Okitask

Package leaflet: Information for the user

Okitask 40 mg granules

ketoprofen lysine salt
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

1. What Okitask is and what it is used for
2. What you need to know before taking Okitask
3. How to take Okitask
4. Possible side effects
5. How to store Okitask
6. Contents of the pack and other information

1. What Okitask 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 the treatment of pain of various origin and nature, particularly: headache, toothache, neuralgia (nerve pain), menstrual pain, and musculoskeletal pain (muscle, bone and joint pain).
Consult your doctor if you do not feel better or if you feel worse after a few days of treatment.

2. What you need to know before taking Okitask

Do not take Okitask

• if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 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-inflammatory medicines), such as asthma (bronchial inflammation and narrowing of the airways), bronchospasm (constriction of the bronchi), allergic rhinitis (allergic inflammation of the nasal mucosa), urticaria, skin rashes, nasal polyps, angioedema (swelling of the skin and mucous membranes), or other allergic-type reactions;
• if you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways);
• if you have severe heart failure (the heart's inability to pump enough blood to meet the body’s needs);
• if you have gastritis (inflammation of the stomach lining);
• if you currently have a peptic ulcer (a lesion in the stomach or the first part of the intestine) or gastrointestinal bleeding, or if you have previously experienced recurrent peptic ulcer or bleeding (two or more distinct, confirmed episodes of bleeding or ulceration);
• if you have previously suffered from gastrointestinal bleeding, ulceration, perforation, or chronic dyspepsia (indigestion);
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs;
• if you suffer from Crohn’s disease (intestinal inflammation) or ulcerative colitis (intestinal inflammation with ulcers);
• if you have severe liver failure (reduced liver function due to cirrhosis or severe hepatitis) or kidney failure (reduced kidney function);
• if you suffer from leucopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets);
• if you suffer from haemorrhagic diathesis (predisposition to bleeding) or other coagulation disorders, or if you have haemostatic disorders (difficulty in stopping bleeding);
• if you are being treated with high doses 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
Talk to your doctor or pharmacist before taking Okitask.
Warnings
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see "How to take Okitask" and the sections below on gastrointestinal and cardiovascular risks).
Concomitant use of Okitask with other anti-inflammatory medicines should be avoided.
During treatment with all NSAIDs, including Okitask, gastrointestinal bleeding, ulceration, and perforation—sometimes fatal—may occur at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Patients who have previously experienced these conditions are at 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 to treat inflammatory conditions), anticoagulants (medicines that delay blood clotting), such as warfarin, selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet agents (medicines that prevent platelet aggregation) such as acetylsalicylic acid (see "Other medicines and Okitask").
Elderly patients are at greater risk of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
Stop treatment with Okitask immediately at the first signs of gastrointestinal bleeding or ulceration.
Severe skin reactions, some of which have been fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported in association with NSAID use (see "Possible side effects"). These reactions usually occur in the early stages of treatment. Discontinue use of Okitask if a skin rash, mucosal lesions, or any other sign of hypersensitivity (allergic reaction) appear.
Precautions
Consult your doctor or pharmacist before taking Okitask:

• If your kidneys do not function properly, as Okitask should be used with caution in such cases. If you use Okitask, kidney function should be monitored, especially if you are elderly or taking diuretics (medicines that lower blood pressure).
• If you have liver problems, regular check-ups are necessary.
• If you have an infection – see the section «Infections» below. If you suffer from uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate heart pump function), established ischaemic heart disease (heart disease caused by reduced blood flow due to narrowing of the coronary arteries), peripheral arterial disease, and/or cerebrovascular disease (disease of the arteries and blood vessels in the brain), as you should only take Okitask after careful evaluation by your doctor.
• If you have risk factors for these conditions, such as high blood pressure, diabetes (a disease caused by high blood glucose levels), hyperlipidaemia (high levels of fats in the blood), or if you smoke.
• If you have allergic manifestations or a history of allergy, as the medicine should be administered with caution.
• If you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways), or have allergic diathesis (predisposition to develop allergies), chronic rhinitis (inflammation of the nasal mucosa), allergic rhinitis, chronic sinusitis, and/or nasal polyposis.
• If you have haematopoietic disorders (affecting the formation and maturation of blood cells), systemic lupus erythematosus (an autoimmune disease), or mixed connective tissue disorders, as Okitask should be used with caution.
• If you have hepatic porphyria (a rare blood disorder 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 are insufficient data to exclude a similar risk for OKITASK.

An increased risk of atrial fibrillation (a disturbance in the heart's rhythm) has been reported with the use of NSAIDs.
Hyperkalaemia (increased potassium levels in the blood) may occur, particularly if you have diabetes, kidney failure, and/or are taking medicines that can cause hyperkalaemia (see "Other medicines and Okitask"). In these circumstances, potassium levels should be monitored periodically.
Okitask may mask symptoms of infections such as fever and pain. Therefore, Okitask could delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of infection persist or worsen, consult your doctor immediately.
Consult your doctor if you experience visual disturbances, such as blurred vision, as treatment must be discontinued.
Other medicines and Okitask
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is not recommended to use Okitask in combination with:

• Other anti-inflammatory medicines, such as NSAIDs, selective COX-2 inhibitors, and high doses of salicylates (over 3 g per day);
• Medicines that delay blood clotting, such as heparin and warfarin, and medicines that prevent platelet aggregation, such as ticlopidine and clopidogrel;
• Lithium (a medicine used to treat manic-depressive psychosis);
• Methotrexate at doses exceeding 15 mg/week (a medicine indicated for the treatment of certain autoimmune diseases and some cancers);
• Hydantoins (used to treat epilepsy) and sulfonamides (such as certain antibiotics used to treat bacterial infections).
  Caution is required when using Okitask in combination with:
• Potassium salts;
• Potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers (medicines used to lower blood pressure);
• NSAIDs (anti-inflammatory medicines);
• Heparins (anticoagulants);
• Cyclosporine and tacrolimus (medicines used to prevent organ transplant rejection or for certain immune system diseases);
• Trimethoprim (an antibiotic used for bacterial infections);
• Tenofovir (a medicine used to treat certain viral infections);
• Methotrexate at doses below 15 mg/week (a medicine indicated for the treatment of certain autoimmune diseases and some cancers);
• Corticosteroids (medicines used to treat inflammatory conditions);
• Pentoxifylline (a medicine used to improve blood circulation in the limbs);
• Zidovudine (a medicine used to treat HIV);
• Sulfonylureas (medicines used to treat diabetes);
• Cardiac glycosides (medicines acting on the heart).

Consider the combination of Okitask with:

• Beta-blockers, ACE inhibitors, diuretics (medicines used to lower blood pressure);
• Mifepristone (a medicine used for medical termination of pregnancy);
• Intrauterine contraceptive devices;
• Cyclosporine, tacrolimus (medicines used to prevent organ transplant rejection or for certain immune system diseases);
• Thrombolytics (medicines that help dissolve blood clots);
• Ticlopidine and clopidogrel (medicines that prevent platelet aggregation);
• Selective serotonin reuptake inhibitors (some antidepressants);
• Probenecid (a medicine used to treat gout);
• Quinolones and sulfonamides (antibiotics used to treat bacterial infections);
• Phenytoin (a medicine used to treat epilepsy);
• Gemeprost (a medicine used for uterine examinations and surgical procedures).
  Alcoholic beverages are not recommended during treatment with Okitask.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of ketoprofen during the first and second trimesters of pregnancy should be avoided. The use of ketoprofen should only be considered if the expected benefit to the mother outweighs the risk to the embryo or fetus.
Do not use Okitask during the first and second trimesters of pregnancy unless strictly necessary. If Okitask is used in women who are trying to conceive or during the first and second trimesters 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 medicines of the same class as Okitask may expose the fetus to:

• cardiopulmonary toxicity;
• renal dysfunction; and the mother and newborn, at the end of pregnancy, to:
• possible prolongation of bleeding time and anti-aggregatory effects, which may occur even at very low doses;
• inhibition of uterine contractions, leading to delayed or prolonged labour.
  Use of the medicine close to delivery may cause disturbances in the newborn’s circulation and respiration. Therefore, DO NOT use Okitask during the third trimester of pregnancy (see "Do not take Okitask").
  Breastfeeding
  There is no available information on the excretion of ketoprofen in breast milk. Ketoprofen is not recommended during breastfeeding.
  Fertility
  The use of NSAIDs, including Okitask, may reduce female fertility; therefore, it is not recommended for women attempting to conceive. Discontinue
  administration of Okitask if you have fertility problems or are undergoing fertility investigations.
  Driving and using machines
  After taking Okitask, drowsiness, dizziness, seizures, and visual disturbances may occur. Therefore, it is recommended to avoid driving, operating machinery, or performing activities requiring special alertness (see "Possible side effects").
  Okitask 40 mg granules contain aspartame.
  This medicine contains 0.35 mg of aspartame per sachet.
  Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation due to the body’s inability to properly metabolize it.
  Okitask 40 mg granules contain sodium.
  This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially 'sodium-free'.
  Okitask 40 mg granules contain lemon flavour.
  The lemon flavour contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
  Okitask 40 mg granules contain lime flavour.
  The lime flavour contains glucose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Okitask

Take this medicine exactly as stated in this leaflet or as directed by your pharmacist. If you have any doubts, consult your pharmacist.

Dosage
Recommended doses are:
Adults and patients over 15 years of age: The recommended dose is 40 mg (corresponding to 1 sachet) per day; this dose may be repeated 2–3 times daily in cases of more intense pain. Do not exceed the recommended doses.

Elderly and patients with hepatic or renal impairment
Use the lowest effective dose.
Do not use in case of severe hepatic or renal insufficiency (see "Do not use Okitask").

Children
The safety and efficacy of Okitask have not yet been established.

Method of administration
Take the medicine preferably with a full stomach, after meals.

Duration of treatment
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
Treatment duration should be limited to the resolution of the painful episode.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.

Administration instructions
Place the medicine directly on the tongue. It dissolves with saliva, allowing administration without water.

If you take more Okitask than you should
In case of accidental ingestion/overdose of Okitask, contact your doctor immediately or go to the nearest hospital.
Cases of overdose with doses up to 2.5 g of ketoprofen have been reported. In most cases, symptoms were limited to lethargy, confusion, loss of consciousness, drowsiness, headache, dizziness, vertigo, nausea, vomiting, epigastric pain (in the upper part of the abdomen), abdominal pain, and diarrhoea.
Gastrointestinal bleeding, hypotension (low blood pressure), respiratory depression, and cyanosis (bluish discoloration of the skin and mucous membranes) may also occur.
There are no specific antidotes in case of ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended, along with symptomatic and supportive treatment.
In case of renal impairment, haemodialysis (a blood purification technique using extracorporeal circulation) may be useful to remove the circulating medicine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The most commonly observed adverse events are of gastrointestinal 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 (indigestion), nausea, abdominal pain, and vomiting

Uncommon (may affect up to 1 in 100 people)

• Headache, dizziness, drowsiness
• Constipation, diarrhoea, flatulence (passing intestinal gas through the anus), gastritis (inflammation of the stomach lining)
• Rash, pruritus (itching), and fatigue

Rare (may affect up to 1 in 1,000 people)

• Haemorrhagic anaemia (reduction in haemoglobin in the blood—the substance that carries oxygen in the blood—caused by bleeding)
• Paraesthesia (numbness or tingling sensations)
• Blurred vision (see "Warnings and precautions")
• Tinnitus (persistent perception of ringing or noise in the ear)
• Asthma (bronchial inflammation and narrowing of the airways)
• Stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (lesion in the stomach or the first part of the intestine)
• Hepatitis (liver inflammation), increased transaminases (elevated levels of certain enzymes indicating liver function), increased bilirubin (a substance indicating liver function)
• Weight gain

Very rare (may affect up to 1 in 10,000 people)

• Facial oedema (swelling) and erythema (redness of the skin)

Frequency not known (frequency cannot be estimated from the available data)

• Thrombocytopenia (reduced platelet count), agranulocytosis (severe reduction in a type of white blood cells), bone marrow failure (reduced production of blood cells by the bone marrow), haemolytic anaemia (reduction in haemoglobin in the blood caused by destruction of red blood cells), leucopenia (decreased white blood cell count), neutropenia (reduced number of a type of white blood cells), aplastic anaemia (reduction in haemoglobin in the blood due to insufficient production of blood cells by the bone marrow), leucocytosis (increased white blood cell count), thrombocytopenic purpura (skin spots due to reduced platelet count)
• Anaphylactic reaction (severe allergic reaction, including shock), hypersensitivity (allergy)
• Jaundice (yellowing of the skin and whites of the eyes)
• Depression, hallucination (perception of things not present in reality), confusion, altered mood, agitation, insomnia, seizures (uncontrolled body movements), dizziness, dysgeusia (altered taste), tremor, dyskinesia (involuntary movements), syncope (fainting), hyperkinesia (involuntary and uncoordinated movements), periorbital oedema (swelling around the eye), peripheral oedema
• Chills, asthenia (weakness)
• Heart failure (inability of the heart to pump sufficient blood to meet the body's needs), atrial fibrillation (irregular heart rhythm), palpitations (awareness of heartbeat), tachycardia (increased heart rate), hypertension (high blood pressure), hypotension (low blood pressure)
• Vasodilation (dilation of blood vessels), vasculitis (inflammation of blood vessels), including leukocytoclastic vasculitis (inflammation of small blood vessels)
• Bronchospasm (constriction of the bronchi), especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs, rhinitis (inflammation of the nasal mucosa), dyspnoea (difficulty breathing), laryngeal oedema (swelling of the larynx due to fluid accumulation), laryngospasm (narrowing of the larynx), acute respiratory failure (one fatal case 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 haemorrhage (bleeding from the stomach or intestine), gastrointestinal perforation (sometimes fatal, especially in elderly patients; see "Warnings"), gastric ulcer (lesion in the stomach), oral ulceration, duodenal ulcer (lesion in the first part of the intestine), duodenal perforation, gastric pyrosis (heartburn), oedema (swelling) of the mouth, pancreatitis (inflammation of the pancreas), melena (presence of digested blood in stools), haematemesis (vomiting blood), abdominal discomfort, colitis, hyperchlorhydria (excess stomach acid), gastric pain, erosive gastritis (severe inflammation of the stomach lining), oedema of the tongue (swelling of the tongue)
• Photosensitivity reactions (sensitivity to sunlight or UV lamps), alopecia (loss of hair), urticaria, angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause breathing or swallowing difficulties), bullous eruptions including Stevens-Johnson syndrome, Lyell’s syndrome, and toxic epidermal necrolysis (severe skin reactions), oedema (fluid retention), exanthema (skin rash), maculopapular exanthema (skin rash with spots), purpura (purple spots on the skin due to abnormal blood accumulation), generalised acute exanthematous pustulosis (skin eruption with formation of pus-filled lesions), dermatitis (skin irritation)
• Acute kidney injury (reduced kidney function), tubulointerstitial nephritis, nephritis and nephrotic syndrome (kidney inflammation and syndrome), nephrotic syndrome (kidney disorder causing protein loss in urine), glomerulonephritis (inflammatory kidney disease), fluid and sodium retention with possible oedema (accumulation of water and sodium causing swelling), acute tubular necrosis and renal papillary necrosis (severe kidney damage), oliguria (reduced urine output), abnormal kidney function tests, haematuria (presence of blood in urine)
• Aseptic meningitis (inflammation of the membranes covering the brain not caused by infection), lymphangitis (inflammation of the lymphatic vessels)
• Hyperkalaemia (increased potassium levels in blood), hyponatraemia (decreased sodium levels in blood)

Following the instructions provided in the package leaflet reduces the risk of adverse effects.

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

5. How to store Okitask

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in its original, unopened packaging, properly stored.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Okitask contains

• The active substance is ketoprofen lysine salt. Each sachet contains 40 mg of ketoprofen lysine salt, equivalent to 25 mg of ketoprofen.
• The other components are: povidone, colloidal silicon dioxide, hypromellose, eudragit EPO, sodium dodecyl sulfate, stearic acid, magnesium stearate, aspartame, mannitol, xylitol, talc, lime flavor, lemon flavor, freshfort flavor.

Description of the appearance of Okitask and contents of the pack
Oral granules – pack containing 10, 20 or 30 sachets.
Marketing Authorization Holder and Manufacturer
Dompé farmaceutici S.p.A.
Via San Martino 12 – 20122 Milan
Manufacturer
Dompé farmaceutici S.p.A.
Via Campo di Pile – 67100 L’Aquila

Package leaflet: Information for the user

Okitask 40 mg film-coated tablets

ketoprofen lysine salt
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

7. What Okitask is and what it is used for
8. What you need to know before taking Okitask
9. How to take Okitask
10. Possible side effects
11. How to store Okitask
12. Package contents and other information

1. What Okitask 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 the treatment of pain of various origins and types, in particular: headache, toothache, neuralgia (nerve pain), menstrual pain, muscle pain, and osteoarticular pain (pain in bones and joints).
Consult your doctor if you do not feel better or if you feel worse after treatment.

2. What you should know before taking Okitask

Do not take Okitask

• if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
• if you have a history of hypersensitivity reactions (allergy) triggered by ketoprofen or substances with a similar mechanism of action, for example, acetylsalicylic acid or other NSAIDs (other anti-inflammatory drugs), such as asthma (bronchial inflammation and narrowing of the airways), bronchospasm (constriction of the bronchi), allergic rhinitis (allergic inflammation of the nasal mucosa), urticaria, skin rashes, nasal polyps, angioedema (swelling of the skin and mucous membranes), or other allergic-type reactions;
• if you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways);
• if you have severe heart failure (inability of the heart to pump sufficient blood to meet the body's needs);
• if you suffer from gastritis (inflammation of the stomach lining);
• if you currently have a peptic ulcer (a lesion in the stomach or the first part of the intestine) or gastrointestinal bleeding, or if you have previously suffered from recurrent peptic ulcer or bleeding (two or more distinct, confirmed episodes of bleeding or ulceration);
• if you have previously experienced gastrointestinal bleeding (bleeding from the stomach or intestine), ulceration, perforation, or chronic dyspepsia (indigestion);
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs;
• if you suffer from Crohn’s disease (intestinal inflammation) or ulcerative colitis (intestinal inflammation with ulcers);
• if you have severe liver (reduced liver function due to cirrhosis or severe hepatitis) or kidney (reduced kidney function) insufficiency;
• if you suffer from leucopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets);
• if you suffer from haemorrhagic diathesis (predisposition to bleeding) or other coagulation disorders, or if you have haemostatic disorders (difficulty in stopping bleeding);
• if you are being treated with high-dose 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
Talk to your doctor or pharmacist before taking Okitask.
Warnings
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see “How to take Okitask” and the sections below on gastrointestinal and cardiovascular risks).
Concomitant use of Okitask with other anti-inflammatory drugs should be avoided.
During treatment with all NSAIDs, including Okitask, gastrointestinal bleeding, ulceration, and perforation—sometimes fatal—have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events. Patients with a prior history of these conditions are at 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 to treat inflammatory conditions), anticoagulants (medicines that delay blood clotting), such as warfarin, selective serotonin reuptake inhibitors (medicines used to treat depression), or antiplatelet agents (medicines that prevent platelet aggregation) such as acetylsalicylic acid (see “Other medicines and Okitask”).
Elderly patients are at increased risk of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.
Immediately discontinue treatment with Okitask at the first signs of gastrointestinal bleeding or ulceration.
Severe skin reactions, some of which have been fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported in association with NSAID use (see “Possible side effects”). These reactions usually occur early in treatment. Discontinue use of Okitask if skin rash, mucosal lesions, or any other sign of hypersensitivity (allergic reaction) appear.
Precautions
Consult your doctor or pharmacist before taking Okitask

• If your kidneys do not function properly, as Okitask should be used with caution in such cases. If you use Okitask, kidney function should be monitored, especially if you are elderly or taking diuretics (medicines that lower blood pressure).
• If you have liver problems, periodic monitoring is required.
• If you have an infection – see section “Infections” below.
• If you suffer from uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate heart pumping function), established ischemic heart disease (heart disease resulting from reduced blood flow due to narrowing of the coronary arteries), peripheral arterial disease, and/or cerebrovascular disease (disease of the brain's arteries and blood vessels), as Okitask should only be taken after careful medical evaluation.
• If you have risk factors for these conditions, such as high blood pressure, diabetes (a disease caused by high blood glucose levels), hyperlipidemia (elevated blood fat levels), or if you smoke.
• If you have allergic manifestations or a history of allergy, as the medicine should be administered with caution.
• If you suffer from bronchial asthma (bronchial inflammation and narrowing of the airways), or have allergic diathesis (predisposition to develop allergies), chronic rhinitis (inflammation of the nasal mucosa), allergic rhinitis, chronic sinusitis, and/or nasal polyposis.
• If you have hematopoietic disorders (affecting blood cell formation and maturation), systemic lupus erythematosus (an immune system disease), or mixed connective tissue disorders, as Okitask should be used with caution.
• If you have hepatic porphyria (a rare blood disorder caused by impaired liver enzyme activity), 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). There are currently insufficient data to exclude a similar risk with OKITASK. An increased risk of atrial fibrillation (abnormal heart rhythm) has been reported with NSAID use. Hyperkalemia (increased potassium levels in the blood) may occur, especially if you have diabetes, kidney failure, and/or are taking medicines that can cause hyperkalemia (see “Other medicines and Okitask”). In such cases, potassium levels should be monitored periodically.

Okitask may mask symptoms of infections such as fever and pain. Therefore, Okitask may delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Consult your doctor if you experience visual disturbances, such as blurred vision, as treatment must be discontinued.

Other medicines and Okitask
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
The use of Okitask in combination with the following is not recommended:

• Other anti-inflammatory drugs, such as NSAIDs, selective COX-2 inhibitors, and high-dose salicylates (over 3 g/day);
• Medicines that delay blood clotting (such as heparin and warfarin) and antiplatelet agents (such as ticlopidine and clopidogrel);
• Lithium (a medicine used to treat manic-depressive psychosis);
• Methotrexate at doses exceeding 15 mg/week (a medicine indicated for the treatment of certain autoimmune diseases and some cancers);
• Hydantoins (used to treat epilepsy) and sulfonamides (such as certain antibiotics used to treat bacterial infections).

Caution is required when using Okitask in combination with:

• Potassium salts;
• Potassium-sparing diuretics;
• ACE inhibitors, angiotensin II receptor blockers (medicines used to lower blood pressure);
• NSAIDs (anti-inflammatory drugs);
• Heparins (anticoagulants);
• Cyclosporine and tacrolimus (medicines used to prevent organ transplant rejection or for certain immune system diseases);
• Trimethoprim (an antibiotic used for bacterial infections);
• Tenofovir (a medicine used to treat certain viral infections);
• Methotrexate at doses below 15 mg/week (a medicine indicated for the treatment of certain autoimmune diseases and some cancers);
• Corticosteroids (medicines used to treat inflammatory conditions);
• Pentoxifylline (a medicine used to improve blood circulation in the limbs);
• Zidovudine (a medicine used for HIV treatment);
• Sulfonylureas (medicines used to treat diabetes);
• Cardiac glycosides (medicines that act on the heart).

Consider the combination of Okitask with:

• Beta-blockers, ACE inhibitors, diuretics (medicines used to lower blood pressure);
• Mifepristone (a medicine used for medical termination of pregnancy);
• Intrauterine contraceptive devices;
• Cyclosporine, tacrolimus (medicines used to prevent organ transplant rejection or for certain immune system diseases);
• Thrombolytics (medicines that help dissolve blood clots);
• Ticlopidine and clopidogrel (medicines that prevent platelet aggregation);
• Selective serotonin reuptake inhibitors (some antidepressants);
• Probenecid (a medicine used to treat gout);
• Quinolones and sulfonamides (antibiotics used to treat bacterial infections);
• Phenytoin (a medicine used to treat epilepsy);
• Gemeprost (a medicine used for uterine examinations and surgical procedures).

Alcohol consumption is not recommended during treatment with Okitask.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ketoprofen use during the first and second trimesters of pregnancy should be avoided. Ketoprofen use should only be considered if the expected benefit to the mother outweighs the risk to the embryo or fetus.
Do not use Okitask during the first and second trimesters of pregnancy unless strictly necessary. If Okitask is used in women attempting to become pregnant or during the first and second trimesters 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 medicines in the same class as Okitask may expose the fetus to:

• cardiopulmonary toxicity;
• renal dysfunction in both the mother and the newborn, at the end of pregnancy, to:
• possible prolongation of bleeding time and antiplatelet effects, which may occur even at very low doses;
• inhibition of uterine contractions, leading to delayed or prolonged labor. Use of the medicine near delivery may cause disturbances in the newborn’s circulation and respiration. Therefore, DO NOT use Okitask during the third trimester of pregnancy (see “Do not take Okitask”).
  Breastfeeding
  There is no available information on the excretion of ketoprofen in breast milk. Ketoprofen is not recommended during breastfeeding.
  Fertility
  The use of NSAIDs, including Okitask, may reduce female fertility and is therefore not recommended in women attempting to conceive. Discontinue Okitask if you have fertility problems or are undergoing fertility investigations.

Driving and using machines
After taking Okitask, drowsiness, dizziness, convulsions, and visual disturbances may occur. It is therefore advisable to avoid driving, operating machinery, or performing tasks requiring special alertness (see “Possible side effects”).

Okitask 40 mg film-coated tablets contain sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially 'sodium-free'.

3. How to take Okitask

Take this medicine exactly as stated in this leaflet or as directed by your pharmacist. If you have any doubts, consult your pharmacist.
Dosing
The recommended doses are:
Adults and individuals over 15 years of age: The recommended dose is 1 tablet per day. This dose may be repeated 2–3 times daily in cases of more intense pain. Do not exceed the recommended doses.
Elderly patients and patients with hepatic or renal impairment
Use the lowest effective dose.
Do not use in case of severe hepatic or renal impairment (see "Do not use Okitask").
Children
The safety and efficacy of Okitask have not yet been established.
Method of administration
Take the medicine preferably with food, after meals.
Duration of treatment
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
Treatment duration should be limited to the resolution of the painful episode.
Consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes in its characteristics.
If you take more Okitask than you should
In case of accidental ingestion or overdose of Okitask, contact your doctor immediately or go to the nearest hospital.
Cases of overdose with doses up to 2.5 g of ketoprofen have been reported. In most cases, symptoms were limited to lethargy, confusion, loss of consciousness, drowsiness, headache, vertigo, dizziness, nausea, vomiting, epigastric pain (in the upper abdomen), abdominal pain, and diarrhea.
Gastrointestinal bleeding, hypotension (low blood pressure), respiratory depression, and cyanosis (bluish discoloration of the skin and mucous membranes) may also occur.
There are no specific antidotes in case of ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended, along with symptomatic and supportive treatment.
In case of renal impairment, hemodialysis (a technique for extracorporeal blood purification) may be useful to remove the circulating medicine.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 (indigestion), nausea, abdominal pain, and vomiting. Uncommon (may affect up to 1 in 100 people)

• headache, dizziness, drowsiness, constipation, diarrhoea, flatulence (passing wind), gastritis (inflammation of the stomach lining)

• rash, pruritus (itching), and fatigue Rare (may affect up to 1 in 1,000 people)

• haemorrhagic anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen in the blood, caused by bleeding)

• paraesthesia (numbness or tingling sensations)

• blurred vision (see “Warnings and precautions”)

• tinnitus (persistent perception of noise in the ear)

• asthma (bronchial inflammation and narrowing of the airways)

• stomatitis (inflammation of the mucous membranes lining the mouth), peptic ulcer (lesion in the stomach or the first part of the intestine)

• hepatitis (liver inflammation), increased transaminases (elevated levels of certain enzymes indicating liver function), increased bilirubin (a substance indicating liver function)

• weight gain. Very rare (may affect up to 1 in 10,000 people)

• facial oedema (swelling) and erythema (redness of the skin) Frequency not known (cannot be estimated from the available data)

• thrombocytopenia (reduced platelet count), agranulocytosis (severe reduction in a type of white blood cells), bone marrow failure (reduced production of blood cells by the bone marrow), haemolytic anaemia (reduction in haemoglobin in the blood caused by destruction of red blood cells), leucopenia (decrease in white blood cells), neutropenia (reduction in a type of white blood cells), aplastic anaemia (reduction in haemoglobin in the blood due to insufficient production of blood cells by the bone marrow), leucocytosis (increase in white blood cells), thrombocytopenic purpura (skin spots due to reduced platelet count)

• anaphylactic reaction (severe allergic reaction, including shock), hypersensitivity (allergy)

• jaundice (yellowing of the skin and whites of the eyes)

• depression, hallucination (perception of non-existent things), confusion, mood alterations, agitation, insomnia, convulsions (uncontrolled body movements), dizziness, dysgeusia (altered taste), tremor,
  dyskinesia (involuntary movements), syncope (fainting), hyperkinesia (involuntary and uncoordinated movements), periorbital oedema (swelling around the eye),
  peripheral oedema

• chills, asthenia (weakness)

• heart failure (inability of the heart to pump sufficient blood to meet the body's needs), atrial fibrillation (irregular heart rhythm), palpitations (awareness of heartbeats), tachycardia (increased heart rate), hypertension (high blood pressure), hypotension (low blood pressure)

• vasodilation (widening of blood vessels), vasculitis (inflammation of blood vessels), including leukocytoclastic vasculitis (inflammation of small blood vessels)

• bronchospasm (constriction of the airways), especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs, rhinitis (inflammation of the nasal mucosa), dyspnoea (difficulty breathing), laryngeal oedema (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 haemorrhage (bleeding from the stomach or intestine), gastrointestinal perforation (sometimes fatal, especially in the elderly; see “Warnings”), gastric ulcer (lesion in the stomach), oral ulceration, duodenal ulcer (lesion in the first part of the intestine), duodenal perforation, pyrosis (heartburn), oedema (swelling) of the mouth, pancreatitis (inflammation of the pancreas), melena (presence of digested blood in stools), haematemesis (vomiting blood), abdominal discomfort, colitis, hyperchlorhydria (excess stomach acid), gastric pain (stomach ache), erosive gastritis (severe inflammation of the stomach lining), oedema of the tongue (swelling of the tongue)

• photosensitivity reactions (sensitivity to sunlight or UV lamps), alopecia (loss of hair), urticaria, angioedema (swelling of the face, lips, mouth, tongue or throat which may cause breathing or swallowing difficulties), bullous eruptions including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis (serious skin reactions), oedema (fluid retention), exanthema (skin rash), maculopapular exanthema (skin rash with spots), purpura (purple spots on the skin due to abnormal blood accumulation), generalised acute exanthematous pustulosis (skin eruption with pus-filled blisters), dermatitis (skin irritation)

• acute renal failure (reduced kidney function), tubulointerstitial nephritis, nephritis and nephritic syndrome (kidney inflammations), nephrotic syndrome (kidney disorder causing protein loss in urine), glomerulonephritis (inflammatory kidney disease), fluid/sodium retention with possible oedema (accumulation of water and sodium causing swelling), acute tubular necrosis and renal papillary necrosis (severe kidney damage), oliguria (reduced urine production), abnormal kidney function test, haematuria (blood in urine)

• aseptic meningitis (inflammation of the membranes covering the brain not caused by infection), lymphangitis (inflammation of lymphatic vessels)

• hyperkalaemia (increased potassium levels in the blood) and hyponatraemia (decreased sodium levels in the blood). Following the instructions provided in this leaflet reduces the risk of side effects. Reporting of side effects If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Okitask

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product in its original, unopened packaging stored correctly.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Okitask contains

• The active substance is ketoprofen lysine salt. One tablet contains 40 mg of ketoprofen lysine salt, equivalent to 25 mg of ketoprofen.
• Other components are:
  Core: crospovidone, anhydrous colloidal silica, sodium lauryl sulfate, mannitol (E421), sodium stearyl fumarate
  Coating: (Opadry II 85 F blue 320 U) polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc, brilliant blue aluminium lake (E133), quinoline yellow aluminium lake (E104).

Description of the appearance of Okitask and contents of the pack
Film-coated tablets for oral use – pack sizes of 10, 20 or 30 tablets.
Marketing Authorization Holder and Manufacturer
Dompé farmaceutici S.p.A.
Via San Martino 12 - 20122 Milan
Manufacturer
Abiogen Pharma spa - via Meucci 36 - 56014 Ospedaletto (PI)