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Ketonal® Extra Plus 50 mg granules for oral solution Ketoprofen for short-term symptomatic treatment of mild to moderate pain Read the package leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this package leaflet or as advised by your doctor or pharmacist. - Keep this leaflet. You may need to read it again. - If you need more information or have questions, ask your doctor or pharmacist. - If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - See a doctor if you do not feel better or if you feel worse: - after 3 days, if you are an adolescent; - after 3 days for fever treatment and after 5 days for pain treatment, if you are an adult. Contents: 1. What Ketonal Extra Plus is and what it is used for 2. Before you take Ketonal Extra Plus 3. How to take Ketonal Extra Plus 4. Possible side effects 5. How to store Ketonal Extra Plus 6. Contents of the pack and other information 1. What Ketonal Extra Plus is and what it is used for The active substance is ketoprofen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). This medicine is used for short-term symptomatic treatment of mild to moderate pain in adults and adolescents over 16 years of age, such as: - Headache; - Toothache - Menstrual pain; - Pain after minor sprains, muscle, ligament, and tendon injuries. 2. Before you take Ketonal Extra Plus Do not take Ketonal Extra Plus if: · you are allergic to ketoprofen or any of the other ingredients of this medicine listed in section 6; · you have experienced allergic reactions in the past after taking acetylsalicylic acid or analgesics such as ketoprofen, ibuprofen or diclofenac, such as: - bronchial asthma, difficulty breathing; - swelling of the face, lips, tongue or throat; - hives, runny nose with itching; - other allergic reactions. People with a history of these reactions may develop severe anaphylactic reactions, including fatal ones. you have bronchial asthma; · you have a stomach/duodenal ulcer or have had gastrointestinal bleeding, ulceration or perforation in the past; · you have inflammatory bowel disease, such as ulcerative colitis or Crohn's disease; you have severe heart failure; you have severe kidney or liver dysfunction; you are prone to bleeding; you are in the third trimester of pregnancy; you should not take this medicine without specific medical advice if you are at risk of developing stomach side effects, for example, if you are elderly or if you are taking certain other medicines, such as anticoagulants, antiplatelet agents, corticosteroids, other non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors (SSRIs) or nicorandil (see also sections "Special warnings and precautions" and "Interactions with other medicines" below). Special warnings and precautions Talk to your doctor or pharmacist before taking this medicine if: you have chronic inflammation in your nose or paranasal sinuses and (or) nasal polyps; you have or have had heart problems, such as mild to moderate heart failure. Signs of heart failure include fluid accumulation in the lungs, abdomen, arms, and legs. For severe heart failure, see section 2 "Do not take this medicine"; you have undergone coronary artery bypass surgery; you have mild to moderate kidney or liver disease, including abnormalities in liver and kidney function tests. For severe kidney or liver dysfunction, see section 2 "Do not take this medicine"; you have or have had high blood pressure; you have disease of the arteries in your arms, legs or brain; you have diabetes or high cholesterol levels; you have an infection (see also "Infections" below); you are a smoker; you are elderly. Elderly patients are at increased risk of side effects, especially gastrointestinal bleeding and perforation, which can be fatal, when taking analgesics similar to ketoprofen. Therefore, elderly patients should pay attention to any unusual symptoms, especially gastrointestinal bleeding, particularly at the start of treatment. Such patients require close medical supervision. Cases of gastrointestinal bleeding, ulceration and perforation, in some cases fatal, have been reported with treatment with any analgesic similar to ketoprofen. Such reactions can occur at any time, with or without warning symptoms, or with a history of serious gastrointestinal disease. The risk of gastrointestinal bleeding, ulceration or perforation increases with dose. It is also high in patients with a history of ulcers, especially with concomitant bleeding and perforation, and in the elderly. See also section 2 "Do not take this medicine". Taking ketoprofen, especially at high doses, may be associated with a risk of severe gastrointestinal toxicity. If this applies to you, consult your doctor. They will prescribe protective medication for your gastrointestinal tract. Also consult your doctor for protective medication for your gastrointestinal tract if you need additional therapy with low-dose acetylsalicylic acid or other medicines that can increase the risk of gastrointestinal damage (oral corticosteroids (e.g., prednisolone), anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors (SSRIs) or nicorandil (see also sections "Special warnings and precautions" and "Interactions with other medicines" below)). If symptoms of gastrointestinal bleeding, ulceration or perforation occur, stop taking this medicine immediately and consult your doctor. See section 4 "Possible side effects". Medicines like Ketonal Extra Plus may be associated with a small increased risk of heart attack or stroke. The risk increases with high doses or prolonged use. Do not exceed the recommended dose or duration of use. Consult your doctor or pharmacist if you have heart problems or have had a stroke or are at risk of such events, for example: · if you have high blood pressure, diabetes or high cholesterol levels; if you are a smoker. Serious skin reactions, including redness and blistering of the skin, sometimes fatal, have been reported with analgesics similar to ketoprofen. See section 4 "Possible side effects". In most cases, such reactions occur within the first month of treatment. Stop taking this medicine immediately and inform your doctor if you develop a rash, mucosal lesions, or other signs of hypersensitivity. The incidence of side effects may be reduced by using the lowest effective dose for the shortest possible duration needed to control symptoms. Do not exceed the recommended dose or duration of use. Infections This medicine can mask the symptoms of infectious diseases (fever and pain). This may delay the start of appropriate treatment and increase the risk of complications. This has been observed with bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and its symptoms persist or worsen, consult your doctor immediately. Children and adolescents This medicine is contraindicated in children and adolescents under 16 years of age. Adolescents aged 16 and over should consult a doctor. The doctor may monitor your health more frequently. Interactions with other medicines If you are taking, have recently taken or might take any other medicines, tell your doctor or pharmacist. Taking this medicine is not recommended if you are taking: any other analgesic, such as - medicines similar to ketoprofen (ibuprofen, diclofenac, naproxen); - acetylsalicylic acid, at doses for pain or inflammation or to reduce fever; - medicines for pain, inflammation or rheumatism whose active substance names end in "-coxib". · medicines that inhibit blood clotting or platelet aggregation. Such as acetylsalicylic acid, heparin, vitamin K antagonists (e.g., warfarin), platelet aggregation inhibitors (e.g., ticlopidine, clopidogrel), thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitors (e.g., apixaban, rivaroxaban, edoxaban); · lithium, used to treat depression and mental disorders; · methotrexate at a dose of 15 mg per week or more, used to treat cancer; · certain medicines for epilepsy, such as phenytoin; · medicines known as sulfonamides, used as diuretics or to treat bacterial infections. · If simultaneous use of Ketonal Extra Plus with the above-mentioned medicines cannot be avoided, you must be under close medical supervision. Some other medicines may also affect the action of Ketonal Extra Plus or vice versa. Therefore, you should always consult your doctor or pharmacist before taking Ketonal Extra Plus with other medicines. This particularly applies to the following medicines: · medicines that increase water excretion by the kidneys and lower blood pressure, also known as "diuretics"; · methotrexate at a dose of less than 15 mg per week, used to treat cancer, severe joint inflammation and psoriasis; · medicines that lower high blood pressure, whose active substance names end in "-pril" or "-sartan/-zartan" or "-olol" (e.g., ramipril, captopril, valsartan, losartan, bisoprolol); · cardiac glycosides (e.g., digoxin, used to treat heart rhythm disorders or heart failure); · medicines used to treat depression, so-called selective serotonin reuptake inhibitors; · corticosteroids (used to treat inflammation, allergies, prevent rejection of transplanted organs (e.g., cortisone)); · pentoxifylline (used to treat muscle pain caused by diseases of the arteries in the arms and (or) legs); · probenecid (used to treat gout and high levels of uric acid in the blood); · cyclosporine and tacrolimus (used to suppress the immune system, e.g., after organ transplantation); thrombolytic drugs; · tenofovir (used to treat certain viral infections); · zidovudine (used to treat HIV infection); · antidiabetic drugs, such as glibenclamide or glimepiride; · medicines that can increase potassium levels in the blood (e.g., potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim); · nicorandil (used for the prevention and treatment of angina attacks). Pregnancy, breastfeeding and fertility If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine during the last three months of pregnancy, as it can harm the fetus (worsen kidney and heart function) and cause problems during childbirth (increased tendency to bleed in mother and child, delayed and prolonged labor). During the first 6 months of pregnancy, this medicine may only be taken in urgent cases and only on prescription. If Ketonal Extra Plus is taken during the first or second trimester of pregnancy or by a woman trying to conceive, the dose should be as low as possible and the duration of use as short as possible. From the 20th week of pregnancy, if Ketonal Extra Plus is used for several days, the fetus may develop kidney problems or narrowing of the arterial duct. Kidney problems in the fetus can lead to oligohydramnios (very little amniotic fluid). If Ketonal Extra Plus needs to be used for more than a few days, your doctor may order additional tests. It is unknown whether the medicine is excreted in breast milk. Taking Ketonal Extra Plus is not recommended during breastfeeding. If you are planning to become pregnant or have problems with fertility, inform your doctor. Ketonal Extra Plus may make it difficult to conceive. Driving and using machines This medicine usually does not affect the ability to drive and use machines. However, if you experience side effects such as dizziness, drowsiness, convulsions or blurred vision, do not drive or operate machinery. The medicine contains sodium. The medicine contains less than 1 mmol of sodium (23 mg) per sachet, which means it can be considered "sodium-free". 3. How to take Ketonal Extra Plus: Take this medicine exactly as described in this package leaflet or as your doctor or pharmacist has told you. If you are unsure about anything, ask your doctor or pharmacist. Recommended dose: Adults and adolescents over 16 years of age 25 mg ketoprofen 1-3 times a day or 50 mg ketoprofen 1-2 times a day. Half of a double sachet provides a dose of 25 mg ketoprofen, and a whole double sachet provides 50 mg ketoprofen. The interval between doses should be at least 8 hours. The medicine should be taken at the lowest effective dose for the shortest possible duration needed to control symptoms. If you are using this medicine during an infection, seek medical attention immediately if infection symptoms (fever and pain) persist or worsen (see section 2). Elderly patients The dose will be determined by the doctor and reduced if necessary. See section 2 "Special warnings and precautions". Patients with liver/kidney dysfunction If you have mild to moderate liver and (or) kidney dysfunction, your doctor may reduce the dose of the medicine. Severe liver and (or) kidney dysfunction is a contraindication for taking this medicine. How to use For oral use. · Pour half of the contents of a double sachet (25 mg) into 50 ml, and the contents of a whole double sachet (50 mg) into 100 ml of water. · Stir for about 30 seconds until the granules are completely dissolved. · Drink the solution immediately after preparation, during meals. Duration of use Adults. If your condition does not improve or worsens after 3 days of treatment for fever or 5 days for pain, consult your doctor. Adolescents. If the adolescent's condition does not improve or worsens after 3 days, consult a doctor. Overdose If you have taken too much of this medicine, inform your doctor immediately or go to the nearest medical facility. In most cases, overdose symptoms are limited to lethargy, drowsiness, nausea, vomiting, and upper abdominal pain. Missed dose If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed dose. If you have any questions about the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking the medicine and seek immediate medical attention or go to the nearest medical facility: Rare (affects up to 1 in 1000 people) Asthma attack; · Burning or dull pain in the stomach on an empty stomach. This may be a sign of a stomach or intestinal ulcer. Very rare (affects up to 1 in 10,000 people) Blood in urine; swelling of the larynx. Frequency not known · Vomiting blood, severe stomach pain, black tarry stools, which indicate gastrointestinal bleeding or perforation; · Blisters, vesicles, peeling or bleeding of the skin in any area, which may or may not be accompanied by a rash with itching. Lips, eyes, mouth, nose, genitals, palms or soles of the feet are affected. Flu-like symptoms may also occur. You may experience severe skin damage requiring urgent medical attention (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis); · Changes in the amount of urine and swelling, especially in the legs, ankles and feet, which may indicate serious kidney problems; · Chest pain (symptom of heart attack) or sudden severe headache, nausea, dizziness, numbness, inability to speak or difficulty speaking, paralysis (symptoms of stroke). Medicines like Ketonal Extra Plus may be associated with a small increased risk of heart attack or stroke. See section 2 "Special warnings and precautions". · Symptoms of severe allergic reactions, such as: - swelling of the face and lips, mouth, throat or larynx, leading to wheezing, difficulty swallowing or breathing; - feeling of pressure in the chest, rapid heartbeat, drop in blood pressure, shock; - itching, rash; laryngeal spasm causing difficulty breathing; · Increased susceptibility to infections, which may be caused by a severe blood disorder called agranulocytosis; convulsions. Inform your doctor as soon as possible if you develop any of the following side effects: Rare (affects up to 1 in 1000 people) · Unusual skin sensations, numbness, tingling, prickling, burning or "pins and needles" sensation. · Pale skin, fatigue, weakness or dizziness, which may be caused by a lack of red blood cells due to bleeding; blurred vision; · Yellowing of the skin or whites of the eyes, which may indicate liver damage. Frequency not known · Easy bruising or prolonged bleeding. This may be a serious problem related to platelet count; · Destruction of red blood cells, which can cause pale yellowish skin and may lead to weakness or difficulty breathing (hemolytic anemia); · Reduction in the number of white blood cells, which may lead to increased susceptibility to infections; · Exacerbation of gastrointestinal diseases, such as Crohn's disease or colitis; · Increased sensitivity of the skin to light or artificial UV radiation (photosensitivity). Other side effects may occur with the following frequencies: Common (affects up to 1 in 10 people) Indigestion, abdominal pain; nausea, vomiting Uncommon (affects up to 1 in 100 people) Inflammation of the stomach lining; constipation, diarrhea, flatulence; rash, itching; · Fluid retention, which may lead to swelling of the hands and (or) feet; headache, dizziness or drowsiness; fatigue or feeling unwell; sensation of dizziness or spinning. Rare (affects up to 1 in 1000 people) Tinnitus; weight gain; pain and inflammation of the oral mucosa. Very rare (affects up to 1 in 10,000 people) · Involuntary rhythmic movements of the muscles of the mouth, tongue and face (so-called dyskinesia); fainting; low blood pressure; · Swelling of the face (facial edema); feeling of weakness. Frequency not known · Heart failure with symptoms such as shortness of breath, difficulty breathing when lying down, swelling of the legs or ankles; palpitations, irregular heartbeat; high blood pressure; · Redness of the skin, indicating vasodilation; rapid heartbeat; mood swings; confusion; irritability; sleep problems; taste changes; heartburn; swelling around the eyes; runny nose, itching, sneezing and nasal congestion; hair loss; · Hives, redness and inflammation of the skin, bumpy rash. · Lower than normal levels of sodium in the blood, which can cause fatigue and confusion, muscle cramps, seizures and coma; · Higher than normal levels of potassium in the blood, which can cause heart rhythm disturbances; · Aseptic meningitis (inflammation of the brain membranes), which may manifest as neck stiffness, headache, fever, nausea, vomiting; · Inflammation of blood vessels, often accompanied by a rash (vasculitis, including leukocytoclastic vasculitis); · Inflammation of the pancreas, the signs of which may include severe pain in the abdomen and back. Blood tests Blood tests may show impaired liver or kidney function. Tell your doctor or pharmacist if you experience any side effects, including any that are not listed in this leaflet. 5. How to store Ketonal Extra Plus: Keep out of reach of children, at a temperature not exceeding 25°C. Shelf life: 3 years. Do not use after the expiry date indicated on the packaging. The expiry date is the last day of the month indicated. The solution should be taken immediately after preparation. 6. Contents of the pack and other information: Composition Active substance: ketoprofen A double sachet contains 50 mg of ketoprofen (equivalent to 80 mg of ketoprofen lysine salt). A double sachet can provide half (25 mg) or a full (50 mg) dose. Excipients: mannitol (E421), povidone K30, mint flavor, sodium chloride, sodium saccharin, colloidal anhydrous silica. Appearance and contents of the pack White or yellowish granules in a sachet. 12 double sachets with package leaflet in a cardboard box. How to obtain: Pharmaceutical product group - III, available without prescription Also see: KETONAL DUO - Ketonal Duo 150 mg 30 capsules
