ibuprofen Mylan

tablets

Composition:

Each tablet contains 200 mg of ibuprofen (as lysine salt). Each tablet contains 400 mg of ibuprofen (as lysine salt). For a full list of excipients, see section 6.1.

excipients

Tablet core Cellulose, microcrystalline (E460), colloidal anhydrous silica (E551) Crospovidone (E1202) Povidone (E1201) Magnesium stearate (E572) Talc (E553b). Tablet coating Polyvinyl alcohol hydrolyzed (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b). Printing ink Shellac (E904) Black iron oxide (E172) Ammonium hydroxide (E527).

Therapeutic indications

(Only 200 mg) for the symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, and fever and pain in the common cold. (Only 400 mg) for the symptomatic treatment of mild to moderate pain, such as headache, acute migraine headache with or without aura, dental pain, menstrual pain, and fever and pain in the common cold.

Contraindications

Ibuprofen is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients listed in section 6.1, - with previous hypersensitivity reactions (eg. Bronchospasm, angioedema, rhinitis, urticaria or asthma) in response to acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory drugs (NSAIDs), - with existence or history of peptic ulcer / hemorrhage recurrent (two or more distinct episodes of proven ulceration or bleeding), - with a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs - with severe hepatic impairment, severe renal failure or severe heart failure (see section 4.4) - (only 200 mg), children under 20 kg of weight (about 6 years) - (only 400 mg) teenagers the undersized 40 kg or children under 12 years of age - with cerebrovascular bleeding or other active bleeding - with disorders of the formation of an unexplained blood - with severe dehydration (caused by vomiting, diarrhea or insufficient intake liquids), - during the last trimester of pregnancy (see section 4.6).

dosage

Adults and adolescents ≥ 40 kg body weight (12 years of age and over): (only 200 mg) Initial dose: 200 mg or 400 mg. If necessary an additional dose of 1 or 2 tablets (200 mg to 400 mg) can be taken. The corresponding interval between doses should be chosen according to the symptoms and the maximum recommended daily dose. It must not be less than 6 hours for a 400 mg dose and not less than 4 hours for a 200 mg dose. Do not exceed the dose of 1200 mg in any 24 hour period. (Only 400 mg) Initial dose: 400 mg. If necessary may be taken by an additional dose of 400 mg. The corresponding interval between doses should be chosen according to the symptoms and the maximum recommended daily dose. It must not be less than 6 hours for a 400 mg dose. Do not exceed the dose of 1200 mg in any 24 hour period. For the treatment of migraine the dose should be of a tablet of 400 mg as a single dose, if necessary 400 mg with intervals of 4 to 6 hours. Do not exceed the dose of 1200 mg in any 24 hour period. pediatric population (only 200 mg) Children over six years (20 kg - 40 kg body weight): ibuprofen should be used only in children with a body weight of 20 kg. The maximum daily dose of ibuprofen is 20 - 30 mg of ibuprofen per kg of body weight, divided into 3 or 4 individual doses with an interval between doses of 6 to 8 hours. It must not exceed the maximum recommended daily dose. It must not be exceeded a maximum dosage of 30 mg / kg of ibuprofen over a period of 24 hours. Apply the following information on dosing:

body weight Single dose Maximum daily dose
20 kg - 29 kg 1 tablet (200 mg of ibuprofen) 3 tablets (equivalent to 600 mg of ibuprofen)
30 kg - 39 kg 1 tablet (200 mg of ibuprofen) 4 tablets (equivalent to 800 mg of ibuprofen)

Children under 6 years old Ibuprofen Mylan is contraindicated in children less than 6 years. (Only 400 mg) Ibuprofen Mylan is contraindicated in adolescents under 40 kg body weight or in children less than 12 years. It should be used in the minimum effective dose for the shortest time needed to control symptoms. When the product is required for more than 3 days in the chaos of migraine or fever or for more than 4 days for the treatment of pain, or if symptoms worsen, the patient should be advised to seek medical advice. Elderly patients No dose adjustment is necessary. Elderly patients should be monitored particularly carefully because of the possible side effect profile (see section 4.4). Patients with gastric sensitivity Patients with sensitive stomachs should take Ibuprofen Mylan during a meal. Taking ibuprofen after a meal can delay the onset of its action. If this happens, it should not be taken additional ibuprofen in addition to that specified in section 4.2 (Posology) or until the corresponding interval has elapsed between dosi.Pazienti with renal impairment No dose reduction is required in patients with impaired renal function mild and moderate. For patients with severe renal impairment, see section 4.3. Patients with hepatic impairment No dose reduction is required in patients with hepatic impairment Mild and moderate. For patients with severe hepatic dysfunction, see section 4.3. Method of administration For oral administration and short term use. Ibuprofen tablets should be swallowed whole with water. Do not chew the tablets.

Warnings and Precautions

The side effects can be minimized by using the lowest effective dose for the shortest time necessary to obtain symptom control (see effects on gastrointestinal and cardiovascular systems). Caution should be exercised when administering ibuprofen in patients suffering from the following conditions, which may worsen: - congenital disorders of porphyrin metabolism (eg. Acute intermittent porphyria) - Coagulation disorders (ibuprofen may extend the life of clotting), - directly after major surgery, - systemic lupus erythematosus and mixed connective tissue disease (eg. increased risk of aseptic meningitis) (see section 4.8), - hypertension and / or heart failure, since renal function may deteriorate (see sections 4.3 and 4.8), - in patients who suffer from hay fever, nasal polyps or chronic obstructive respiratory ailments, because for them there is an increased risk of allergic reactions. These may have an asthma attack (so-called analgesic asthma), Quincke's edema or urticaria, - in patients who react with allergy to other substances, since there is also an increased risk of developing hypersensitivity reactions while using ibuprofene.Anziani the elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation, which may be fatal. respiratory reactions A bronchospasm may be precipitated in patients suffering from bronchial asthma or allergic disease or a history of these diseases. Other NSAIDs The use of ibuprofen with other NSAIDs, including selective inhibitors oxygenase-2 cycle, increases the risk of adverse reactions and should be avoided (see section 4.5). Renal effects Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). In general terms, the habitual intake of analgesics, in particular the association of different analgesic substances, can lead to a permanent renal damage with the risk of renal failure (analgesic nephropathy). This risk may be increased under physical strain associated with loss of salt and dehydration. It should therefore be avoided. Hepatic effects Liver dysfunction (see sections 4.3 and 4.8). And 'appropriate to discontinue therapy with ibuprofen when there is deterioration in liver function in conjunction with its administration. Following withdrawal of treatment, usually it returns to normal health. It 'also appropriate an occasional monitoring of blood glucose. Cardiovascular and cerebrovascular effects It requires special care (discuss with your doctor or pharmacist) before initiating treatment in patients with a history of hypertension and / or heart failure, because in combination therapy with NSAIDs have been reported fluid retention, hypertension and edema . Patients suffering from uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ibuprofen after careful consideration. A similar caution is also necessary before starting the long-term treatment in patients with risk factors for cardiovascular disease (eg. Hypertension, hyperlipidemia, diabetes mellitus, smoking). Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke ). In general, epidemiological studies do not indicate that low doses of ibuprofen (eg. ≤1200 mg per day) are associated with an increased risk of myocardial infarction. Impairment of female fertility There is some evidence that drugs which inhibit the synthesis of cyclooxygenase / prostaglandin synthesis, may cause changes in female fertility by an effect on ovulation. This is reversible upon discontinuation of treatment (see section 4.6). GI safety NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). During treatment with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events, they were reported gastrointestinal bleeding, ulceration or perforation, which can be fatal. In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and the elderly, the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses. These patients should start treatment with the lowest available dose. It is appropriate considering the concomitant use of protective agents (eg. Misoprostol or proton pump inhibitors) and for these patients and for patients taking low-dose acetylsalicylic acid concomitantly or other drugs that may increase the risk of gastrointestinal events ( see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be exercised when treating patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid (see section 4.5). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Skin reactions Serious skin reactions, some of them fatal, as exfoliative dermatitis syndrome Steven - Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy patients appear to be at highest risk of these reactions: in fact, the onset of the reaction occurs in the majority of cases within the first month of treatment. The use of ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Exceptionally varicella can cause serious skin reactions and infectious complications to the soft tissues. So far, the contributory role of NSAIDs in the worsening of these infections can not be excluded. Therefore we recommend to avoid the use of ibuprofen in case of varicella. Other observations In rare cases were observed severe acute hypersensitivity reactions (eg. Anaphylactic shock). Therapy should be discontinued at the first signs of a hypersensitivity reaction after taking / administration of ibuprofen. Appropriate medical procedures to symptoms must be performed by skilled personnel. Ibuprofen may mask the signs or symptoms of an infection (fever, pain and swelling). Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore it is recommended to carefully monitor patients with coagulation disorders. In prolonged administration of ibuprofen, it is recommended regular monitoring of hepatic tests, kidney function and blood cell counts. Prolonged use of any type of painkiller for headaches can cause a deterioration. If you encounter or suspect such a situation, you should get medical advice and treatment should be discontinued. The diagnosis of medication overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of medication for the headache. Headache from overuse of drugs should not be treated by increasing the dose of the medicine. During treatment with ibuprofen, some cases with symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed in patients with preexisting autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease ). Alcohol consumption should be avoided since it may intensify side effects of NSAIDs, especially those related to the gastrointestinal tract or the central nervous system. Patients in treatment with ibuprofen should report to the doctor signs or symptoms of gastrointestinal ulcers or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or edema. If problems appear to vision, blurred vision, scotoma or malfunction of color perception, treatment discontinuation is required.

interactions

The use of ibuprofen should be avoided in combination with ASA (low dose): Unless low-dose ASA (no more than 75 mg / day) has been recommended by your doctor, because it may increase the risk of adverse reactions (see section 4.4). Experimental data suggest that ibuprofen may inhibit the effect of acetylsalicylic acid on platelet aggregation at low doses when the two drugs are co-administered. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation, do not allow firm conclusions to the regular use of ibuprofen, and no clinically relevant effect is considered likely following occasional use of ibuprofen (see section 5.1). Other NSAIDs including salicylates and selective cyclooxygenase-2: avoid concomitant use of two or more NSAIDs, because it may increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect (see section 4.4). Anticoagulants. NSAIDs may enhance the effect of anticoagulants, such as warfarin (see section 4.4). Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (eg. Dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit cyclo-oxygenase system, may have as result in further deterioration of renal function, including acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and subsequently at regular intervals. Potassium-sparing diuretics: The concomitant administration of ibuprofen and potassium-sparing diuretics can lead to hyperkalemia (recommended to be monitored in serum potassium). Corticosteroids: increased risk of adverse reactions, especially of the gastrointestinal tract (gastrointestinal ulceration or bleeding) (see section 4.4). Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4) Digoxin: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma levels of digoxin. A check of serum digoxin is not required, as a rule, the correct use (maximum 4 days). Phenytoin: concomitant use of ibuprofen with fenotoina preparations can aumentar and serum levels of phenytoin. A check of serum phenytoin is not required, as a rule, the correct use (maximum 4 days). Lithium: There is evidence for potential increases in plasma levels of lithium. A serum lithium control is not required, as a rule, the correct use (maximum 4 days). Methotrexate: the administration of ibuprofen within 24 hours before the administration of methotrexate can lead to an increase in the concentration of methotrexate and an increase of toxic effects. Cyclosporine: The risk of a detrimental effect on the kidneys due to ciclosporin is increased by co-administration of some NSAIDs. This effect can not be excluded for the association of cyclosporine with ibuprofene.Mifepristone. NSAIDs should not be used for 8-12 days after administration of mifepristone, because NSAIDs can reduce the effect of mifepristone. Sulfinpyrazone: medicines containing sulfinpyrazone may delay the excretion of ibuprofen. Probenecid: medicines that contain probenecid may reduce the excretion of NSAIDs and may increase their serum concentrations. Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are administered concomitantly with tacrolimus. Zidovudine: Increased risk of haematological toxicity when NSAIDs are administered concomitantly with zidovudine. It is recommended that a count of blood cells 1-2 weeks after the start of co-administration. There are indications of an increased risk of haemarthroses and hematoma in HIV-positive haemophiliac patients receiving concomitant treatment with zidovudine and ibuprofen. Sulfonylureas: NSAIDs can either increase or decrease the blood glucose lowering effect of sulfonylureas. Caution is advised in case of simultaneous treatment. quinolone antibiotics: animal studies indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Alcohol, bisphosphonates, oxpentifylline (pentoxifylline) and sulfinpyrazone: may enhance the effects and the risk of gastrointestinal bleeding or ulceration. Baclofen: increased toxicity of baclofen.

Side effects

The possible side effects are those seen with ibuprofen acid. The most commonly observed adverse events are gastrointestinal in nature. May occur peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly (see section 4.4). After administration of ibuprofen were reported nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Less frequently, gastritis has been observed. Side effects are mainly dose-dependent and vary individually. In particular the risk of gastrointestinal bleeding is dependent on dose and duration of treatment. For other risk factors, see section 4.4. clinical and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long term treatment may be associated with a slightly increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). In association with NSAID treatment they have been reported edema, hypertension and heart failure. Some of he side effects listed below are less frequent when the maximum daily dose is 1200 mg compared to treatment at high doses in rheumatic patients. Assessment of adverse reactions is normally based on the following frequencies: Very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1,000 to <1/100), rare ( ≥1 / 10,000 to <1/1000), very rare (<1 / 10,000), not known (can not be determined from the available data). # See "Description of selected adverse reactions", below. Blood and lymphatic disorders: Very rare: haematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). # Immune system disorders: Uncommon: hypersensitivity reactions such as urticaria, pruritus, purpura and exanthema as well as asthma attacks (sometimes with hypotension) (see section 4.4). Rare: lupus erythematosus syndrome. Very rare: severe hypersensitivity reactions. Symptoms may include: facial edema, swelling of the tongue and the interior of the larynx with constriction of the respiratory tract, shortness of breath, tachycardia, drop in blood pressure to the point of a life-threatening shock (see section 4.4). Exacerbation of inflammation associated with infections (eg in. Development of necrotising fasciitis) coinciding with the use of NSAIDs. # Psychiatric disorders: Rare: depression, confusion, hallucinations, psychotic reactions. Nervous system disorders: Common: headache (see section 4.4), drowsiness, dizziness, fatigue, agitation, dizziness, insomnia, irritability. Moto rare: aseptic meningitis. #. Eye disorders: Common: visual disturbances. # Rare: toxic amblyopia. Ear and labyrinth disorders: Rare: tinnitus. Cardiac disorders: Very rare: palpitations, heart failure (see section 4.4), myocardial infarction, acute pulmonary edema, edema (see section 4.4) Vascular disorders: Very rare: arterial hypertension (see section 4.4) Respiratory, thoracic and mediastinal disorders: Uncommon: rhinitis, bronchospasm. Gastrointestinal disorders: Very common: Gastrointestinal disorders such as heartburn or indigestion, abdominal pain, nausea, vomiting, flatulence, diarrhea, stipsi.Comuni: gastrointestinal ulcers, sometimes with bleeding and perforation (see section 4.4), occult blood loss that can lead to anemia, melaena, haematemesis, ulcerative stomatitis, colitis, exacerbation of inflammatory bowel disease, complications of colonic diverticula (perforation, fistula). Uncommon: gastritis. Very rare: oesophagitis, pancreatitis, intestinal narrowing. Hepatobiliary disorders: Very rare: liver dysfunction, liver damage, especially long-term use, liver failure, acute hepatitis and jaundice. Skin and subcutaneous tissue disorders: Uncommon. Photosensitivity. Very rare: severe skin reactions (erythema multiforme, exfoliative dermatitis, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia, necrotising fasciitis (see section 4.4). Serious skin infections with complications of soft tissue can occur during chickenpox. renal and urinary disorders: Uncommon: development of edema, especially in patients with arterial hypertension or renal failure, nephrotic syndrome, interstitial nephritis that may be associated with renal failure. # Rare: renal papillary necrosis. # pregnancy conditions, puerperium and perinatal conditions: Very rare: menstrual disturbances. diagnosticiRari Investigations: increased blood urea nitrogen, transaminases and alkaline phosphatase, decrease in hemoglobin and hematocrit, platelet aggregation, prolonged bleeding time, decrease serum calcium, increased uric acid. Description of selected adverse reactions Blood and lymphatic system: the first symptoms or signs may include: fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding. These blood dyscrasias may occur in particular after long-term use of high doses. In long-term therapy, blood tests should be performed regularly (see section 4.4). Immune system disorders: These can be in connection with the mechanism of action of NSAIDs. If during administration of ibuprofen, occur or are aggravated signs or symptoms of infection, it is recommended to patients to seek immediate medical attention. It must check whether there is an indication for anti-infective / antibiotic therapy. Nervous system disorders During treatment with ibuprofen were observed symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or clouding of consciousness. Patients with autoimmune collagen diseases (systemic lupus erythematosus, mixed connective tissue disease) appear to be predisposed. Eye disorders reversible disorders were observed eye, as toxic amblyopia, blurred vision and changes in color perception. In case of such reactions, ibuprofen should be discontinued. Renal and urinary disorders: There may be varying degrees of renal impairment, particularly with long-term use of high doses. A sudden worsening of kidney function may also be associated with a generalized hypersensitivity reaction. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may negatively affect pregnancy and / or the embryo / fetus. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. It is believed that the risk increases with dose and duration of therapy. In animals, administration of inhibitors of prostaglandin synthesis induced an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, in animals to which inhibitors of the synthesis of prostaglandins were administered during organogenesis, there was one reported increased incidences of various malformations, including cardiovascular. During the first and second trimester of pregnancy, ibuprofen should not be given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - Renal dysfunction, which may progress to renal failure with oligo hydramnios; • the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time and antiplatelet effect which may occur even at very low doses; - Inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, the use of ibuprofen is contraindicated during the third trimester of pregnancy. Lactation Only small amounts of ibuprofen and products of its metabolism are excreted in breast milk. Because no known side effects in nursing infants, it is not generally necessary to stop breast-feeding during short-term use and the doses recommended for the treatment of mild to moderate pain. However, in the case of prescription of the drug or for prolonged treatment at high doses, it must be taken into consideration early weaning. Fertility There is no evidence to show that drugs that inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility as a result of an effect on ovulation. This event is, however, reversible on discontinuation of treatment.