MOMENACTCOMPII 10CPS 25MG

MOMENACTCOM? 25 MG CAPSULE MOLLI

active ingredients

One tablet contains: Active ingredient: Ketoprofene: 25 mg. Excipients with known effects: soybean oil, sorbitol, propyle paraoxide sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Vegetable oil, partially hydrogenated vegetable oils, soy oil, yellow wax, soy lecithin. Capsule constituents: gelatin, glycerol (E422), sorbitol (E420) special solution, sodium paraoxidise of ethyl, , sodium propile paraoxidise (E217), titanium dioxide (E171), iron oxide red (E172), purified water.

Therapeutic indications

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

Contraindications

Momenactcompì is contraindicated in patients with positive anamnesis for hypersensitivity reactions, such as bronchospasm, asthmatic attacks, rhinitis, hives or other allergic reactions, ketoprofen, acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (FANS). Serious, rarely fatal anaphylactic reactions were reported in these patients (see paragraph 4.8). Momenactcompì is also contraindicated in the following cases: - hypersensitivity to any of the excipients listed in paragraph 6.1; - in process of intensive diuretic therapy or in treatment with anticoagulants; - severe kidney failure; - severe forms of liver failure (hepatic cirrhosis, severe hepatitis); - leucopenia and piastrinopenia; - subjects with bleeding in place; - hemorrhagic diathesis; - subjects with hemostatic disorders; - severe heart failure; - active peptic ulcer, or previous anamnestics of gastrointestinal hemorrhage, ulceration or perforation; - if you're allergic to peanuts or soy. Momenactcompì is also contraindicated during the third trimester of pregnancy (see paragraph 4.6) and in pediatric age.

Dosage

The use of the medicine is reserved for adults only. One capsule in a single or repeated dose 2-3 times a day in the most intense algic forms, preferably on a full stomach. Do not exceed the recommended doses. Special populations Patients with kidney failure 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 paragraph 5.2). Patients with liver failure Patients with mild or moderate liver failure must be followed carefully and treated with the minimum effective daily dose (see paragraphs 4.3, 4.4 and 5.2). Pediatric population The safety and efficacy of ketoprofen have not been studied in children.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Warnings Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see paragraph 4.2 and the following paragraphs). Concurrent use of Momenactcomplied with other NSAIDs, including selective cyclooxygenase-2 inhibitors, must be avoided. Gastrointestinal bleeding, ulceration or drilling: During treatment with t ucts the NSAIDs, at any time, with or without symptoms of notice or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. In the elderly and in patients with history of ulcer, especially if complicated by hemorrhage or perforation (see paragraph 4.3), the risk of gastrointestinal hemorrhage, ulceration or perforation and higher with increased doses of NSAID. These patients must begin treatment with the lowest dose available. Concurrent use of protective agents (misoprostol or protonic pump inhibitors) must be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5). Patients with history of gastrointestinal toxicity, especially the elderly, must report any abdominal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent to patients who absurd concomitant drugs that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin re-uptake inhibitors or anti-aggregating agents such as aspirin (see paragraph 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking Momenactcompi treatment must be suspended immediately. NSAIDs should be administered with caution in patients with a history of gastrointestinal disease ( ulcerative colitis, Crohn's disease) since such conditions can be exacerbated (see paragraph 4.8). Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of severe gastrointestinal toxicity compared to other NSAIDs, especially at high doses (see also paragraphs 4.2 and 4.3). Seniors: Senior patients have an increased frequency of adverse reactions to NSAIDs, especially hemorrhages and gastrointestinal perforations, which can be fatal (see paragraph 4.2). Skin reactions: Severe skin reactions some of which fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of the NSAID (see paragraph 4.8). In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. Momenactcompì must be stopped at the first appearance of skin rash, mucosa lesions or any other sign of hypersensitivity. Precautions Cardiovascular, kidney and liver dysfunction: It should be carefully monitored the kidney function at the beginning of treatment in patients with heart failure, with cirrhosis and nephrosis, in patients in diuretic therapy, with chronic kidney failure especially if elderly. In such patients the administration of ketoprofen can cause a reduction in kidney blood flow, caused by the inhibition of prostaglandins and lead to a renal breakdown (see paragraph 4.3). In patients with impaired liver function tests or with previous liver disease, transaminers should be regularly assessed particularly during long-term therapy. With ketoprofen cases of jaundice and hepatitis were reported. Cardiovascular and cerebrovascular effects: Cautisus is required in patients with positive anamnesis for hypertension and/or congestive heart failure from mild to moderate because in association with the treatment with the NSAIDs, fluid and edema were found. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke). There is not enough data to exclude a similar risk for ketoprofen. Patients with uncontrolled hypertension, congestive heart failure, established ischemic cardiopathy, peripheral arterial disease and/or cerebrovascular disease should be treated with ketoprofen only after careful evaluation. Analogue considerations must be made before starting a long-term process in patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking). An increase in the risk of atrial fibrillation associated with the use of NSAIDs has been reported. Hyperpotassiemia can occur, especially in patients with diabetes below, kidney failure, and/or concomitant treatment with hyperpotassiemia agents (see paragraph 4.5). Under these circumstances, potassium levels must 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 can mask the symptoms of progression of infection such as fever. Respiratory diseases: Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyps have a higher risk of aspirin allergies and/or NSAIDs than the rest of the population. The administration of this medicine may cause asthma or bronchospasm attacks, particularly in aspirin or NSAIDs (see paragraph 4.3). For the interaction of the drug with the metabolism of arachidonic acid, in asthmatics and prepared subjects can arise bronchospasm crisis and possibly shock and other allergic phenomena. Visual disturbances: If you experience vision disorders as blurred vision the treatment must be stopped. important information about some excipients:- Sorbitol: contains 3 mg of sorbitol per capsule equivalent to 0.18 mg/kg/day. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. - P-oxybenzoate ethyl sodium (E215) and p-roxybenzoate propile sodium (E217):can cause allergic reactions (also delayed). - Sodium: Momenactcompì contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially "without sodium". - Soybean oil: Momenactcompì contains soy oil. If you are allergic to peanuts or soy, do not take this medicine.

Interactions

UNCONSOLIDATED ASSOCIATIONS Other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors) and salicylates at high doses : increased risk of ulcers and gastroenteric bleeding. Antiagulants (heparine and warfarin) and anti-aggregating agents (e.g. ticlopidine and chlopidogrel) : increased risk of bleeding (see paragraph 4.4). NSAIDs can amplify the effects of anticoagulants as warfarin. If it is not possible to avoid concurrent administration, patients must be followed carefully. Litio : risk of increased plasma levels of lithium, which can sometimes reach toxic levels due to reduced renal excretion of lithium. Where necessary the plasma levels of lithium should be monitored with possible adjustment of the dosage during and after therapy with NSAIDs. Metotrexate at doses greater than 15 mg/week : increased risk of hematological toxicity by metotrexate, especially when administered at high doses (> 15 mg/week); probably due to displacement of metotrexate from protein bond and reduced kidney clearance. In patients already in treatment with ketoprofen it is necessary to stop therapy at least 12 hours before administration of metotrexate. If ketoprofen should be administered at the end of metotrexate therapy, it is necessary to wait 12 hours before administration. ASSOCIATIONS REQUEST CAUTEL Drugs or therapeutic categories that can promote hyperpotassiemia(e.g. potassium salts, potassium-saving diuretics, ACE inhibitors and antagonists of angiotensin II, NSAIDs, eparine (low molecular weight or not fractionated), cyclosporin, tacrolimus and trimetoprim): the occurrence of hyperpotassiemia may depend on the presence of cofactors. The risk of hyperpotassiemia is strengthened when the drugs mentioned above are administered simultaneously (see paragraph 4.5). Courtesy : increased risk of gastrointestinal ulceration or bleeding (see paragraph 4.4). Diuretics : patients who are taking diuretics and, among them, particularly dehydrated patients have a high risk of developing kidney failure resulting in a decrease in kidney blood flow caused by prostaglandin inhibition. These patients must be rehydrated before the start of co-administration and their kidney function must be monitored when the treatment begins (see paragraph 4.4). ACE inhibitors and angiotensin antagonists II : In patients with impaired kidney function (e.g. dehydrated patients or elderly patients) co-administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxidase system may lead to further deterioration of kidney function, which includes a possible acute kidney failure. These interactions must be considered in patients taking Momenactcompi in conjunction with ACE inhibitors or antagonists of angiotensin II. Therefore, the combination should be given with caution, especially in elderly patients. Patients should be properly hydrated and monitoring of renal function should be taken into account the beginning of concomitant therapy (see paragraph 4.4). Metotrexate at doses less than 15 mg/week : during the first weeks of combined therapy, an emochromocytometric examination must be carried out every week. In the presence of kidney function alterations or older patients, monitoring must be more frequent. Pentoxins : hemorrhagic risk increases. More careful clinical monitoring and bleeding time monitoring is required. Tenofovir : Concurrent administration of tenofovir disoproxil fumarate and FANS may increase the risk of kidney failure. Cardioactive glycosides : NSAIDs can exacerbate heart failure, reduce glomerural filtration rate and increase heart glycoside levels; however, drug interaction between ketoprofen and active glycosides has not been demonstrated. ASSOCIATIONS TO CONSIDER Antihypertensives (beta-blockers, enzymes angiotensin converters, diuretics) : risk of decrease in antihypertensive activity (inhibition of vasodilation from prostaglandin caused by NSAs). Trombolites : increased risk of bleeding. Several substances are involved in interactions due to their anti-aggregating effect: thyrofiban, eptifibarid, abciximab and iloprost. The use of several anti-platelet drugs increases the risk of bleeding. Probenecid : concurrent administration of probenecid can greatly reduce the plasma clearance of ketoprofen. Selective serotonin re-uptake inhibitors (SSRIs) : increased risk of gastrointestinal hemorrhage (see paragraph 4.4). Gemeprost : reduced gemeprost effectiveness. Intrauterine contraceptive devices (IUDs) : the effectiveness of the device can be reduced resulting in pregnancy. Mifepristone : The effectiveness of the method can, theoretically, be reduced due to the antiprostaglandinic properties of non-steroidal anti-inflammatory drugs (NSAID) including aspirin (acetylsalicylic acid). There are some evidence suggesting that the simultaneous administration of FANS on the day of administration of the dose of prostaglandin does not adversely affect the effects of mifepristone or prostaglandin on cervical maturation or uterine contractility and does not reduce the clinical effectiveness of the medical interruption of pregnancy. Ciclosporin and Tacrolimus : contemporary treatment with NSAIDs can lead to a greater risk of nephrotoxicity, especially in older individuals. Chinolonic Antibiotics : animal data indicate that NSAIDs can increase the risk of convulsions associated with chinolonic antibiotics. Patients taking NSAIDs and Knolones can have an increased risk of developing seizures.

Effects

Like all medicines, Momenactcompì can cause unwanted effects, although not all people manifest them. Classification of expected frequencies: very common (≥ 1/10), common (≥ 1/100, gastrointestinal pathologies The most commonly observed adverse events are gastrointestinal. Common: dyspepsia, nausea, abdominal pain, vomiting. Not common: stips, diarrhea, flatulence, gastritis. Rare: ulcerative stomatitis, peptic ulcers, colitis. Notable: exacerbation of colitis and Crohn's disease, perforation or gastrointestinal hemorrhage, sometimes fatal, especially in the elderly (see paragraph 4.4), pancreatitis, melena, ematemesis. Pathologies of skin and subcutaneous tissue: Not common: rash, itching. Notable: photosensitization, skin analopecia, hives, angioedema, erythema, bollose reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, generalized acute exantematic pulstolosis. Thoracic and mediastinic respiratory pathologies: Rare: asthma attacks. Not known: bronchospasm (particularly in patients with known hypersensitivity to acetylsalicylic acid ASA and other NSAs), rhinitis, disconnect. Diseases of the nervous system: Not common: headache, dizziness, dizziness, drowsiness. Rare: parestesia. Notable: asyptic meningitis, seizures, disgeusia. Pathologies of the eye: Rare: blurred vision (see paragraph 4.4). Ear and labyrinth pathologies: Rare: Tinnitus. Kidney and urinary pathologies: Not known: abnormality in kidney function tests, acute kidney failure, interstitial tubular nephritis, nephrosic syndrome. Hepatobiliary diseases: Rare: hepatitis, increased transaminese levels, increased serum bilirubin due to liver disease, jaundice. Emolinfopoietic system pathologies: Rare: anemia due to bleeding, leucopenia. Notable: agranulocytosis, thrombocytopenia, midollar aplasia, hemolytic anemia. Immune system disorders: Notable: anaphylactic reactions (including shock). Psychiatric disorders: Notable: depression, hallucinations, confusion, mood changes. Heart disease: Notable: heart failure, atrial fibrillation, palpitations and tachycardia. Vascular diseases: Not known: hypertension, vasodilation, vasculitis (including leukocytoclastic vasculitis). Systemic pathologies and conditions for administration: Not common: edema, fatigue. Disorders of metabolism and nutrition: Notable: hypothoraemia, hyperpotassiemia (see paragraphs 4.4 and 4.5). Diagnostic examinations: Rare: weight gain. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and long-term treatments) may be associated with a modest increase in the risk of arterial thromboembolic events (e.g. myocardial infarction or stroke) (see paragraph 4.4). Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Overdose cases were reported with doses of up to 2.5 g ketoprofen. In most cases, the observed symptoms were benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. There are no specific antidotes for overdosing ketoprofen. In the event of a suspicion of severe overdose, gastric lavender and the establishment of supporting and symptomatic therapies to compensate for dehydration, to monitor renal function and to correct acidosis if present. In case of kidney failure, hemodialysis may be useful for removing the drug from the circle. If the patient is brought to the observation of the doctor within a short time of ingestion of excessive doses, a gastric washing should be performed in order to recover the granules still present in the stomach, which are recognizable in gastric content. The treatment is however symptomatic and supportive. It should also be taken into account the administration of activated charcoal in an attempt to reduce the absorption of slow cession ketoprofen. In adults the main signs of overdose are headaches, dizziness, drowsiness, nausea, vomiting, diarrhea and abdominal pain. In case of severe overdose, hypotension, respiratory depression and gastrointestinal bleeding were observed. The patient must be immediately transferred to a specialist center to begin symptomatic treatment.

Pregnancy

: The use of ketoprofen during the first and second trimester of pregnancy must be avoided. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and heart disease and gastroschisis after the use of an inhibitor of prostaglandin synthesis, in the early stages of pregnancy. The absolute risk of heart failure had increased from less than 1% to about 1.5%. It has been estimated that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disease, was reported in animals that had been given inhibitors of prostaglandin synthesis during the organogenetic period. During the first and second trimester of pregnancy Momenactcompì must be used only in case of need. If Momenactcompì is used by women who are trying to have a child or during the first and second trimester of pregnancy, the dose must 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 arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. The use of the drug in proximity to the childbirth can cause alterations of the hemodynamics of the small circle of the child with serious consequences for breathing. As a result, ketoprofen is contraindicated during the third trimester of pregnancy.

Food

There is no information available on the excretion of Ketoprofene in human milk. Ketoprofen is not recommended during breastfeeding.

Fertility

The use of NSAIDs can compromise female fertility and is not recommended in women who want to start a pregnancy. In women who have fertility problems or who are subject to fertility investigations, the suspension of treatment must be taken into account.

Source: Farmadati