Ibuprofen Tablets Bp 200mg
Patient Information Leaflet
Ibuprofen Tablets BP 200 mg, 400 mg and 600 mg
What you should know about Ibuprofen Tablets
Please read this leaflet carefully before you start to take your tablets. It provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
The active ingredient in IBUPROFEN tablets is Ibuprofen. The tablets are available in three different strengths containing either 200 mg, 400 mg or 600 mg of Ibuprofen.
IBUPROFEN Tablets 200 mg tablets are biconvex and pink in colour.
IBUPROFEN Tablets 400 mg tablets are also biconvex and pink in colour.
IBUPROFEN Tablets 600 mg tablets are capsule shaped and pink in colour.
The inactive ingredients in IBUPROFEN Tablets 200 mg, 400mg and are pregelatinised starch, maize starch, maize starch paste, magnesium stearate, colloidal anhydrous silica, Hydroxypropyl methylcellulose, polyethylene glycol 6000, erythrosine (E127), titanium dioxide (E171) and dioctyl sodium.
Ibuprofen tablets 200 mg also contain purified water.
IBUPROFEN Tablets are available in securitainers of 100, 250, 500 and 1000 tablets.
IBUPROFEN belongs to a group of medicines called anti-inflammatory pain killers. Product licence holder:
Waymade Plc t/a Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR.
Manufacturer responsible for release:
Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR.
What are your tablets for?
IBUPROFEN can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis, swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, low back pain, sprains and strains. IBUPROFEN can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache including migraine.
Do not take this medicine and tell your doctor if:
• You currently have, or have ever previously had, peptic ulceration (ulcer in your stomach
or duodenum) or bleeding in your digestive tract.
• You have ever had an allergic reaction to ibuprofen or to any of the other ingredients.
• You have ever suffered asthma, urticaria or other allergic reactions after taking aspirin, ibuprofen or any similar medicine (known as nonsteroidal anti-inflammatory or NSAIDs).
• You are already taking other non steroidal anti-inflammatory medicine (NSAIDs e.g. ibuprofen or ketoprofen, or COX-2 inhibitors e.g. celecoxib).
• You are in the last trimester of pregnancy.
• You have severe problems with your liver, kidney or heart.
Make sure your doctor knows if:
• You suffer from bowel disorders for example, ulcerative colitis, Crohn's disease or have a history of other gastrointestinal disease.
• You suffer from liver, kidney, heart problems or high blood pressure.
• 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 suffer from or have a history of asthma or other breathing difficulties.
• You have recently undergone major surgery.
There is a risk of renal impairment in dehydrated children and adolescents.
Taking other medicines
Ibuprofen and other medicines that you may be taking sometimes affect each other’s
action.
Tell your doctor if you are taking any other medicines, including:
• Other analgesics for pain relief or non steroidal anti-inflammatory drugs (NSAIDs) including aspirin.
• Anti-hypertensives to treat high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists) and diuretics (water tablets).
• Cardiac glycosides for heart failure e.g. digoxin.
• Lithium (used to treat manic-depressive psychosis or mania).
• Methotrexate (used in the treatment of some types of cancer).
• Ciclosporin and tacrolimus (used to help prevent rejection of transplanted organs).
• Mifepristone (used to produce an abortion).
• Corticosteroids used in the treatment of inflammation, allergic and rheumatic conditions (e.g. hydrocortisone).
• Anticoagulants (e.g. aspirin, warfarin, ticlopidine) to thin your blood.
• A group of antibiotics known as quinoline antibiotics (e.g. ciprofloxacin)
• Selective serotonin reuptake inhibitors (medicines used to treat depression)
• 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, ticlopidin), 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.
You should also mention to your doctor or pharmacist any other medicines that you are taking, including any that you can buy without a prescription.
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.
If you have heart problems, have previously experienced a 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.
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 using machines
Dizziness, drowsiness, fatigue, visual disturbances or headaches are possible undesirable effects after taking NSAIDs. If affected patients should not drive or operate machinery.
What else do you need to know about Ibuprofen tablets?
A small number of people may be sensitive to the sodium benzoate contained in IBUPROFEN 200 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.
How to take Ibuprofen Tablets
Follow your doctor's directions about when and how to take your tablets and look at the label on the bottle. Your pharmacist will also help if you are not sure.
Ibuprofen tablets should be taken with or after food.
Adults; The usual daily dose is 600 mg to 1800 mg spread throughout the day. Your doctor may choose to increase this dose depending on your symptoms, but no more than 2400 mg should be taken each 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.
It is important that you keep taking these tablets until your doctor tells you to stop. Don't stop just because you feel better. If you stop taking the tablets too soon, your condition may get worse.
What to do if you forget a dose, or take too many tablets
If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose.
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 hospital casualty department.
Will Ibuprofen Tablets cause any problems?
As with all medicines, ibuprofen can cause unwanted side effects in some people.
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 Stevens Johnson 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.
Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature.
Nausea (feeling sick), vomiting (being sick), diarrhoea, flatulence (wind), constipation, dyspepsia (indigestion), heartburn, anorexia (loss of appetite), and abdominal pain have all been reported.
Non steroidal anti-inflammatory medicines have been associated with ulcers of the stomach and intestine which may perforate or bleed.
NSAID use has also been associated with inflammation of the stomach and mouth ulcers.
Inflammation of the pancreas has also been reported (pancreatitis).
Using non steroidal anti-inflammatory medicines has also lead to an exacerbation of inflammatory bowel conditions (ulcerative colitis and Crohn’s disease).
Hypersensitivity:
Allergic reactions have been reported following use of NSAIDs.
These may include mild symptoms such as itching and/or rash or more severe symptoms such as swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).
If any of the above occur tell your doctor immediately.
Cardiovascular:
Oedema (swelling), high blood pressure (hypertension) and heart failure have been reported with NSAID use.
Medicines such as ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction”) or stroke.
Other side effects include:
• problems with kidneys including kidney failure and raised levels of protein and blood in the urine.
• inflammation of the liver (hepatitis) and yellowing of the skin (and whites of eyes) (jaundice)
• visual disturbances
• headaches
• pins and needless
• depression
• confusion,
• hallucinations,
• a ringing noise in the ears (tinnitus),
• vertigo,
• dizziness,
• vague feelings of discomfort,
• tiredness
• drowsiness
• sensitivity to light
NSAID use has been associated with a range of blood disorders. Your doctor may decide to perform blood cell counts to determine if there are problems with your blood.
There have been isolated cases of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus).
If you experience any other unusual symptoms whilst taking your tablets, tell your doctor or pharmacist.
Storing your tablets
Do not take your tablets after the expiry date shown on the bottle. Keep them in a safe place where children cannot see or reach them. Your medicine could harm them.
IBUPROFEN Tablets should be stored below 25°C and protected from light.
If your doctor decides to stop the treatment, return any left over to your pharmacist. Only keep the tablets if your doctor tells you to.
Other information
Remember: This medicine is for you and has been prescribed for you by a doctor. Never give it to anybody else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
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Date of preparation: March 2016