OKITASK*10FC 40MG

Okitask 40 mg film-coated tablets
Ketoprofen lysine salt

What it is and what it is used for
Okitask contains ketoprofen, which belongs to a group of medicines called "Non-Steroidal Anti-Inflammatory Drugs" (NSAIDs). Ketoprofen blocks the chemicals that cause inflammation.
Okitask is indicated for treating pain of various origins and natures, and in particular: headaches, toothaches, neuralgia (nerve pain), menstrual pain, muscle pain, and osteoarticular pain (bone and joint pain).
Consult your doctor if you do not feel better or if you feel worse after treatment.

What you need to know before taking the medicine
Do not take Okitask:
- If you are allergic to ketoprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in paragraph 6);
- If you have a history of hypersensitivity reactions (allergy) triggered by the use of ketoprofen or substances with a similar mechanism of action, for example, acetylsalicylic acid or other NSAIDs (other anti-inflammatories) such as asthma (bronchial inflammation and airway narrowing), bronchospasm (constriction of the bronchi), allergic rhinitis (allergic inflammation of the nasal mucosa), urticaria, skin rashes, nasal polyps, angioneurotic edema (swelling of the skin and mucous membranes) or other allergic reactions;
- If you suffer from bronchial asthma (bronchial inflammation and airway narrowing);
- If you have severe heart failure (inability of the heart to pump the adequate amount of blood needed by the body's needs);
- If you suffer from gastritis (inflammation of the stomach lining);
- If you currently have a peptic ulcer (a lesion of the stomach or the first part of the intestine) or bleeding, or if you have suffered in the past from recurrent bleeding or peptic ulcer (two or more distinct, proven episodes of bleeding or ulceration);
- If you have suffered in the past from gastrointestinal bleeding, ulceration, or perforation or chronic dyspepsia (difficult digestion);
- If you have a history of gastrointestinal bleeding or perforation resulting from previous NSAID therapy;
- If you suffer from Crohn's disease (inflammation of the intestine) or ulcerative colitis (inflammation of the intestine with ulcers);
- If you have severe hepatic insufficiency (reduced liver function due to liver cirrhosis, severe hepatitis) or renal insufficiency (reduced kidney function);
- If you suffer from leukopenia (reduction in the number of white blood cells) or thrombocytopenia (reduction in the number of platelets);
- If you suffer from hemorrhagic diathesis (predisposition to develop hemorrhages) and other coagulation disorders or if you have hemostatic disorders (difficulty in stopping bleeding);
- If you are being treated with a high dose of diuretics;
- If you are in the third trimester of pregnancy;
- If the person to be treated is under 15 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Okitask.
Warnings
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see How to take Okitask and the paragraphs below on gastrointestinal and cardiovascular risks).
The concomitant use of Okitask with other anti-inflammatories should be avoided. During treatment with all NSAIDs, such as Okitask, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration, and perforation, which can be fatal, have been reported. Patients who have previously suffered from these conditions have a higher risk (see Do not take Okitask).
Report any abdominal signs or symptoms (including gastrointestinal bleeding) even at the beginning of treatment. Inform your doctor if you are taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used for the treatment of inflammatory conditions), anticoagulants (medicines that slow down blood clotting), such as warfarin, selective serotonin reuptake inhibitors (medicines used for the treatment of depression), or antiplatelet agents (medicines that prevent platelet aggregation) such as acetylsalicylic acid (see Other medicines and Okitask).
The elderly are more exposed to the risk of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforations, which can be fatal. Immediately suspend treatment with Okitask at the first signs of gastrointestinal bleeding or ulceration.
Severe skin reactions, some of which fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see Possible side effects). The reaction occurs in most cases in the early stages of treatment. Discontinue the use of Okitask if a rash, mucosal lesions, or any other sign of hypersensitivity (allergic reaction) appears.

Precautions
Ask your doctor or pharmacist for advice before taking Okitask
- If your kidneys are not working well because in this case Okitask should be taken with caution. If you use Okitask, you should monitor your kidneys, especially if you are elderly or if you are being treated with diuretics (medicines that lower blood pressure).
- If you have liver problems, you should have periodic check-ups.
- If you have an infection - see the Infections paragraph below.
- If you suffer from uncontrolled hypertension (high blood pressure), congestive heart failure (accumulation of fluid in the lungs, abdominal organs, and peripheral tissues due to inadequate heart pump function), confirmed ischemic heart disease (heart disease that occurs following a reduction in blood flow due to narrowing of the coronary arteries), peripheral arterial disease and/or cerebrovascular disease (disease of the arteries and blood vessels of the brain), as you should only take Okitask after careful medical evaluation.
- If you have risk factors for these conditions, for example, if you have high blood pressure, diabetes (disease caused by high blood glucose levels), hyperlipidemia (high levels of fats in the blood), if you smoke.
- If you have allergic manifestations or have suffered from allergies in the past, as the medicine should be administered with caution.
- If you suffer from bronchial asthma (bronchial inflammation and airway narrowing) or allergic diathesis (predisposition to the onset of allergy), chronic rhinitis (inflammation of the nasal mucosa) and allergic rhinitis (allergic inflammation of the nasal mucosa), chronic sinusitis and/or nasal polyposis.
- If you suffer from hematopoietic alterations (which modify the formation and maturation of blood cells), systemic lupus erythematosus (immune system disease) or mixed connective tissue diseases, as Okitask should be used with caution.
- If you have hepatic porphyria (rare blood disease characterized by altered activity of one of the liver enzymes), as the medicine could trigger an attack.
Some NSAIDs may be associated with an increased risk of arterial thrombotic events (e.g., heart attack or stroke). Currently, there is insufficient data to exclude a similar risk for OKITASK. An increased risk of atrial fibrillation (alteration of the heart rhythm) associated with the use of NSAIDs has been reported. Hyperkalemia (increased amount of potassium in the blood) may occur, especially if you suffer from diabetes, renal insufficiency, and/or are being treated with medicines that can cause hyperkalemia (see Other medicines and Okitask). In these circumstances, potassium levels should be monitored periodically.

Infections
Okitask can mask the symptoms of infections such as fever and pain. Therefore, it is possible that Okitask may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the infection symptoms persist or worsen, contact your doctor immediately.
Consult your doctor if you experience vision problems, such as blurred vision, as treatment must be discontinued.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most commonly observed adverse events are gastrointestinal in nature.
The following adverse reactions have been observed with the use of ketoprofen in adults:

Common (may affect up to 1 in 10 people)
- dyspepsia (difficult digestion), nausea, abdominal pain and vomiting.

Uncommon (may affect up to 1 in 100 people)
- headache, dizziness, drowsiness, constipation, diarrhea, flatulence (emission of intestinal gas from the anus), gastritis (inflammation of the stomach lining)
- rash, itching and fatigue

Rare (may affect up to 1 in 1,000 people)
- hemorrhagic anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood caused by bleeding)
- paraesthesia (sensation of numbness, tingling)
- blurred vision (see Warnings and precautions)
- tinnitus (persistent perception of noises in the ear)
- asthma (bronchial inflammation and airway narrowing)
- stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (lesion of the stomach or the first part of the intestine)
- hepatitis (inflammation of the liver), increased transaminases (increase in certain enzymes indicating liver function), increased bilirubin (a substance indicating liver function)
- increased weight.

Very rare (may affect up to 1 in 10,000 people)
- edema (swelling) of the face and erythema (redness of the skin)

Frequency not known (frequency cannot be estimated from the available data)
- thrombocytopenia (reduction in the number of platelets), agranulocytosis (severe reduction in the number of a type of white blood cells), bone marrow failure (reduction in the production of blood cells by the bone marrow), hemolytic anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood, caused by the destruction of red blood cells), leukopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of a type of white blood cells), aplastic anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood, caused by insufficient production of blood cells by the bone marrow), leukocytosis (increase in the number of white blood cells), thrombocytopenic purpura (presence of spots on the skin due to a reduction in the number of platelets)
- anaphylactic reaction (severe allergic reaction, including shock), hypersensitivity (allergy)
- jaundice (yellowing of the skin and the whites of the eyes)
- depression, hallucination (perception of non-existent things in reality), confusional state, altered mood, agitation, insomnia, convulsions (uncontrolled body movements), dizziness, dysgeusia (altered taste), tremor, dyskinesia (involuntary movements), syncope (fainting), hyperkinesia (involuntary and uncoordinated movements), periorbital edema (swelling around the eye), peripheral edema
- chills, asthenia (weakness)
- heart failure (inability of the heart to pump the adequate amount of blood needed by the body's needs), atrial fibrillation (altered heart rhythm), palpitations (perception of heart beat), tachycardia (increase in heart rate), hypertension (high blood pressure), hypotension (low blood pressure)
- vasodilation (dilation of blood vessels), vasculitis (inflammation of vessels), including leukocytoclastic vasculitis (inflammation of small vessels)
- bronchospasm (constriction of the bronchi), especially in patients with confirmed hypersensitivity to acetylsalicylic acid and other NSAIDs, rhinitis (inflammation of the nasal mucosa), dyspnea (difficult breathing), laryngeal edema (swelling of the throat due to fluid accumulation), laryngospasm (narrowing of the larynx), acute respiratory failure (one fatal case has been reported in an asthmatic patient sensitive to acetylsalicylic acid)
- exacerbation of colitis (worsening of intestinal inflammation), exacerbation of Crohn's disease (worsening of intestinal inflammation), gastrointestinal bleeding (stomach or intestinal bleeding), gastrointestinal perforation (sometimes fatal, particularly in the elderly, see Warnings), gastric ulcer (stomach lesion), mouth ulceration, duodenal ulcer (lesion of the first part of the intestine), duodenal perforation, heartburn (stomach burning), mouth edema (swelling of the mouth), pancreatitis (inflammation of the pancreas), melena (presence of digested blood in stools), hematemesis (vomiting blood), abdominal discomfort, colitis, hyperchlorhydria (excess stomach acid), stomach pain, erosive gastritis (severe inflammation of the stomach lining), tongue edema (swelling of the tongue)
- photosensitivity reactions (sensitivity reaction to sunlight or UV lamps), alopecia (hair loss), urticaria, angioedema (swelling of the face, lips, mouth, tongue or throat that can cause difficulty breathing and swallowing), bullous eruptions including Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis (severe skin reactions), edema (fluid retention), exanthema (skin rash), maculopapular exanthema (skin rash with patches), purpura (purplish spots on the skin due to abnormal blood accumulation), acute generalized exanthematous pustulosis (skin rash with formation of purulent collections), dermatitis (skin irritation)
- acute renal failure (reduced kidney function), tubulointerstitial nephritis, nephritis and nephritic syndrome (inflammation of the kidneys), nephrotic syndrome (renal disorder involving protein loss in the urine), glomerulonephritis (inflammatory kidney disease), water/sodium retention with possible edema (accumulation of water and sodium causing swelling), acute tubular necrosis and renal papillary necrosis (severe kidney damage), oliguria (decreased urine production), abnormal kidney function test, hematuria (presence of blood in the urine)
- aseptic meningitis (inflammation of the membranes covering the brain not caused by infection), lymphangitis (inflammation of the lymphatic vessels)
- hyperkalemia (increased amount of potassium in the blood) and hyponatremia (decreased amount of sodium in the blood).

Adherence to the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.