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IBUPROFEN TABLETS 400MG

Active substance(s): IBUPROFEN

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KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN
IBUPROFEN TABLETS
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY

This leaflet contains a summary of the information about your medicine, Ibuprofen Tablets.
YOUR MEDICINE
Your medicine is in the form of a tablet. There are three different strengths of Ibuprofen
Tablets available. Each tablet contains either 200mg, 400mg or 600mg of the
active ingredient Ibuprofen. The 200mg tablet is pink and marked ‘IB 200’ and ‘G’ on one
side. The 400mg tablet is pink and marked ‘IB 400’ and ‘G’ on one side and the 600mg
tablet is also pink and marked ‘IB 600’ and ‘G’ on one side.
Each tablet also contains lactose, povidone, chloroform spirit, maize starch, talc, colloidal
silicon dioxide, sodium starch glycollate, magnesium stearate, chloroform, chloroform spirit,
hydroxypropylmethylcellulose, diethyl phthalate, titanium dioxide, erythrosine aluminium
lake (E127), hydroxypropylcellulose and carnauba wax. The 400mg tablets also contain
microcrystalline cellulose.
Ibuprofen Tablets 200mg and 400mg are available in containers of 100, 250 and 500* tablets.
Ibuprofen Tablets 600mg are available in containers of 20, 50, 100 and 250* tablets.
Your pharmacist will dispense the number of tablets prescribed by your doctor.
(*Only marketed pack sizes will feature on the printed leaflet)
HOW DOES YOUR MEDICINE WORK
Your tablet contains IBUPROFEN which belongs to a group of medicines called NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs). Ibuprofen acts as a painkiller
and also helps to reduce fever. It works by reducing inflammation so relieving pain, swelling
and stiffness in the joints and muscles.
Product Licence Holder:
Manufacturer:

Generics [UK] Limited, Station Close, Potters Bar, Herts
EN6 1TL
Alphapharm [Pty] Limited, Carole Park, Brisbane,
Queensland, Australia, 4300

WHY DO YOU NEED TO TAKE YOUR MEDICINE?
There are a number of painful conditions that can affect your joints and muscles which can be
helped by taking Ibuprofen Tablets. These conditions include:
 Rheumatoid arthritis
 Ankylosing spondylitis (arthritis in the spine)
 Osteoarthritis
 Other musculo-skeletal disorders such as a frozen shoulder, lumbago, sprains, strains and
other injuries including back pain and stiffness.
 Painful periods
 Pain following surgery
 Headache

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WHAT SHOULD YOU DO BEFORE TAKING YOUR MEDICINE?
You must tell your doctor before taking your medicine if:
 You are allergic (hypersensitive) to Ibuprofen or any of the other ingredients of this
medicine.
 You have a bleeding disorder

 You have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have
had two or more episodes of peptic ulcers, stomach bleeding or perforation.

 You have taken Ibuprofen or a similar medicine before (including Aspirin) and you
suffered an unpleasant or allergic reaction including asthma, skin rash or an itchy, runny
nose
 You have taken Mifepristone tablets (for abortion) less than 8-12 days ago
 You suffer or have suffered, from bronchial asthma
 You have a history of heart failure or high blood pressure,
 You have kidney, heart or liver disease

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 or 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.
Ibuprofen may affect or be affected by some other medicines, for example:
 Medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, ticlopidine, warfarin)
 Diuretics (‘water’ tablets) eg Bendrofluazide
 Medicines that reduce high blood pressure (ACE-inhibitors such as captopril or ramipril,
beta-blockers such as atenolol or carvedilol, angiotensin-II receptor antagonists such as
valsartan or losartan)
 Medicine to treat a heart condition eg Digoxin
 Methotrexate
 Lithium fluoxetine or paroxetine (used to treat depression)
 Tacrolimus (used after organ transplantation)
 Zidovudine (used in the treatment of AIDs)
 Corticosteroids
 Ciclosporin
 Any other non-steroidal anti-inflammatory drug or analgesic (e.g.aceclofenac, celecoxib)
 Quinoline antibiotics (to treat infection) e.g. Ciprofloxacin or Norfloxacin
Some other medicines may also affect or be affected by treatment with Ibuprofen. You
should therefore always seek the advice of your doctor or pharmacist before you use
Ibuprofen with other medicines.
There is a risk of renal impairment in dehydrated children and adolescents.

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Pregnancy and breast-feeding
 Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you
are planning to become pregnant or if you have problems becoming pregnant.
 Ibuprofen should not be taken during the first two trimesters of pregnancy unless the benefits to
the mother outweigh the risks to the baby. Ibuprofen should not be taken in the last three months
of pregnancy as it can affect the growth of your unborn baby and may also affect your labour.



Do not breast-feed your baby, as small amounts of Ibuprofen can pass into breast milk.

Driving and using machines
 Do not drive or operate machinery if you feel dizzy or drowsy, or you have eyesight problems
while taking this medicine.

Do not take these tablets if you think you are allergic to any of the ingredients.

HOW SHOULD YOU TAKE YOUR TABLETS?
Ibuprofen Tablets should be taken with or after food to reduce the likelihood of stomach
upset.
Adults
The usual adult dose ranges from 1200 mg to 1800 mg of Ibuprofen a day. However,
depending on the severity of your condition, this daily dose may be increased to a maximum
of 2400 mg of Ibuprofen a day. The total daily dose should be split up in to three or four
doses throughout the day.
Elderly
The usual dose is similar to that stated above, unless you are suffering from kidney or liver
problems. If you are, your doctor will give you a lower dose. F or the first four weeks after
starting your medicine, your doctor may want to monitor you to check for bleeding in your
stomach.
Children
For children over 12 years old, the usual daily dose is 20mg per kg of bodyweight, divided up
throughout the day. Children who suffer from the condition juvenile rheumatoid arthritis
(Still’s disease) may need up to 40mg per kg of bodyweight daily. For children weighing less
than 30kg the total daily dose should not be greater than 500mg of Ibuprofen.
If in children aged from 12 years and in adolescents this medicinal product is required for
more than 3 days, or if symptoms worsen a doctor should be consulted.
If you forget to take your dose of Ibuprofen Tablets, unless it is almost time for your next
dose, take it as soon as you remember. Otherwise, if you miss a dose do not double the next
dose, just carry on as before.
If you, or someone else, take too much of your medicine contact your doctor
immediately.
Symptoms of overdose include headache, vomiting, stomach pain, diarrhoea, dizziness,
drowsiness, ringing in the ears, disorientation, excitation, coma, fainting and fits.

CAN YOUR MEDICINE HAVE ANY SIDE EFFECTS?

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If any of the following happen, stop taking Ibuprofen and tell your doctor immediately or go
to your nearest hospital emergency department:
 Pass blood in your faeces (stools/motions), pass black tarry stools, vomit any blood or
dark particles that look like coffee grounds
 itchy swollen skin, burning eyes, fever, tightness of the chest and difficulty breathing.
These side effects are rare but serious. You may need medical attention.
Stop taking Ibuprofen and tell your doctor if you experience:
 Indigestion or heartburn
 Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
The most common side effects include heartburn, indigestion, feeling or being sick, vomiting
blood or black vomit, diarrhoea, stomach ache, back ache, wind, constipation, Crohn’s
disease, mouth ulcers, bleeding in the stomach, asthma, tightness of the chest, difficulty in
breathing, bruising more easily than normal, red blotches under the skin, water retention,
stomach upset, skin rashes or itching, headache, nervousness, ringing in the ears or swelling
of the lower legs.
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack
("myocardial infarction") or stroke.
The following side effects rarely occur and include severe skin rashes, scaly dry skin, skin
flaking, problems with the way your liver or kidney’s work, changes in your blood count,
blurred vision or other eyesight changes, headache, painful or tender eyes, stiff neck,
headache, nausea, vomiting, fever or disorientation, feeling strange sensations, depression,
confusion, hallucinations, ringing in the ears, vertigo, dizziness, feeling tired, sensitivity to
light, drowsiness or generally feeling unwell, yellowing of the skin or whites of the eyes, sore
throat, feeling feverish, changes or difficulty passing urine
If you should suffer from any of these unwanted side effects or any undesired effect
please tell your pharmacist or doctor.
DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE SHOWN ON THE LABEL.

REMEMBER this medicine was prescribed by your doctor for you.
DO NOT give it to others. It may harm them.
Store in a cool dry place. Protect from light.
Date of revision of leaflet: 05/2015

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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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