Ketoprofen lysine salt - pain relief medicament 12 bags

Product Description

Symptomatic treatment of acute pain of mild to moderate severity.

Indications

Zentiva Ketoprofen lysine salt is indicated in the treatment of pain of various origins and natures, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and osteoarticular pain.

Composition

Active ingredients

ketoprofen lysine salt 40 mg (corresponding to 25 mg of ketoprofen) Excipient with known effect: aspartame.

Excipients

Mannitol, xylitol, lime flavouring, lemon flavouring, frescofort flavouring, aspartame, talc, basic butylated methacrylate copolymer, magnesium stearate, hydrated colloidal silica, hypromellose, stearic acid, povidone, sodium lauryl sulfate.

Directions for use and Dosage

Adults and children over 15 years: 1 sachet, as a single dose, or repeated 2-3 times a day, for more intense painful conditions.
The contents of the sachet can be placed directly on the tongue.
It dissolves in saliva: this allows it to be used without water.
It is preferable to take the product on a full stomach.
Do not exceed the recommended doses: elderly patients in particular should stick to the minimum doses indicated above.
The duration of therapy should be limited to overcoming the painful episode.

Warnings

Undesirable effects can be minimized by using the lowest effective dose for the most intense pain. shortest possible duration of treatment as needed to control symptoms.
Caution should be exercised in 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 anti-platelet agents such as aspirin.
Concomitant use of the medicinal product with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
Gastrointestinal bleeding, ulceration and perforation, which may be fatal, have been reported.
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.
These patients should start treatment on the lowest possible dose.
Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients taking concomitant low-dose aspirin or other drugs likely to increase the risk of gastrointestinal events.
Patients with a history of gastrointestinal toxicity, especially if elderly, should report any abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
If gastrointestinal bleeding or ulceration occurs in patients receiving the medicinal product, discontinue the drug. 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 highest risk early in the course of therapy: the onset of the reaction occurs in the majority of cases within the first month of treatment.
The drug should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Clinical trials and epidemiological data suggest that the use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with an increased risk of arterial thrombotic events.
There are currently insufficient data to exclude a similar risk for ketoprofen when it is administered at the daily dose of one sachet, as a single dose, or repeated 2-3 times a day.
The product contains aspartame as a sweetener.
The drug does not affect low-calorie or controlled diets and can also be administered to diabetic patients.
Patients with active peptic ulcer or a history of peptic ulcer.
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.
At the beginning of treatment, renal function should be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patients are
elderly. In these patients, the administration of ketoprofen may cause a decrease in renal blood flow caused by prostaglandin inhibition and lead to renal failure.
Caution is advised before initiating treatment in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention, hypertension, and edema have been reported in association with NSAID therapy.
As with other NSAIDs, in the presence of an infection, it should be borne in mind that the anti-inflammatory, analgesic, and antipyretic properties of ketoprofen may mask common symptoms of infection progression, such as fever.
In patients with abnormal liver function tests or a history of liver disease, transaminase levels should be monitored periodically, especially during long-term therapy.
Rare cases of jaundice and hepatitis have been reported with the use of ketoprofen.
Patients with asthma associated with chronic and allergic rhinitis, chronic sinusitis, and/or nasal polyps are at greater risk of allergies to acetylsalicylic acid and/or NSAIDs than the rest of the population.
Administration of this drug may cause asthma attacks or bronchospasm, especially in subjects allergic to acetylsalicylic acid or NSAIDs. Therefore, in these subjects, as well as in cases of chronic obstructive pulmonary disease or nephropathy, the product should be used only under medical supervision. As with other NSAIDs, patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should be treated with ketoprofen only after careful consideration.
Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease. If visual disturbances, such as blurred vision, occur, treatment should be discontinued. Administer with caution in patients with allergic reactions or a history of allergies. Patients with current or previous gastrointestinal disease should be carefully monitored for digestive disturbances, especially gastrointestinal bleeding.
When the product is administered to patients with hepatic porphyria, caution is required as the drug may trigger an attack. 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.
Elderly patients are more susceptible to this risk. predisposed to reduced renal, cardiovascular or hepatic function.

Contraindications

Patients with a history of hypersensitivity reactions such as bronchospasm, asthma attacks, acute rhinitis, urticaria, skin rashes or other allergic-type reactions to ketoprofen or to substances with a similar mechanism of action (for example, acetylsalicylic acid or other NSAIDs); serious, rarely fatal, anaphylactic reactions have been observed in these patients; patients with hypersensitivity to any of the excipients; third trimester of pregnancy, confirmed or suspected pregnancy, during breastfeeding and in children under 15 years;
severe heart failure; patients with gastric or duodenal ulcer, gastritis and chronic dyspepsia; subjects with leukopenia or thrombocytopenia, with active bleeding or bleeding diathesis, under treatment with anticoagulants; patients with severe renal or hepatic insufficiency; patients undergoing major surgery.
Furthermore, concomitant administration with other anti-inflammatory drugs and acetylsalicylic acid is not recommended.
Active peptic ulcer/haemorrhage or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or haemorrhage).
Previous history of gastrointestinal bleeding, ulceration or perforation related to previous NSAID treatment.

Interactions

• Combinations not recommended. Other NSAIDs (including selective cyclooxygenase-2 inhibitors) and high doses of salicylates: increased risk of gastrointestinal ulceration and bleeding. Anticoagulants (heparin and warfarin) and platelet aggregation inhibitors (ticlopidine, clopidogrel): Increased risk of bleeding. If coadministration is unavoidable, patients must be closely monitored. Lithium: Risk of increased plasma lithium levels, which may reach toxic levels due to decreased renal lithium excretion. If necessary, lithium plasma levels should be carefully monitored and the lithium dosage adjusted during and after NSAID therapy. Methotrexate, at doses greater than 15 mg/week: Increased risk of methotrexate haematological toxicity, especially when administered at high doses (greater than 15 mg/week), probably related to displacement from methotrexate-binding proteins and decreased renal clearance. Therefore, patients undergoing treatment with these drugs should consult their doctor before taking the product.
• Combinations requiring precaution. Diuretics: Patients taking diuretics, particularly those who are particularly dehydrated, are at increased risk of developing renal failure secondary to the reduction in renal blood flow caused by prostaglandin inhibition. These patients should be rehydrated before initiating coadministration, and renal function should be closely monitored after initiating treatment. NSAIDs may reduce the effect of diuretics. ACE inhibitors and angiotensin II antagonists: In patients with impaired renal function (e.g., dehydrated patients and elderly patients), coadministration of an ACE inhibitor or an angiotensin II antagonist and agents capable of inhibiting cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure. 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 initiating concomitant therapy. Methotrexate at doses less than 15 mg/week: Perform weekly monitoring of complete blood counts during the first weeks of the combination. Increase the frequency of monitoring in the presence of even mild worsening of renal function, as well as in the elderly. Corticosteroids: increased risk of gastrointestinal ulceration or bleeding. Pentoxifylline: increased risk of bleeding. More frequent clinical checks and monitoring of bleeding time. Possible interactions with the following drugs should be taken into account: oral hypoglycemics.
• Combinations that need to be taken into consideration. Antihypertensive drugs (Beta-blockers, ACE inhibitors and angiotensin II antagonists, diuretics): treatment with an NSAID may reduce the effect of antihypertensive drugs by inhibiting the synthesis of vasodilatory prostaglandins. Thrombolytics and antiplatelet agents: increased risk of bleeding. Selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding. Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen.
  Diphenylhydantoin and sulfonamides: Since ketoprofen is highly protein bound, it may be necessary to reduce the dosage of diphenylhydantoin or sulfonamides administered concomitantly.