Momenactcompì 10 soft capsules

Directions for use and Dosage

The medicine is reserved for adult patients only. One capsule in a single dose or repeated 2-3 times a day for more intense pain, 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 initial dose and perform maintenance therapy with the minimum effective dose. Individualized adjustments can be considered only after establishing good tolerability of the drug. Patients with hepatic impairment: Patients with mild or moderate hepatic impairment should be monitored closely and treated with the lowest effective daily dose. Paediatric population The safety and efficacy of ketoprofen have not been studied in children.

Warnings

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Concomitant use of Momenactcomp 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 gastrointestinal events. In the elderly and in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing doses of NSAIDs. These patients should start treatment on 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. 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 reuptake inhibitors, or antiplatelet agents such as aspirin. If gastrointestinal bleeding or ulceration occurs in patients receiving Momenactcomp, treatment should be discontinued 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. Some epidemiological evidence suggests that ketoprofen may increase the risk of gastrointestinal bleeding. be associated with a higher risk of serious gastrointestinal toxicity than other NSAIDs, particularly at high doses.

Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

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.

Patients appear to be at higher risk early in the course of therapy: the onset of the reaction occurs in the majority of 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 beginning of treatment in patients with heart failure, cirrhosis, and nephrosis, in patients on diuretic therapy, and in patients with chronic renal insufficiency, particularly if elderly. In these patients, the administration of ketoprofen may cause a reduction in renal blood flow, caused by prostaglandin inhibition, and lead to renal decompensation. In patients with impaired liver function tests or previous liver disease, transaminases should be regularly assessed, particularly during long-term therapy. Cases of jaundice and hepatitis have been reported with ketoprofen.

Cardiovascular and cerebrovascular effects: Caution is advised in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been reported in association with NSAID treatment. 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 (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 (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 that promote hyperkalaemia. In these circumstances, potassium levels should be monitored.

Infections: As with other nonsteroidal anti-inflammatory drugs, in the presence of infection, the anti-inflammatory, analgesic, and antipyretic effects of ketoprofen may mask the symptoms of progressive infection, such as fever.

Respiratory disorders: Patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyps are at increased risk. High incidence of allergies to aspirin and/or NSAIDs in the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, particularly in subjects allergic to aspirin or NSAIDs. Due to the drug's interaction with the metabolism of arachidonic acid, bronchospasm attacks and possibly shock and other allergic phenomena may occur in asthmatics and predisposed subjects.

Visual disturbances: If visual disturbances such as blurred vision occur, treatment should be discontinued.

Format

10 soft capsules of 25 mg.