Ketonal

Leaflet accompanying the packaging: patient information

Ketonal, 50 mg/ml, solution for injection

Ketoprofen

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ketonal and what is it used for
• 2. Important information before using Ketonal
• 3. How to use Ketonal
• 4. Possible side effects
• 5. How to store Ketonal
• 6. Contents of the packaging and other information

1. What is Ketonal and what is it used for

The Ketonal injection solution contains the active substance ketoprofen - a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, antipyretic, and analgesic effects. Ketonal is used to treat the symptoms of inflammatory and degenerative rheumatic diseases of the musculoskeletal system and to alleviate certain pain syndromes. Indications for intramuscular administration: rheumatoid arthritis, osteoarthritis, moderate pain. Indications for intravenous administration: postoperative pain.

2. Important information before using Ketonal

When not to use Ketonal

If the patient is hypersensitive to ketoprofen or any of the other ingredients of this medicine (listed in section 6). In patients who have experienced hypersensitivity reactions in the past, such as bronchospasm, asthma, nasal mucositis, urticaria, or other allergic reactions caused by ketoprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs). In patients with severe heart failure, active or recurrent gastric or duodenal ulcers, and (or) gastrointestinal bleeding. In patients with a history of gastrointestinal bleeding or perforation related to previous use of non-steroidal anti-inflammatory drugs. In patients with a tendency to bleed, severe liver failure, or severe kidney failure. The use of Ketonal is contraindicated in cases of cerebral hemorrhage or any active bleeding. Intramuscular administration of Ketonal is contraindicated in patients with coagulation disorders or those receiving anticoagulant therapy. The medicine should not be used in children under 15 years of age.

Warnings and precautions

Before using Ketonal, discuss with your doctor if any of the following warnings apply to you or have applied in the past. It is very important to use the medicine in the smallest effective dose for the shortest period necessary to alleviate the symptoms. The use of such medicines as Ketonal may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not use higher doses or longer treatment than recommended. If the patient experiences heart problems, including heart failure, angina pectoris (chest pain), or has had a myocardial infarction, coronary artery bypass grafting, peripheral artery disease (circulatory problems in the legs or feet due to narrowing or blockage of arteries), or any form of stroke (including transient ischemic attack), the treatment should be discussed with a doctor or pharmacist. The use of Ketonal should also be discussed with a doctor if the patient smokes, has high blood pressure, high cholesterol, diabetes, or a history of heart disease or stroke in the family. Non-steroidal anti-inflammatory drugs (NSAIDs), including ketoprofen, may cause bleeding, ulceration, or perforation of the gastrointestinal tract (in very rare cases, fatal). Particular caution is required in patients receiving Ketonal in high doses, patients with a history of ulcer disease (especially if complicated by bleeding or perforation), ulcerative colitis, or Crohn's disease, as well as in elderly patients. All patients, especially the elderly, who experience unusual gastrointestinal symptoms (especially bleeding) while using Ketonal, must immediately inform their doctor. The risk of allergic reactions is increased in patients with asthma, chronic rhinitis, chronic sinusitis, and (or) nasal polyps. The administration of Ketonal may cause an asthma attack or bronchospasm, especially in individuals allergic to acetylsalicylic acid and (or) NSAIDs. In patients after coronary artery bypass grafting, some non-steroidal anti-inflammatory drugs increased the risk of arterial thrombotic events. Inform your doctor if you have diabetes or are taking potassium-sparing medicines, as monitoring of potassium levels in the blood may be necessary. In patients with coagulation disorders, hemophilia, von Willebrand disease, severe thrombocytopenia, kidney or liver failure, and patients taking anticoagulant medicines (such as coumarin and heparin), the risk of bleeding is increased. In very rare cases, NSAIDs may cause serious skin reactions (some life-threatening), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The risk of such reactions is likely to be highest at the beginning of treatment (especially in the first month of using the medicine). After the first signs of a rash, mucosal lesions, or other allergic symptoms, Ketonal should be discontinued, and medical help should be sought immediately. Ketoprofen may impair renal function in patients with: heart failure; cirrhosis; nephrotic syndrome; chronic renal failure; liver dysfunction; chronic renal impairment; water balance disorders (e.g., in dehydrated patients); elderly patients. In patients with liver failure, the doctor may recommend a dose adjustment.

Use of Ketonal in elderly patients

In elderly patients, the risk of adverse reactions associated with the use of non-steroidal anti-inflammatory drugs is increased. This particularly applies to gastrointestinal bleeding and perforation, which can be life-threatening.

Ketonal and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Ketonal should not be used simultaneously with other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors, COX-2) and salicylates (e.g., acetylsalicylic acid). Ketonal and other medicines may interact with each other, affecting their efficacy and the occurrence of side effects. This applies, in particular, to such medicines as: other NSAIDs and salicylates (including acetylsalicylic acid) in high doses, corticosteroids (anti-inflammatory medicines), anticoagulant medicines (e.g., heparin and warfarin), antiplatelet medicines (e.g., acetylsalicylic acid, ticlopidine, clopidogrel), lithium (a medicine used to treat certain mental illnesses), methotrexate (a medicine used in cancer and rheumatoid diseases), diuretics, blood pressure-lowering medicines, selective serotonin reuptake inhibitors (medicines used to treat depression), potassium salts, tacrolimus (an immunosuppressive medicine), cyclosporine (an immunosuppressive medicine used to prevent organ or bone marrow transplant rejection), trimethoprim (an antibiotic), oral antidiabetic medicines, antiepileptic medicines (e.g., phenytoin), digitalis glycosides (medicines used to treat heart conditions), mifepristone (a medicine used, among others, to treat uterine fibroids), quinolone antibiotics, beta-blockers (medicines used to treat heart conditions), tenofovir (an antiretroviral medicine used to treat HIV and chronic hepatitis B). The use of ketoprofen may reduce the effectiveness of intrauterine contraceptives. If in doubt about the mentioned medicines, consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Pregnancy Do not take Ketonal if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause complications during delivery. Ketonal may cause renal and cardiac disorders in the unborn baby. It may also increase the risk of bleeding in the mother and child and prolong labor. During the first 6 months of pregnancy, do not use Ketonal unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time. From the 20th week of pregnancy, Ketonal may cause renal disorders in the unborn baby if used for more than a few days. This may lead to low amniotic fluid levels or narrowing of the arterial duct in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring. Breastfeeding It is not known whether ketoprofen passes into breast milk. Breastfeeding women should not be given Ketonal. Fertility Ketonal may make it more difficult to become pregnant. If you are planning a pregnancy, have problems with becoming pregnant, or are undergoing fertility tests, inform your doctor. Your doctor may consider stopping the use of Ketonal.

Driving and using machines

Ketonal may cause dizziness, drowsiness, convulsions, and vision disturbances in some patients. If you experience these symptoms, do not drive or operate machinery.

Ketonal contains ethanol, benzyl alcohol, propylene glycol, and sodium

The Ketonal injection solution contains 12.3% v/v ethanol (alcohol), i.e., 200 mg of ethanol per dose (2 ml), equivalent to 4 ml of beer and 2 ml of wine per dose. Harmful to individuals with alcohol dependence. This should be taken into account when using in pregnant or breastfeeding women, children, and individuals at high risk, such as patients with liver disease or epilepsy. The medicine contains 40 mg of benzyl alcohol in each 2 ml ampoule. Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women, as well as patients with liver or kidney disease, should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause side effects (so-called metabolic acidosis). The medicine contains 800 mg of propylene glycol in each 2 ml ampoule. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., the medicine is considered "sodium-free".

3. How to use Ketonal

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, nurse, or pharmacist. Adults and children over 15 years of ageIntramuscular administration 1 ampoule (100 mg of ketoprofen) once or twice a day. If necessary, the treatment with the solution can be supplemented with oral or transdermal treatment. Intravenous administration Ketoprofen can be administered intravenously only in a hospital setting. The infusion should be administered over ½ to 1 hour, for a maximum of 48 hours. The maximum dose is 200 mg per day. Short infusionThe contents of 1 to 2 ampoules (100 mg to 200 mg of ketoprofen) should be diluted to 100 ml with 0.9% sodium chloride solution and administered over ½ to 1 hour. The infusion can be repeated after 8 hours. The maximum dose is 200 mg per day. Continuous infusionThe contents of 1 to 2 ampoules (100 mg to 200 mg of ketoprofen) should be diluted to 500 ml with infusion fluid (0.9% sodium chloride solution, Ringer's lactate solution, 5% glucose solution) and administered over 8 hours. The infusion can be repeated after 8 hours. The maximum dose is 200 mg per day. Ketoprofen can be administered simultaneously with centrally acting analgesics. The solution can be mixed in the same bottle with morphine: 10 mg to 20 mg of morphine and 100 mg to 200 mg of ketoprofen diluted in 500 ml of 0.9% sodium chloride solution or Ringer's lactate solution. The infusion can be repeated after 8 hours. Use the smallest effective dose for the shortest period necessary to alleviate the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen while using this medicine, consult your doctor immediately (see section 2). The maximum daily dose is 200 mg. Before starting treatment with a dose of 200 mg per day, your doctor will carefully weigh the benefits and risks. Using a higher dose is not recommended. Elderly patientsIn elderly patients, treatment with ketoprofen should be started with the smallest available dose and continued with the smallest effective dose. In elderly patients, the risk of serious side effects is higher.

Caution

Do not mix the tramadol and ketoprofen solution in the same bottle due to the possibility of precipitate formation. Infusion bottles should be wrapped in black paper or aluminum foil, as ketoprofen is sensitive to light. If you feel that the effect of Ketonal is too strong or too weak, consult your doctor or pharmacist.

Overdose of Ketonal

In adults, the main symptoms of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhea, and abdominal pain. In case of severe poisoning, the patient should be immediately transported to a specialized hospital department for symptomatic treatment. There is no specific antidote.

Missed dose of Ketonal

Do not take a double dose to make up for a missed dose. If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may occur with the following frequencies: Very common(may affect more than 1 in 10 people): increased liver function test results to borderline values. Common(may affect up to 1 in 10 people): depression, nervousness, nightmares, drowsiness, general weakness, malaise, feeling of tingling, edema, nausea, loss of appetite, vomiting. Uncommon(may affect up to 1 in 100 people): anemia, hemolysis (red blood cell breakdown), purpura, and skin allergic reactions, headache, dizziness, drowsiness, hemoptysis, dyspnea, pharyngitis, laryngeal edema, constipation, diarrhea, gastritis, rash, alopecia, pruritus, urticaria, urticaria-like rash, excessive sweating, exfoliative dermatitis, menstrual bleeding or irregular menstrual bleeding, significant increase in aminotransferase activity (AST and ALT), edema, feeling of fatigue. Rare(may affect up to 1 in 1,000 people): hemolytic anemia, hallucinations with visual and auditory illusions, disorientation and speech disorders, vision disturbances, tinnitus, bronchial asthma, stomatitis, gastric ulcer and (or) duodenal ulcer, hepatitis, increased bilirubin levels in the blood due to hepatitis, colitis. Very rare(may affect less than 1 in 10,000 people): relapse of ulcerative colitis or Crohn's disease, enteropathy with perforation, ulceration, or stenosis (also with minor bleeding or protein loss), acute interstitial nephritis. One case of colon perforation has been reported in an elderly woman. Frequency not known(frequency cannot be estimated from the available data): complete or almost complete lack of granulocytes (agranulocytosis), decreased platelet count (thrombocytopenia), hemolytic anemia (anemia due to red blood cell breakdown), decreased white blood cell count (leukopenia), anaphylactic reactions (including anaphylactic shock), mood changes, convulsions, heart failure, hypertension, bronchospasm (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs), nasal mucositis, gastrointestinal bleeding and perforation (sometimes fatal), hypersensitivity to light, alopecia, urticaria, exacerbation of chronic urticaria, blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis, acute renal failure, tubulointerstitial nephritis, nephrotic syndrome, decreased sodium levels in the blood (hyponatremia), increased potassium levels in the blood (hyperkalemia), confusion, aseptic meningitis, vasculitis (including leukocytoclastic vasculitis), pancreatitis, angioedema, burning sensation, pain at the injection site, mottling of the skin. Ketoprofen in high doses may inhibit platelet aggregation, prolonging bleeding time and causing nosebleeds and a tendency to bruise. One case of a suspected brain tumor and one case of conjunctivitis have been reported. There have also been reports of gastrointestinal discomfort and stomach pain, as well as water/sodium retention (with possible edema), organic kidney damage, which may lead to acute renal failure, single cases of acute tubular necrosis, and renal papillary necrosis. The use of some NSAIDs (especially long-term and in high doses) may increase the risk of arterial thrombosis (e.g., myocardial infarction or stroke). It cannot be excluded that this also applies to ketoprofen.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketonal

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month. Store in a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ketonal contains

The active substance of the medicine is ketoprofen. Each 2 ml solution for injection (1 ampoule) contains 100 mg of ketoprofen. The other ingredients are propylene glycol, ethanol, benzyl alcohol, sodium hydroxide, water for injections.

What Ketonal looks like and contents of the packaging

Ketonal is a clear solution without visible particles. It is available in orange glass ampoules in a cardboard box, containing 2 ml of solution. Packaging sizes: 5, 10, 50 ampoules.

Marketing authorization holder

Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia For more detailed information, please contact: Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. +48 22 209 70 00

Date of last revision of the leaflet:

Sandoz logo