Momentact 400 mg 12 sachets granules for oral solution

Momentact 400 mg 12 sachets granules for oral solution is an analgesic and anti-inflammatory based on ibuprofen , ideal for the symptomatic treatment of pain of various origins and natures . Thanks to its formulation in sachets of granules for oral solution , Momentact guarantees a rapid and targeted action, proving particularly effective against headaches, migraines, toothaches, neuralgia, osteo-articular pain, muscle pain and menstrual pain . The product is also indicated for the relief of pain associated with flu symptoms and fever , offering a practical and fast solution for adults and adolescents over 12 years.

The presence of ibuprofen as an active ingredient ensures an effective analgesic and anti-inflammatory action, acting directly on the processes that cause pain and inflammation. The soluble granule formulation allows for easy intake and rapid assimilation, ideal for those seeking immediate relief from painful symptoms. Momentact 400 mg is produced by Angelini , a leading company in the pharmaceutical sector, synonymous with quality and reliability.

Choosing Momentact 400 mg granulated sachets for oral solution means relying on a specific product for the rapid and safe treatment of acute pain , with the convenience of a ready-to-use formulation and a pleasant taste. Ideal for those who need an effective pain reliever to always carry with them, to face the most demanding days with serenity.

ACTIVE INGREDIENTS

Active ingredients contained in Momentact 400 mg 12 sachets granules for oral solution - What is the active ingredient in Momentact 400 mg 12 sachets granules for oral solution?

One sachet contains: Active ingredient : ibuprofen sodium salt dihydrate 512 mg (corresponding to 400 mg of ibuprofen). Excipients with known effect: 2148 mg of Sucrose, 20 mg of Aspartame, 90 mg of Potassium, 39.2 mg of Sodium For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Momentact 400 mg 12 sachets granules for oral solution - What does Momentact 400 mg 12 sachets granules for oral solution contain?

Sucrose , potassium bicarbonate, orange flavouring, acesulfame potassium , aspartame .

DIRECTIONS

Therapeutic indications Momentact 400 mg 12 sachets granules for oral solution - Why is Momentact 400 mg 12 sachets granules for oral solution used? What is it used for?

Momentact analgesic 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).

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Momentact 400 mg 12 sachets granules for oral solution - When should Momentact 400 mg 12 sachets granules for oral solution not be used?

• Hypersensitivity to the active substance, to other antirheumatics (acetylsalicylic acid, etc.) or to any of the excipients listed in section 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 bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Severe hepatic or renal insufficiency. • Severe cardiac insufficiency (NYHA class IV). • Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). • Subjects with phenylketonuria (see section 4.4).

DOSAGE

Quantity and method of taking Momentact 400 mg 12 sachets granules for oral solution - How do you take Momentact 400 mg 12 sachets granules for oral solution?

Dosage Adults and adolescents over 12 years : 1 sachet 2-3 times a day. Do not exceed 3 sachets per day. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). If the use of the medicinal product is necessary for more than 3 days in adolescents, or in case of worsening of symptoms, a doctor should be consulted. Do not exceed the recommended doses: in particular, elderly patients should adhere 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 impairment : In patients with mild or moderate reduction of 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. Hepatic impairment : In patients with mild or moderate reduction of 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 ANALGESICO is contraindicated in patients with severe hepatic impairment (see section 4.3). Paediatric population Momentact analgesic is contraindicated in children under 12 years of age (see section 4.3). Method of administration Dissolve the contents of the sachet in a glass of water, stirring with a teaspoon until dissolved and drink the solution immediately. MOMENTACT ANALGESICO can be taken on an empty stomach. In subjects with gastric tolerability problems, it is preferable to take the medicine on a full stomach.

CONSERVATION

Storage Momentact 400 mg 12 sachets granules for oral solution - How do you store Momentact 400 mg 12 sachets granules for oral solution?

This medicine does not require any special storage temperatures.

WARNINGS

Warnings Momentact 400 mg 12 sachets granules for oral solution - About Momentact 400 mg 12 sachets granules for oral solution it is important to know that:

• The use of MOMENTACT ANALGESICO, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant. • The administration of MOMENTACT ANALGESICO should be suspended in women who have fertility problems or who are undergoing investigation of fertility. • Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary 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 paragraph 4.2). • Cardiovascular and cerebrovascular effects Caution is required before initiating treatment in patients with a history of hypertension and/or heart failure since fluid retention, hypertension and oedema have been reported in association with NSAID treatment. NSAIDs may reduce the effect of diuretics, and other antihypertensive drugs (see section 4.5). Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events. Patients with uncontrolled hypertension, congestive heart failure (NYHA class II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses (2400 mg/day) of ibuprofen are required. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar consideration should be exercised before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). • Gastrointestinal bleeding, ulceration and perforation The use of MOMENTACT ANALGESICO should be avoided in combination with NSAIDs, including cyclooxygenase-2 (COX-2) selective inhibitors due to an increased risk of ulceration or bleeding (see section 4.5). In particular, gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3). These patients should start treatment on the lowest available dose. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Carefully monitor patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving MOMENTACT ANALGESICO, the treatment should be withdrawn. 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 highest risk early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in association with medicinal products containing ibuprofen. 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 starting treatment with ibuprofen, caution should be exercised in patients with considerable dehydration. Ibuprofen may cause water, sodium and potassium retention in patients who have never suffered from renal disorders due to its effects on renal perfusion. This may cause oedema or cardiac failure or hypertension in predisposed patients. Long-term use of ibuprofen, as with other NSAIDs, has led to renal papillary necrosis and other pathological renal changes. In general, habitual use of analgesics, especially combinations of several analgesic active ingredients, may lead to permanent renal damage, with risk of onset of renal failure (analgesic nephropathy). Renal toxicity has been observed in patients in whom renal prostaglandins have a compensatory role in maintaining renal perfusion. Administration of NSAIDs in these patients may result in a dose-dependent reduction in prostaglandin formation and, as a secondary effect, renal blood flow, which may rapidly lead to renal failure. Patients most at risk of these reactions are those with reduced renal function, heart failure, liver dysfunction, the elderly, and all patients taking diuretics and ACE inhibitors. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state. There is a risk of impaired renal function in dehydrated adolescents. In case of prolonged use, monitor renal function, particularly in cases of diffuse lupus erythematosus. • Respiratory disorders MOMENTACT ANALGESICO should be prescribed with caution in patients with bronchial asthma, chronic rhinitis, nasal polyps, sinusitis or allergic diseases in progress or in the past 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 hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have presented 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 as 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 a hypersensitivity reaction after administration of ibuprofen, treatment should be discontinued. Medically assisted measures should be initiated by specialized medical personnel, in line with the symptoms.• Reduced cardiac, renal and hepatic function Particular caution should be exercised when treating patients with reduced cardiac, hepatic or renal function since the use of NSAIDs may lead to a deterioration of renal function. The habitual concomitant use of several painkillers may 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 to periodically monitor clinical and laboratory parameters, especially in the case of prolonged treatment. • Haematological effects Ibuprofen, like other NSAIDs, may inhibit platelet aggregation and has been shown to prolong 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 receiving ibuprofen. Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been observed in patients without concomitant chronic disease (see section 4.8). • Since ocular changes have been observed in animal studies with NSAIDs, periodic ophthalmological checks are recommended in case of prolonged treatment. • Alcohol consumption should be avoided as it may intensify the side effects of NSAIDs, especially those affecting the gastrointestinal tract or the central nervous system. • Masking of symptoms of underlying infections Momentact Analgesic may mask the symptoms of infection, which may delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and in bacterial complications of chickenpox. When Momentact Analgesic is administered for the relief of infection-related pain, monitoring for infection is advised. In non-hospital settings, the patient should seek medical advice if symptoms persist or worsen. Important information about some of the excipients MOMENTACT ANALGESIC contains: - Sucrose : patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. - Sodium: This medicine contains 39.2 mg sodium per sachet, per maximum daily dose of 3 sachets 117.6 mg sodium, equivalent to 5.9% of the WHO recommended maximum daily intake of 2 g sodium for an adult. - Potassium: This medicine contains 90 mg potassium (2.3 mmol) per sachet. To be taken into consideration by patients with reduced kidney function or patients on a low potassium diet. - Aspartame: This medicine contains 20 mg aspartame per sachet equivalent to 20 mg/3000 mg. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria, a rare genetic disorder in which the amount of phenylalanine builds up because the body cannot process it properly.

INTERACTIONS

Interactions Momentact 400 mg 12 sachets granules for oral solution - Which medicines or foods can modify the effect of Momentact 400 mg 12 sachets granules for oral solution?

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 bleeding (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 the 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). Ibuprofen should not be combined with other NSAIDs, including COX-2 selective inhibitors, due to the potential for 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 adverse effects. Experimental data suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when the two drugs are administered concomitantly. Although there are uncertainties 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 low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered likely following occasional use of ibuprofen (see section 5.1). • Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4). • Diuretics, ACE inhibitors (such as captopril), beta blockers and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of nephrotoxicity associated with NSAIDs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclooxygenase 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 ANALGESICO 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 consideration should be given to monitoring renal function 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 medicinal products with consequent increase in their plasma levels with the possibility of reaching the toxic threshold. If this combination is deemed necessary, monitoring of phenytoin and lithium plasma levels is recommended in order to adapt the appropriate dosage during concomitant 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 consequent increase in the risk of toxicity. • Moclobemide: increases the effect of ibuprofen. • Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides, increasing their toxicity. • Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce the glomerular filtration rate and increase plasma levels of cardiac glycosides. Monitoring of serum glycoside levels is recommended. • Cholestyramine: Concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen from the gastrointestinal tract. However, the clinical relevance of this interaction is unknown. • Ciclosporins: 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 mifepristone administration may reduce the effect of mifepristone. Limited evidence suggests that co-administration of NSAIDs and prostaglandins on the same day does not adversely affect the effects of mifepristone or the 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 convulsions. • Sulfonylureas: NSAIDs may enhance the hypoglycaemic effect of sulfonylureas. In case of simultaneous treatment, monitoring of blood glucose levels is recommended. • Tacrolimus: Co-administration of NSAIDs and tacrolimus may increase the risk of nephrotoxicity. • Zidovudine: There is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophiliac patients receiving concomitant 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 plasma concentrations. • CYP2C9 inhibitors: Concomitant administration of ibuprofen and CYP2C9 inhibitors may slow the elimination of ibuprofen (CYP2C9 substrate) resulting in increased exposure to ibuprofen. In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased exposure to S(+)-ibuprofen of approximately 80% to 100% was observed. Consideration should be given to reducing the dose of ibuprofen when co-administered with strong CYP2C9 inhibitors, particularly when high doses of ibuprofen are administered with voriconazole or fluconazole. • Alcohol, bisphosphonates and oxypentifylline (pentoxifylline): may enhance gastrointestinal side effects and the risk of bleeding and ulceration. • Baclofen: high toxicity of baclofen.

SIDE EFFECTS

Like all medicines, Momentact 400 mg 12 sachets granules for oral solution can cause side effects - What are the side effects of Momentact 400 mg 12 sachets granules for oral solution?

The undesirable 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 trial and epidemiological data suggest that use of ibuprofen (particularly at high doses (2400 mg/day) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Gastrointestinal disorders: Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Gastrointestinal perforation with ibuprofen has been observed rarely. After administration of MOMENTACT ANALGESICO the following have been reported: feeling of heaviness in the stomach, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4). Uncommon: gastritis. Very rare: pancreatitis. Immune system disorders : The following undesirable 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, including severe asthma, bronchospasm or dyspnoea, asthmatic attack (sometimes with hypotension); rare: lupus erythematosus syndrome; very rare: severe hypersensitivity reactions. Symptoms may include: facial oedema, tongue oedema, laryngeal oedema, airway oedema with constriction, dyspnoea, tachycardia, anaphylaxis, exfoliative and bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme). Cardiac and vascular disorders: Oedema, fatigue, hypertension and cardiac failure have been reported in association with treatment with NSAIDs. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg/day) and in long-term treatment, may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). Very rare: palpitations, heart failure, myocardial infarction, acute pulmonary oedema, oedema, hypertension. These events generally tend to resolve on discontinuation of treatment. Other adverse events reported less frequently and for which causality has not necessarily been established include: Blood and lymphatic system disorders . Rare: leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia. Psychiatric disorders . Uncommon: insomnia, anxiety; Rare: depression, confusional state, hallucinations. Nervous system disorders . Common: dizziness; Uncommon: paraesthesia, somnolence; Rare: optic neuritis. Infections and infestations. Uncommon: rhinitis; Rare: aseptic meningitis. Rhinitis and aseptic meningitis (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4). Exacerbation of infection-related inflammation (e.g. development of necrotising fasciitis) has been described. Respiratory, thoracic and mediastinal disorders . Uncommon: bronchospasm, dyspnoea, apnoea. Eye disorders. Uncommon: visual disturbances; Rare: ocular impairment resulting in visual disturbances, toxic optic neuropathy. Ear and labyrinth disorders. Uncommon: hearing impaired, tinnitus, vertigo. Hepatobiliary disorders. Uncommon: abnormal liver function, hepatitis and jaundice; Very rare: liver failure. Skin and subcutaneous tissue disorders. Allergic skin rashes (erythema, pruritus, urticaria) may occasionally occur. 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 varicella infection (see “infections and infestations”). Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP). Renal and urinary disorders. Uncommon: renal function impairment and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. General disorders and administration site conditions. Common: malaise, fatigue; Rare: oedema. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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

Overdose Momentact 400 mg 12 sachets granules for oral solution - What are the risks of Momentact 400 mg 12 sachets granules for oral solution in case of overdose?

Toxicity Signs and symptoms of toxicity have not generally been 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 ingestion of ibuprofen at doses of 400 mg/kg or greater. Symptoms Most patients who have ingested significant quantities of ibuprofen will exhibit symptoms within 4 to 6 hours. The most commonly reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and somnolence. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions and loss of consciousness. Nystagmus, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and CNS and respiratory depression have also been reported rarely. Disorientation, excitement, fainting and cardiovascular toxicity including hypotension, bradycardia and tachycardia have been reported. Renal failure and liver damage are possible in cases of significant overdose. In cases of severe poisoning, metabolic acidosis may occur. Treatment There is no specific antidote for ibuprofen overdose. Symptomatic and supportive treatment is indicated in cases of overdose. Particular attention should be paid to monitoring blood pressure, acid-base balance and gastrointestinal bleeding. Administration of activated charcoal should be considered within one hour of ingestion of a potentially toxic amount. Alternatively, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose in adults. Adequate diuresis should be ensured and renal and hepatic function should be closely monitored. The patient should remain under observation for at least four hours following ingestion of a potentially toxic amount. If frequent or prolonged convulsions occur, they should be treated with intravenous diazepam. Other supportive measures may be necessary depending on the patient's clinical condition. Contact your local poison control center for more information.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Momentact 400 mg 12 sachets granules for oral solution.

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1%, up to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. From the twentieth week of pregnancy onwards, the use of MOMENTACT ANALGESICO may cause oligohydramnios resulting from fetal renal dysfunction. This condition may occur shortly after the start of treatment and is usually reversible after discontinuation. In addition, cases of constriction of the ductus arteriosus 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 ANALGESICO should not be administered unless clearly necessary. If MOMENTACT ANALGESICO is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. Following exposure to MOMENTACT ANALGESICO for several days from gestational week 20 onwards, prenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. MOMENTACT ANALGESICO should be discontinued if oligohydramnios or constriction of the ductus arteriosus are observed. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may 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 prostaglandin synthesis inhibitors may expose the mother and the neonate to : - possible prolongation of bleeding time, and antiaggregant effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently MOMENTACT ANALGESICO is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3). Breast-feeding Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of influence on the neonate seems unlikely. If, however, treatment is longer term, early weaning should be considered. NSAIDs should be avoided during breastfeeding. Fertility The use of Ibuprofen may impair female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women who have difficulties conceiving or who are undergoing investigation of infertility, discontinuation of treatment with ibuprofen should be considered.

DRIVING AND USE OF MACHINERY

Taking Momentact 400 mg 12 sachets granules for oral solution before driving or using machines - Does Momentact 400 mg 12 sachets granules for oral solution affect driving or using machines?

The use of ibuprofen does not usually affect the ability to drive or use machines. However, those patients whose activities require alertness should exercise caution if they experience drowsiness, dizziness or depression during therapy with ibuprofen.