IBUPROFEN 400MG TABLETS

Active substance: IBUPROFEN

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IBUPROFEN 400mg TABLETS

Ibuprofen

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 effect 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

1.

WHAT IBUPROFEN TABLETS ARE AND
WHAT 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 nonsteroidal 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 (hypersensitive) to Ibuprofen or any of
the other ingredients of Ibuprofen Tablets. See
section 6.
• are allergic to Aspirin or other NSAIDs, like
cyclooxygenase-2 specific inhibitor.
• suffer from asthma, especially if you also have
frequent stuffed or runny nose or swelling of the
inside of the nose.
• have swelling of the hands, arms, feet, ankles, or
lower legs.
• develop hives (red and sometimes itchy bumps) on
your skin after taking this medicine, Aspirin or any
other NSAIDs.
• suffer from severe liver, kidney or heart disease.
• if you currently have an active ulcer or a history of
recurrent peptic ulcers (more than two) in your
stomach or duodenum.
• have ever had bleeding in your digestive tract.
• get blurred or poorer vision, blind spots, or changes
in colour vision.
• if you are in the last three months of pregnancy.
Take special care with Ibuprofen Tablets if you:
• have a previous history of bronchial asthma or
allergic disease
• suffer from high blood pressure
• have or ever had Crohn’s disease (inflammation of
the digestive system) or ulcerative colitis (disease
that causes ulcers in the lining of the rectum and
colon)
• have or ever had lupus (a condition in which the
body attacks many of its own tissues and organs,
often including the skin, joints, blood, and kidneys)

• are having surgery, including dental surgery
• are taking more than 75mg Aspirin daily
• Medicines such as Ibuprofen Tablets 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. If you have heart
problems, previous stroke or think that you might
be at risk of these conditions (for example if you
have high blood pressure, diabetes or high
cholesterol or are a smoker) you should discuss
your treatment with your doctor or pharmacist.
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.
Examples of medicines that can affect Ibuprofen
Tablets are:
• any other anti-inflammatory pain killers
• Aspirin
• antibiotics (Aminoglycosides, Quinolones)
• medicines for high blood pressure
• diuretics (water tablets)
• Digoxin (cardiac glycosides)
• Lithium to stabilise, normalise or even-out mood
swings
• Methotrexate to treat cancer and auto immune
diseases
• Ciclosporin to dampen down the body's immune
reactions
• Mifepristone used to induce abortion in first two
months of pregnancy
• Corticosteroids
• Warfarin, to prevent blood clots
• Ciprofloxacin - antibiotics called quinolones
• Tacrolimus to prevent rejection of liver transplants
• Phenytoin to treat epilepsy
• Zidovudine to treat human immunodeficiency virus
(HIV infection)
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
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. Do
not take this medicinal product if you are in the last
three months of pregnancy.
Consult your doctor if you are pregnant, you plan to
become pregnant, or you are breastfeeding. If you
become pregnant while taking Ibuprofen, call your
doctor. Ask your doctor or pharmacist for advice before
taking any medicine.

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.

CP.IBU.400.T.RC.V2P1

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.
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.
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, Ibuprofen Tablets 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:
• Rare allergic (hypersensitive) reactions such as
difficulty of breathing, wheezing or dizziness
• skin reactions including paling of skin, rash, itching,
hives, blisters, blood spots, swelling of the skin with
wheals and, less often, blistering skin diseases
which may appear like a burn, or as a red/purple
rash, or a scaly skin.
• Asthma attacks (condition that affects the airways
of the lungs causing breathing difficulties) or
worsening of asthma
• Sensitivity to light
• Stomach ulcers, bleeding, or holes in the stomach
or intestine, High blood pressure, fluid retention
(particularly in the elderly), vomiting a substance
that is bloody or looks like coffee grounds, blood in
the stool, or black and tarry stools. The risk may be
higher for people who are older in age.
• Pass blood in your faeces (stools/ motions)
• Pass black tarry stools
• Vomit any blood or any dark particles that look like
coffee grounds
• STOP TAKING the medicine if you experience:
indigestion or heartburn, abdominal pain (pains in
stomach) or other abnormal stomach symptoms.
Common (occurring in less than 1 in 10 patients)
• Nausea, Vomiting
• Gastro-intestinal:
• Diarrhoea , Gas or Bloating, Constipation, Pain in
abdomen or Upset stomach
• Worsening of ulcers in the lining of the rectum and
colon
• Worsening of inflammation of the digestive system
• Inflammation or irritation of the lining of the
stomach
• Indigestion
• Effects on heart:
• Medicines such as Ibuprofen may be associated with
a small increased risk of heart attack ("myocardial
infarction") or stroke
• Hypertension
Uncommon (occurring in less than 1 in 100 patients)
• Effects on Kidney: Inflammation of kidney tissue,
kidneys disorder causing them to leak large
amounts of protein from the blood into the urine,
kidney failure, appearance of blood in the urine.
• Effects on Liver: Abnormal liver function tests,
swelling of the liver that makes it stop working well
(hepatitis) and yellowing of skin and the whites of
your eyes (jaundice)





















Effects on Nervous system and special senses:
Visual problems
Inflammation of eye nerve
Headache
Feeling of burning, itching, prickling or tingling in
the skin
Aseptic Inflammation of the lining of the brain (With
symptoms such as stiff neck, headache, nausea,
vomiting, fever or disorientation) especially in
patients with diseases like lupus erythromatous (a
condition in which immune system attacks healthy
cells and tissues of many parts of the body), mixed
connective tissue disease (overlap disease)
Nervousness,
Depression,
Confusion,
Hallucinations
Ringing in the ears
Light-headedness (loss of balance)
Feeling of general discomfort or uneasiness
Sleeplessness
Excessive Tiredness
Drowsiness
Effects on blood:
Low platelet count
Affected blood cell counts
Failure of the bone marrow to produce sufficient
blood cells for the circulation (Aplastic anaemia)
Abnormal breakdown of red blood cells

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.

5.

HOW TO STORE IBUPROFEN TABLETS

Keep out of the reach and sight 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 Ltd
Cheshire House
Gorsey Lane
Widnes
Cheshire, WA8 0RP
UK
Tel: 0207 419 5043
Fax: 0207 419 5024
Email: Info@relonchem.com
Distributed By:
Kent Pharmaceuticals Limited
Repton Road
Measham, DE12 7DT
UK
PL 20395/0080
Date leaflet revised: October 2012.

CP.IBU.400.T.RC.V2P1

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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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