BRUFEN ANALGES 12CPR RIV 200MG

BRUFEN COMPRESENT ANALYGES

active ingredients

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

Excellent

Compressed core Cellulose, microcrystalline (E460) Silica colloidal anidra (E551) Crospovidone (E1202) Povidone (E1201) Magnesium stearate (E572) Talco (E553b). Coating of the tablet Polyvinyl Hydrolyzed Alcohol (E1203) Titanium Dioxide (E171) Macrogol (E1521) Talco (E553b). Printing Ink Rubber (E904) Black Iron oxide (E172) Ammonia oxide (E527).

Therapeutic indications

For symptomatic treatment of mild to moderate pain, such as headache, 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 any of the excipients listed in paragraph 6.1, - with previous reactions from hypersensitivity (e.g. bronchospasm, angioedema, rhinitis, urticaria or asthma) in response to acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory drugs (FANS), - with presence or anamnesinetic ulceration- (Only 200 mg) children under 20 kg of weight (about 6 years of age) - (Only 400 mg) adolescents under 40 kg of weight or children under 12 years of age - with cerebrovascular hemorrhage or other types of active hemorrhage, - with unclear blood formation disorders, - with severe dehydration (caused by vomiting, diarrhea or insufficient intake of liquids), - during the last trimester of pregnancy (see paragraph 4.6).

Population

Adults and teenagers ≥ 40 kg body weight (12 years of age and beyond): (Only 200 mg) Initial dose: 200 mg or 400 mg. If necessary, an additional dose of 1 or 2 tablets may be taken (from 200 mg to 400 mg). The corresponding dose range must be chosen according to the symptoms and recommended maximum daily dose. It should 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 1200 mg dose at any time of 24 hours. (Only 400 mg) Initial dose: 400 mg. An additional dose of 400 mg can be taken if necessary. The corresponding dose range must be chosen according to the symptoms and recommended maximum daily dose. It should not be less than 6 hours for a 400 mg dose. Do not exceed 1200 mg dose at any time of 24 hours. Pediatric population (Only 200 mg) Children over 6 years (20 kg - 40 kg body weight): Hybuprofen should only be used in children with a body weight of at least 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 a range of 6 to 8 hours. The recommended maximum daily dose should not be exceeded. A maximum dosage of 30 mg/kg of ibuprofen should not be exceeded in a period of 24 hours. The following dosage information applies:

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)

In case this medicine is required for more than 3 days in children older than 6 years and in teenagers or in case the symptoms worsen it is necessary to contact your doctor. Children under 6 years BRUFEN ANALGESICO is contraindicated in children under 6 years. (Only 400 mg) BRUFEN ANALGESICO is contraindicated in adolescents under 40 kg of body weight or in children under 12 years. In case this medicine is required for more than 3 days in children over 12 years of age and adolescents or in case the symptoms worsen it is necessary to contact your doctor. Undesirable effects can be minimized with the use of the minimum effective dose for the shortest possible duration of treatment required to control symptoms (see paragraph 4.4). Only for short-term use. If the medicine is required for more than 3 days in case of fever or for more than 4 days for pain treatment or if symptoms worsen, the patient should be advised to consult a doctor. Senior Patients No dose adjustment is required. Older patients must be monitored particularly carefully due to the possible profile of unwanted effects (see paragraph 4.4). Patients with gastric sensitivity Patients with sensitive stomach should take BRUFEN ANALGESIC during a meal. Taking ibuprofen after a meal may delay the onset of its action. If this happens, additional ibuprofen should not be assumed in addition to what is specified in paragraph 4.2 (Posology) or until the corresponding interval between doses has passed. Patients with renal compromise No dose reduction is required in patients with mild to moderate kidney function compromise. For patients with severe kidney dysfunction, see paragraph 4.3. Patients with liver impairment No dose reduction is required in patients with impairment of mild to moderate liver function. For patients with severe liver dysfunction, see paragraph 4.3. Method of administration Only for oral administration and short-term use. The tablets of ibuprofen should be swallowed whole with abundant water. Do not chew the tablets.

Conservation

This medicine does not require special storage conditions.

Warnings

Undesirable effects can be minimised using the minimum effective dose for the shortest time needed to get control of symptoms (see effects on gastrointestinal and cardiovascular systems). Caution should be used during the administration of ibuprofen in patients suffering from the following conditions, which may worsen: - congenital disorders of porphyrin metabolism (e.g. intermittent acute porphyria), - coagulation disorders (hybuprofen may prolong the duration of coagulation), - directly after interventions of major surgery, - lupus erythematosus systemic and mixed disease of connective tissue (e.g. increased risk of aseptic meningitis) (see paragraph 48). These can present an asthma attack (so called analgesic asthma), Quincke edema or hives, - in patients who react with allergy to other substances, since there is also an increased risk of emergence of hypersensitivity reactions during the use of ibuprofen. Seniors The elderly have an increased frequency of adverse reactions to the NSAIDs, especially gastrointestinal bleeding and drilling, which can be fatal (see Section 4.2). Respiratory reactions A bronchospasm may be precipitated into patients suffering from bronchial asthma or allergic diseases or with anamnesis of such pathologies. Other Using ibuprofen with other NSAIDs, including selective cyclo-oxidase-2 inhibitors, increases the risk of adverse reactions and must be avoided (see paragraph 4.5). Renal effects Renal compromise, as renal functionality may deteriorate further (see paragraphs 4.3 and 4.8). In general terms, the habitual intake of analgesics, in particular the association of different analgesic substances, can lead to permanent kidney damage with risk of kidney failure (nephropathy from analgesics). This risk can increase under physical effort associated with loss of salts and dehydration. Therefore it must be avoided. There is a risk of kidney impairment in dehydrated children and adolescents. Hepatitis effects Hepatic dysfunction (see paragraphs 4.3 and 4.8). It is appropriate to suspend therapy with ibuprofen when deterioration of liver function occurs in conjunction with its administration. After suspension of treatment, the state of health usually normalizes. Occasional blood glucose monitoring is also appropriate. Cardiovascular and cerebrovascular effects It requires special caution (disputing with your doctor or pharmacist) before you begin treatment in patients with anamnesi of hypertension and/or heart failure, because in association with NSAID therapy water retention, hypertension and edema were reported. Patients suffering from uncontrolled hypertension (NYHA class II-III), congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful evaluation and should avoid high doses (2400 mg/day). Careful consideration should be exercised even before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus or smoke), especially if high doses of ibuprofen are needed (2400 mg/die). Clinical studies suggest that the use of ibuprofen, especially at a high dose (2400 mg/die) and long-term treatments, may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). In general, epidemiological studies do not indicate that low doses of ibuprofen (e.g. ≤1200 mg/die) are associated with increased risk of arterial thrombotic events. Women's fertility growth There are some evidence that drugs that inhibit the synthesis of cyclooxygenases/prostaglandins can cause alterations in female fertility, through an effect on ovulation. This is reversible after suspension of treatment (see paragraph 4.6). Gastrointestinal safety NSAIDs should be administered with caution in patients with gastrointestinal disease anamnesis ( ulcerative colitis, Crohn's disease), since these conditions may be exacerbated (see paragraph 4.8). During treatment with all NSAIDs, at any time during therapy, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration or perforation, which may be fatal. In patients with ulcer anamnesi, especially if complicated by hemorrhage or perforation (see paragraph 4.3), and in the elderly, the risk of gastrointestinal hemorrhage, ulceration or perforation is greater with the increase in doses of NSAIDs. These patients must begin treatment with the lowest dose available. It is appropriate to consider the concomitant use of protective agents (e.g. misoprostol or protonic pump inhibitors) both for these patients and for patients taking low doses of acetylicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially if elderly, must report any unusual gastrointestinal nature (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caution is required in the treatment of patients taking concomitant medications that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as acetyl acid (see paragraph 4.5). When bleeding or gastrointestinal ulceration occurs in patients taking ibuprofen, treatment must be suspended. Strict skin reactions Severe skin reactions, some of which fatal, such as exfoliative dermatitis, Steven - Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAID (see paragraph 4.8). In the early stages of therapy patients seem to be at the highest risk of these reactions: in fact the onset of the reaction occurs in most cases within the first month of treatment. Generalized acute urstolosis (PEAG) was reported in relation to medicines containing ibuprofen. The use of ibuprofen should be suspended at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Exceptionally chickenpox can cause severe skin reactions and infectious complications to soft tissues. So far the contribution of the NSAs to the worsening of these infections cannot be excluded. Therefore, it is recommended to avoid the use of ibuprofen in case of chickenpox. Masking the symptoms of underlying infections BRUFEN ANALGESICO 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 BRUFEN ANALGESICO 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. Other comments In rare cases severe acute reactions of hypersensitivity were observed (e.g. anaphylactic shock). The therapy must be suspended at the first signs of a hypersensitivity reaction after taking/ administering ibuprofen. Syntomatology-appropriate medical procedures must be performed by specialized personnel. Hybuprofen can temporarily inhibit pyastrinic function (trombocyte aggregation). Therefore it is recommended to carefully monitor patients with clotting disorders. In prolonged administration of ibuprofen, regular control of liver parameters, kidney function and blood cell count is recommended. Prolonged use of any type of analgesic for cephalea can cause a worsening. If you experience or suspect such situation, you should get medical advice and treatment should be suspended. Diagnosis of headache from excessive use of drugs must be suspected in patients who have frequent or daily headaches despite (or due to) regular use of cephalea medications. The headache from excessive use of drugs should not be treated by increasing the dosage of the drug. During treatment with ibuprofen, some cases with symptoms of aseptic meningitis, such as nucan stiffness, headache, nausea, vomiting, fever or disorientation, have been observed in patients with pre-existing autoimmune disorders (such as systemic erythematosus Lupus, mixed connective tissue disease). Alcohol consumption must be avoided since it can intensify the side effects of NSAIDs, especially those related to gastrointestinal tract or central nervous system. Patients in treatment with ibuprofen should report to the doctor signs or symptoms of gastrointestinal ulcer or bleeding, cloud vision or other eye symptoms, skin rash, weight gain or edema. If vision problems arise, sight clouding, drowsiness or malfunctioning of color perception, the termination of treatment is necessary.

Interactions

The use of ibuprofen should be avoided in association with: Acetylsalicylic acid Concurrent administration of ibuprofen and acetylsalicylic 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 uncertainties regarding the extrapolation of these data from the clinical situation, it cannot be ruled out the possibility that regular use, long term of ibuprofen, can 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). Other NSAIDs included salicylates and selective cyclooxygenase-2 inhibitors: avoid the concomitant use of two or more NSAIDs, because it can increase the risk of gastrointestinal ulcers and bleeding due to a synergistic effect (see paragraph 4.4). Antiagulants. nSAIDs can increase the effects of anticoagulants, such as warfarin (see paragraph 4.4). Diuretics, ACE inhibitors, beta blockers and antagonists of angiotensin II: nSAIDs can reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function) co-administration of an inhibitor ACE, a blocker beta or an antagonist of angiotensin II and agents inhibiting the cyclooxygenase system, may result in further deterioration of the kidney function, including acute kidney failure, which is generally reversible. Therefore, the association must be administered with caution, especially in elderly patients. Patients should be properly hydrated and should be taken into account the monitoring of renal function after the start of concomitant therapy and subsequently with regular cadence. Diuretic potassium savers: Concomitant administration of ibuprofen and potassium-sparing diuretics may lead to hyperkalaemia (control of serum potassium is recommended). Corticosteroids: increased risk of adverse reactions, especially gastrointestinal tract (gastrointestinal ulceration or bleeding) (see paragraph 4.4). Anti-aggregating agents and selective serotonin reuptake inhibitors (SSRI): increased risk of gastrointestinal bleeding (see paragraph 4.4) Digoxin: NSAIDs can exacerbate heart failure, reduce glomerular filtration speed and increase plasma levels of digoxin. Serum digoxin control is not required, as a rule, in proper use (maximum 4 days). Fenitoin: the concomitant use of ibuprofen with phenytoin preparations can increase the serum levels of phenytoin. Serum phenytoin control is not required, as a rule, in the correct use (maximum 4 days). Litio: there is evidence of potential increases in plasma levels of lithium. Serum lithium control is not required, as a rule, in the correct use (maximum 4 days). Methodology: the administration of ibuprofen within 24 hours before the administration of metotrexate may lead to an increase in metotrexate concentration and an increase in toxic effects. Ciclosporin: the risk of a harmful effect on the kidneys due to cyclosporin is increased by the co-administration of some NSAIDs. This effect cannot also be excluded for the association of cyclosporin with ibuprofen. Mifepristone. NSAIDs should not be used for 8-12 days after mifepristone administration, because NSAIDs can reduce the effect of mifepristone. Sulfinpyrase: medicinal products containing sulfinpirazone may delay the excretion of ibuprofen. Probenecid: drugs containing probenecid may reduce the excretion of NSAIDs and may increase their serum concentrations. Tacrolimus: possible increase in the risk of nephrotoxicity if NSAIDs are co- administered with tacrolimus. Zidovudina: increased risk of hematological toxicity when NSAIDs are co-administrated with zidovudine. A blood cell count is recommended 1-2 weeks after the start of co-administration. There are indications of increased risk of hematoma and hematoma in positive HIV patients with hemophilia in concomitant treatment with zidovudine and ibuprofen. Sulfaniluree: NSAIDs can both increase and decrease the hypoglycemic effect of sulfaniluree. It is recommended caution in case of simultaneous treatment. Chinolonic Antibiotics: animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and kinolones can present an increased risk of developing seizures. Alcohol, biphosphonate, oxpentifilline (pentoxyfillin) and sulfinpirazone: can enhance gastrointestinal effects and the risk of bleeding or ulceration. Baclofene: increase in baclofene toxicity.

Effects

The possible side effects are those observed with acid ibuprofen.The side effects are mostly dose-dependent and vary individually.In particular, the risk of gastrointestinal bleeding is dependent on the dose and duration of the treatment.For other risk factors, see section 4.4. The following side effects are linked to short -term use of low dosage ibuprofen (up to 1200 mg per day for mild to moderate pains and fever).Other side effects may occur with treatments for other indications or prolonged use.The side effects associated with ibuprofen are listed in the table below according to classification for systems and organs and frequency.Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 e Classification for systems and organs Frequency Undesirable effects Emolinfopoietic system pathologies Very rare hematopoietic pathologies1 Immune system disorders Not common hypersensitivity reactions with urticaria and itching2 Very rare severe reactions from hypersensitivity. Symptoms may include: swelling of face, tongue and larynx, edema, dispnea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)2 Psychiatric disorders Rare confusion, hallucinations Notable psychotic disorders, depression Diseases of the nervous system Town headache, drowsiness, dizziness, fatigue, agitation, dizziness, insomnia, irritability Very rare aseptic meningitis Pathologies of the eye Notable ambliopia⁴, blurred vision⁴, reduced vision⁴ Ear and labyrinth pathologies Rare Tinnitus Heart disease Very rare Palpitations, myocardial infarction, acute pulmonary edema Notable heart failure, edema Vascular diseases Notable arterial hypertension Respiratory, chest and mediastinic pathologies Not common Rehabilitation Very rare Exacerbation of asthma Notable Reactions of respiratory tract such as bronchospasm, asthma or dispnea2 Gastrointestinal diseases Very common Pyrosis, abdominal pain, nausea, dyspepsia, diarrhea, flatulence, constipation and vomiting⁵ Town Peptic ulcer⁶, gastrointestinal perforation or bleeding⁶, melena, ematemesis, ulcerative stomatitis, colitis Not common gastritis Very rare esophagitis, pancreatis, intestinal shrinkage Notable exacerbation of colitis and Crohn's disease⁷ Hepatobiliary diseases Very rare hepatic dysfunction, liver damage, especially in long-term use, liver failure, acute hepatitis and jaundice⁸ Pathologies of skin and subcutaneous tissue Not common Sensitivity, rash2 Very rare severe forms of skin reactions of soft tissues may occur during infections of chickenpox, necrotizing fascites, exfoliatory dermatitis, boiling reactions, including Steven-Johnson syndrome, multiform erythema and toxic epidermal necrolysis2 Notable Alopecia⁹, adverse reaction with eosinophilia and systemic symptoms ( DRESS syndrome). Generalized acute exantelosis (PEAG). Kidney and urinary pathologies Not common edema development, especially in patients with arterial hypertension or kidney failure, nephrotic syndrome, interstitial nephritis that can be associated with kidney failure¹⁰ Rare renal papillary necrosis¹⁰ Very rare Acute kidney failure¹⁰, dysuria Pathologies of the reproductive apparatus and of the breast Notable menstrual disorders Diagnostic examinations Rare increase in urethic nitrogen, transaminase and alkaline phosphate, decrease in hemoglobin and hematocrite values, inhibition of piastrinic aggregation, decrease in serum calcium, increase in serum uric acid Notable extension of bleeding time¹¹ Description of selected adverse reactions 1 Examples include anemia, leucopenia, thrombocytopenia, pancitopenia and agranulacitosis. First signs: fever, sore throat, mouth ulcers, flu-like symptoms, symptoms of severe fatigue, nasal bleeding and skin. 2 Hypersensitivity reactions: may include (a) non-specific allergic reactions and anaphylaxis, (b) respiratory reactions including asthma, asthma exacerbation, bronchospasm and dispnea, or (c) various skin reactions, including urticaria, esantema and porpora, sometimes associated with itching. Angioedema has been reported and, in rare cases, exfoliative and bollose dermatitis, including toxic epidermal necrolysis, Stevens-Johnson syndrome and multiform erythema. Some reactions that include meningea irritation and lethargy are considered associated with hypersensitivity reactions. Systemic erythematous lupus and other collagen pathologies are risk factors for serious cases of generalized reactions of hypersensitivity. General reactions of hypersensitivity are not common. Symptoms may include fever with rash, abdominal pain, headache, nausea and vomiting, signs of liver damage and even meninge symptoms. In rare cases, ibuprofen can lead to bronchospasm in predisposed subjects. 3 The pathogenic mechanism of drug-induced meningitis is not fully understood. However, the data available on the aseptic meningitis NSAID-correct suggests a reaction of hypersensitivity (due to the temporal correlation between the administration of the medicinal product and the disappearance of symptoms after treatment interruption). Insulated cases of aseptic meningitis symptoms such as nuke stiffness, headaches, vomiting, fever and disorientation during treatment with ibuprofen in patients with pre-existing autoimmune diseases (systemic erythematosus and mixed pathologies of connective tissue). ⁴ Reversible effects have been observed. ⁵ The most common side effects are undesirable gastrointestinal effects. ⁶ Not commonly fatal, especially in elderly patients. See Special Warnings and Employment Precautions. ⁷ see paragraph 4.4 ⁸ Hepatotoxic reactions can occur as part of generalized reactions of hypersensitivity. ⁹ has been reported reversible alopecia in black women. ¹⁰ Especially for prolonged use, associated with high concentrations of serum urea, decreased urine excretion and edema. Includes papillary necrosis. ¹¹ Hybuprofen can prolong bleeding time at doses greater than 1000 mg per day. Clinical studies and epidemiological data suggest that the use of ibuprofen, especially at high doses (2400 mg per day) and for prolonged periods, may be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). 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 children ingestion of more than 400 mg/kg can cause symptoms. In adults the dose-response effect is less obvious. The half-life in case of overdose and 1,5-3 hours. Synonyms Relevant overdosages are generally well tolerated as long as other medicinal products are not involved. Most patients who have ingested significant amounts of NSAIDs will no longer manifest nausea, vomiting, epigastric pain or more rarely, diarrhea. Tinnitus, headache, and gastrointestinal bleeding are also possible. In more severe poisoning, toxicity is observed on the central nervous system, which is manifested with dizziness, drowsiness, occasionally excitation disorientation, loss of consciousness (in children also myclonic seizures) or coma. Occasionally, patients have seizures. In severe poisoning can appear metabolic acidosis and protrombine/time/ INR can be prolonged, probably due to interference with the actions of the circulating factors of the coagulation. Acute kidney failure and liver damage may occur. In asthmatics it is possible to reacut the asthma. Hypotension, respiratory depression and cyanosis are also possible. Treatment A specific antidote is not available. The treatment must be symptomatic and supportive and includes maintaining the pervity of the respiratory tract and cardiac monitoring and vital signs until stabilization. If necessary, it is necessary to carry out a correction of the budget of the serum electrolytes. Forced diuresis and hemodialysis are not useful, as ibuprofen is widely metabolized and almost totally related to proteins. Gastric emptying or oral administration of activated carbon are indicated if the patient is present within an hour of ingestion of a large amount. In case of gastrointestinal bleeding, activated carbon may hinder endoscopy. If frequent and prolonged, seizures should be treated with diazepam or lorazepam e.v. Asthma should be administered bronchodilators.

Pregnancy The inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. The data from epidemiological studies show an increased risk of abortion and heart disease and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has led to an increase in pre- and post-system loss and embryo-fetal mortality. In addition, in animals that had been given inhibitors of the synthesis of prostaglandin during the period of organgenesis, an increase in the incidence of various malformations, including cardiovascular disease was reported. During the first and second quarter of pregnancy, ibuprofen should not be administered, if not in strictly necessary cases. If ibuprofen 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. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo hydraulics; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time and anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, the use of ibuprofen is contraindicated during the third trimester of pregnancy. Food Only small amounts of ibuprofen and the products of its metabolism are excrete in breast milk. There are no known harmful effects in the infant. As a result, ibuprofen can be used during breastfeeding for treatment of short-term pain and fever and recommended doses. Safety for prolonged use has not been established. Fertility There are evidence that drugs that inhibit cyclooxygenase/synthesis of prostaglandins can cause impairment of female fertility as a result of an effect on ovulation. This event is however reversible with the suspension of treatment.

Source: Farmadati