Ibuprofen 200mg Tablets
Information for the user
Ibuprofen 200mg Tablets
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.
If any side effects get 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 200mg Tablets are and what they are used for
2. Before you take Ibuprofen 200mg Tablets
3. How to take Ibuprofen 200mg Tablets
4. Possible side effects
5. How to store this medicine
6. Further Information
1. What Ibuprofen 200mg Tablets are and what they are used 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, pain from non-serious arthritic conditions, backache, migraine, period pain, dental pain and neuralgia. It can also be used to reduce fever and relieve the symptoms of colds and flu.
2. Before you take Ibuprofen 200mg Tablets Do not take if you:
• have a stomach ulcer, perforation or bleeding
or have had one twice or more in the past
• 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)
• are allergic to ibuprofen or any other ingredients of the product, aspirin or other non-steroidal anti-inflammatory medicines, (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)
• are taking aspirin with a daily dose above 75mg or
other non-steroidal anti-inflammatory medicines
• have severe heart, kidney or liver failure
• have an intolerance to some sugars, unless your doctor tells you to, (this medicine contains sucrose)
• are pregnant and in the last 3 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
♦ have other kidney, heart or liver problems,
(see above)
♦ have a connective tissue disorder such as SLE,
(Systemic Lupus Erythematosus)
♦ are elderly - you may get more side effects,
(see back of leaflet)
♦ are taking any other painkillers or receiving regular treatment from your doctor
♦ 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
♦ are pregnant and in the first 6 months of pregnancy
♦ are breastfeeding
♦ 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. However, tell your doctor before taking this medicine if you have problems becoming pregnant
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. Pregnancy and breast feeding Tell your doctor if you become pregnant whilst taking this medicine. Speak to your doctor or pharmacist before taking this medicine if you are breastfeeding. Do not take this medicine in the last 3 months of pregnancy.
Avoid the use of this medicine in the first 6 months of pregnancy, unless the doctor advises otherwise.
1 or 2 tablets up to 3 times a day, as required
Every 4 hours, if required
For short term use only. Do not take more than 6 tablets in 24 hours. Leave at least 4 hours between doses. Take the lowest amount for the shortest possible time to relieve your symptoms.
3. How to take Ibuprofen 200mg Tablets
If the foil is broken do not take that tablet.
HOW MANY HOW OFTEN
Adults and children and adolescents between 12-18 years
Swallow the tablets with water.
Do not give to children under 12 years.
Children and adolescents between 12 -18 years:
If this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
Adults: Do not take for longer than 10 days unless your doctor tells you to. If symptoms persist, the pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.
If you take too many tablets:
Talk to a doctor straight away. Take your medicine and this leaflet with you.
4. Possible side effects Like all medicines, Ibuprofen can cause side effects although not everybody gets them. Side effects may be minimized by taking the lowest dose for the shortest time necessary to relieve the symptoms.
You may suffer one of the known side effects of NSAIDs (see below). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
STOP TAKING the medicine and seek immediate medical help if you develop signs of:
• intestinal bleeding such as: bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds
• serious allergic reaction such as difficulty breathing or unexplained wheezing, dizziness or faster heartbeat. Severe forms of skin reaction such as itchiness, skin rash with redness, peeling, flaking or blistering (e.g. Steven-Johnson syndrome). Swelling of your face, tongue or throat
• kidney problems such as passing less or more urine, cloudy urine or blood in urine.
Pain in the back and /or swelling (particularly in the legs)
• aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness. Patients with auto-immune disorders (lupus, mixed connective-tissue disease) may be more likely to be affected.
STOP TAKING the medicine and tell your doctor if you experience the following uncommon side effects
which affect 1 to 10 users in 1,000:
• Indigestion, heartburn or feeling sick
• Pains in your stomach (abdomen) or other abnormal stomach problems
TELL YOUR DOCTOR if you have any of the following side effects, they become worse or you notice any side effect not listed:
Uncommon side effects which affect 1 to 10 users in 1,000:
• allergic reactions, such as skin rashes (urticaria), itching, peeling
• headaches.
Rare side effects which affect 1 to 10 users in 10,000:
• flatulence (wind), diarrhoea, constipation and vomiting. Very rare side effects which affect less than 1 user in 10,000:
• blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and sever exhaustion
• drop in blood pressure or irregular heartbeat
• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)
• liver problems
Side effects with which the frequency cannot be estimated from available data:
• worsening of asthma or bronchospasm
• swelling (oedema), high blood pressure, heart failure or attack
• worsening of colitis and Crohn's disease.
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction), or stroke See section 2. 'Other important information'. 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.
5. 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’).
6. Further Information
Each tablet contains: ibuprofen 200mg. This is the active ingredient. 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, 16, 24, 48, 84 or 96 white sugar coated tablets, (not all pack sizes may be marketed).
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 revised August 2016.
If you would like any further information about this product, please contact Max Healthcare Ltd, at the above address. P17349 MH/DRUGS/KD-492 PLL820T