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IBUPROFEN TABLETS 400MG

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibuprofen Tablets 200 mg, 400 mg and 600 mg
Read all of this leaflet carefully before you start taking this medicine
* Please 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 becomes severe, 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
1. WHAT IBUPROFEN TABLETS ARE AND WHAT THEY ARE USED FOR
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs), which are used to reduce inflammation and pain in the joints or muscles and
can also reduce a fever.
Ibuprofen tablets are used to treat:
* osteoarthritis;
* rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease);
* ankylosing spondylitis (a condition affecting the spine);
* short-term injuries such as frozen shoulder, sprains and strains and other soft tissue
injuries;
* lower back pain;
* toothache, pain after operations, period pain and headache;
* migraine.
2. BEFORE YOU TAKE IBUPROFEN TABLETS
Do not take this medicine if:
* you are allergic to Ibuprofen or to any of the other ingredients;
* you have previously taken another NSAID (e.g. diclofenac) or aspirin and had an
allergic reaction. This reaction may have been signs of asthma (e.g. wheeziness),
runny nose, swelling of the skin or itching;
* you have, or have ever had an ulcer of the stomach or duodenum (gut);
* you have ever suffered from bleeding in the stomach or intestines (gastrointestinal
bleeding) or bleeding in the brain (cerebrovascular bleeding) or you have a bleeding
disorder.
* you have severe problems with your liver, kidney or heart.
Tell your doctor or pharmacist if you are not sure if any of the conditions above
apply to you.

Take special care and tell your doctor or pharmacist before taking this medicine if:
* you have a history of stomach or bowel problems e.g. inflammation of the stomach
(gastritis) or gullet (oesophagitis), ulcerative colitis, Crohn’s disease;
* you are elderly;
* you have any liver, kidney or heart problems including high blood pressure: your doctor
may want to keep a check on these before and during treatment;
* you have, or have had, asthma;
* you suffer from or have a history of haematological (blood) abnormalities;
* you suffer from rare conditions known as systemic lupus erythematosus (SLE) or mixed
connective tissue disorder;
* you are at risk of heart attack or stroke (e.g. if you have diabetes, high cholesterol or are
a smoker). NSAIDs like Ibuprofen may be associated with an increased risk of heart
attack or stroke, so your doctor will want to discuss this with you. Taking ibuprofen in
high doses or for a long time will increase this risk. Do not exceed the recommended
dose or duration of treatment;
* you have recently undergone major surgery.
Tell your doctor or pharmacist if you think any of these apply to you, or you are not sure.
Tell the doctor if you are due to have a liver function test. This is important because
taking Ibuprofen tablets can affect the results.
There is a risk of renal impairment in dehydrated children and adolescents.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any of the
following medicines:
* other non-steroidal anti-inflammatory drugs (NSAIDs including COX-2 inhibitors) e.g.
aspirin, naproxen or any other ibuprofen preparations such as those you can buy without
a prescription;
* any medicine used to treat heart problems or high blood pressure e.g. “water tablets”
such as bendroflumethiazide or furosemide or digoxin, beta-blockers such as atenolol;
* medicines which prevent blood clotting such as warfarin;
* ciclosporin, used to prevent and treat the rejection of an organ transplant and also
used in immune diseases;
* steroids (such as cortisol or cortisone) used to treat inflammation;
* lithium, used to treat depression;
* methotrexate, used to treat some types of cancer, or for psoriasis or rheumatoid
arthritis;
* quinolone antibiotics to treat infections such as ciprofloxacin;
* mifepristone (taken within the last 12 days) which is usually prescribed through
hospitals and is used to cause an abortion.
* selective serotonin reuptake inhibitors (medicines used to treat depression) such as
paroxetine;
* zidovudine (a medicine used to treat viral infections with the Human Immunodeficiency
Virus (HIV));
* anti-platelet agents e.g. ticlodipine, aspirin;
* some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/
acetylsalicylic acid, warfarin, ticlopidine), some medicines against high blood
pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or
angiotensin-II receptor antagonists such as losartan), and other medicines may affect or

be affected by treatment with ibuprofen. You should therefore always seek the advice
of your doctor before you take ibuprofen with other medicines.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine,
including any medicines that you have bought yourself without a prescription.
Pregnancy and breast-feeding
Tell your doctor before taking Ibuprofen if you are or think you may be pregnant or are
breast-feeding. If you are trying to become pregnant, Ibuprofen may make it more difficult
to become pregnant.
Driving and operating machinery
You can drive while taking Ibuprofen but do not drive until you know how the tablets affect
you. They may make you feel light headed, dizzy or drowsy, and may cause blurred vision.
If they affect you in this way DO NOT drive or operate machinery.
Important information about one of the ingredients of Ibuprofen Tablets
A small number of people may be sensitive to the sodium benzoate contained in Ibuprofen
200 mg and 400 mg. If you develop an unexpected skin rash, sore eyes or a sore mouth,
stop taking the tablets and contact your doctor for advice.
3. HOW TO TAKE IBUPROFEN TABLETS
Always take Ibuprofen exactly as your doctor has told you. Check with your doctor or the
pharmacist if you are not sure.
Your doctor will wish to treat you with the lowest dose that is suitable for you, for as short a
time as possible.
Ibuprofen tablets should be taken with or after food.
Adults:
The usual daily dose is between 600 mg and 1800 mg spread throughout the day. Your
doctor may choose to increase this dose depending on your symptoms, but DO NOT
TAKE more than 2400 mg in a day.
Children:
The usual daily dose is 20 mg per kg of bodyweight. Ibuprofen should not be taken by
children weighing less than 7 kg. In juvenile rheumatoid arthritis, up to 40 mg/kg of body
weight daily in divided doses may be taken.
It is important that you keep taking these tablets until your doctor tells you to stop. Do not
stop just because you feel better. If you stop taking the tablets too soon, your condition
may get worse.
If you take more Ibuprofen tablets than you should
Contact your nearest hospital casualty department immediately if you have taken more
tablets than you should, or if someone else has swallowed any. Remember to take this
leaflet and the pack with you to show the doctor, whether or not there are any tablets left.
If you forget to take Ibuprofen
If you forget to take your Ibuprofen tablets, take the next dose 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 dose.
4. POSSIBLE SIDE EFFECTS
As with all medicines, Ibuprofen Tablets can cause side effects although not everybody
gets them. Many years experience have shown that problems with Ibuprofen are rare. If
side effects do occur, they are usually mild.
If you notice:
* swelling of the face, lips, tongue or throat;
* itching or skin rashes;
* difficulty breathing or wheeziness.
Stop taking the medicine and seek medical advice immediately. These may be signs
of an allergic reaction.
If you experience any of the following symptoms at any time during your treatment STOP
TAKING the medicine and seek immediate medical help:
* Passing blood in your faeces (stools/motions).
* Passing black tarry stools.
* Vomiting blood or dark particles that look like coffee grounds.
* Blisters of the eye, mouth, anus, genitals, skin or urethra; peeling of the skin, usually
with a high fever and general weakness (Toxic Epidermal Necrolysis or StevensJohnson Syndrome).
STOP TAKING the medicine and tell your doctor if you experience:
* Indigestion, heartburn, diarrhoea, constipation, wind, loss of appetite (anorexia);
* Abdominal pains (pains in your stomach) or other abnormal stomach symptoms,
stomach ulcer;
* Symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation
(Aseptic Meningitis).
* Sore throats, bruising or bleeding, mouth ulcers, fever, or malaise as NSAID use has
been associated with a range of blood disorders.
Other side effects may include:
* Build up of fluid in the body, including the legs, which causes swelling;
* Inflammation of the pancreas (pancreatitis);
* Oedema (swelling), high blood pressure (hypertension);
* Headache and dizziness, vertigo;
* Generally feeling unwell, drowsy or tired;
* Tingling of the hands and feet (pins and needles);
* Ringing in the ears (tinnitus);
* The skin may be more sensitive to light (photosensitivity);
* Blurred or disturbed vision, or seeing/hearing strange things (hallucinations);
* Depression, mood swings or confusion;
* Inflammation of the kidney, other kidney problems (raised levels of protein and blood in
the urine)or kidney failure;
* Blisters of the eye, mouth, anus, genitals, skin or urethra; peeling of the skin, usually
with a high fever and general weakness (Stevens-Johnson Syndrome);
* Inflammation of the liver (hepatitis);
* Yellowing of the skin or whites of the eyes (jaundice);
* Vague feelings of discomfort;

* Drowsiness;
* Medicines such as Ibuprofen tablets may be associated with a small increased risk of
heart attack (“myocardial infarction”) or stroke.
If any of the side effects get severe, or you experience any other side effect not mentioned
above, tell your doctor or pharmacist.
5. HOW TO STORE IBUPROFEN TABLETS
Do not take your tablets after the expiry date shown on the carton. The expiry date refers
to the last day of that month. Ibuprofen Tablets should not be stored above 25ºC.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
6. FURTHER INFORMATION
What Ibuprofen tablets contain:
The tablets are available in three different strengths containing either 200 mg, 400 mg or
600 mg of the active ingredient Ibuprofen.
The inactive ingredients in Ibuprofen Tablets 200 mg and 400 mg are: sucrose, maize
starch, calcium sulphate dihydrate, stearic acid, acacia, carmellose sodium, titanium
dioxide (E171), erythrosine (E127), shellac, carnauba wax, povidone and sodium benzoate
(E211). Ibuprofen 400 mg tablets also contain silica and pregelled starch.
The inactive ingredients in Ibuprofen Tablets 600 mg are: maize starch, pregelled starch,
hypromellose, macrogol, stearic acid, silica, titanium dioxide (E171) and erythrosine
(E127).
What Ibuprofen tablets look like and the contents of the pack:
IbuprofenTablets 200 mg tablets are round and pink in colour.
Ibuprofen Tablets 400 mg tablets are round and pink in colour.
Ibuprofen Tablets 600 mg tablets are oblong and pink in colour.
Ibuprofen Tablets 200 mg, 400 mg and 600 mg are available in packs of 500, 250 and 100
respectively. The tablets are also available in blister packs of 84.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Waymade Plc t/a Sovereign Medical,
Sovereign House,
Miles Gray Road,
Basildon,
Essex SS14 3FR.

Date of preparation: February 2016

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