SCHEDULING STATUS<\/p>\n\n\n\n
S1<\/strong><\/p>\n\n\n\n BRUFEN\u00ae 200 Film-coated tablets<\/strong><\/p>\n\n\n\n BRUFEN\u00ae 200 is available without a doctor\u2019s prescription for the treatment of a mild illness. It should still be used carefully to get the best results.<\/p>\n\n\n\n Keep this information because it may be needed again. If further questions arise, ask a doctor or pharmacist.<\/p>\n\n\n\n BRUFEN\u00ae 200 has been prescribed personally and should not be shared with other people. It may harm them, even if their symptoms are the same.<\/p>\n\n\n\n A doctor should be consulted if symptoms worsen or do not improve after 3 days<\/strong>.<\/p>\n\n\n\n Each film-coated tablet contains 200 mg ibuprofen<\/strong>.<\/p>\n\n\n\n The other ingredients include:<\/p>\n\n\n\n BRUFEN\u00ae 200 contains lactose monohydrate<\/strong>.<\/p>\n\n\n\n BRUFEN\u00ae 200 is used for the treatment of mild to moderate pain of inflammatory origin<\/strong> and fever<\/strong>.<\/p>\n\n\n\n It may be used for:<\/p>\n\n\n\n Do not use BRUFEN\u00ae 200 if any of the following apply:<\/p>\n\n\n\n Speak to your doctor or pharmacist before using BRUFEN\u00ae 200 if any of the following apply:<\/p>\n\n\n\n Elderly patients may have an increased frequency of adverse reactions to NSAIDs, including gastrointestinal perforation, ulceration and bleeding, which may be fatal.<\/p>\n\n\n\n Serious skin reactions, some of them fatal, have been reported with non-steroidal anti-inflammatory medicines such as BRUFEN\u00ae 200. BRUFEN\u00ae 200 should be stopped at the first appearance of skin rash, skin lesion or any other sign of hypersensitivity.<\/p>\n\n\n\n Always tell your healthcare professional if you are taking any other medicine, including complementary or traditional medicines.<\/p>\n\n\n\n Tell your doctor if you take:<\/p>\n\n\n\n Keep a list of medicines you take and show it to your doctor and pharmacist whenever you receive a new medicine.<\/p>\n\n\n\n Do not use BRUFEN\u00ae 200 in the last 3 months of pregnancy<\/strong> or during labour.<\/p>\n\n\n\n Do not use BRUFEN\u00ae 200 while breastfeeding.<\/p>\n\n\n\n If pregnant or breastfeeding, consult a doctor, pharmacist or other healthcare professional before taking BRUFEN\u00ae 200.<\/p>\n\n\n\n BRUFEN\u00ae 200 may make you feel drowsy or sleepy, tired, and may disturb your vision.<\/p>\n\n\n\n Do not drive, use tools or operate machines if affected.<\/p>\n\n\n\n Always take BRUFEN\u00ae 200 exactly as instructed by a doctor or pharmacist. Check with a doctor or pharmacist if unsure.<\/p>\n\n\n\n If the effect of BRUFEN\u00ae 200 seems too strong or too weak, speak to a doctor or pharmacist.<\/p>\n\n\n\n The lowest effective dose should be used for the shortest possible duration.<\/p>\n\n\n\n BRUFEN\u00ae 200 may be used for relief of:<\/p>\n\n\n\n The most common symptoms of overdose are pain in the upper middle part of the abdomen and nausea.<\/p>\n\n\n\n Other symptoms may include:<\/p>\n\n\n\n If BRUFEN\u00ae 200 was taken recently, gastric lavage may remove unabsorbed medicine. Treatment is symptomatic and supportive.<\/p>\n\n\n\n In the event of overdose, consult a doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.<\/p>\n\n\n\n If a dose is missed, take it as soon as remembered unless it is almost time for the next dose.<\/p>\n\n\n\n If it is almost time for the next dose, do not take the missed dose.<\/p>\n\n\n\n Do not take a double dose to make up for forgotten individual doses.<\/strong><\/p>\n\n\n\n BRUFEN\u00ae 200 can have side effects.<\/p>\n\n\n\n If any serious reaction occurs, stop taking BRUFEN\u00ae 200 and tell a doctor immediately or go to the casualty department at the nearest hospital.<\/p>\n\n\n\n Keep all medicines out of the reach and sight of children.<\/p>\n\n\n\n Store at or below 25 \u00b0C<\/strong>.<\/p>\n\n\n\n Return any unused or expired medicines to a pharmacist for safe disposal.<\/p>\n\n\n\n BRUFEN\u00ae 200 is supplied in PVC\/Aluminium<\/strong> or PVC\/PVDC\/Aluminium blister strips<\/strong>.<\/p>\n\n\n\n Pack sizes:<\/p>\n\n\n\nPROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM<\/h2>\n\n\n\n
\n\n\n\nRead Before Using BRUFEN\u00ae 200<\/h1>\n\n\n\n
\n\n\n\n1. What BRUFEN\u00ae 200 Contains<\/h1>\n\n\n\n
Other Ingredients<\/h2>\n\n\n\n
Other ingredients<\/th><\/tr><\/thead> Microcrystalline cellulose<\/td><\/tr> Croscarmellose sodium<\/td><\/tr> Lactose monohydrate<\/td><\/tr> Colloidal anhydrous silica<\/td><\/tr> Sodium laurilsulfate<\/td><\/tr> Magnesium stearate<\/td><\/tr> Hypromellose<\/td><\/tr> Talc<\/td><\/tr> Titanium dioxide<\/td><\/tr> Dry color dispersion, white 06A28611<\/td><\/tr> Opaspray white M-1-7111B<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n2. What BRUFEN\u00ae 200 Is Used For<\/h1>\n\n\n\n
Uses<\/th><\/tr><\/thead> Soft tissue injuries such as sprains and strains<\/td><\/tr> Headache<\/td><\/tr> Back pain of musculo-skeletal origin<\/td><\/tr> Fever<\/td><\/tr> Muscular aches and pain<\/td><\/tr> Menstrual pain<\/td><\/tr> Toothache<\/td><\/tr> Pain associated with migraine<\/td><\/tr> Earache<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n3. Before You Use BRUFEN\u00ae 200<\/h1>\n\n\n\n
Do Not Use BRUFEN\u00ae 200<\/h2>\n\n\n\n
Do not use BRUFEN\u00ae 200 if<\/th> Details<\/th><\/tr><\/thead> You are allergic to ibuprofen<\/td> This includes allergy to the active ingredient<\/td><\/tr> You are allergic to any other ingredient in BRUFEN\u00ae 200<\/td> Check the ingredients before use<\/td><\/tr> You have experienced asthma after taking aspirin, ibuprofen or another NSAID<\/td> This may indicate sensitivity to NSAIDs<\/td><\/tr> You have experienced skin rash or allergic-type reaction after aspirin, ibuprofen or another NSAID<\/td> This may indicate a serious allergy risk<\/td><\/tr> You have a history of stomach or bowel perforation or bleeding related to NSAID use<\/td> BRUFEN\u00ae 200 may increase gastrointestinal risk<\/td><\/tr> You have or have had peptic ulceration<\/td> BRUFEN\u00ae 200 may not be suitable<\/td><\/tr> You have ulcerative colitis or Crohn\u2019s disease<\/td> BRUFEN\u00ae 200 may worsen bowel problems<\/td><\/tr> You have heart failure<\/td> BRUFEN\u00ae 200 should not be used<\/td><\/tr> You have renal failure<\/td> BRUFEN\u00ae 200 should not be used<\/td><\/tr> You are in the third trimester of pregnancy<\/td> BRUFEN\u00ae 200 should not be used<\/td><\/tr> You are in labour or delivery<\/td> BRUFEN\u00ae 200 should not be used<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nTake Special Care With BRUFEN\u00ae 200<\/h2>\n\n\n\n
Situation requiring care<\/th><\/tr><\/thead> You are allergic to ibuprofen<\/td><\/tr> You are allergic to other medicines, colourants, preservatives or foods<\/td><\/tr> You are taking other prescription medicines<\/td><\/tr> You are taking medicines bought without a prescription<\/td><\/tr> You are taking herbal medicines<\/td><\/tr> You have asthma<\/td><\/tr> You have high blood pressure<\/td><\/tr> You have heart failure<\/td><\/tr> You have a stomach ulcer<\/td><\/tr> You have bleeding from the stomach or bowel<\/td><\/tr> You have any other gastric complaint<\/td><\/tr> You cannot tolerate milk or dairy products<\/td><\/tr> You have lactose intolerance<\/td><\/tr> You have a history of high blood pressure<\/td><\/tr> You have a history of heart failure<\/td><\/tr> You have a history of peptic ulcers or other stomach or bowel disease<\/td><\/tr> You experience unusual abdominal symptoms, especially bleeding from the stomach or bowel<\/td><\/tr> You are elderly<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nUsing Other Medicines With BRUFEN\u00ae 200<\/h2>\n\n\n\n
Medicine or medicine group<\/th> Possible interaction<\/th><\/tr><\/thead> Medicines for high blood pressure including diuretics<\/td> BRUFEN\u00ae 200 may reduce the effect of anti-hypertensives, ACE inhibitors, beta-blockers and diuretics<\/td><\/tr> Lithium salts<\/td> BRUFEN\u00ae 200 may reduce lithium removal from the body, leading to lithium build-up<\/td><\/tr> Methotrexate<\/td> BRUFEN\u00ae 200 may interact and increase risk of toxicity<\/td><\/tr> Anti-coagulants or anti-platelet agents<\/td> BRUFEN\u00ae 200 may enhance their effect and increase bleeding risk<\/td><\/tr> Selective serotonin reuptake inhibitors<\/td> May increase the risk of bleeding inside the digestive system<\/td><\/tr> Aminoglycosides<\/td> BRUFEN\u00ae 200 may reduce removal of aminoglycosides, increasing their levels<\/td><\/tr> Aspirin<\/td> Concomitant use is not recommended because of increased adverse effects<\/td><\/tr> Digoxin<\/td> BRUFEN\u00ae 200 may reduce digoxin removal, increasing digoxin levels<\/td><\/tr> Ciclosporin<\/td> May increase risk of kidney and liver damage<\/td><\/tr> Corticosteroids<\/td> May increase risk of gastrointestinal ulceration or bleeding<\/td><\/tr> Other non-steroidal anti-inflammatory medicines<\/td> Use of more than one NSAID may increase side-effect risk<\/td><\/tr> Ginkgo biloba<\/td> May increase risk of bleeding<\/td><\/tr> Mifepristone<\/td> BRUFEN\u00ae 200 may decrease the efficacy of mifepristone<\/td><\/tr> Quinolone antibiotics<\/td> May increase the risk of seizures<\/td><\/tr> Tacrolimus<\/td> May increase the risk of kidney damage<\/td><\/tr> Zidovudine<\/td> May increase the risk of blood toxicity<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nPregnancy and Breastfeeding<\/h1>\n\n\n\n
\n\n\n\nDriving and Using Machinery<\/h1>\n\n\n\n
\n\n\n\n4. How to Take BRUFEN\u00ae 200<\/h1>\n\n\n\n
Usual Dose of BRUFEN\u00ae 200<\/h2>\n\n\n\n
Patient group<\/th> Dose<\/th><\/tr><\/thead> Adults<\/td> 1200 mg daily in divided doses<\/td><\/tr> Adults: practical dosing<\/td> 1 to 2 tablets every four hours<\/td><\/tr> Children under 12 years<\/td> Do not give BRUFEN\u00ae 200<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Conditions<\/th><\/tr><\/thead> Mild to moderate pain of soft tissue injuries such as sprains and strains<\/td><\/tr> Toothache<\/td><\/tr> Back pain of musculo-skeletal origin<\/td><\/tr> Earache<\/td><\/tr> Headache<\/td><\/tr> Pain associated with migraine<\/td><\/tr> Muscular aches and pains<\/td><\/tr> Fever<\/td><\/tr> Period pain<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nIf You Take More BRUFEN\u00ae 200 Than You Should<\/h2>\n\n\n\n
Possible overdose symptoms<\/th><\/tr><\/thead> Vomiting<\/td><\/tr> Dizziness<\/td><\/tr> Convulsion<\/td><\/tr> Loss of consciousness<\/td><\/tr> Depression of the central nervous system<\/td><\/tr> Depression of the respiratory system<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nIf You Forget to Take BRUFEN\u00ae 200<\/h2>\n\n\n\n
\n\n\n\n5. Possible Side Effects<\/h1>\n\n\n\n
Side Effects Table<\/h2>\n\n\n\n
System \/ category<\/th> Frequency<\/th> Side effects \/ symptoms<\/th> Recommended action<\/th><\/tr><\/thead> Gastrointestinal system disorders<\/td> Common<\/td> Indigestion, nausea, vomiting, constipation, diarrhoea, abdominal pain, flatulence, black stools, vomiting of blood, bleeding from the stomach or bowel<\/td> Stop taking BRUFEN\u00ae 200 and seek medical advice immediately if bleeding, black stools, vomiting blood or severe symptoms occur<\/td><\/tr> Gastrointestinal system disorders<\/td> Less frequent<\/td> Abdominal discomfort or pain, nausea, vomiting, gastro-intestinal ulcers, sometimes with bleeding<\/td> Tell your doctor immediately<\/td><\/tr> General commonly reported effects<\/td> Common<\/td> Headache, dizziness and rash<\/td> Tell your doctor if troublesome or persistent<\/td><\/tr> Immune disorders<\/td> Less frequent<\/td> Aseptic meningitis, meaning non-infectious inflammation of the membranes covering the brain<\/td> Seek urgent medical attention<\/td><\/tr> Immune disorders<\/td> Less frequent<\/td> Angioedema, a type of swelling affecting deeper layers of the skin, often around the eyes and lips<\/td> Stop taking BRUFEN\u00ae 200 and seek urgent medical attention<\/td><\/tr> Immune disorders<\/td> Less frequent<\/td> Anaphylaxis, a severe and potentially life-threatening allergic reaction<\/td> Stop taking BRUFEN\u00ae 200 and seek emergency medical help<\/td><\/tr> Nervous system disorders<\/td> Frequent<\/td> Dizziness, nervousness, tinnitus, drowsiness and insomnia<\/td> Tell your doctor<\/td><\/tr> Psychiatric disorders<\/td> Frequent<\/td> Depression<\/td> Tell your doctor<\/td><\/tr> Eye disorders<\/td> Frequency not stated<\/td> Visual impairment, changes in visual colour perception, toxic amblyopia<\/td> Tell your doctor immediately<\/td><\/tr> Renal and urinary disorders<\/td> Less frequent<\/td> Acute renal failure, cystitis, haematuria, interstitial nephritis and nephrotic syndrome<\/td> Tell your doctor immediately or seek urgent medical care<\/td><\/tr> Hepatobiliary disorders<\/td> Less frequent<\/td> Hepatotoxicity and abnormalities in liver function tests<\/td> Tell your doctor immediately<\/td><\/tr> Blood and lymphatic system disorders<\/td> Less frequent<\/td> Low blood cell count, anaemia, thrombocytopenia, neutropenia, eosinophilia and agranulocytosis<\/td> Tell your doctor immediately<\/td><\/tr> Hypersensitivity disorders<\/td> Less frequent<\/td> Fever, rashes, exacerbation of asthma and bronchospasm<\/td> Stop taking BRUFEN\u00ae 200 and seek medical advice immediately<\/td><\/tr> Cardiovascular disorders<\/td> Frequency unknown<\/td> Oedema, hypertension and cardiac failure<\/td> Tell your doctor immediately<\/td><\/tr> Skin and subcutaneous tissue disorders<\/td> Frequency unknown<\/td> Bullous reactions, sensitivity of the skin to the sun, blistering and swelling<\/td> Stop taking BRUFEN\u00ae 200 and seek urgent medical attention<\/td><\/tr> Skin and subcutaneous tissue disorders<\/td> Frequency unknown<\/td> Stevens-Johnson syndrome and toxic epidermal necrolysis<\/td> Stop taking BRUFEN\u00ae 200 and seek emergency medical help<\/td><\/tr> Side effects not listed<\/td> Not applicable<\/td> Any side effect not mentioned or any worsening of general health<\/td> Consult a doctor, pharmacist or other healthcare professional<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n6. Storing and Disposing of BRUFEN\u00ae 200<\/h1>\n\n\n\n
\n\n\n\n7. Presentation of BRUFEN\u00ae 200<\/h1>\n\n\n\n