Momentact 400 mg Analgesic 20 Tablets

Momentact Tablets is an over-the-counter ibuprofen-based analgesic drug for the treatment of pain of various origins and nature such as: headache, toothache, neuralgia, bone and joint and muscle pain, menstrual pain.

The 400 mg of ibuprofen in Momentact Tablets are a valid aid in the symptomatic treatment of feverish states, to lower the temperature and fight flu symptoms .

Momentact 400 mg is indicated in adults and adolescents over 12 years of age.

Dosage and method of use Momentact 400 mg Analgesic 20 Tablets

Posology Adults and adolescents over 12 years Momentact 400 mg : Take 1 tablet 2-3 times a day of Momentact 400 mg. Momentact can be taken on an empty stomach. In subjects with gastric tolerability problems, it is preferable to take the medicine with food.

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. If the use of the medicine is necessary for more than 3 days in adolescents, or in the case of worsening of the symptoms, the doctor should be consulted.

Posology Elderly Momentact 400 mg : 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. If treatment is considered necessary, the lowest dose for the shortest duration needed to control symptoms should be used.

Posology Children Momentact 400 mg: Momentact is contraindicated in children under 12 years of age

Active ingredients Momentact 400 mg Analgesic 20 Tablets

Active ingredients Momentact 400 mg Analgesic 20 Tablets:

Each film-coated tablet contains: Active ingredient : ibuprofen 400 mg. Excipients with known effect : lactose, sodium.

Excipients Momentact 400 mg Analgesic 20 Tablets:

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

Contraindications and Side Effects Momentact 400 mg Analgesic 20 Tablets

Contraindications Momentact 400 mg Analgesic 20 Tablets:

• Hypersensitivity to the active substance, to other antirheumatics (acetylsalicylic acid, etc.) or to any of the excipients listed
• Do not administer to children under 12 years of age.
• Ibuprofen is contraindicated during the third trimester of pregnancy and while breastfeeding.
• 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 heart failure (NYHA class IV).
• Severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).

The undesirable effects observed with ibuprofen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and are presented below using the following convention: Very common (≥1/10) Common (≥1/100 to <1/10) Not common (≥1/1,000 to <1/100) Rare (≥1/10,000 to <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 treatments may be associated with a small increased risk of arterial thrombotic events (eg myocardial infarction or stroke).

• Gastrointestinal disorders Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Gastrointestinal perforation with the use of ibuprofen 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, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. 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 various types of rash, urticaria, pruritus, purpura, angioedema, exanthema, respiratory tract reactions including asthma, including severe, bronchospasm or dyspnoea asthmatic attack (sometimes with hypotension). rare: lupus erythematosus syndrome; very rare: severe hypersensitivity reactions. Symptoms may include: face oedema, tongue oedema, laryngeal oedema, airway oedema, 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 heart failure have been reported in association with NSAID treatment. Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Very rare: Palpitations, heart failure, myocardial infarction, acute pulmonary oedema, oedema, hypertension. These phenomena generally tend to regress upon discontinuation of treatment. Other adverse events that are reported less frequently and for which causality has not necessarily been established include:
• Blood and lymphatic system disorders Rare: leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia 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 inflammations (e.g. development of necrotizing 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: impaired hearing, tinnitus, vertigo.
• Hepatobiliary disorders Uncommon: liver function abnormal, hepatitis and jaundice. Very rare: hepatic failure.
• Skin and subcutaneous tissue disorders 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, severe skin infections and soft tissue pathologies can occur during chickenpox infection (see "Infections and infestations"). Not known: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
• Renal and urinary disorders Uncommon: Impairment of renal function 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.

Warnings Momentact 400 mg Analgesic 20 Tablets

Warnings Momentact 400 mg Analgesic 20 Tablets:

• The use of Momentact, like any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women intending to become pregnant.
• Momentact administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations. • Undesirable effects may be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see sections on gastrointestinal and cardiovascular risks below).
• Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
• 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 NSAID treatment. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs (see section 4.5). Clinical studies suggest that the use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a small increased risk of arterial thrombotic events (e.g. 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 ischemic 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 of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, cigarette smoking), especially if high doses are required (2400 mg/ day) of ibuprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar considerations should be made before starting long-term treatment in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
• Gastrointestinal haemorrhage, ulceration and perforation The use of Momentact should be avoided with concomitant NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors due to an increased risk of ulceration or bleeding (see section 4.5). In particular, GI bleeding, ulceration and perforation, which can be fatal, have been reported at any time with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events, during treatment with all NSAIDs. In the elderly and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased NSAID doses. These patients should start treatment on the lowest available dose. 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 GI toxicity, particularly the elderly, should report any unusual GI symptoms (especially GI bleeding) particularly in the initial stages of treatment. Monitor closely patients receiving concomitant medications which 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 the 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).
• Dermatological effects Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Momentact should be discontinued at the first appearance of skin 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 can cause sodium, potassium and water retention in patients who have never suffered from renal disorders due to its effects on renal perfusion. This can 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 renal failure (analgesic nephropathy). Renal toxicity has been reported in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. The administration of NSAIDs in these patients can lead to a dose-dependent reduction in prostaglandin formation and, as a secondary effect, in renal blood flow which can quickly lead to renal failure. Patients most at risk of these reactions are those with impaired 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 of the pretreatment state. There is a risk of impaired renal function in dehydrated adolescents. In case of prolonged use monitor renal function especially in case of widespread 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 could arise. 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 drug. 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 respiratory disease obstructive disorders or previous episodes of angioedema (see sections 4.3 and 4.8). Hypersensitivity reactions can take the form of asthma attacks (so-called analgesic asthma), Quincke's edema or urticaria. Serious hypersensitivity reactions (e.g. anaphylactic shock) have been rarely observed. At the first signs of a hypersensitivity reaction after administration of ibuprofen, the treatment should be discontinued. Medically assisted measures must be initiated by specialized medical personnel, in line with the symptoms.
• Impaired cardiac, renal and hepatic function Particular caution should be exercised in the treatment of patients with impaired cardiac, hepatic or renal function since the use of NSAIDs may lead to deterioration of renal function. The habitual concomitant use of several 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.
• Haematological effects Ibuprofen, like other NSAIDs, can 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 observed carefully.
• Aseptic meningitis Symptoms of aseptic meningitis have been observed on rare occasions in patients receiving ibuprofen. While this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue disorders, it has also been observed in patients who did not have any underlying chronic disease (see section 4.8). • Since ocular alterations have been found 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. • Ibuprofen may mask the signs or symptoms of infection (fever, pain and swelling). Important information about some of the excipients Momentact contains: - Lactose : patients with 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, ie essentially 'sodium-free'.

Interactions with other drugs Momentact 400 mg Analgesic 20 Tablets

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 enhance 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). It is advisable not to combine ibuprofen with other NSAIDs, including selective COX-2 inhibitors, due to the potential additive effect (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 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 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 effects are considered likely for occasional ibuprofen use (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 can reduce the effect of diuretics and other antihypertensive drugs. Diuretics may also increase the risk of NSAID-associated nephrotoxicity. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, 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 can lead to a reduced elimination of these medicinal products with a 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 adequate dosage during simultaneous treatment with ibuprofen. • Methotrexate: NSAIDs can inhibit the tubular secretion of methotrexate and certain metabolic interactions can occur resulting in decreased clearance of methotrexate and consequently 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: 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. • Cyclosporine: Concomitant administration of cyclosporine 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 can increase the risk of bleeding in association with NSAIDs. • Mifepristone: due to the anti-prostaglandin properties of NSAIDs, their use after administration of mifepristone may lead to a reduction of 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 prostaglandin on cervical ripening or uterine contractility and does not reduce the medicinal product's clinical efficacy on pregnancy termination. • Quinolone antibiotics: Patients taking NSAIDs and quinolones may have an increased risk of developing seizures. • Sulphonylureas: NSAIDs can increase the hypoglycaemic effect of sulphonylureas. 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 receiving zidovudine and other NSAIDs at the same time. A haematological examination is recommended 1-2 weeks after initiation of treatment. • Ritonavir: may cause an increase in the plasma concentrations of NSAIDs. • Probenecid: slows down the excretion of ibuprofen, with possible increase of their plasma concentrations. • CYP2C9 inhibitors: Co-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), an increased exposure of S(+)-ibuprofen by approximately 80% to 100% was observed. Consideration should be given to reducing the ibuprofen dose in cases of co-administration with strong CYP2C9 inhibitors, especially when high doses of ibuprofen are co-administered with voriconazole or fluconazole. • Alcohol, bisphosphonates and oxypentifylline (pentoxifylline): May enhance gastrointestinal side effects and risk of bleeding and ulcers. • Baclofen: high toxicity of baclofen.

Overdose Momentact 400 mg Analgesic 20 Tablets

Toxicity Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children or adults. However, supportive treatment may be required in some cases. 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 amounts of ibuprofen will experience symptoms within 4-6 hours. The most commonly reported overdose symptoms include: nausea, vomiting, abdominal pain, lethargy and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsions, and unconsciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhea and CNS and respiratory depression have also been reported rarely. Disorientation, excitation, 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. Symptomatic and supportive treatment is therefore indicated in the event of an overdose. Particular attention is due to the control of blood pressure, acid-base balance and any gastrointestinal bleeding. The 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 must be ensured and renal and hepatic functions must be closely monitored. The patient should be observed for at least four hours following the ingestion of a potentially toxic amount of drug. Any occurrence of frequent or prolonged convulsions should be treated with intravenous diazepam. Other supportive measures may be necessary depending on the patient's clinical condition. For more information, contact your local poison control center.

Momentact 400 mg Analgesic 20 Tablets in Pregnancy and lactation

Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development . Results of epidemiological studies suggest an increased risk of miscarriage and of 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 was thought to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, Momentact should not be administered unless strictly necessary. If Momentact is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to : - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydramnios; At the end of pregnancy, all prostaglandin synthesis inhibitors can expose the mother and the newborn to : - possible prolongation of bleeding time, and antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently Momentact is contraindicated during the third trimester of pregnancy.

Breastfeeding Ibuprofen is excreted in breast milk, but at therapeutic doses during short-term treatment, the risk of affecting the infant seems 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 impair female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women who are having difficulty conceiving or who are undergoing investigation of infertility, discontinuation of ibuprofen should be considered.

Expiration and conservation Momentact 400 mg Analgesic 20 Tablets

This medicinal product does not require any special temperature storage conditions.