Ketonal

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Ketonal (Ketonal 100 mg/2 ml), 50 mg/ml, solution for injection/infusion

Ketoprofen
Ketonal and Ketonal 100 mg/2 ml are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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

Ketonal 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 allergic 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 attack, rhinitis, urticaria, or other types of allergic reactions caused by ketoprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs). In such patients, severe, sometimes fatal, anaphylactic reactions have been reported.
• In women in the third trimester of pregnancy.
• In the following patients:
• with severe heart failure
• with active or recurrent gastric or duodenal ulcers and (or) gastrointestinal bleeding in the past
• with gastrointestinal bleeding or perforation in the past, associated with previous use of non-steroidal anti-inflammatory drugs
• with a tendency to bleed
• with severe liver failure
• with 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 blood 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, you should discuss it 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. You should not use higher doses or longer treatment than recommended.
• If the patient has heart disease, including heart failure, angina pectoris (chest pain), or has had a heart attack, coronary artery bypass grafting, peripheral artery disease (circulatory disorders 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 has a family history of heart disease or stroke.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including ketoprofen, may cause bleeding, ulcers, or perforation in the gastrointestinal tract (in very rare cases, fatal). Particular caution should be exercised in patients receiving Ketonal in high doses, patients with a history of ulcer disease (especially if it was complicated by bleeding or perforation), ulcerative colitis, or Crohn's disease, and 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.
• You should inform your doctor if you have diabetes or are taking potassium-sparing medicines. It may be necessary to monitor potassium levels in the blood.
• In patients with coagulation disorders, hemophilia, von Willebrand disease, severe thrombocytopenia, kidney or liver failure, and in patients taking anticoagulant medicines (such as coumarin and heparin), the risk of bleeding is increased.
• In very rare cases, NSAIDs can cause severe, potentially life-threatening skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

separation of the skin. 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, changes in the mucous membranes, or other symptoms of an allergic reaction, Ketonal should be discontinued and medical attention should be sought immediately.

• Ketoprofen may impair renal function in patients with:
• heart failure;
• liver cirrhosis;
• nephrotic syndrome;
• chronic kidney failure;
• liver dysfunction;
• chronic kidney disease;
• fluid balance disorders (e.g., in dehydrated patients);
• elderly patients.
• In patients with liver failure, the doctor may recommend a dose adjustment.

You should inform your doctor if:

• you have had hypersensitivity to sunlight or phototoxicity in the past,
• you have had gastrointestinal diseases (gastric or duodenal ulcer, ulcerative colitis, Crohn's disease, esophageal hiatus hernia), blood diseases, or coagulation disorders,
• you drink large amounts of alcohol and (or) smoke,
• you have high blood pressure, heart failure, and edema,
• you have an infection - see below, the section entitled "Infections"
• you have liver or kidney failure or are taking diuretics,
• you are to undergo surgery.

Infections
Ketonal may mask the symptoms of an infection, such as fever and pain. Therefore, Ketonal may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection, and the symptoms of the infection persist or worsen, you should consult your doctor immediately.

Using 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

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Ketonal should not be used at the same time as other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 (COX-2) inhibitors) and salicylates (e.g., acetylsalicylic acid).
Ketonal and other medicines may interact with each other and affect each other's efficacy and the occurrence of side effects.
This particularly applies to such medicines as:

• other NSAIDs and salicylates (including acetylsalicylic acid) in high doses,
• corticosteroids (anti-inflammatory medicines),
• anticoagulant medicines, such as heparin and warfarin, dabigatran, apixaban, rivaroxaban, edoxaban,
• antiplatelet medicines, such as acetylsalicylic acid, ticlopidine, clopidogrel, tirofiban,
• nicorandil (a medicine used to treat coronary heart disease),
• 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),
• cyclosporin (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 to treat uterine fibroids),
• quinolone antibiotics,
• beta-adrenergic 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 you are unsure what these medicines are, you should consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
You should not use Ketonal if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Ketonal may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and the baby and prolong the delivery time.
In the first 6 months of pregnancy, you should not use Ketonal unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, you should use the smallest dose for the shortest possible time.
From the 20th week of pregnancy, Ketonal may cause kidney problems in the unborn baby if used for more than a few days. This may lead to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) 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 use Ketonal.
Fertility
Ketonal may make it more difficult to become pregnant. If you are planning to become pregnant, have problems becoming pregnant, or are undergoing fertility tests, you should inform your doctor. Your doctor may consider stopping the use of Ketonal.

Driving and using machines

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

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

The Ketonal injection/infusion solution contains 200 mg of ethanol (alcohol) per dose (2 ml), which is equivalent to 5 ml of beer and 2 ml of wine per dose. This is harmful to individuals with alcohol dependence.
You should take this into account when using it 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 a large amount of benzyl alcohol may accumulate in their body 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, which means it is essentially "sodium-free".

3. How to use Ketonal

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor, nurse, or pharmacist.
Adults and children over 15 years of age
Intramuscular 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-term infusion
The 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 infusion
The 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.
You should 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 during the infection, you should 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. The use of higher doses is not recommended.
Elderly patients
In 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.

Warning

• The solution of tramadol and ketoprofen should not be mixed 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, you should consult your doctor or pharmacist.

Using a higher dose of Ketonal than recommended

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.

Missing a dose of Ketonal

You should not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, Ketonal 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): elevated liver function test results to borderline values.
Common(may affect less than 1 in 10 people): depression, nervousness, nightmares, drowsiness, general weakness, malaise, tingling sensation, edema, nausea, loss of appetite, vomiting.
Uncommon(may affect less than 1 in 100 people): anemia, hemolysis (red blood cell breakdown), thrombocytopenia and skin allergic reactions, headache, dizziness, drowsiness, hemoptysis, dyspnea, pharyngitis, laryngeal edema, constipation, diarrhea, gastritis, rash, hair loss, pruritus, urticaria, erythema multiforme, excessive sweating, exfoliative dermatitis, menstrual bleeding or irregular heavy menstrual bleeding, significant increase in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) activity, edema, fatigue.
Rare(may affect less than 1 in 1000 people): hemolytic anemia, hallucinations with visual and auditory disturbances, disorientation and speech disorders, vision disturbances, tinnitus, bronchial asthma attack, oral mucositis, gastric and (or) duodenal ulcers, hepatitis, increased bilirubin levels in the blood due to hepatitis, colitis.
Very rare(may affect less than 1 in 10,000 people): recurrence of ulcerative colitis or Crohn's disease, enteropathy with perforation, ulceration, or strictures (also with minimal bleeding or protein loss), acute interstitial nephritis.
A 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, seizures, heart failure, hypertension, bronchospasm (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, gastrointestinal bleeding and perforation (sometimes fatal), hypersensitivity to sunlight, hair loss, 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, mottled skin.
Ketoprofen in high doses may inhibit platelet aggregation, prolonging bleeding time and causing nosebleeds and a tendency to bruise.
A case of alleged brain tumor and a case of conjunctivitis have been reported. There have also been reports of gastrointestinal discomfort and stomach pain, as well as fluid/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 any side effects not listed in this leaflet, you should 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketonal

• The medicine should be stored out of 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 the month.
• Do not store above 25°C.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ketonal contains

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

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.
Pack sizes: 5, 10, 50 ampoules.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Sandoz d.d.
Verovškova 57
1000 Ljubljana, Slovenia

Manufacturer:

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, export country marketing authorization number:LT/1/95/0447/005

Parallel import authorization number: 232/25

Date of leaflet approval: 01.07.2025

[Information about the trademark]