MOMENACTCOMPI * 10CPS 25MG

MOMENACTCOMPI * 10CPS 25MG

Therapeutic indications

Pain of various origins or nature (headache, toothache, neuralgia, menstrual pain, osteoarticular and muscle pain).

Dosage and method of use

The use of the medicinal product is reserved for adult patients only. One capsule in single or repeated dose 2-3 times a day in the painful forms of greater intensity, preferably on a full stomach. Do not exceed the recommended dose.Special populations Patients with renal insufficiency and the elderly It is advisable to reduce the starting dose and practice maintenance therapy with the lowest effective dose. Individualized adjustments can only be considered after establishing good tolerability of the drug (see section 5.2). Patients with hepatic insufficiency Patients with mild or moderate hepatic impairment should be followed closely and treated with the lowest effective daily dose (see sections 4.3, 4.4 and 5.2).Pediatric populationThe safety and efficacy of ketoprofen have not been studied in children.

Contraindications

Momenactcompì is contraindicated in patients with a history of hypersensitivity reactions, such as bronchospasm, asthma attacks, rhinitis, urticaria or other allergic reactions, to ketoprofen, acetylsalicylic acid (ASA) or other non-steroidal 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; - during intensive diuretic therapy or treatment with anticoagulants; - severe renal insufficiency; - severe forms of liver failure (liver cirrhosis, severe hepatitis); - leukopenia and thrombocytopenia; - subjects with ongoing bleeding; - hemorrhagic diathesis; - subjects with haemostatic disorders; - severe heart failure; - active peptic ulcer, or a history of gastrointestinal bleeding, ulceration or perforation; - if you are allergic to peanuts or soy. Momenactcompì is also contraindicated during the third trimester of pregnancy (see section 4.6) and in pediatric 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, Gastrointestinal disorders The most commonly observed adverse events are gastrointestinal in nature. Common: dyspepsia, nausea, abdominal pain, vomiting. Uncommon: constipation, diarrhea, 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 , hematemesis.Skin and subcutaneous tissue disorders: Uncommon: rash, pruritus. Not known: photosensitization, skin rash, alopecia, urticaria, angioedema, erythema, bullous reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized 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, dizziness, 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, interstitial tubular nephritis, nephrotic syndrome.Hepatobiliary disorders: Rare: hepatitis, increased transaminase levels, increased serum bilirubin due to liver disease, jaundice.Disorders of the blood and lymphatic system: Rare: anemia due to bleeding, leukopenia. Not known: agranulocytosis, thrombocytopenia, bone marrow aplasia, haemolytic anemia.Disorders of the immune system: Not known: anaphylactic reactions (including shock).Psychiatric disorders: Not known: depression, hallucinations, confusion, mood changes.Cardiac pathologies: Not known: heart failure, atrial fibrillation, palpitations and tachycardia.Vascular pathologies: Not known: hypertension, vasodilation, vasculitis (including leukocytoclastic vasculitis).General disorders and administration site conditions: Uncommon: edema, fatigue.Metabolism and nutrition disorders: Not known: hyponatraemia, hyperkalaemia (see sections 4.4 and 4.5).Diagnostic tests: Rare: weight gain. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thromboembolic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

WarningsUndesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the following sections). The concomitant use of Momenactcompì with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.Gastrointestinal bleeding, ulceration or perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. ulcer, especially if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with 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 dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin re-uptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking Momenactcompì the treatment should be stopped 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 severe gastrointestinal toxicity compared to other NSAIDs, especially at high doses (see also sections 4.2 and 4.3).Elderly people: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can 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 should 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 initiation of treatment in patients with heart failure, with cirrhosis and nephrosis, in patients on diuretic therapy, with chronic renal failure particularly if the elderly. In such patients the administration of ketoprofen may cause a reduction in renal blood flow, caused by the inhibition of prostaglandins and lead to renal decompensation (see section 4.3). In patients with impaired liver function tests or with previous liver disease, transaminases should be evaluated regularly, particularly 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 mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There are insufficient data to exclude such a risk for ketoprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ketoprofen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidemia, 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 the potassium levels need to be monitored.Infections: As with other non-steroidal anti-inflammatory drugs, in the presence of infection, the anti-inflammatory, analgesic and antipyretic effects of ketoprofen may mask the symptoms of progression of the infection such as fever.Respiratory pathologies: 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). For the interaction of the drug with the metabolism of arachidonic acid, bronchospasm crises and possibly shock and other allergic phenomena may arise in asthmatics and predisposed subjects.Visual disturbances: If visual disturbances such as blurred vision occur, treatment should be discontinued.Important information about some of the excipients: -Sorbitol: contains 3 mg of sorbitol per capsule equivalent to 0.18 mg / kg / day. The additive effect of co-administration of sorbitol (or fructose) containing medicinal products and the daily dietary intake of sorbitol (or fructose) should be considered. The content of sorbitol in oral medicinal products may modify the bioavailability of other co-administered oral medicinal products. -Sodium p-ethyl hydroxybenzoate (E215) and sodium p-propyl redbenzoate (E217): they can cause allergic reactions (even delayed). -Sodium: Momenactcompì contains less than 1 mmol (23 mg) sodium per capsule, ie essentially "sodium free". -Soybean oil: Momenactcompì contains soybean oil. If you are allergic to peanuts or soya, do not take this medicine.

Pregnancy and breastfeeding

Pregnancy: The use of ketoprofen during the first and second trimester of pregnancy should be avoided. Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and 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% 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 cause 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, Momenactcompì should only be used in case of need. If Momenactcompì is used by women who are trying to have a baby or during the first and second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. The use of the drug close to childbirth can cause changes in the haemodynamics of the small circulation of the unborn child with serious consequences for breathing. Consequently, ketoprofen is contraindicated during the third trimester of pregnancy.Feeding timeThere is no information available on the excretion of Ketoprofen in human milk. Ketoprofen is not recommended during breastfeeding.FertilityThe use of NSAIDs can impair female fertility and is not recommended in women planning to become pregnant. In women who have fertility problems or who are undergoing fertility investigations, discontinuation of treatment should be considered.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

ASSOCIATIONS NOT RECOMMENDED Other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors) And salicylates in high doses : increased risk of gastrointestinal ulcers and bleeding. Anticoagulants (heparin and warfarin) and antiplatelet agents (e.g. ticlopidine and clopidogrel) : increased risk of bleeding (see section 4.4). NSAIDs can amplify the effects of blood thinners such as warfarin. If concomitant administration cannot be avoided, patients should be followed closely. Lithium : risk of increased plasma lithium levels, which can sometimes reach toxic levels due to reduced renal excretion of lithium. Where necessary, plasma lithium levels should be monitored with possible dosage adjustment during and after NSAID therapy. Methotrexate at doses above 15 mg / week : increased risk of haematological toxicity from methotrexate, particularly when administered in high doses (> 15 mg / week); possibly due to protein binding shift of methotrexate and reduced renal clearance. In patients already being treated with ketoprofen, therapy should be stopped at least 12 hours before methotrexate administration. If ketoprofen is to be administered at the end of methotrexate therapy, it is necessary to wait 12 hours before administration. ASSOCIATIONS THAT REQUIRE CAUTION Drugs or therapeutic categories that can promote hyperkalaemia(e.g. potassium salts, potassium-sparing diuretics, ACE inhibitors and angiotensin II antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim): the occurrence of hyperkalaemia may depend on the presence of cofactors. The risk of hyperkalaemia is enhanced when the above-mentioned drugs are administered concomitantly (see section 4.5). Corticosteroids : increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Diuretics : patients who are taking diuretics and, among them, particularly dehydrated patients have a high risk of developing renal failure following a decrease in renal blood flow caused by the inhibition of prostaglandins. These patients must be rehydrated prior to initiation of co-administration and their renal function monitored when treatment is initiated (see section 4.4). ACE inhibitors and angiotensin II antagonists : In patients with impaired renal function (e.g. dehydrated patients or elderly patients) co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, which includes possible acute renal failure. These interactions should be considered in patients taking Momenactcompì 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 (see section 4.4). Methotrexate at doses below 15 mg / week A complete blood count should be performed every week during the first few weeks of combination therapy. In the presence of impaired renal function or in elderly patients, monitoring should be more frequent. Pentoxifylline : there is an increased risk of bleeding. Closer clinical monitoring and bleeding time monitoring is required. Tenofovir : Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure. Cardiac glycosides : NSAIDs can exacerbate heart failure, reduce glomerural filtration rate and increase cardiac glycoside levels; however, the pharmacokinetic interaction between ketoprofen and active glycosides has not been demonstrated. ASSOCIATIONS TO CONSIDER Antihypertensives (beta blockers, angiotensin converting enzymes, diuretics) : risk of decreased antihypertensive activity (inhibition of prostaglandin vasodilation caused by NSAIDs). Thrombolytics : increased risk of bleeding. Several substances are involved in interactions due to their antiplatelet effect: tirofiban, eptifibarid, abciximab and iloprost. The use of various antiplatelet drugs increases the risk of bleeding. Probenecid : Concomitant administration of probenecid can significantly reduce the plasma clearance of ketoprofen. Selective serotonin re-uptake inhibitors (SSRIs) : increased risk of gastrointestinal bleeding (see section 4.4). Gemeprost : reduced efficacy of gemeprost. Intrauterine contraceptive devices (IUDs) : the effectiveness of the device may be reduced resulting in pregnancy. Mifepristone : The efficacy of the method may theoretically be reduced due to the antiprostaglandin properties of non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin (acetylsalicylic acid). There is some evidence to suggest that co-administration of NSAIDs on the day of administration of the prostaglandin dose does not adversely affect the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical discontinuation. of pregnancy. Ciclosporin and Tacrolimus : simultaneous treatment with NSAIDs may involve a greater risk of nephrotoxicity especially in elderly subjects. Quinolone antibiotics : Animal data indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing seizures.

Overdose

Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most cases, the symptoms observed were benign in nature and limited to lethargy, somnolence, nausea, vomiting and epigastric pain. There is no specific antidote to ketoprofen overdose. If severe overdose is suspected, gastric lavage and the institution of supportive and symptomatic therapies are recommended to compensate for dehydration, to monitor renal function and to correct acidosis if present. In case of renal insufficiency, hemodialysis may be useful to remove the drug from the circulation. If the patient is brought to the doctor's observation within a short time after the ingestion of excessive doses, a gastric lavage should be performed in order to recover the granules still present in the stomach, which are recognizable in the gastric contents. However, the treatment is symptomatic and supportive. 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, somnolence, nausea, vomiting, diarrhea and abdominal pain. In cases of severe overdose, hypotension, respiratory depression and gastrointestinal bleeding have been observed. The patient must be immediately transferred to a specialist center to begin symptomatic treatment.

Active principles

One tablet contains:Active principle: Ketoprofen: 25 mg.Excipients with known effects: soybean oil, sorbitol, sodium ethyl paroxybenzoate, sodium propyl paroxybenzoate For a full list of excipients, see section 6.1.

Excipients

Vegetable oil, partially hydrogenated vegetable oils,soybean oil, yellow wax, soy lecithin.Constituents of the capsule: gelatin, glycerol (E422),sorbitol(E420) special solution,ethyl sodium paraoxybenzoate,propyl sodium paraoxybenzoate(E217), titanium dioxide (E171), red iron oxide (E172), purified water.