Pain of various origins or natures (headache, toothache, neuralgia, menstrual pain, osteoarticular and muscular pain).
Active Ingredients
One tablet contains: Active ingredient : Ketoprofen: 25 mg. Excipients with known effect: soya oil, sorbitol, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. For the full list of excipients, see section 6.1.
Excipients
Vegetable oil, partially hydrogenated vegetable oils, soya oil , yellow wax, soya lecithin. Capsule components: gelatin, glycerol (E422), sorbitol (E420) special solution, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E217), titanium dioxide (E171), red iron oxide (E172), purified water.
Dosage
Adults and adolescents over 15 years: One capsule in a single dose or repeated 2-3 times a day in the most severe forms of pain, preferably on a full stomach. Do not exceed the recommended doses. The lowest effective dose should be used for the shortest period necessary to relieve symptoms (see section 4.4). Special populations Patients with renal insufficiency and elderly It is recommended to reduce the initial dose and perform maintenance therapy with the minimum effective dose. Individualized adjustments can be considered only after establishing good tolerability of the drug (see section 5.2). Patients with hepatic insufficiency Patients with mild or moderate hepatic impairment should be monitored carefully and treated with the minimum effective daily dose (see sections 4.3, 4.4 and 5.2). Paediatric population Do not use in children and adolescents under 15 years of age.
Warnings
Warnings Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and following paragraphs). The concomitant use of Momenactcompì with other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided. Gastrointestinal bleeding, ulceration or perforation: 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 (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose aspirin or other drugs likely to increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be advised in patients taking 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 aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients receiving Momenactcompì, the treatment should be withdrawn immediately. 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). Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of serious gastrointestinal toxicity compared with other NSAIDs, particularly at high doses (see also sections 4.2 and 4.3). 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). Skin reactions: 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. Momenactcompì must be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Precautions Cardiovascular, renal and hepatic dysfunction: Renal function should be carefully monitored at the start of treatment in patients with heart failure, cirrhosis and nephrosis, in patients on diuretic therapy, with chronic renal insufficiency, especially if elderly. In such patients, the administration of ketoprofen may cause a reduction in renal blood flow, caused by prostaglandin inhibition and lead to renal decompensation (see section 4.3). In patients with impaired liver function tests or with previous liver disease, transaminases should be regularly assessed, especially during long-term therapy. Cases of jaundice and hepatitis have been reported with ketoprofen. Cardiovascular and cerebrovascular effects: Caution is required in patients with a history of hypertension and/or mild to moderate congestive heart failure since fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for ketoprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ketoprofen after careful consideration. Similar consideration should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). An increased risk of atrial fibrillation associated with the use of NSAIDs has been reported. Hyperkalaemia may occur, especially in patients with underlying diabetes, renal insufficiency, and/or concomitant treatment with agents promoting hyperkalaemia (see section 4.5). In these circumstances, potassium levels should be monitored. Masking of symptoms of underlying infections Momenactcompì may mask the symptoms of infection, which may delay 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 varicella. When Momenactcompì is administered for the relief of infection-related pain, monitoring for infection is recommended. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen. Respiratory disorders: Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyps have a higher risk of allergies to aspirin and/or NSAIDs than the rest of the population. Administration of this medicinal product may cause asthma attacks or bronchospasm, particularly in subjects allergic to aspirin or NSAIDs (see section 4.3). Due to the interaction of the drug with the metabolism of arachidonic acid, asthmatics and predisposed subjects may experience bronchospasm attacks and possibly shock and other allergic phenomena. Visual disturbances: If visual disturbances such as blurred vision occur, treatment should be discontinued. Important information about some excipients: - Sorbitol: contains 3 mg sorbitol per capsule equivalent to 0.18 mg/kg/day. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and daily intake of sorbitol (or fructose) with the diet should be taken into account. The sorbitol content in medicinal products for oral use may modify the bioavailability of other medicinal products for oral use co-administered . - Sodium ethyl p-hydroxybenzoate (E215) and sodium propyl p-hydroxybenzoate (E217): may cause allergic reactions (possibly delayed). - Sodium : Momenactcompì contains less than 1 mmol (23 mg) sodium per capsule, i.e. essentially “sodium-free”. - Soya oil: Momenactcompì contains soya oil. If you are allergic to peanuts or soya, do not take this medicine.
Conservation
This medicinal product does not require any special storage conditions.
Contraindications
Momenactcompì is contraindicated in patients with a history of hypersensitivity reactions, such as bronchospasm, asthmatic attacks, rhinitis, urticaria or other allergic-type reactions, to ketoprofen, acetylsalicylic acid (ASA) or other nonsteroidal anti-inflammatory drugs (NSAIDs). Serious, rarely fatal, anaphylactic reactions have been reported in these patients (see section 4.8). Momenactcompì is also contraindicated in the following cases: - hypersensitivity to any of the excipients listed in section 6.1; - undergoing intensive diuretic therapy or treatment with anticoagulants; - severe renal insufficiency; - severe forms of liver insufficiency (liver cirrhosis, severe hepatitis); - leukopenia and thrombocytopenia; - subjects with active haemorrhages; - haemorrhagic diathesis; - subjects with haemostatic disorders; - severe cardiac insufficiency; - active peptic ulcer, or previous history of gastrointestinal bleeding, ulceration or perforation; - if you are allergic to peanuts or soya. Momenactcompì is also contraindicated during the third trimester of pregnancy (see section 4.6) and in children and adolescents under 15 years of age.
Side effects
Like all medicines, Momenactcompì can cause side effects, although not everybody gets them. Classification of expected frequencies: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), not known (frequency cannot be estimated from the available data). The following reactions have been reported with the use of ketoprofen in adults: Gastrointestinal disorders . The most commonly observed adverse events are gastrointestinal in nature. Common: dyspepsia, nausea, abdominal pain, vomiting; Uncommon: constipation, diarrhoea, flatulence, gastritis; Rare: ulcerative stomatitis, peptic ulcers, colitis; Not known: exacerbation of colitis and Crohn's disease, gastrointestinal perforation or haemorrhage, sometimes fatal, particularly in the elderly (see section 4.4), pancreatitis, melaena, haematemesis. Skin and subcutaneous tissue disorders. Uncommon: rash, pruritus; Not known: photosensitivity, skin rash, alopecia, urticaria, angioedema, erythema, bullous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis. Respiratory, thoracic and mediastinal disorders. Rare: asthma attacks; Not known: bronchospasm (particularly in patients with known hypersensitivity to acetylsalicylic acid, ASA and other NSAIDs), rhinitis, dyspnoea. Nervous system disorders. Uncommon: headache, vertigo, dizziness, somnolence; Rare: paraesthesia; Not known: aseptic meningitis, convulsions, dysgeusia. Eye disorders. Rare: blurred vision (see section 4.4). Ear and labyrinth disorders. Rare: tinnitus. Renal and urinary disorders. Not known: renal function test abnormalities, acute renal failure, tubular interstitial nephritis, nephrotic syndrome. Hepatobiliary disorders. Rare: hepatitis, increased transaminase levels, increased serum bilirubin due to liver disease, jaundice. Blood and lymphatic system disorders. Rare: anaemia due to bleeding, leukopenia; Not known: agranulocytosis, thrombocytopenia, bone marrow aplasia, haemolytic anaemia. Immune system disorders. Not known: anaphylactic reactions (including shock). Psychiatric disorders. Not known: depression, hallucinations, confusion, mood alterations. Cardiac disorders. Not known: cardiac failure, atrial fibrillation, palpitations and tachycardia. Vascular disorders. Not known: hypertension, vasodilatation, vasculitis (including leukocytoclastic vasculitis). General disorders and administration site conditions. Uncommon: oedema, fatigue. Metabolism and nutrition disorders. Not known: hyponatraemia, hyperkalaemia (see sections 4.4 and 4.5). Investigations. Rare: weight gain. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thromboembolic events (for example myocardial infarction or stroke) (see section 4.4). Reporting of suspected adverse reactions Reporting of 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
Overdosage with doses of up to 2.5 g of ketoprofen has been reported. In most cases, the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes for ketoprofen overdose. If a serious overdose is suspected, gastric lavage and supportive and symptomatic therapy are recommended to compensate for dehydration, monitor renal function and correct acidosis if present. In renal failure, haemodialysis may be useful to remove the drug from the circulation. If the patient is brought to medical attention shortly after ingestion of excessive doses, gastric lavage should be performed in order to recover any granules still present in the stomach, which are recognisable in the gastric contents. Treatment is symptomatic and supportive. The administration of activated charcoal should also be considered in an attempt to reduce the absorption of slow-release ketoprofen. In adults, the main signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhoea and abdominal pain. Hypotension, respiratory depression and gastrointestinal bleeding have been observed in severe overdose. The patient should be transferred immediately to a specialist centre for symptomatic treatment.
Pregnancy
Pregnancy : The use of ketoprofen during the first and second trimester of pregnancy should be avoided. 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 was increased from less than 1%, up to approximately 1.5%. The risk has been estimated 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 20th week of pregnancy onwards, the use of Momenactcompì may cause oligohydramnios resulting from fetal renal dysfunction. This condition may be encountered shortly after the start of treatment and is usually reversible with treatment 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 Momenactcompì should not be administered unless strictly necessary. If Momenactcompì is used by a woman who is planning a pregnancy, or during the first and second trimester of pregnancy, the lowest possible dose should be used for the shortest possible duration. Following exposure to Momenactcompì for several days from the 20th week of gestation onwards, antenatal monitoring for oligohydramnios and constriction of the ductus arteriosus should be considered. In case of oligohydramnios or constriction of the ductus arteriosus, treatment with Momenactcompì should be discontinued. 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); the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, and antiaggregant effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delay or prolongation of labor. The use of the drug close to delivery may cause alterations in the haemodynamics of the small circulation of the newborn with serious consequences for respiration. Consequently, Momenactcompì is contraindicated during the third trimester of pregnancy (see sections 4.3 and 5.3) Breastfeeding There is no information available on the excretion of Ketoprofen in human milk. Ketoprofen is not recommended during breastfeeding. Fertility The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have fertility problems or who are undergoing investigation of fertility, discontinuation of treatment should be considered.
