IBUPROFENE DOC 12CPR RIV 400MG

IBUPROFENE DOC 400 MG COMPRESSE RIVESTITES WITH FILM

active ingredients

Each film-coated tablet contains 400 mg of ibuprofen. For the full list of excipients, see paragraph 6.1.

Excellent

Compressed core: corn starch, pregelatinized starch, microcrystalline cellulose, anidra colloidal silica, magnesium stearate. Coating of the tablet: cellulose/polyoxide derivative 40 stearate, ipromellose, titanium dioxide, propylenglycol, macrogol 8000.

Therapeutic indications

Pain from various origins and nature: headaches, toothaches, nerves, muscle pain and osteoarthritis, menstrual pain. Helpful in the symptomatic treatment of feverish and flu states.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - Subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAID), especially when hypersensitivity is associated with nasal polyposes, angioedema and/or asthma. - Severe liver failure. - Severe renal insufficiency (glomeral filtration less than 30 ml/min). - Severe heart failure (IV class NYHA). - Severe or active peptic ulcer. - History of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/recurring peptic ulcer (two or more separate episodes of proven ulceration or bleeding). - Ibuprofen should not be given to patients with clinical conditions that result in an increase in the tendency to bleeding. - Ibuprofen is contraindicated during the third trimester of pregnancy (see paragraph 4.6). - Severe dehydration (caused by vomiting, diarrhea or insufficient liquid intake). - IBUPROFENE DOC is contraindicated in children under 12 years of age.

Population

Population The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see paragraph 4.4). Adults and teenagers over 12 years One tablet 2 - 3 times a day. Do not exceed the dose of 1200 mg (3 tablets) in 24 hours. In case the use of the medicinal product is necessary for more than 3 days in adolescents aged 12 or over, or in case of worsening of symptomatology, the doctor must be consulted. If symptoms persist or worsen, or if treatment with IBUPROFENE DOC is required for a period of more than 3 days in case of fever and 5 days in case of pain, adult patients should consult the doctor. Pediatric population The safety and effectiveness of IBUPROFENE DOC in children under 12 years has not yet been established and therefore IBUPROFENE DOC is contraindicated in children under 12 years of age. Special popularity Senior population Senior patients must comply with the minimum doses indicated. Renal Compromise In patients with mild or moderate renal function reduction, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored. In the presence of kidney failure, elimination can be reduced and posology is therefore appropriate. Epathetic Comprogation In patients with mild or moderate reduction of liver function, the dosage must be kept as low as possible for the shortest duration necessary to control symptoms and liver function must be monitored. IBUPROFENE DOC and contraindicated in patients with severe liver failure (see paragraph 4.3). Method of administration Oral administration. In order to obtain a faster onset of action, the dose can be taken on an empty stomach. In patients with gastric sensitivity it is recommended to take IBUPROFENE DOC with food. Take IBUPROFENE DOC with a glass of water. To avoid oral discomfort and throat irritation the tablets should be swallowed whole and should not be chewed, broken, broken or sucked.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Caution is required in patients suffering from certain conditions, which may worsen: • congenital disorders of porphyrin metabolism (e.g. intermittent acute porphyria); • Lupus Eritematoso Sistemico and mixed connective tissue disease - increased risk of aseptic meningitis (see paragraph 4.8); • directly after major surgery; • in patients who react allergicly to other substances, since there is an increase in the risk of hypersensitivity reactions even with the use of IBUPROFENE DOC; • in patients suffering from hay fever, nasal polyps or chronic obstructive respiratory diseases since there is an increase in the risk of allergic reactions for them. These may occur as attacks of asthma (called analgesic asthma), edema of Quincke or hives. The use of IBUPROFENE DOC in conjunction with other NSAIDs, including selective cycloxygenase-2 inhibitors (COX-2), must be avoided due to an increase in the risk of ulceration or bleeding (see paragraph 4.5). Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2 and below paragraphs on gastrointestinal and cardiovascular risks). Masking the symptoms of underlying infections IBUPROFENE DOC can mask the symptoms of infection, which may delay the start of proper treatment and thus worsen the outcome of the infection. This was observed in bacterial pneumonia acquired in communities and bacterial complications of chickenpox. When IBUPROFENE DOC is administered for relief from fever or pain related to infection, it is recommended to monitor the infection. In non-hospital contexts, the patient should contact the doctor if symptoms persist or worsen. Seniors Senior patients have an increase in the frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). Gastrointestinal bleeding, ulceration and drilling During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. For these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events should be taken into account the concomitant use of gastroprotector agents (misoprostol or protonic pump inhibitors) (see below and paragraph “Interactions”). Patients with history of gastrointestinal toxicity, particularly elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent to patients taking medications at the same time that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or pyastrinic antiaggregant agents such as acetilsalicylic acid (see paragraph 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking IBUPROFENE DOC the treatment must be suspended. NSAIDs should be given with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Cardiovascular and cerebrovascular effects Adequate monitoring and appropriate instructions are necessary in patients with positive anamnesiums for hypertension and/or mild to moderate congestive heart failure, as fluid and edema retention was found in association with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not suggest that low doses of ibuprofen (e.g. ≤1200 mg/die) are associated with increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (II-III class NYHA), proven ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and should avoid high doses (2400 mg/die). Careful consideration should be exercised even before starting long-term treatment patients with risk factors for cardiovascular events (p.es. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit), especially if high doses (2400 mg/die) of ibuprofen are required. Severe skin reactions Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk, the onset of reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. Treatment with IBUPROFENE DOC should be stopped at the first appearance of signs and symptoms of severe skin reactions such as rash, mucosa lesions or any other sign of hypersensitivity. In exceptional cases, chickenpox can be the origin of severe skin and infectious complications of soft tissues. So far, the contribution of NSAIDs in the worsening of these infections cannot be excluded. Therefore, it is recommended to avoid the use of IBUPROFENE DOC in case of chickenpox. Renal effects When treatment with ibuprofen begins, care should be given to patients with considerable dehydration. Long-term use of ibuprofen, as with other NSAIDs, has led to kidney papillar necrosis and other kidney pathological alterations. In general, the habitual use of analgesics, especially of the associations of different active analgesics, can lead to permanent kidney injuries, with the risk of kidney failure (nephropathy from analgesics). This risk can increase in case of physical effort associated with loss of salts and dehydration. This condition must therefore be avoided. Renal toxicity has been found in patients where kidney prostaglandins have a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients may result in a dose-dependent reduction in prostaglandin formation and, as a secondary effect, kidney blood flow. This can lead quickly to kidney failure. Patients most at risk of these reactions are those with reduced kidney function, heart failure, liver dysfunction, elderly and all those patients taking diuretics and ACE inhibitors. The suspension of treatment with NSAIDs is usually followed by the recovery of pretreatment. In case of prolonged use, watch the kidney function, especially in case of widespread erythematous lupus. In dehydrated children and adolescents there is a risk of alteration of kidney function. Respiratory disorders IBUPROFENE DOC should be prescribed with caution in patients with bronchial asthma or allergic diseases in place or in advance because it may arise bronchospasm. The same applies to those who have manifested bronchospasm after the use of aspirin or other NSAIDs. Reactions of hypersensitivity Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of medication. The risk of hypersensitivity reactions after hiring ibuprofen is greater in individuals who have presented such reactions after the use of other analgesic, antipyretic, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), nasal polyposi or previous angioedema episodes (see sections 4.3 and 4.8). Reduced heart, kidney and liver function Particular caution should be taken in the treatment of patients with reduced heart, liver or kidney function. In such patients, periodic monitoring of clinical and laboratory parameters should be used, especially in case of prolonged treatment. Ematologic effects Ibuprofen, like other NSAIDs, can inhibit piastrinic aggregation and has given evidence to prolong bleeding time in healthy subjects. Therefore it is recommended to carefully monitor patients with clotting disorders or in therapy with anticoagulants. Synthetic Meningitis On rare occasions in patients with ibuprofen has been observed aseptic meningitis. Although it is more likely that this occurs in patients with systemic erythematous lupus and related connective tissue pathologies, it was also observed in patients who did not manifest concomitant chronic pathologies (see paragraph 4.8). Ocular alterations are detected during animal studies with non-steroidal anti-inflammatory drugs, it is recommended, in case of prolonged treatments, to carry out periodical ophthalmologic controls. Prolonged use of any headache painkiller can make it worse. If this situation is manifested or suspected, you should ask for advice to the doctor and treatment must be stopped. Diagnosis of drug abuse headache (MOH) must be suspected in patients who have frequent or daily headache despite (or due to) regular use of headache medications. Following concurrent consumption of alcohol, the side effects related to the active ingredient, especially those concerning the gastrointestinal tract or the central nervous system, can increase during the use of NSAIDs. Comprogation of fertility The use of IBUPROFENE DOC, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant (see also section 4.6).The administration of IBUPROFENE DOC should be suspended in women who have fertility problems or who are undergoing investigation of fertility.

Interactions

Ibuprofen (like other NSAIDs) should not be used in combination with: - acetylsalicylic acid: the concomitant administration of ibuprofen and acetylylylethyl acid is not generally recommended due to the potential increase in unwanted effects. Experimental data suggests that ibuprofen can competitively inhibit the effect of acetylsalicylic acid at low doses on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainty regarding the extrapolation of these data to the clinical situation, the possibility that regular long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No significant clinical effect is considered likely due to occasional use of ibuprofen (see paragraph 5.1). This interaction can reduce the desired effect of cardiovascular protection of acetylsalicylic acid. Therefore, ibuprofen should only be used with particular caution in patients treated with acetylsalicylic acid for the inhibition of platelet aggregation. - other NSAIDs including salicylates > 100 mg/die: these substances may increase the risk of adverse reactions to the gastrointestinal tract (see paragraph 4.4). It is however appropriate not to associate ibuprofen with other NSAIDs (see paragraph 4.4). The following combinations should be avoided with ibuprofen: - anticoagulants (dicumarolici): nSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). It is appropriate to monitor patients in treatment with cumarinics. Experimental studies show that ibuprofen strengthens warfarin effects on bleeding time. The NSAIDs and dicumarolics are metabolized by the same enzyme CYP2C9. - anti-aggregating agents: nSAIDs should not be associated with antiplatelet agents such as ticlopidine due to the additive inhibition of the pyastrinic function (see below). - methotrexate: nSAIDs may inhibit the tubular secretion of methotrexate and reduce its clearance, resulting in an increased risk of toxicity;consequently, in case of treatment with high doses of methotrexate, the prescription of NSAIDs should always be avoided (see below). - cardiac glycosides: nSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides. - Cox-2 inhibitors: concurrent use with other NSAIDs, including selective cycloxygenase-2 inhibitors, must be avoided by potential additive effect (see paragraph 4.4). - plant extracts: Ginkgo Biloba may increase the risk of bleeding in combination with NSAIDs. - mifepristone: due to the anti-prostaglandiniche properties of the NSAIDs can theoretically determine a decrease in the effectiveness of the medicinal product. The limited evidence suggests that co-administration of NSAIDs on the day of administration of prostaglandins does not negatively affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility and does not reduce the clinical effectiveness of the drug on the interruption of pregnancy. - solfaniluree: nSAIDs can increase the effect of sulphur dioxide. Rare cases of hypoglycemia have been reported in patients treated with sulphanluree taking ibuprofen. - zidovudina: increased risk of blood toxicity in case of co-administration with NSAIDs. There is evidence of an increase in the risk of hematoma and hematoma in hemophiliac patients with HIV in contemporary treatment with Zidovudine and other NSAIDs. The following associations with ibuprofen may require a dose adjustment: - aminoglycosides: nSAIDs can decrease the excretion of aminoglycosides. - lithium: the simultaneous administration of lithium and NSAID causes increased plasma levels of lithium by reduced elimination, with the possibility of reaching the toxic threshold. If this association is necessary, you must monitor the lithemia, in order to adapt the lithium posology during the contemporary treatment with ibuprofen. - diuretics, inhibitors and antagonists of angiotensin II: nSAIDs can reduce the effect of diuretics and other antihypertensive drugs. Diuretics can also increase the risk of nephrotoxicity associated with NSAIDs. - in some patients with impaired kidney function (e.g. dehydrated or elderly patients) the co-administration of an ACE inhibitor or an antagonist of angiotensin II and agents that inhibit the cyclo-oxidase system can lead to further deterioration of the kidney function, which includes a possible acute kidney failure, generally reversible. These interactions must be considered in patients taking IBUPROFENE DOC in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, this combination should be administered with caution, especially in elderly patients. - patients should be properly hydrated and should be taken into account monitoring of kidney function after the start of concomitant therapy and, periodically, from then on. - betabloccanti: nSAIDs counteract the antihypertensive effect of agents blocking beta-adrenoreceptors. - selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal hemorrhage (see paragraph 4.4); The mechanism can be linked to a reduction of serotonin uptake in platelets (see paragraph 4.4). - cyclosporine: it is believed that concomitant administration with NSAIDs increases the risk of nephrotoxicity due to a reduced synthesis of prostacycline in the kidney. Therefore, in case of association treatment, the renal function must be monitored closely. - captopril: experimental studies indicate that ibuprofen contrasts the effect of captopril on sodium excretion. - colestiramina: the concomitant administration of ibuprofen and choleramine can reduce the absorption of ibuprofen (25%) at the gastrointestinal tract level. These medicines should be administered at a range of at least 2 hours. - thiazides, tiazide-correlate preparations and anaesthetic diuretics: nSAIDs can counteract the diuretic effect of furosemide and bumetanide, probably by inhibiting the synthesis of prostaglandins. They can also counteract the antihypertensive effect of thiazides. - tacrolimus: it is believed that concomitant administration with NSAIDs and tacrolimus is able to increase the risk of nephrotoxicity due to a reduced synthesis of prostacycline in the kidney. Therefore, in case of association treatment, the renal function must be monitored closely.- methotrexate: the risk of potential interaction between an NSAID and metotrexate should also be taken into account in relation to low dose metotrexate treatment, particularly in patients with kidney impairment. When the association treatment is administered, you must monitor the kidney function. Caution should be exercised when both the NSAID and metotrexate are administered within 24 hours, as plasma levels of metotrexate can increase, causing an increase in toxicity (see above). - corticosteroids: increased risk of gastrointestinal ulceration or hemorrhage (see paragraph 4.4). - antiplatelet medicines: increased risk of gastrointestinal bleeding (see above). - chinolonic antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and Knolones can have an increased risk of developing seizures. - ritonavir: an increase in the concentration of NSAs is possible. - probenecid: slows down the excretion of the NSAs, with possible increase of their plasma concentrations. - CYP2C9 inhibitors: concurrent administration of ibuprofen and inhibitors of CYP2C9 may increase exposure to ibuprofen (substrate of CYP2C9). In a study with voriconazole and fluconazole (CYP2C9) inhibitors, an increased exposure to S(+)-ibuprofen from approximately 8O% to 100% was observed. You should consider reducing the dose of ibuprofen when concurrently administering strong inhibitors of CYP2C9, especially when high doses of ibuprofen are administered with voriconazole or fluconazole. Interaction studies were carried out only in adults.

Effects

The undesirable effects observed with ibuprofen are generally common to other analgesic, antipyretic, non-steroidal anti-inflammatory drugs. Gastrointestinal diseases: the most commonly observed adverse events are gastrointestinal. Peptic ulcers, perforation or gastrointestinal hemorrhage may occur, sometimes fatal, especially in the elderly (see paragraph 4.4). Gastrointestinal drilling with the use of ibuprofen has rarely been observed. After administration of IBUPROFENE DOC have been reported: nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, epigastric pain, gastric pyrosis, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see paragraph 4.4). Less frequently gastritis were observed. Very rarely, esophagitised pancreatitis and bowel tightenings have been observed. The patient must be instructed to suspend the medicinal product and to go to the doctor immediately if there is severe pain in the upper abdomen or melena or ematemesis. Immune system disorders: after treatment with NSAIDs, hypersensitivity reactions were reported. These can consist of a) non-specific allergic reaction and anaphylaxis, b) reaction to the respiratory tract including asthma, also severe, bronchospasm or dispnea or c) different disorders to the load of the skin, including skin rashes of various types, itching, hives, porpora, angioedema and, more rarely, Steven esfoliclusive and bollose syndrome. Very rarely: severe reactions of general hypersensitivity. Symptoms could be: swelling of the face, tongue and larynx, dispnea, tachycardia, hypotension (angioedema or severe shock). If one of these symptoms is manifested, which can also occur when using first, immediate medical assistance is required. Heart and vascular disease: In association with NSAID treatment edema, fatigue, hypertension and heart failure, vasculitis were reported. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/die), may be associated with a modest increase in the risk of arterial thrombotic events (p.es. myocardial infarction or stroke) (see paragraph 4.4). Emolinfopoietic system pathologies: leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. The first signs are: fever, throat, superficial ulcers of the mouth, flu-like symptoms, severe exhaustion, bleeding and inexplicable contusion. In these cases, the patient should immediately stop the medicine, avoid any automedication medication containing analgesics or antipyretics and consult the doctor. In long-term therapy, the blood count must be performed regularly. Very rarely: pancitopenia. Psychiatric disorders: insomnia, anxiety, depression, confusion, hallucinations, psychotic reactions. Diseases of the nervous system: headache, paresthesia, dizziness, drowsiness, optic neuritis, insomnia, agitation, irritability or fatigue. Infections and infestations: aseptic rhinitis and meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic erythereal lupus and mixed connectivity) with symptoms of nucan stiffness, headache, nausea, vomiting, fever or disorientation (see paragraph 4.4). If signs of an infection are manifested or this worsens the use of IBUPROFENE DOC, it is recommended for the patient to go to the doctor without delay. Exams must be taken to see if this is an indication of anti-infective/antibiotic therapy. Diseases of the respiratory system: bronchospasm, dispnea, apnea, asthma. Pathologies of the eye: rare cases of ocular alteration with consequent visual disorders, toxic optic neuropathy.Ear and labyrinth pathologies: hearing compromise, tinnitus, vertigo. Hepatobiliary diseases: impairment of liver function, liver failure, hepatitis and jaundice, liver damage, liver injury. Pathologies of skin and subcutaneous tissue: Reaction from drug with heosinophilia and systemic symptoms ( DRESS syndrome) and generalized acute hexantelosis (PEAG) (unknown frequency), rashes, itching, purple, angiolopeedema, bollose reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare), multifaceted photorythema. In exceptional cases during a chickenpox infection, severe skin infections and soft tissue complications can occur (see also “Infections and infestations”). Kidney and urinary pathologies: impairment of the kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure. Rarely renal tissue damage (paint necrosis) and high concentrations of uric acid in the blood may also occur. Very rarely: edema formation, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis that can be accompanied by acute kidney failure. The renal function must therefore be monitored regularly. Systemic pathologies and conditions for administration: malaise, fatigue and edema. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In adolescents and adults, the response effect to the dose is not clearly defined in overdose. The half-life in overdose is 1.5 to 3 hours. Toxicity Signs and symptoms of toxicity were generally not observed at doses less than 100 mg/kg in children or adults. However, in some cases you may need a support treatment. It has been observed that children manifest signs and symptoms of toxicity after ingestion of ibuprofen at doses of 400 mg/kg or greater. Synonyms Most patients who have ingested significant quantities of ibuprofen will manifest symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness and very rarely diarrhea. Gastrointestinal bleeding is also possible. The effects on the central nervous system (SNC) include headaches, tinnitus, dizziness, seizures and loss of consciousness. In case of more severe poisoning, toxicity is observed in the central nervous system, which is manifested as drowsiness, and occasionally excitation and disorientation or coma. Occasionally patients develop seizures. Rarely, nistagm, metabolic acidosis, hypothermia, kidney effects, gastrointestinal bleeding, coma, apnea, diarrhea and depression of the SNC and respiratory system were also reported. Disorientation, state of excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose are possible kidney failure and liver damage. In cases of severe poisoning, it is possible that metabolic acidosis occurs and protrombine/INR time may be prolonged, probably due to interference with the actions of circulatory factors of coagulation. Asthma exacerbation is possible in asthma patients. Treatment There is no specific antidote for overdosing ibuprofen. In case of overdosing, a symptomatic and support treatment is therefore indicated, which includes maintaining the pervity of the areas streets. Particular attention is given to the control of blood pressure, vital signs, acid-base balance and any gastrointestinal bleeding. Within an hour of the ingestion of a potentially toxic quantity must be considered the administration of activated carbon. Alternatively, in the adult, within an hour of the ingestion of a potentially dangerous overdose for life must be taken into account the gastric lavender. An adequate diuresis must be ensured and renal and hepatic functions must be closely monitored. The patient must remain under observation for at least four hours after ingestion of a potentially toxic drug. Any occurrence of frequent or prolonged seizures must be treated with diazepam or lorazepam intravenously. Other support measures may be required in relation to the patient's clinical conditions. Administer bronchodilators for asthma. For more information, contact the local anti-veleni center.

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-system and embryo mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. From the 20th week of pregnancy onwards, the use of IBUPROFENE DOC can cause oligoidramnios derived from fetal kidney dysfunction. This condition may be found shortly after the start of treatment and is usually reversible with the termination of treatment. In addition, there were reports of constriction of arterial duct after treatment in the second quarter, most of which was resolved after the termination of treatment. Therefore, during the first and second trimester of pregnancy, IBUPROFENE DOC should not be administered if not in strictly necessary cases. If IBUPROFENE DOC is used by a woman waiting for conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. Following the exposure to IBUPROFENE DOC for several days from the 20th week of gestation onwards, it should be considered an antenatal monitoring of oligoidramnios and the constriction of arterial duct. In case of oligoidramnios or constriction of the arterial duct, the treatment with IBUPROFENE DOC must be stopped. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (premature/closing of arterial duct and pulmonary hypertension); - kidney dysfunction (see above), which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - Possible extension of the time of bleeding, and anti-aggregating effect that can also take place at very low doses; - Inhibition of uterine contractions resulting in delay or extension of labor. Therefore IBUPROFENE DOC is contraindicated during the third trimester of pregnancy.

Food

In the few studies available today, NSAIDs can be found in breast milk in very low concentrations. NSAIDs, if possible, should be avoided during breastfeeding.

Fertility

The use of Ibuprofen can compromise female fertility through effects on ovulation and is not recommended in women waiting for conception. In women who have difficulty in conceiving or who are being investigated on infertility, it should be considered the interruption of treatment with ibuprofen.

Source: Farmadati