MOMENTAct 400 mg oral suspension in sachets ibuprofen

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.

Active Ingredients

Each capsule contains: Active substance : ibuprofen 400 mg Excipients with known effect : sorbitol, Ponceau 4R (E124)For the full list of excipients, see section 6.1.

Excipients

Macrogol 600, potassium hydroxide, gelatin, partially dehydrated liquid sorbitol , purified water, ponceau 4R (E124) , lecithin, fractionated coconut oil.

Dosage

Dosage Adults and adolescents over 12 years : 1 capsule 2-3 times a day. Do not exceed 3 capsules a 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 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 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 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.

Warnings

• The use of Momentact, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women attempting to conceive. • Administration of Momentact should be suspended in women who have problems conceiving or who are undergoing investigation of infertility. • Undesirable effects may 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 section 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 therapy. 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 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 of 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 made before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). • 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). 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 GI 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 dose available. Concomitant use of protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking low dose 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 (SSRIs) 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 given 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). 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. 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 starting treatment with ibuprofen, caution should be exercised in patients with considerable dehydration. Ibuprofen may cause water, sodium and 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 different analgesic active ingredients, can lead to permanent renal damage, with the risk of renal failure (analgesic nephropathy). Renal toxicity has been observed 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 failure. 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. Suspension of NSAID therapy is usually followed by recovery of the pre-treatment 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 allergic diseases in progress or in the past because bronchospasm, urticaria and angioedema may occur. The same applies to those subjects who have manifested 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 edema or urticaria. Serious hypersensitivity reactions (e.g. anaphylactic shock) have been observed rarely. At the first signs of a hypersensitivity reaction after administration of ibuprofen, treatment must 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 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 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 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 capsules contain: - Sorbitol (E420 ): this medicine contains 23.46 mg of sorbitol per dose, equivalent to 23.46 mg/1180 mg. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and daily dietary intake of sorbitol (or fructose) should be considered. The sorbitol content of oral medicinal products may modify the bioavailability of other concomitantly administered oral medicinal products; - Ponceau 4R (E124) : may cause allergic reactions.

Conservation

Store below 25°C.

Contraindications

• 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. • 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).

Side effects

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 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 various types of skin rash, 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 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) (see section 4.4). Very rare: palpitations, cardiac failure, myocardial infarction, acute pulmonary oedema, oedema, hypertension. 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 inflammations (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 alteration 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). 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 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 http://www.agenziafarmaco.gov.it/content/comesegnalare-una-sospetta-reazione-avversa .

Overdose

Toxicity Signs and symptoms of toxicity have not generally been observed at doses below 100 mg/kg in children or adults. However, supportive treatment may be necessary in some cases. Children have been observed to exhibit signs and symptoms of toxicity following ingestion of ibuprofen at doses of 400 mg/kg or greater. Symptoms Most patients who have ingested significant amounts 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, metabolic acidosis, 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

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 malformation 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. 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.