Ibuprofen 200mg Tablets
Information for the user
Read this leaflet carefully because it contains important information for you.
This medicine is available without prescription for you to treat a mild condition without a doctor’s help. However, you still need to use it carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
What this medicine is for
This medicine contains Ibuprofen, which belongs
to a group of medicines called non-steroidal anti-inflammatory
medicines, which act to relieve pain and reduce swelling.
It can be used to relieve headaches, rheumatic and muscular pain, backache, migraine, period pain, dental pain and neuralgia. It can also be used to reduce fever and relieve the symptoms of colds and flu.
Before you take this medicine
These tablets can be taken by adults and children from the age of 12 years. However, some people should not take this medicine or should talk to their pharmacist or doctor first.
Do not take if
• You have a stomach ulcer, perforation or bleeding, or
have had one twice or more in the past
• You have had perforation or a bleeding stomach
after taking a non-steroidal anti-inflammatory medicine (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black, tarry stools)
• You are allergic to ibuprofen or any other ingredients of the product, aspirin or other non-steroidal antiinflammatory medicines (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)
• You are taking aspirin with a daily dose above 75mg, or other non-steroidal anti-inflammatory medicines
• You have severe heart, kidney or liver failure
• You have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose)
• You are pregnant and in the last three months of pregnancy
Talk to your pharmacist or doctor if
• You have asthma, a history of asthma or other allergic disease, bowel problems, ulcerative colitis, Crohn's disease
• You have other kidney, heart or liver problems (see above)
• You have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)
• You are elderly - you may get more side effects (see back of leaflet)
• You are taking any other painkillers or receiving regular treatment from your doctor
• You have had a stroke, or have heart problems, high blood pressure, diabetes, high cholesterol, or you smoke - see ‘Risk of heart attack or stroke’ below
• You are pregnant and in the first 6 months of pregnancy
• You are breastfeeding
• You are an adolescent between the age of 12-18 years and have been taking this medicinal product for more than 3 days or if your symptoms worsen.
Other important information
Risk of heart attack or stroke: Ibuprofen may increase the risk if you take large amounts for a long time. The risk is small. Take the lowest amount for the shortest possible time to reduce the risk.
Women of childbearing age: If you take this medicine, it may reduce your ability to become pregnant. This effect will be reversed when you stop taking the medicine.
There is a risk of renal impairment in dehydrated children and adolescents.
If you take other medicines
Before you take these tablets, please tell your pharmacist about ANY other medicines that you are taking or might be taking at the same time, in particular the following:
• Other pain killers
• Aspirin 75mg (to prevent heart attacks and strokes) -the protection may be reduced when you take ibuprofen
• Tablets that thin your blood (e.g. warfarin)
• Mifepristone (for termination of pregnancy) - do not take ibuprofen if you have taken mifepristone in the last 12 days
• Water tablets (diuretics), medicines to treat high blood pressure (antihypertensives), medicines for heart problems
• Corticosteroids, lithium, methotrexate, zidovudine
• Quinolone antibiotics (for infections)
• Medicines for depression
• Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)
If you are unsure about interactions with other medicines that you may be taking, talk to your pharmacist. This includes medicines prescribed by your doctor and medicines you have bought for yourself, including herbal and homeopathic remedies
AGE HOW MANY HOW OFTEN
|
Adults and |
Two tablets to |
Every four hours, |
|
children over |
begin with. |
if required. |
|
12 years. |
One or two | |
|
tablets after that. |
Do not take more than 6 tablets in 24 hours. Take the lowest amount for the shortest possible time to relieve your symptoms.
Swallow the tablets with water.
Do not give to children under 12 years.
Do not take more than recommended in the table above. If your symptoms worsen at any time, talk to your doctor. If your symptoms do not go away within 10 days, talk to your doctor.
If you take too many tablets
Talk to a doctor straight away. Take your medicine and this leaflet with you.
Possible side effects
Most people can take this medicine without any problems
but sometimes you may notice some side effects.
If you are elderly, you may be more likely to get some of
these side effects.
If you have any of the following serious side effects,
stop taking the tablets and see a doctor straight away:
• You are sick (vomiting) and it contains blood or dark particles that look like coffee grounds
• Pass blood in your stools or pass black, tarry stools
• Stomach problems including pain, indigestion or heartburn
• Allergic reactions such as skin rash (which can sometimes be severe and include peeling and blistering of the skin), swelling of the face, neck or throat, worsening of asthma, difficulty in breathing
• Meningitis (e.g. stiff neck, fever, disorientation)
Talk to your pharmacist if these other less serious side effects concern you:
• Kidney problems, which may lead to kidney failure
• Feeling sick or being sick
• Headache, hearing problems
• High blood pressure, heart failure
• Fluid retention, which may cause swelling of the limbs
• Rarely, liver problems, diarrhoea, wind, constipation, worsening of colitis or Crohn’s disease
• Very rarely, tiredness or severe exhaustion, changes in the blood which may cause unusual bruising and an increase in the number of infections that you get (e.g. sore throats, mouth ulcers, flu-like symptoms)
• A small increased risk of heart attack or stroke if you take large amounts for a long time
If any problem becomes severe, or you notice other side effects not stated here, talk to your pharmacist or doctor.
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.
How to store this medicine
Do not store above 25°C.
Keep this medicine out of the sight and reach of children. Do not use after the Use By date on the end flap of the carton (marked ‘EXP’).
What is in this medicine
Each tablet contains: ibuprofen 200mg. This is the active ingredient.
These tablets also contain maize starch, stearic acid, sucrose, calcium sulphate dihydrate, acacia, sodium carboxymethylcellulose, carnauba wax, shellac, acetylated monoglyceride, povidone, sodium benzoate, titanium dioxide (E171).
The pack contains 2, 4, 6, 8, 12 or 16 white, sugar coated tablets with no markings.
Who makes this medicine
The medicine is manufactured for the Marketing Authorisation holder Max Remedies Ltd, by Max Healthcare Ltd, both located at William Nadin Way, Swadlincote, Derbyshire, DE11 0BB.
Leaflet prepared November 2015.
If you would like any further information about this product, please contact Max Healthcare Ltd, at the above address.
P17165