Momentact 400 mg Analgesic 12 Tablets

INDICATIONS

Momentact is indicated in adults and adolescents over 12 years of age. Pain of various origins and nature (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain). Adjuvant in the symptomatic treatment of fever and flu.

ACTIVE INGREDIENTS

Each film-coated tablet contains: Active ingredient: ibuprofen 400 mg. Excipients with known effects: lactose, sodium. For the complete list of excipients see section 6.1.

EXCIPIENTS

Pregelatinized starch, carboxymethyl starch sodium, carmellosa sodium, povidone, microcrystalline cellulose, precipitated silica, talc, sodium lauryl sulfate, lactose monohydrate, hypromellose, titanium dioxide, Macrogol 4000.

CONTRAINDICATIONS AND SIDE EFFECTS

• Hypersensitivity to the active ingredient, to other antirheumatic drugs (acetylsalicylic acid, etc.) or to any of the excipients listed in paragraph 6.1. • Do not administer to children under 12 years of age. • Ibuprofen is contraindicated during the third trimester of pregnancy and during breastfeeding (see section 4.6). • Active or severe gastroduodenal ulcer or other gastropathies. • History of gastrointestinal hemorrhage or perforation related to previous active treatment or history of recurrent peptic hemorrhage/ulcer (two or more distinct episodes of demonstrated ulceration or bleeding). • Severe hepatic or renal insufficiency. • Severe heart failure (NYHA class IV). • Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).

DOSAGE

Dosage Adults and adolescents over 12 years old: 1 tablet 2-3 times a day. Do not exceed the dose of 3 tablets per day. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible treatment duration needed to control symptoms (see section 4.4). If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of symptoms, the doctor should be consulted. Do not exceed the recommended doses: elderly patients in particular must stick to the minimum dosages indicated above. Elderly: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events and are at increased risk of potentially fatal gastrointestinal bleeding, ulceration or perforation (see section 4.4). If treatment is considered necessary, the lowest dose for the shortest duration necessary to control symptoms should be used (see section 4.4). Renal failure: In patients with mild or moderate reduction in renal function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and renal function should be monitored. Liver failure: In patients with mild or moderate reduction in liver function, the dosage should be kept as low as possible for the shortest duration necessary to control symptoms and liver function should be monitored. Momentact is contraindicated in patients with severe hepatic impairment (see section 4.3). Pediatric population Momentact is contraindicated in children under 12 years of age (see section 4.3). Method of administration You can take Momentact on an empty stomach. In subjects with gastric tolerability problems, it is preferable to take the medicine on a full stomach.

CONSERVATION

This medicine does not require any particular storage temperature.

WARNINGS

• The use of Momentact, like any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. • The administration of Momentact should be suspended in women who have fertility problems or who are undergoing fertility investigations. • Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraphs below on gastrointestinal and cardiovascular risks). • Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). • Cardiovascular and cerebrovascular effects Caution is required before starting treatment in patients with a history of hypertension and/or heart failure since fluid retention, hypertension and edema have been reported in association with treatment with NSAIDs. NSAIDs can reduce the effect of diuretics and other antihypertensive drugs (see section 4.5). Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day), 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/day) are associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration must also be exercised before starting patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, cigarette smoking habit) on long-term treatment, especially if high doses (2400 mg/day) of ibuprofen are necessary. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with ibuprofen only after careful consideration. Similar considerations must be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). • Gastrointestinal bleeding, ulceration and perforation The use of Momentact should be avoided concomitantly with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors due to an increased risk of ulceration or bleeding (see section 4.5). In particular, gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or previous history of serious gastrointestinal events. In the elderly and in patients with a history of ulcer, especially if complicated by haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. The concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid 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 the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal haemorrhage) particularly in the initial stages of treatment. Carefully monitor patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Momentact, treatment should be discontinued. NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8). • Severe skin reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. Acute generalized exanthematous pustulosis (PEAG) has been reported in connection with ibuprofen-containing medicinal products. Ibuprofen should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as rash, mucosal lesions or any other sign of hypersensitivity as well as if visual disturbances or persistent signs of liver dysfunction occur. • Renal effects When initiating treatment with ibuprofen, caution should be exercised in patients with considerable dehydration. Ibuprofen may cause water and sodium, potassium retention in patients who have never suffered from kidney disease due to its effects on renal perfusion. This may cause edema or heart failure or hypertension in predisposed patients. Long-term use of ibuprofen, as with other NSAIDs, has led to renal papillary necrosis and other renal pathological changes. In general, the habitual use of analgesics, especially combinations of different analgesic active ingredients, can lead to permanent kidney damage, with the risk of onset of renal failure (analgesic nephropathy). Renal toxicity has been reported in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients can lead to a dose-dependent reduction in the formation of prostaglandins and, as a secondary effect, in renal blood flow which can quickly lead to renal decompensation. The patients most at risk of these reactions are those with reduced renal function, heart failure, liver dysfunction, the elderly and all those patients taking diuretics and ACE inhibitors. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. In dehydrated adolescents there is a risk of impaired renal function. In case of prolonged use, monitor renal function, particularly in cases of diffuse lupus erythematosus. • Respiratory disorders Momentact should be prescribed with caution in patients with bronchial asthma, chronic rhinitis, nasal polyps, sinusitis or current or previous allergic diseases because bronchospasm, urticaria and angioedema may occur. The same applies to those subjects who have experienced bronchospasm after the use of acetylsalicylic acid or other NSAIDs. • Hypersensitivity reactions Analgesics, antipyretics, NSAIDs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drugs. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, NSAIDs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis or chronic obstructive respiratory diseases or previous episodes of angioedema (see sections 4.3 and 4.8). Hypersensitivity reactions may present in the form of asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Severe hypersensitivity reactions (e.g. anaphylactic shock) have been observed rarely. At the first signs of hypersensitivity reaction after administration of ibuprofen, treatment should be discontinued. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms. • Reduced cardiac, renal and hepatic function Particular caution must be taken when treating patients with reduced cardiac, hepatic or renal function since the use of NSAIDs may cause a deterioration of renal function. The usual concomitant use of different painkillers can further increase this risk. In patients with reduced cardiac, hepatic or renal function it is advisable to use the lowest effective dose for the shortest period of treatment and periodic monitoring of clinical and laboratory parameters, especially in case of prolonged treatment. • Hematological effects Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and has shown evidence of prolonging bleeding time in healthy subjects. Therefore, patients with coagulation defects or on anticoagulant therapy should be carefully observed. • Aseptic meningitis On rare occasions, symptoms of aseptic meningitis have been observed in patients treated with ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients without concomitant chronic diseases (see section 4.8). • Since ocular alterations have been detected during animal studies with NSAIDs, it is recommended, in case of prolonged treatments, to carry out periodic ophthalmological checks. • Alcohol consumption should be avoided as it can intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or central nervous system. • Masking of symptoms of underlying infections • Momentact may mask symptoms of infection, which may delay the initiation of appropriate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Momentact is administered for the relief of fever or pain related to infection, monitoring of the infection is recommended. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Important information about some excipients Momentact contains:- Lactose: Patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. - Sodium: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially 'sodium-free'.

INTERACTIONS

It is advisable to seek medical advice in case of any concomitant therapy before administering the product. Ibuprofen (like other NSAIDs) should be taken with caution in combination with the substances listed below. • Corticosteroids: increased risk of gastrointestinal ulceration or haemorrhage (see section 4.4). • Anticoagulants: NSAIDs may increase the effects of anticoagulants, such as warfarin or heparin (see section 4.4). In case of concomitant treatment, monitoring of coagulation status is recommended. • Cyclooxygenase-2 (COX-2) inhibitors and other NSAIDs: these substances may increase the risk of adverse reactions affecting the gastrointestinal tract (see section 4.4). It is advisable not to combine ibuprofen with other NSAIDs, including selective COX-2 inhibitors, due to potential additive effects (see section 4.4). • Acetylsalicylic acid: Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased side effects. Experimental data suggest that ibuprofen can competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered simultaneously. Although there are uncertainties regarding the extrapolation of these data to the clinical situation, the possibility cannot be excluded that regular, long-term use of ibuprofen may reduce the cardioprotective effect of acetylsalicylic acid at low doses. No relevant clinical effects are considered likely following occasional use of ibuprofen (see section 5.1). • Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal haemorrhage (see section 4.4). • Diuretics, ACE inhibitors (such as captopril), beta blockers and angiotensin II antagonists: NSAIDs can reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of NSAID-associated nephrotoxicity. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking Momentact concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and thereafter. • Phenytoin and lithium: concomitant administration of ibuprofen and phenytoin or lithium preparations may result in reduced elimination of these medicines with consequent increase in their plasma levels with the possibility of reaching the toxic threshold. If this association is deemed necessary, monitoring of plasma levels of phenytoin and lithium is recommended in order to adapt the appropriate dosage during simultaneous treatment with ibuprofen. • Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and some metabolic interactions may occur resulting in reduced clearance of methotrexate and resulting in an increased risk of toxicity. • Moclobemide: increases the effect of ibuprofen. • Aminoglycosides: NSAIDs can decrease the excretion of aminoglycosides, increasing their toxicity. • Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce the glomerular filtration rate and increase plasma levels of cardiac glycosides. Monitoring of serum glycoside levels is recommended. • Cholestyramine: the concomitant administration of ibuprofen and cholestyramine can reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical relevance of this interaction is not known.• Cyclosporins: concomitant administration of ciclosporin and some NSAIDs causes an increased risk of renal damage. This effect cannot be excluded for the combination of ciclosporin and ibuprofen. • Plant extracts: Ginkgo Biloba may increase the risk of bleeding in association with NSAIDs. • Mifepristone: due to the anti-prostaglandin properties of NSAIDs, their use after the administration of mifepristone may lead to a reduction in the effect of mifepristone. Limited evidence suggests that co-administration of NSAIDs and prostaglandins on the same day does not adversely influence the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of the medicinal product on pregnancy termination. • Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. • Sulfonylureas: NSAIDs can increase the hypoglycemic effect of sulfonylureas. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended. • Tacrolimus: co-administration of NSAIDs and tacrolimus may lead to an increased risk of nephrotoxicity. • Zidovudine: there is evidence of an increased risk of haemarthrosis and hematoma in HIV-positive haemophiliac patients in simultaneous treatment with Zidovudine and other NSAIDs. A haematological examination is recommended 1-2 weeks after starting treatment. • Ritonavir: may cause an increase in plasma concentrations of NSAIDs. • Probenecid: slows the excretion of ibuprofen, with possible increase in their plasma concentrations. • CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may slow the elimination of ibuprofen (CYP2C9 substrate) resulting in increased ibuprofen exposure. In a study with voriconazole and fluconazole (CYP2C9 inhibitors), increased exposure to S(+)-ibuprofen by approximately 80% to 100% was observed. Reduction of the ibuprofen dose should be considered in cases of co-administration with strong CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. • Alcohol, bisphosphonates and oxypentifylline (pentoxifylline): can potentiate gastrointestinal side effects and the risk of bleeding and ulcers. • Baclofen: high toxicity of baclofen.

SIDE EFFECTS

The side effects observed with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and are reported below using the following convention: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥1/10,000, <1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data). The most commonly observed adverse events are gastrointestinal in nature. Clinical studies and epidemiological data suggest that the use of ibuprofen (especially at high doses 2400 mg/day) and for long-term treatments may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Gastrointestinal disorders: Peptic ulcers, perforation or gastrointestinal haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4). Gastrointestinal perforation with ibuprofen use has been observed rarely. After administration of ibuprofen the following have been reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Uncommon: gastritis; Very rare: pancreatitis. Immune system disorders. The following side effects have been reported following treatment with NSAIDs: non-specific allergic reaction and anaphylaxis; uncommon: hypersensitivity reactions such as skin rash of various types, urticaria, pruritus, purpura, angioedema, exanthema, respiratory tract reactions including asthma, even severe, bronchospasm or dyspnea asthmatic attack (sometimes with hypotension); rare: lupus erythematosus syndrome; very rare: serious hypersensitivity reactions. Symptoms may include: facial edema, tongue edema, laryngeal edema, airway edema with constriction, dyspnoea, tachycardia, anaphylaxis, exfoliative and bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Cardiac and vascular pathologies: Edema, fatigue, hypertension and heart failure have been reported in association with treatment with NSAIDs. Clinical studies suggest that the use of ibuprofen, especially at high doses (2400 mg/day) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see section 4.4). Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary edema, edema, hypertension. These phenomena generally tend to regress upon suspension of treatment. Other adverse events reported less frequently and for which causality has not necessarily been established include: Pathologies of the blood and lymphatic system. Rare: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and haemolytic anemia. Psychiatric disorders. Uncommon: insomnia, anxiety; Rare: depression, confusional state, hallucinations. Nervous system disorders. Common: dizziness; Uncommon: paraesthesia, drowsiness; Rare: optic neuritis. Infections and infestations. Uncommon: rhinitis; Rare: aseptic meningitis. Aseptic rhinitis and meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of neck stiffness, headache, nausea, vomiting, fever or disorientation (see section 4.4). Exacerbation of infection-related inflammation has been described (e.g. development of necrotizing fasciitis). Thoracic and mediastinal respiratory disorders. Uncommon: bronchospasm, dyspnea, apnea. Eye pathologies. Uncommon: visual disturbances; Rare: ocular alteration resulting in visual disturbances, toxic optic neuropathy. Ear and labyrinth disorders. Uncommon: impaired hearing, tinnitus, vertigo. Hepatobiliary disorders. Uncommon: abnormal liver function, hepatitis and jaundice; Very rare: liver failure. Pathologies of the skin and subcutaneous tissue. Sometimes allergic skin rashes may occur (erythema, itching, urticaria). Uncommon: photosensitivity reactions; Very rare: bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. In exceptional cases, serious skin infections and soft tissue disorders may occur during chickenpox infection (see “infections and infestations”). Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (PEAG). Renal and urinary disorders. Uncommon: impairment of renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. Systemic pathologies and conditions relating to the administration site. Common: malaise, fatigue; Rare: edema. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Toxicity Signs and symptoms of toxicity were generally not observed at doses below 100 mg/kg in children or adults. However, in some cases supportive treatment may be necessary. Children have been observed to exhibit signs and symptoms of toxicity after ingesting ibuprofen at doses of 400 mg/kg or greater. Symptoms Most patients who have ingested significant amounts of ibuprofen will experience symptoms within 4 to 6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy, and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, seizures, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, arousal, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. In cases of significant overdose, renal failure and liver damage are possible. In cases of severe poisoning, metabolic acidosis may occur. Treatment There is no specific antidote for ibuprofen overdose. In case of overdose, symptomatic and supportive treatment is therefore indicated. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingesting a potentially toxic quantity. Alternatively, in adults, gastric lavage should be considered within one hour of ingesting a potentially life-threatening overdose. 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 following ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. Depending on the patient's clinical condition, other support measures may be necessary. For more information, contact your local poison control center.

PREGNANCY AND BREASTFEEDING

Pregnancy Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been thought to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals to which prostaglandin synthesis inhibitors were administered during the organogenetic period. From the twentieth week of pregnancy onwards, the use of Momentact may cause oligohydramnios resulting from fetal renal dysfunction. This may occur shortly after starting treatment and is usually reversible upon discontinuation. Additionally, cases of ductus arteriosus constriction have been reported following treatment in the second trimester, most of which resolved after treatment discontinuation. Therefore, during the first and second trimester of pregnancy, Momentact should not be administered unless strictly necessary. If Momentact is used by a woman trying to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. Following exposure to MOMENTACT for several days from gestational week 20 onwards, prenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered. MOMENTACT should be discontinued if oligohydramnios or constriction of the ductus arteriosus occurs. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction (see above); At the end of pregnancy, all inhibitors of prostaglandin synthesis can expose the mother and newborn, to:- possible prolongation of bleeding time, and anti-aggregating effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, Momentact is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breastfeeding Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influencing the newborn appears unlikely. If, however, the treatment is longer term, early weaning should be considered. NSAIDs should be avoided during breastfeeding. Fertility The use of Ibuprofen may compromise female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women who have difficulty conceiving or who are under investigation for infertility, discontinuation of ibuprofen treatment should be considered.

EFFECTS ON DRIVING ABILITY

As a rule, the use of ibuprofen does not alter the ability to drive or use machinery. However, patients whose activity requires vigilance should use caution if they notice drowsiness, dizziness or depression during ibuprofen therapy.