Ketoprofen-sf

Leaflet attached to the packaging: patient information

Ketoprofen-SF, 50 mg/ml, solution for injection

For adult use only
Ketoprofen

Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, as you may need to read it again. 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. The medicine 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, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ketoprofen-SF and what is it used for
• 2. Important information before taking Ketoprofen-SF
• 3. How to take Ketoprofen-SF
• 4. Possible side effects
• 5. How to store Ketoprofen-SF
• 6. Contents of the packaging and other information

1. What is Ketoprofen-SF and what is it used for

Ketoprofen-SF is used for the symptomatic treatment of severe acute pain in cases of:

• acute joint inflammation,
• chronic joint inflammation, especially rheumatoid arthritis (chronic polyarthritis),
• ankylosing spondylitis (Bechterew's disease) and other rheumatoid inflammatory conditions of the spine,
• exacerbation of degenerative joint and spine disease (degenerative joint disease).

2. Important information before taking Ketoprofen-SF

When not to take Ketoprofen-SF:

• if the patient is hypersensitive to ketoprofen, benzyl alcohol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever experienced bronchospasm, asthma attack, nasal mucosal swelling (rhinitis) or skin reactions (hives) or other allergic reactions after taking ketoprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient has ever experienced skin hypersensitivity reactions to light (photoallergic or phototoxic reactions) when taking ketoprofen or fibrates (lipid-lowering drugs),
• if the patient has unexplained blood disorders (blood system disorders),
• if the patient has an active peptic ulcer (gastric and/or duodenal ulcer) or a history of gastrointestinal bleeding, ulceration or perforation,
• if the patient has bleeding disorders or coagulation disorders or is being treated with anticoagulant medications,
• if the patient has cerebral bleeding or other active bleeding,
• if the patient has severe heart failure,
• if the patient has severe liver or kidney dysfunction,
• in children and adolescents under 18 years of age,
• in the last three months of pregnancy.

Warnings and precautions

Before starting treatment with Ketoprofen-SF, discuss it with your doctor or pharmacist.
Please inform your pharmacist or doctor if you have an infection - see below, section entitled "Infections".
The "Warnings and precautions" section contains information on when the patient may take Ketoprofen-SF only under certain conditions (i.e. at longer intervals between doses or in smaller doses, with concurrent monitoring of body functions). However, even in these cases, special caution is required. For further information, please contact your doctor.
This section also applies to patients who have experienced the following situations in the past.
The solution for injection is indicated only in cases where rapid onset of action is required or when oral or rectal administration is not possible. In such cases, treatment should usually be administered as a single initial injection.
Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of side effects.
Gastrointestinal effects (stomach and intestines)
Concomitant use of Ketoprofen-SF with other NSAIDs (non-steroidal anti-inflammatory drugs), including so-called selective cyclooxygenase-2 inhibitors, should be avoided.
Elderly patients
The risk of side effects, especially gastrointestinal bleeding or perforation, which can be fatal, is higher in elderly patients. Therefore, elderly patients require special medical care.
Gastrointestinal bleeding, ulcers and perforations
Gastrointestinal bleeding, ulcers or perforations, which can be fatal, have been reported for all NSAIDs, at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.
Epidemiological data indicate that the use of ketoprofen may be associated with an increased, compared to other NSAIDs, toxic effect on the gastrointestinal tract, especially when using higher doses.
The risk of gastrointestinal bleeding, ulcers or perforations increases with increasing NSAID dose in patients with a history of ulcer disease, especially when complicated by bleeding or perforation (see section 2 "When not to take Ketoprofen-SF"), and in elderly patients. In elderly patients, therefore, treatment should be started with the lowest available dose.
It is recommended to consider the use of concomitant protective therapy (e.g. misoprostol or proton pump inhibitors) in these patients, as well as in patients requiring concurrent treatment with low-dose acetylsalicylic acid and other drugs that increase the risk of gastrointestinal side effects.
Patients, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Caution is recommended in patients taking concomitant medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulant medications (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat depression) or antiplatelet agents such as acetylsalicylic acid (see section 2 "Ketoprofen-SF and other medicines").
The relative risk of gastrointestinal bleeding is higher in patients with low body weight. In the event of gastrointestinal ulcers or bleeding, Ketoprofen-SF should be discontinued immediately.
NSAIDs should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these drugs may exacerbate the course of these diseases (see section 4 "Possible side effects").
Cardiovascular effects
Taking such medicines as Ketoprofen-SF may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is higher in cases of long-term use of high doses of the medicine. Do not take higher doses or longer treatment than recommended.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss your treatment with your doctor or pharmacist.
Caution is recommended in patients with hypertension and/or mild to moderate heart failure in their medical history, as fluid retention and edema have been reported in association with NSAID treatment.
Skin reactions
Very rare cases of serious and sometimes fatal skin reactions have been reported during NSAID treatment (including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis); see section 4 "Possible side effects". The risk of these reactions is probably higher at the start of treatment, as most of these reactions occurred within the first month of treatment. In case of the first symptoms of skin rash, changes in the mucous membranes and other symptoms of hypersensitivity, discontinue Ketoprofen-SF and consult a doctor.
Photoallergic reactions caused by NSAIDs are well-known side effects of these drugs and are most often attributed to UV radiation. Ketoprofen can cause an increased risk of photoallergic contact dermatitis. Sometimes symptoms may first appear after a latency period of hypersensitivity. The disappearance of skin symptoms after discontinuation of the medicine may take several months. In case of a photoallergic reaction in patients taking Ketoprofen-SF, discontinue the medicine and consult a doctor.
Infections
Ketoprofen-SF may mask the symptoms of infection, such as fever and pain. Therefore, Ketoprofen-SF may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, consult a doctor immediately.
Other information
Ketoprofen-SF should only be used after careful consideration of the benefit-risk ratio in cases of specific congenital blood production disorders (acquired porphyria).

In the following cases, close medical supervision is required:

• in patients with pre-existing kidney damage,
• in patients with liver function disorders,
• in patients immediately after major surgery,
• in patients with allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic rhinitis, chronic respiratory diseases with airway obstruction,
• in patients taking potent diuretics,
• in patients taking NSAIDs or other painkillers,
• in patients with blood coagulation disorders and taking anticoagulant medications.

Acute hypersensitivity reactions (e.g. anaphylactic shock) are very rare.
In case of the first symptoms of severe hypersensitivity reactions after taking Ketoprofen-SF, discontinue the medicine. Depending on the symptoms, any medical intervention must be performed by a specialist.
If vision disturbances occur, such as blurred vision, treatment should be discontinued.
Ketoprofen, the active substance of Ketoprofen-SF, may temporarily inhibit platelet aggregation. Patients with coagulation disorders should be closely monitored.
If anticoagulant medications (blood thinners) or blood sugar-lowering medications are taken during ketoprofen treatment, blood sugar and blood clotting should be closely monitored.
Diabetes or concurrent use of potassium-sparing medications may lead to hyperkalemia (see section 2 "Ketoprofen-SF and other medicines"). In such cases, regular monitoring of potassium levels in the blood is recommended.
Like other NSAIDs, ketoprofen may mask the symptoms of infectious diseases.
In patients with abnormal liver function test results or a history of liver disease, liver enzyme levels should be periodically monitored, especially during long-term treatment.
During longer-term use of Ketoprofen-SF, regular monitoring of liver enzyme activity, kidney function, and blood morphology is required.
In patients with asthma combined with chronic rhinitis, chronic sinusitis and/or nasal polyps, there is a higher risk of hypersensitivity to acetylsalicylic acid or NSAIDs than in the rest of the population. Taking this medicine may cause asthma attacks or bronchospasm, especially in individuals hypersensitive to acetylsalicylic acid or NSAIDs (see section 2 "When not to take Ketoprofen-SF").
Please inform your doctor or dentist about taking Ketoprofen-SF before surgery.
During long-term use of painkillers, headaches may occur, which should not be treated by increasing the dose of the medicine. If frequent headaches occur despite treatment with Ketoprofen-SF, consult a doctor.
Essentially, habitual use of painkillers, especially when taking several painkillers at the same time, may lead to permanent kidney damage, including analgesic nephropathy.

Ketoprofen-SF and other medicines

Please tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Ketoprofen-SF and digoxin (used to strengthen heart muscle) may lead to worsening of heart failure and increased digoxin levels in the blood. Monitoring of digoxin levels in the blood is recommended.
Concomitant use of Ketoprofen-SF with phenytoin (used to treat epilepsy) or lithium (used to treat mental disorders) may increase their levels in the blood, sometimes leading to toxic lithium levels in the blood due to decreased lithium excretion by the kidneys. Close monitoring of lithium levels in the blood and phenytoin levels in the blood is recommended.
Ketoprofen-SF may reduce the effect of diuretic medicines (diuretics), beta-blockers and medicines used to treat high blood pressure.
Ketoprofen-SF may reduce the effect of angiotensin-converting enzyme inhibitors (medicines used to treat heart failure and high blood pressure). Additionally, concomitant use of these medicines may increase the risk of kidney function disorders.
Concomitant use of Ketoprofen-SF and potassium-sparing diuretics (a group of diuretic medicines) may lead to increased potassium levels in the blood. Potassium levels in the blood should be monitored.
Concomitant use of Ketoprofen-SF with other NSAIDs (including selective cyclooxygenase-2 inhibitors) or corticosteroids increases the risk of ulcers or gastrointestinal bleeding.
Antiplatelet agents (inhibiting or reducing blood clotting) such as acetylsalicylic acid, tirofiban, eptifibatide, abciximab, iloprost and some antidepressants (selective serotonin reuptake inhibitors - SSRI) may increase the risk of gastrointestinal bleeding.
Administration of Ketoprofen-SF within 24 hours before or after administration of methotrexate (a medicine used to treat cancer and autoimmune diseases) may lead to increased methotrexate levels and increased side effects.
In case of concomitant use of Ketoprofen-SF with cyclosporin or tacrolimus, there is a risk of additive toxic effects on the kidneys, especially in elderly patients.
Medicines containing probenecid and sulfinpyrazone (medicines used to treat gout) may delay the excretion of ketoprofen. This may lead to excessive accumulation of Ketoprofen-SF in the body and cause an increased frequency and severity of side effects.
NSAIDs may increase the effect of anticoagulant medications (blood thinners) such as warfarin.
So far, clinical trials have not shown any interaction between ketoprofen and oral antidiabetic medicines (used to treat diabetes). However, as a precaution, it is recommended to monitor blood sugar levels during concurrent treatment.
Concomitant use of loop diuretics (used to treat high blood pressure) may increase the frequency of kidney function disorders.
Antacids may lead to reduced absorption of ketoprofen in the intestine.
Concomitant use of pentoxifylline (a medicine used to treat intermittent claudication) with Ketoprofen-SF may lead to an increased risk of bleeding.
Administration of antibiotics (medicines used to treat bacterial infections) such as quinolone derivatives may increase the risk of seizures.
Ketoprofen-SF increases the effect of thrombolytic medicines (medicines that prevent blood clots).
Certain medicinal products or therapeutic groups of medicines may lead to hyperkalemia, e.g. potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporin, tacrolimus and trimethoprim. The occurrence of hyperkalemia may depend on several concurrent risk factors. This risk is higher when the aforementioned medicines are used concomitantly.

Ketoprofen-SF and alcohol

Do not drink alcohol while taking Ketoprofen-SF.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Ketoprofen-SF if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the mother and child and cause prolongation of labor.
During the first 6 months of pregnancy, do not take Ketoprofen-SF 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, Ketoprofen-SF may cause kidney function disorders in the unborn baby if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
There is no data on the passage of ketoprofen into breast milk. Ketoprofen-SF is not recommended for use in breastfeeding women..
Ketoprofen-SF may make it more difficult to become pregnant. Please inform your doctor if you plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

Since taking higher doses of Ketoprofen-SF may cause side effects related to the central nervous system (e.g. fatigue, dizziness), reaction ability may be impaired in individual cases, and the ability to drive vehicles and operate machinery may be disturbed. The above applies especially when consuming alcohol.
Please inform patients about the possibility of drowsiness, dizziness or seizures and advise them not to drive vehicles or operate machinery if such symptoms occur.
Please inform patients about the possibility of vision disturbances. If the patient experiences such symptoms, they should not drive vehicles or operate machinery.

Ketoprofen-SF contains benzyl alcohol

This medicine contains 50 mg of benzyl alcohol in each ampoule, which corresponds to 25 mg/ml of the solution for injection.
Pregnant women, breastfeeding women and patients with liver or kidney disease should consult their doctor before taking this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause side effects (so-called metabolic acidosis).

3. How to take Ketoprofen-SF

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Ketoprofen-SF is particularly suitable for the treatment of acute pain. The dosage should be determined individually based on the observed symptoms.
Treatment with Ketoprofen-SF solution for injection should be in the form of a single injection. In severe cases, Ketoprofen-SF may be administered twice a day. In this case, the injection site should be changed each time.
Do not exceed the daily dose of 200 mg.
If further treatment is necessary, ketoprofen should be taken in tablets, capsules or suppositories.
Use in children and adolescents
Ketoprofen-SF should not be used in children and adolescents under 18 years of age (see also section 2 "When not to take Ketoprofen-SF").

Method of administration

Ketoprofen-SF solution for injection is usually administered by a doctor or nurse. Due to the route of administration of Ketoprofen-SF, in case of doubts, consult your doctor or pharmacist.
Ketoprofen-SF is injected slowly and deeply into the buttock. As with other non-steroidal anti-inflammatory drugs, the patient should be observed for at least one hour after administration of Ketoprofen-SF, due to the possibility of anaphylactic reactions (allergic reactions).
Medicines intended for injection should be inspected before use.
Only clear solutions without visible particles should be used.

Overdose of Ketoprofen-SF

In case of suspected overdose of Ketoprofen-SF, inform your doctor immediately. The doctor, considering the severity of the poisoning, will decide on the necessary preventive measures.
As symptoms of overdose, central nervous system disorders may occur, such as headache, dizziness, drowsiness, confusion and loss of consciousness, as well as abdominal pain, diarrhea, nausea and vomiting. Additionally, hypotension, respiratory depression (decreased respiratory rate), gastrointestinal bleeding and cyanosis (blue discoloration of the skin and mucous membranes) may occur. There is no specific antidote.

Missed dose of Ketoprofen-SF

Do not take a double dose to make up for a missed dose. Continue taking Ketoprofen-SF as recommended.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketoprofen-SF can cause side effects, although not everybody gets them.
Regarding the listed side effects of the medicine, please note that they are mainly dose-dependent and may vary from patient to patient.
The most common side effects are related to the gastrointestinal tract. Ulcers of the gastrointestinal tract (peptic ulcer), perforation or bleeding - sometimes fatal - may occur, especially in elderly patients (see section 2 "Warnings and precautions"). After administration of Ketoprofen-SF, nausea, vomiting, diarrhea, bloating (gas), constipation, indigestion, abdominal pain, black stools (melena), bloody vomiting, oral ulcers (small ulcers or painful swelling of the mucous membranes of the mouth and tongue), worsening of ulcerative colitis and Crohn's disease (see section 2 "Warnings and precautions") have been reported. Less frequently, gastric mucosal inflammation has been observed. The risk of gastrointestinal bleeding depends in particular on the dose and duration of treatment.
Edema, high blood pressure and heart failure have been reported in association with NSAID treatment.
Taking such medicines as Ketoprofen-SF may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
The following side effects have been reported in association with ketoprofen use in adults:
Very common (may affect more than 1 in 10 people)
Gastrointestinal disorders, such as nausea, vomiting, heartburn, stomach pain, bloating, constipation or diarrhea, as well as minor gastrointestinal bleeding, which may occasionally cause anemia.
Common (may affect up to 1 in 10 people)
Hypersensitivity reactions in the form of skin rash and itching, insomnia, excitement, irritability, headache, dizziness, fatigue, ulcers of the gastrointestinal tract with bleeding and perforation in some cases, fluid accumulation in the upper or lower limbs (peripheral edema), especially in patients with high blood pressure.
After intramuscular administration, side effects may occur at the injection site (pain and burning) or tissue damage (formation of a sterile abscess, destruction of fatty tissue).
Uncommon (may affect up to 1 in 100 people)
Drowsiness, vision disturbances (see section 2 "Warnings and precautions"), tinnitus (ringing in the ears), bloody vomiting, black stools (melena), oral ulcers, gastric inflammation.
If you experience moderate to severe abdominal pain, bloody vomiting, blood in the stool and/or black stools, discontinue Ketoprofen-SF and consult your doctor immediately.
Liver function disorders, hypersensitivity to light, skin rash, itching, edema, fluid retention in the body, excessive protein loss in the urine (nephrotic syndrome), inflammatory changes in kidney tissue (interstitial nephritis).
Decreased urine production, fluid accumulation in the body (edema) and general poor health may be symptoms of kidney function disorders, and even kidney failure.
Rare (may affect up to 1 in 1,000 people)
Hemolytic anemia, leukopenia, asthma, liver inflammation, increased bilirubin levels in the blood due to liver disorders, hyperkalemia (see section 2 "Ketoprofen-SF and other medicines"), colon inflammation.
Very rare (may affect up to 1 in 10,000 people)
There have been reports of worsening of infectious conditions (e.g. development of necrotizing fasciitis) associated with NSAID administration, including Ketoprofen-SF. Therefore, if symptoms of infection occur or worsen during treatment with Ketoprofen-SF (e.g. redness, swelling, overheating, pain, fever), consult your doctor immediately.
Hemolytic anemia (caused by accelerated breakdown of red blood cells), blood system disorders (aplastic anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms may be: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds and bleeding under the skin. In such cases, discontinue Ketoprofen-SF and consult your doctor immediately. Do not treat these symptoms with painkillers or antipyretics.
During long-term treatment, regular blood morphology tests are recommended.
Acute hypersensitivity reactions. Their symptoms include: facial swelling, tongue swelling, internal laryngeal edema with airway obstruction, shortness of breath, palpitations, decreased blood pressure, and even life-threatening anaphylactic shock.
Consult your doctor immediately if you experience the onset of these symptoms, which may occur after the first administration of Ketoprofen-SF.
Heart failure, myocardial infarction, high blood pressure, pancreatitis, liver damage (especially during long-term treatment), hair loss (alopecia), severe skin reactions, e.g. skin rash with redness and blisters (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis), kidney damage (renal papillary necrosis), especially during long-term treatment, as well as increased uric acid levels, acute tubular necrosis.
Regular monitoring of kidney function is recommended.
After several months of treatment without complications, the skin may become sensitive to light, showing signs of redness, itching, blistering and nodules on skin areas exposed to sunlight or artificial UV light (e.g. solarium).
Frequency not known (frequency cannot be estimated from the available data)
Mood changes, seizures, bronchospasm (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs), nasal mucosal inflammation, hives, worsening of chronic urticaria, angioedema, confusion, aseptic meningitis.
Benzyl alcohol may cause allergic reactions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Ketoprofen-SF

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and carton after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light.
Use immediately after opening.
The medicine is for single use only.
Do not use Ketoprofen-SF if you notice signs of deterioration.
Medicines should not be disposed of via wastewater. 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 Ketoprofen-SF contains

The active substance of the medicine is ketoprofen.
1 ml of the solution for injection contains 50 mg of ketoprofen.
One 2 ml ampoule of the solution for injection contains 100 mg of ketoprofen (Ketoprofen).
Excipients: benzyl alcohol, arginine, citric acid monohydrate, water for injections.

What Ketoprofen-SF looks like and contents of the pack

Ketoprofen-SF 50 mg/ml is a clear, colorless to light yellow solution for injection.
One pack contains 1 ampoule made of orange glass, containing 2 ml of the solution for injection.
Ketoprofen-SF is available in packs of 1, 5, 10, 20, 30, 50 ampoules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Gabrilen N i.m.
Poland: Ketoprofen-SF
Date of last revision of the leaflet:10.2022