Ketoprofen-sf

Leaflet attached to the packaging: patient information

Ketoprofen-SF, 50 mg, hard capsules

Ketoprofen-SF, 100 mg, hard capsules

Ketoprofen

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 pain and inflammation in cases of:

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

2. Important information before taking Ketoprofen-SF

When not to take Ketoprofen-SF:

• if the patient is hypersensitive to ketoprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had bronchial asthma, asthma attacks, nasal polyps, or other allergic reactions after taking ketoprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs (NSAIDs). Such patients have reported severe, sometimes life-threatening anaphylactic reactions (see section 4),
• if the patient has ever had 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 active peptic ulcers (gastric and/or duodenal ulcers) or a history of bleeding, ulcers, or perforation of the gastrointestinal tract,
• if the patient has bleeding disorders,
• 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 disorders,
• in the last three months of pregnancy.

Warnings and precautions

Before starting treatment with Ketoprofen-SF, discuss it with your doctor or pharmacist.
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 organ function). However, even in such cases, special caution is required. For further information, contact your doctor.
This section also applies to patients who have had the following situations in the past.
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 (including 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 ketoprofen use may be associated with an increased, compared to other NSAIDs, toxic effect on the gastrointestinal tract, especially with higher doses.
The risk of gastrointestinal bleeding, ulcers, or perforations increases with increasing NSAID dose in patients with a history of ulcers, especially if 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 initiated with the lowest available dose.
Consideration should be given to using concomitant protective therapy (e.g., misoprostol or proton pump inhibitors) in these patients, as well as in patients requiring concomitant use of low-dose acetylsalicylic acid or 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 advised in patients taking concomitant medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat depression), or antiplatelet agents such as acetylsalicylic acid (see "Ketoprofen-SF and other medicines").
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 disorders (ulcerative colitis, Crohn's disease), as these drugs may exacerbate the course of these diseases (see section 4 "Possible side effects").
Effects on the cardiovascular system and blood vessels
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 with prolonged use of high doses of the medicine. Do not take higher doses or longer treatment than recommended.
In case of heart problems, previous stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment with your doctor or pharmacist.
Caution is advised in patients with hypertension and/or mild to moderate heart failure, as fluid retention and edema have been reported in association with NSAID treatment.
Skin reactions
Very rare cases of serious, sometimes fatal skin reactions have been reported with NSAIDs (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 cases occurred within the first month of treatment. In case of first signs of skin rash, mucosal lesions, or other signs 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 commonly attributed to UV radiation. Ketoprofen may increase the risk of photoallergic contact dermatitis. Sometimes, symptoms may first appear after a latency period. The disappearance of skin symptoms after discontinuation of the medicine may take several months. In case of 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 application of appropriate infection treatment and consequently lead to 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).
At the start of treatment in patients with heart failure, liver cirrhosis, and nephrotic syndrome, in patients taking diuretics, in patients with chronic kidney failure, especially in elderly patients, renal function should be closely monitored. In such patients, ketoprofen administration may cause a decrease in renal blood flow due to inhibition of prostaglandin synthesis and lead to renal function disorders.

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 bronchial 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 first signs 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, discontinue treatment.
Ketoprofen, the active substance of Ketoprofen-SF, may temporarily inhibit platelet aggregation. Patients with blood coagulation disorders should be closely monitored.
If anticoagulant medications (blood thinners) or blood sugar-lowering medications are taken during ketoprofen treatment, closely monitor blood sugar and blood coagulation levels.
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, periodically check the level of aminotransferases, especially during long-term treatment.
Rare cases of jaundice and liver inflammation associated with ketoprofen have been reported.
During prolonged use of Ketoprofen-SF, regular examination of liver enzyme activity, kidney function, and blood morphology is required.
Inform your doctor or dentist about taking Ketoprofen-SF before surgery.
In patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps, there is a higher risk of hypersensitivity to acetylsalicylic acid and/or NSAIDs. Taking this medicine may cause asthma attacks or bronchial spasms, especially in individuals hypersensitive to acetylsalicylic acid or NSAIDs (see section 2 "When not to take Ketoprofen-SF").
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 kidney failure (analgesic nephropathy).

Ketoprofen-SF and other medicines

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 increase the risk of heart failure and lead to increased digoxin levels in the blood. Monitor digoxin levels in the blood.
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 renal lithium excretion. Closely monitor lithium levels in the blood and recommend monitoring phenytoin levels in the blood.
Ketoprofen-SF may reduce the effect of diuretics (water pills), 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. Monitor potassium levels in the blood.
Concomitant use of Ketoprofen-SF with other NSAIDs (including selective cyclooxygenase-2 inhibitors) or corticosteroids increases the risk of gastrointestinal ulcers or bleeding.
Antiplatelet agents (inhibiting or reducing blood clotting) such as acetylsalicylic acid and certain antidepressants (selective serotonin reuptake inhibitors - SSRIs) 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 increase its side effects.
In case of concomitant use of Ketoprofen-SF with cyclosporine 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 increase the frequency and severity of side effects.
NSAIDs may increase the effect of anticoagulant medications (blood thinners) such as warfarin.
To date, clinical studies have not shown interactions between ketoprofen and oral antidiabetic medicines (used to treat diabetes). Nevertheless, precautionary monitoring of blood sugar levels is recommended during concomitant 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 increase the risk of bleeding.
Administration of antibiotics (medicines used to combat bacterial infections), such as quinolone derivatives, may increase the risk of seizures.
Ketoprofen-SF increases the effect of thrombolytic agents (medicines that prevent blood clot formation).

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 also increase the risk of bleeding in the mother and child and prolong 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 problems in the unborn baby if taken for more than a few days. This may lead to reduced amniotic fluid levels (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 conceive. Inform your doctor if you plan to conceive or are having trouble conceiving.

Driving and using machines

Since 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. This applies especially when consuming alcohol.
Inform patients about the possibility of drowsiness, dizziness, or seizures and advise them not to drive vehicles or operate machinery if such symptoms occur.

Ketoprofen-SF contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

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.
Adults
Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended daily dose for adults depends on the severity of the disease.
Dose of 50 mg:
Unless otherwise prescribed, the following dosing is recommended:
The recommended daily dose is 1-4 capsules of Ketoprofen-SF (corresponding to 50-200 mg of ketoprofen) administered in 1-2 single doses.
Dose of 100 mg:
Unless otherwise prescribed, the following dosing is recommended:
The recommended daily dose is 1-2 capsules (corresponding to 100-200 mg of ketoprofen) administered in 1-2 single doses.

Use in children and adolescents

Ketoprofen-SF is not recommended for use in children and adolescents due to the lack of appropriate safety and efficacy data in this age group.

How to take the capsules

Always take Ketoprofen-SF exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take Ketoprofen-SF with a glass of water, during or after meals.

Duration of treatment

Your doctor will decide on the duration of treatment.

Overdose of Ketoprofen-SF

As symptoms of overdose, central nervous system disorders may occur, such as headache, dizziness, lethargy, drowsiness, confusion, and loss of consciousness, as well as abdominal pain and nausea and vomiting. Additionally, hypotension, respiratory depression, and cyanosis may occur.
There is no specific antidote.
Inform your doctor in case of suspected overdose of Ketoprofen-SF. The doctor, considering the severity of the poisoning, will decide on the necessary preventive measures.

Missed dose of Ketoprofen-SF

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Ketoprofen-SF

Inform your doctor.
In case of any further doubts about the use of this medicine, consult 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, it should be remembered 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 ulcers), perforation, or bleeding - sometimes fatal - may occur, especially in elderly patients (see section 2 "Warnings and precautions"). After taking Ketoprofen-SF, nausea, vomiting, diarrhea, bloating (gas), constipation, indigestion, abdominal pain, black stools (melena), and bloody vomiting have been reported. Less frequently, stomach inflammation has been observed. If moderate to severe abdominal pain, vomiting blood, blood in the stool, and/or black stools occur, discontinue Ketoprofen-SF and consult a doctor immediately.
Fluid retention, 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 with ketoprofen 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, indigestion, abdominal pain, ulcers of the gastrointestinal tract with bleeding and perforation in some cases, fluid retention in the upper or lower limbs (peripheral edema), especially in patients with high blood pressure.
Uncommon (may affect up to 1 in 100 people)
Drowsiness, vision disturbances (see section 2 "Warnings and precautions"), tinnitus (ringing in the ears), vomiting blood, black stools, oral mucosal inflammation, stomach inflammation.
If abdominal pain, vomiting blood, blood in the stool, and/or black stools occur, discontinue Ketoprofen-SF and consult a doctor immediately.
Liver function disorders, hypersensitivity to light, rash, itching, fluid retention, kidney function disorders, changes in kidney tissue (interstitial nephritis).
Reduced urine production, fluid retention, and general poor health may be symptoms of kidney function disorders or even kidney failure.
Rare (may affect up to 1 in 1,000 people)
Hemolytic anemia, paresthesia, asthma, liver inflammation, increased aminotransferase levels, increased bilirubin levels in the blood due to liver disorders, weight gain.
Very rare (may affect up to 1 in 10,000 people)
Worsening of inflammatory conditions associated with infection (e.g., development of necrotizing fasciitis) has been reported with NSAIDs, including Ketoprofen-SF. Therefore, consult a doctor immediately if signs of infection (e.g., redness, swelling, overheating, pain, fever) occur or worsen during treatment with Ketoprofen-SF.
Hemolytic anemia (caused by accelerated breakdown of red blood cells), blood system disorders (aplastic anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first signs may be: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and bleeding into the skin. In such cases, discontinue Ketoprofen-SF and consult a doctor immediately. Do not treat these symptoms with painkillers or antipyretics.
During long-term treatment, regularly check blood morphology.
Acute hypersensitivity reactions. Their symptoms include: facial swelling, tongue swelling, internal laryngeal edema with bronchial constriction, shortness of breath, palpitations, decreased blood pressure, and even life-threatening anaphylactic shock.
Consult a doctor immediately if the first signs of these symptoms occur, which may appear after the first dose of Ketoprofen-SF.
Heart failure, myocardial infarction, high blood pressure, pancreatitis, intestinal narrowing, kidney damage (especially during long-term treatment), hair loss (alopecia), severe skin reactions (e.g., skin rash with redness and blisters, such as Stevens-Johnson syndrome and toxic epidermal necrolysis), kidney damage (renal necrosis), especially during long-term treatment, as well as increased uric acid levels.
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)
Bone marrow failure, mood changes, seizures, taste disorders, vasodilation, bronchial spasm (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs), nasal mucosal inflammation, worsening of ulcerative colitis and Crohn's disease, urticaria, angioedema, abnormal kidney function test results, confusion, aseptic meningitis.
Regularly check kidney function.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, tell 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, 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 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 blister pack and carton after EXP. The expiry date refers to the last day of the month.
Ketoprofen-SF 50 mg:
Do not store above 25°C.
Ketoprofen-SF 100 mg:
Do not store above 30°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 Ketoprofen-SF contains

Ketoprofen-SF 50 mg:
The active substance is ketoprofen.
Each capsule contains 50 mg of ketoprofen.
Other ingredients are:
Capsule contents:
Lactose monohydrate, magnesium stearate, colloidal anhydrous silica.
Capsule shell:
Gelatin, titanium dioxide (E171), iron oxide, black (E172), erythrosine (E127), indigo carmine (E132).
Ketoprofen-SF 100 mg:
The active substance is ketoprofen.
Each capsule contains 100 mg of ketoprofen.
Other ingredients are:
Capsule contents:
Lactose monohydrate, magnesium stearate, colloidal anhydrous silica.
Capsule shell:
Gelatin, titanium dioxide (E171), iron oxide, black (E172), erythrosine (E127), indigo carmine (E132), iron oxide, yellow (E172).

What Ketoprofen-SF looks like and contents of the pack

Ketoprofen-SF 50 mg:
Ketoprofen-SF is a hard gelatin capsule with a non-transparent blue-violet cap and a white body filled with a grayish-white powder.
Ketoprofen-SF is available in PVC/PVDC/Aluminum blisters in packs of 20, 24, 50, or 100 capsules.
Ketoprofen-SF 100 mg:
Ketoprofen-SF is a hard gelatin capsule with a non-transparent blue-violet cap and a yellow body filled with a grayish-white powder.
Ketoprofen-SF is available in PVC/PVDC/Aluminum blisters in packs of 20, 30, 50, or 100 capsules.
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:

Ketoprofen-SF 50 mg:
Germany: Gabrilen N 50 mg
Poland: Ketoprofen-SF
Ketoprofen-SF 100 mg:
Germany: Gabrilen N 100 mg
Poland: Ketoprofen-SF
Date of last revision of the leaflet:10.2022