Ibuprom Forte 400 mg x 12 tablets US Pharmacia

IBUPROM MAX / IBUPROM MAX Tablet. 400 mg. indications:
IBUPROM is an analgesic drug. It is used in the treatment of inflammatory conditions, which may be one of the causes of pain. The medicinal product lowers body temperature. The indications for use of the drug include the treatment of mild to moderate pain of various origins, including: headache, toothache, muscle pain, back and buttock pain, bone and joint pain. Dysmenorrhea. Fever (especially with flu, colds or other infectious diseases).
IBUPROM MAX / IBUPROM MAX Tablet. 400 mg. dosage and application: 
The usual dose is:
Adults and children over 12 years of age:
For short-term treatment for urgent pain relief: 1 tablet orally every 4 hours (not more than 3 tablets daily).
This medicine should not be used in children under 12 years of age. Do not increase the prescribed dose. If you think that the effect of this medicine is too strong or too weak, consult your doctor. This medicine is intended for short-term use. In case the symptoms remain or worsen, or new symptoms appear, consult your doctor. This medicine should not be taken for more than 3 days without medical advice.
IBUPROM MAX / IBUPROM MAX Tablet. 400 mg. ingredients: 
Ibuprofen – a nonsteroidal anti-inflammatory drug, a derivative of propionic acid
 
PACKAGE LEAFLET: INFORMATION FOR THE USER IBUPROM MAX 400 mg coated tablets IBUPROM MAX 400 mg coated tablets Ibuprofen (Ibuprofen) Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to get the best results from your treatment, you should carefully follow the instructions for use of the medicinal product. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. You should seek medical advice if your symptoms worsen or do not improve after 3 days. If any of the side effects become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist. What this leaflet contains 1. What Ibuprom Max is and what it is used for 2. What you need to know before you take Ibuprom Max 3. How to take Ibuprom Max 4. Possible side effects 5. How to store Ibuprom Max 6. Contents of the pack and other information 1. WHAT IBUPROM MAX IS AND WHAT IT IS USED FOR IBUPROM MAX is a painkiller. It is used to treat inflammation, which is one of the causes of pain. This medicine lowers fever. This medicinal product is indicated for mild to moderate pain of various origins, including headache, migraine, toothache, muscle, back, bone and joint pain, neuralgia. Painful menstruation. Fever (during the course of flu, common cold or other infectious diseases). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROM MAX Do not use Ibuprom Max if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibuprom Max and to other non-steroidal anti-inflammatory drugs (NSAIDs); if after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs you have had allergic symptoms such as rhinitis, urticaria or bronchial asthma, including after treatment with NSAIDs; if you have or have had in the past an active gastric ulcer (s) or duodenal ulcer; if you have a perforated or bleeding ulcer; if you have severe liver, kidney or heart failure; if you are taking other non-steroidal drugs at the same time, including COX-2 inhibitors (increased risk of side effects); in the third trimester of pregnancy, with hemorrhagic diathesis. Warnings and precautions if you have been diagnosed with lupus erythematosus or mixed collagenosis; if you have symptoms of allergic reactions after taking acetylsalicylic acid, if you have been diagnosed with gastrointestinal diseases or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease); if you have been diagnosed with arterial hypertension and/or cardiac dysfunction; if you have been diagnosed with impaired renal function; if you have been diagnosed with impaired liver function; if you have been diagnosed with blood clotting disorders; if you have been diagnosed with active bronchial asthma or have a history of bronchial asthma or symptoms of allergic reactions; bronchospasm may occur after taking this medicine; if you are taking other medicines (especially anticoagulants, diuretics, heart medicines, corticosteroids). There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and may not necessarily be preceded by warning symptoms or may occur in patients who have had similar warning symptoms. In case of gastrointestinal bleeding or ulceration, this medicine should be discontinued immediately. Patients with a history of gastrointestinal disease, especially the elderly, should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), especially at the beginning of treatment. Concomitant, prolonged use of various analgesics may lead to renal damage with a risk of renal failure (analgesic nephropathy). Particular care should be taken (the patient should consult a doctor or pharmacist) before prescribing this medicinal product to patients with hypertension and/or heart failure with fluid retention, hypertension and oedema. associated with the use of HSPBC. Treatment with medicinal products such as ibuprofen may be associated with a slightly increased risk of cardiac event ("myocardial infarction") or stroke. This risk increases with high doses taken for a long time. Do not use higher doses and for longer than recommended. You should consult your doctor if your symptoms persist, worsen or do not go away after three days, or if new symptoms appear. If you have heart problems, a stroke or think you may be at risk of developing them (for example, if you have high blood pressure, diabetes, high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist. Severe skin reactions, some of which have been fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. The risk of developing these severe reactions is highest at the beginning of treatment, in most cases during the first month. The use of this product should be discontinued at the first symptoms: skin rash, mucosal damage or other signs of hypersensitivity. This medicine belongs to the group of non-steroidal anti-inflammatory drugs, which may have an adverse effect on the ability to conceive. This effect is temporary and disappears after discontinuation of treatment. If you have difficulty getting pregnant, consult your doctor before taking Ibuprofen. You should consult your doctor even if the above warnings apply to situations in the past. Use of Ibuprom Max in children This medicine is not indicated for use in children under 12 years of age. Other medicines and Ibuprom Max Do not take Ibuprom Max together with other non-steroidal anti-inflammatory drugs (including cyclooxygenase 2 inhibitors such as celecoxib or etoricoxib), other analgesics or acetylsalicylic acid (in analgesic doses). Please inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, before you start taking ibuprofen, please inform your doctor about the use of the following medicines: acetylsalicylic acid in low doses (75 mg), once a day; antihypertensive medicines or diuretics; medicines that inhibit blood clotting (anticoagulants or antiplatelet agents); corticosteroids (such as prednisolone or dexamethasone); methotrexate (an anticancer agent); lithium (an antidepressant); zidovudine (an antiviral agent). Pregnancy and breast-feeding Pregnancy Ask your doctor before taking any medicine. The use of the medicinal product is not recommended during the first six months of pregnancy. Do not use in women in the third trimester of pregnancy, as it may increase the risk of complications for the mother and child in the period before birth. Breast-feeding Ask your doctor before taking any medicine. Ibuprofen passes into breast milk in very small amounts and there are no known cases of adverse reactions in breast-fed infants. It is not necessary to stop breastfeeding during short-term treatment with ibuprofen at low doses. Driving and using machines There is no data available on the effects of this medicine on the ability to drive and use machines, and on psychophysical abilities when using the medicine at the recommended doses and for the recommended period of treatment. Important information about some of the ingredients of Ibuprom Max If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product. 3. HOW TO TAKE Ibuprom Max Always take Ibuprom Max exactly as described in this leaflet. If you are not sure, ask your doctor or pharmacist. The usual dose is: Adults and children over 12 years of age: For short-term treatment for urgent pain relief: 1 tablet orally every 4 hours (not more than 3 tablets per day). This medicine should not be used in children under 12 years of age. Do not increase the prescribed dose. If you think that the effect of this medicine is too strong or too weak, consult your doctor. This medicine is intended for short-term use. If symptoms persist or worsen, or new symptoms appear, consult your doctor. This medicine should not be taken for more than 3 days without medical advice. If you forget to take Ibuprom Max Do not take a double dose to make up for a missed dose. If you take more Ibuprom Max than you should If you accidentally take a very high dose, contact your doctor as soon as possible, who will take appropriate measures. In most patients, nausea, vomiting, epigastric pain and, less commonly, diarrhea may occur. Tinnitus, headache and gastrointestinal bleeding may also occur. In severe intoxication, the central nervous system is also affected with symptoms of drowsiness and very rarely agitation, disorientation or coma. In very rare cases, seizures may occur. In severe intoxication, metabolic acidosis may occur and the prothrombin time (INR) may be prolonged. Acute renal or hepatic failure may occur. In patients with asthma, asthmatic symptoms may worsen. There is no specific antidote. The doctor will provide symptomatic and supportive treatment. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ibuprom Max can cause side effects, although not everybody gets them. Uncommon side effects (in 1 to 10 out of 1,000 patients taking the medicine): headache, indigestion, nausea, hives, itching. Rare side effects (in 1 to 10 out of 10,000 patients taking the medicine): diarrhea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability and fatigue; swelling due to impaired kidney and urinary tract function. Very rare side effects (in less than 1 out of 10,000 patients taking the medicine): tarry-black stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis or Crohn's disease; gastric and/or duodenal ulcer, gastrointestinal bleeding, perforation, sometimes fatal, especially in elderly patients; in isolated cases, depression, mental reactions and tinnitus, aseptic meningitis have been reported; decreased diuresis, edema, acute renal failure, renal papillary necrosis, increased sodium levels (sodium retention); impaired liver function, especially with prolonged use; disorders of the complete blood count (anemia, leukopenia - reduced number of leukocytes, thrombocytopenia - reduced number of platelets, pancytopenia - a hematological disorder with a deficiency of all normal formed elements: erythrocytes and platelets, agranulocytosis - reduced number of granulocytes). The first symptoms include fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g. bruising, pinpoint hemorrhages, red-purple spots on the skin and mucous membranes, nosebleeds); erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; severe hypersensitivity reactions such as: swelling of the face, tongue and larynx, shortness of breath, tachycardia - cardiac arrhythmias, hypotension - sudden decrease in blood pressure, shock; exacerbation of bronchial asthma and bronchospasm; in patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed collagen diseases) during treatment with ibuprofen there have been isolated reports of symptoms typical of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever and disorientation. When treating NSAIDs in high doses, there have been reports of edema, hypertension and heart failure. Medicines such as Ibuprom Max may be associated with a slightly increased risk of heart attack ("myocardial infarction") or stroke. Side effects are rarely observed when using this product according to needs. Elderly patients are at increased risk of side effects associated with the use of ibuprofen compared to younger patients. The frequency and severity of side effects can be reduced by using the lowest therapeutic dose for the shortest possible time. Some people may experience other side effects while taking this medicine. If any of the side effects become serious or you notice other side effects not described in this leaflet, please tell your doctor. 5. HOW TO STORE Ibuprom Max Store below 25 °C. Keep out of the reach of children. Do not use Ibuprom Max after the expiry date stated on the packaging. Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ibuprom Max contains The active substance is ibuprofen 400 mg. The other ingredients are: Core composition: lactose, povidone, corn starch, talc, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica. Coating composition: sucrose, talc, corn starch, titanium dioxide, carnauba wax, beeswax, white. What Ibuprom Max looks like and contents of the pack Pack types: 6 coated tablets – 1 blister containing 6 tablets. 12 coated tablets – 1 blister containing 12 tablets. 24 coated tablets – 2 blisters containing 12 tablets. Marketing authorisation holder and manufacturer: US Pharmacia Sp.zoo, Poland.