OKI Pain and Fever 25 mg ketoprofen - 12 effervescent tablets

Short-term symptomatic treatment of acute pain of mild to moderate intensity and/or fever. OKi pain and fever is indicated in adults aged 18 years and older.

Active Ingredients

Each tablet contains the active substance ketoprofen 25 mg (as ketoprofen lysine salt 40 mg). Excipients with known effect: This medicinal product contains 147 mg sorbitol per effervescent tablet. This medicinal product contains 321.9 mg sodium per effervescent tablet, equivalent to approximately 16% of the WHO recommended maximum daily intake of 2 g sodium for an adult. For the full list of excipients, see section 6.1.

Excipients

Mannitol (E421), Sodium hydrogen carbonate (E500), Citric acid (E330), Orange flavour, Sorbitol (E420), Sodium carbonate (E500), Leucine, Sodium saccharin (E954), Polysorbate 20 (E432), Simethicone, Colloidal anhydrous silica (E551).

Dosage

Dosage

*Wait at least 4 hours between doses. Do not exceed the recommended daily dose of 75 mg. If symptoms persist for more than three days in the case of fever or five days in the case of pain, or if symptoms worsen, a healthcare professional should be consulted. Elderly : OKi dolore e febbre should be used with caution in the elderly. For elderly patients, a dose of 1 tablet per day is recommended. Paediatric patients : Oki dolore e febbre should not be used in children under 18 years of age. Method of administration : For oral use only. Dissolve the tablet in a glass of water before administration.

Warnings

Very rare cases of serious reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ketoprofen lysine salt should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. The concomitant use of OKi dolore e piangere with other NSAIDs, including cyclooxygenase-2 selective inhibitors, should be avoided. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Excessive use of NSAIDs may cause drug-induced headaches, and patients should be advised to discontinue treatment. Patients should be warned of possible withdrawal symptoms, which may include worsening headache which may last several days. Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported for all NSAIDs at any time during treatment, with or without warning symptoms or even in the absence of a previous history of serious gastrointestinal events. Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of serious gastrointestinal toxicity compared to other NSAIDs, especially at high doses (see also sections 4.2 and 4.3). The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID dosage, in patients who have experienced ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3), and in elderly patients. These patients should start treatment on the lowest available dose. Concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients and for patients receiving concomitant low dose acetylsalicylic acid or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Patients who have experienced GI toxicity, particularly when elderly, should be advised to report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment. Caution should be exercised in treating 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 or antiplatelet agents such as acetylsalicylic acid (see section 4.5). Discontinue treatment if patients treated with ketoprofen lysine salt experience gastrointestinal bleeding or ulceration. NSAIDs should be given with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as the aggravation of these conditions may occur (see section 4.8). Patients should be monitored carefully, particularly for the occurrence of gastrointestinal bleeding. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude a similar risk associated with ketoprofen. As with other NSAIDs, patients with uncontrolled hypertension, confirmed ischaemic cardiomyopathy, peripheral arterial disease and/or cerebrovascular disease should only be treated with ketoprofen lysine salt after careful consideration. Similar consideration should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (e.g. arterial hypertension, hyperlipidaemia, diabetes mellitus, smoking). At the start of treatment, renal function should be carefully monitored in patients with heart failure, cirrhosis, nephrotic syndrome or probable hypovolaemia, due to the increased risk of nephrotoxicity. This applies to patients treated with diuretics (see section 4.5) and to patients with renal impairment, particularly if elderly. In such patients, the use of ketoprofen may cause a reduction in blood flow to the kidneys caused by inhibition of prostaglandins and lead to renal failure. Ketoprofen should be administered with caution in patients with impaired renal function, taking into account that the compound is excreted through the kidneys. Like all NSAIDs, ketoprofen may increase blood urea nitrogen and serum creatinine values. Like other inhibitors of prostaglandin synthesis, ketoprofen may be associated with adverse renal events that may cause glomerulonephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure. In patients with abnormal liver function tests or a history of liver disease, transaminase values ​​should be periodically assessed, particularly during long-term treatment. Rare cases of jaundice and hepatitis have been reported in association with the use of ketoprofen. Caution is advised when the product is administered to patients with hepatic porphyria, as it may trigger an attack. As with other NSAIDs, in the presence of an infection, it should be remembered that the anti-inflammatory, analgesic and antipyretic properties of ketoprofen may mask the symptoms commonly associated with the progression of an infection, such as fever. In case of pregnancy, fertility or breastfeeding, see section 4.6. Administer with caution to patients with previous manifestations of allergy. Patients suffering from asthma associated with chronic or allergic rhinitis, chronic sinusitis and/or nasal polyposis are more prone to allergies to acetylsalicylic acid and/or NSAIDs than the rest of the population. The administration of ketoprofen lysine salt may cause asthma attack or bronchospasm, shock and other allergic reactions in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3). Discontinue treatment in case of vision problems, such as blurred vision. Masking of symptoms of underlying infections: OKi dolore e febbre 25 mg may mask the symptoms of infection, which may delay the 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 OKi dolore e febbre 25 mg is administered for the relief of infection-related fever or pain, monitoring for infection is advised. In non-hospital settings, the patient should seek medical advice if symptoms persist or worsen. Warnings related to excipients: OKi dolore e febbre 25 mg effervescent tablets contain sorbitol; patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine. This medicinal product contains 321.9 mg sodium per effervescent tablet, equivalent to 16% of the WHO recommended maximum daily intake of 2 g sodium for an adult. If symptoms persist or worsen, or a new symptom occurs, the patient should consult a doctor.

Conservation

Store the medicine in the original package in order to protect it from moisture and light.

Contraindications

The medicinal product must not be used in the following cases: • In patients with a history of hypersensitivity reactions such as bronchospasm, asthma attack, acute rhinitis, urticaria, skin rashes or other allergic reactions to ketoprofen or to substances with a similar mechanism of action (such as acetylsalicylic acid or other NSAIDs). Serious and, on rare occasions, fatal reactions have been observed in such patients (see section 4.8). • In patients with hypersensitivity to any of the excipients listed in section 6.1. • During the third trimester of pregnancy (see section 4.6). • In case of severe heart failure. • In patients with active or recurrent peptic ulcer or history of gastrointestinal bleeding, ulceration or perforation. • History of gastrointestinal bleeding or perforation following previous therapy with NSAIDs. • In patients with gastric or duodenal ulcer, chronic dyspepsia and gastritis • In patients with leukocytopenia or thrombocytopenia, active bleeding or bleeding diathesis during treatment with anticoagulants • In patients with severe renal or hepatic insufficiency, e.g. liver cirrhosis or severe hepatitis.

Overdose

Symptoms Overdosages of up to 2.5 g of ketoprofen have been reported. In most cases, symptoms observed were limited to lethargy, drowsiness, abdominal pain, nausea, vomiting, generally reversible with supportive therapy. Respiratory depression, coma or convulsive seizures have also occurred following large overdoses of ketoprofen. In addition, gastrointestinal bleeding, hypotension, hypertension or acute renal failure may occur, but these events are rare. Treatment measures There are no specific antidotes for overdose of ketoprofen lysine salt. In case of suspected overdose, the recommended treatment consists of gastric lavage combined with symptomatic and supportive treatment to compensate for dehydration, monitoring of urinary excretion and correction of acidosis, if present. In case of renal insufficiency, haemodialysis may be useful to remove the medicinal product from circulation.

Pregnancy

Pregnancy : Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo-foetal 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 cardiovascular malformations increased from less than 1%, up to approximately 1.5%. The risk is believed to increase proportionally with the dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. In the first and second trimester of pregnancy, ketoprofen lysine salt should not be administered unless clearly necessary. If ketoprofen lysine salt is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment as short 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; • the mother and the neonate, at the end of pregnancy, to: • possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labor. The use of ketoprofen during labor may adversely affect the pulmonary haemodynamics of the fetus with serious consequences for respiration. Consequently, ketoprofen lysine salt is contraindicated during the third trimester of pregnancy. Breastfeeding : There are insufficient data on the excretion of ketoprofen in human milk. Ketoprofen lysine salt is not recommended in breastfeeding women. Fertility : Long-term use of some NSAIDs is associated with a reduction in female fertility, which is reversible upon discontinuation of treatment. The use of ketoprofen, as with any drug inhibiting cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Discontinuation of treatment with ketoprofen should be considered in women who have difficulties conceiving or who are undergoing investigation of infertility.