Momentact 400mg 8 sachets oral suspension 10ml

Momentact 400mg is a drug based on ibuprofen , an active ingredient belonging to the class of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), known for its analgesic, anti-inflammatory and antipyretic action . It is indicated for the treatment of mild and moderate pain , as well as for the control of fever. Thanks to its oral suspension formulation, Momentact 400mg guarantees rapid absorption and effective action, proving particularly useful for those who have difficulty swallowing tablets and need immediate relief.

Directions

When is Momentact 400mg indicated?

Momentact 400mg is indicated for the treatment of:

• Headache and migraine , including migraine episodes.
• Muscle and joint pain , even those resulting from trauma or inflammation.
• Menstrual cramps , helping to reduce cramps and abdominal tension.
• Toothache and post-tooth extraction pain.
• Fever and flu symptoms , helping to lower body temperature and alleviate general malaise.

ACTIVE INGREDIENTS

Active ingredients contained in Momentact 400mg 8 sachets oral suspension 10ml - What is the active ingredient in Momentact 400mg 8 sachets oral suspension 10ml?

Each sachet contains: Active ingredient : ibuprofen 400 mg. Excipients with known effects : sucrose , sucrose monopalmitate, sodium edetate dihydrate, methyl parahydroxybenzoate , propyl parahydroxybenzoate . For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Momentact 400mg 8 sachets oral suspension 10ml - What does Momentact 400mg 8 sachets oral suspension 10ml contain?

Cetyl alcohol, sucrose , xanthan gum, sucrose monopalmitate, colloidal anhydrous silica, citric acid monohydrate, disodium edetate dihydrate, methyl parahydroxybenzoate , simethicone emulsion, propyl parahydroxybenzoate , red orange flavouring, purified water.

DIRECTIONS

Therapeutic indications Momentact 400mg 8 sachets oral suspension 10ml - Why is Momentact 400mg 8 sachets oral suspension 10ml used? What is it used for?

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 feverish and flu states.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Momentact 400mg 8 sachets oral suspension 10ml - When should Momentact 400mg 8 sachets oral suspension 10ml not be used?

• Hypersensitivity to the active substance (ibuprofen), to acetylsalicylic acid, to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1. • Children under 12 years of age. • Third trimester of pregnancy and breast-feeding (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).

DOSAGE

Quantity and method of taking Momentact 400mg 8 sachets oral suspension 10ml - How to take Momentact 400mg 8 sachets oral suspension 10ml?

Dosage Adults and adolescents aged 12 years and over: 1 sachet 2-3 times a day. Do not exceed the dose of 1200 mg (3 single-dose sachets) per day. If the use of the medicinal product is necessary for more than 3 days in adolescents aged 12 years and over, or in case of worsening of symptoms, a doctor should be consulted. Do not exceed the recommended doses. Elderly patients should adhere to the minimum dosages indicated above (see section 4.4). Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (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 is contraindicated in patients with severe hepatic impairment (see section 4.3). Paediatric population Momentact is contraindicated in children under 12 years of age (see section 4.3). Method of administration Momentact 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 400mg 8 sachets oral suspension 10ml - How do you store Momentact 400mg 8 sachets oral suspension 10ml?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Momentact 400mg 8 sachets oral suspension 10ml - About Momentact 400mg 8 sachets oral suspension 10ml it is important to know that:

• In asthmatic patients the product should be used with caution, following medical evaluation. • The use of Momentact, as of any drug inhibiting the synthesis of prostaglandins and cyclooxygenase is not recommended in women intending to become pregnant. • The administration of Momentact 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 Clinical trials suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, 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 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. Caution is advised 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 therapy. NSAIDs may reduce the effect of diuretics, and other antihypertensive agents (see section 4.5). • Gastrointestinal bleeding, ulceration and perforation The use of Momentact 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). Gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI 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 dose available. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant acetylsalicylic acid or other drugs likely to increase GI risk (see below and section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual GI symptoms (especially GI 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 or anti-platelet agents such as acetylsalicylic acid (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving Momentact, 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). • 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 with no history of renal disease 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, the habitual use of analgesics, especially combinations of several analgesic active ingredients, can 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 can 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 those 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, renal function should be monitored, particularly in case of diffuse lupus erythematosus. • 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). Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in the majority of 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. • Respiratory disorders Momentact should be prescribed with caution in patients with bronchial asthma, chronic rhinitis, nasal polyps, sinusitis or allergic diseases, or with a history of allergic disease, 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 shown 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 themselves in the form of asthma attacks (so-called analgesic asthma), Quincke's oedema or urticaria. Serious hypersensitivity reactions (for example anaphylactic shock) have been observed rarely. At the first signs of hypersensitivity reaction after administration of ibuprofen, treatment should be stopped. 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 taken in the treatment of patients with reduced cardiac, hepatic or renal function since the use of NSAIDs may cause 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 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 carefully observed. • Aseptic meningitis Symptoms of aseptic meningitis have been observed on rare occasions 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 diseases (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. Ibuprofen may mask the signs or symptoms of infection (fever, pain and swelling). Important information about some of the excipients • Momentact contains: Propyl and methyl parahydroxybenzoate : may cause allergic reactions (possibly delayed) 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 less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

INTERACTIONS

Interactions Momentact 400mg 8 sachets oral suspension 10ml - Which medicines or foods can modify the effect of Momentact 400mg 8 sachets oral suspension 10ml?

• Ibuprofen (like other NSAIDs) should be used 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. • 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). • 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 acetylsalicylic acid or other NSAIDs, including selective COX-2 inhibitors, due to the potential additive effect (see section 4.4). • Anti-platelet 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 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 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 drugs with consequent increase in their plasma levels with the possibility of reaching the toxic threshold. If this combination is deemed necessary, monitoring of the plasma levels of phenytoin and lithium is recommended in order to adapt the dosage during concomitant treatment with ibuprofen. • Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and some metabolic interactions may occur with consequent reduction in the clearance of methotrexate and increased 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. • Ciclosporin: 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 its 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 400mg 8 sachets oral suspension 10ml can cause side effects - What are the side effects of Momentact 400mg 8 sachets oral suspension 10ml?

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).

*Rhinitis and aseptic meningitis have been observed 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. ** Clinical studies suggest that use of ibuprofen, particularly at high doses (2400 mg/day), may be associated with a modest increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4). *** Serious skin infections and soft tissue disorders may occur during varicella infection. Reporting of suspected adverse reactions Reporting suspected adverse reactions 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 400mg 8 sachets oral suspension 10ml - What are the risks of Momentact 400mg 8 sachets oral suspension 10ml 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 the event 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 400mg 8 sachets oral suspension 10ml

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo-foetal 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-foetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has 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 clearly 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 may progress to renal failure with oligo-hydroamniosis; At the end of pregnancy, all prostaglandin synthesis inhibitors may expose the mother and the neonate to: - possible prolongation of bleeding time, and anti-aggregating effect which may 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. Breastfeeding 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 ibuprofen treatment should be considered.

DRIVING AND USE OF MACHINERY

Taking Momentact 400mg 8 sachets oral suspension 10ml before driving or using machines - Does Momentact 400mg 8 sachets oral suspension 10ml 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.