyes
turn yellow)
• Wheezing
• Worsening of colitis or Crohn’s disease
• Mouth ulcers
• Stomach or intestine problems sometimes with
bleeding or perforation
• Kidney problems which could include swelling of
the ankles
• Swelling (oedema)
Medicines such as Ibuprofen 400mg Tablets may be
associated with a small increased risk of heart attack
(myocardial infarction) or stroke. See section 2,
Warnings and precautions.
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.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

5. HOW TO STORE IBUPROFEN TABLETS
Keep out of the sight and reach of children.
Do not store the tablets above 25°C. Keep them in the
original pack.
Do not take these tablets after the expiry date shown
on the pack.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines that are no longer required.
These measures will help to protect the environment.

6. FURTHER INFORMATION
What Ibuprofen Tablets contain:
The active substance is Ibuprofen. The other
ingredients are Pregelatinised Starch, Maize Starch,
Colloidal Anhydrous Silica, Magnesium Stearate,
Hypromellose, Macrogol 6000, Erythrosine Lake
(E127), Titanium Dioxide (E171) and Docusate
Sodium.
What Ibuprofen Tablets look like and contents of
the pack:
Ibuprofen 400mg Tablets are pink, biconvex, filmcoated tablets with “I 400” on one side and packed in
tablet containers of 21, 100, 250, 500, 1000 and
blister packs of 12, 21, 24, 28, 48, 56, 84, 96, 100.
Marketing Authorisation Holder and Manufacturer:
Relonchem Limited, Cheshire House, Gorsey Lame,
Widnes, Cheshire, WA8 0RP, UK
Tel: 02074195043
Fax: 02074195024
Email: Info@relonchem.com
Distributed by: Kent Pharmaceuticals Limited,
Repton Road, Measham, DE12 7DT, UK
PL 20395/0080
Date leaflet revised: June 2014
CP.IBU.400.T.RC.V2P8

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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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