KETOPROFEN-SF 50 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Ketoprofen-SF, 50 mg, Hard Capsules
3. Ketoprofen-SF, 100 mg, Hard Capsules
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Ketoprofen-SF and what is it used for
5. Important information before taking Ketoprofen-SF
   1. When not to take Ketoprofen-SF:
   2. Warnings and precautions
   3. Ketoprofen-SF and other medicines
   4. Ketoprofen-SF and alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Ketoprofen-SF contains lactose
6. How to take Ketoprofen-SF
   1. Use in children and adolescents
   2. How to take the capsules
   3. Duration of treatment
   4. Overdose of Ketoprofen-SF
   5. Missed dose of Ketoprofen-SF
   6. Stopping treatment with Ketoprofen-SF
7. Possible side effects
   1. Reporting side effects
8. How to store Ketoprofen-SF
9. Contents of the pack and other information
   1. What Ketoprofen-SF contains
   2. What Ketoprofen-SF looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Ketoprofen-SF, 50 mg, Hard Capsules

Ketoprofen-SF, 100 mg, Hard Capsules

Ketoprofen

Read the package 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 them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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 pack 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 inflammatory conditions of the spine,
• exacerbation of degenerative joint disease and spine (degenerative joint disease).

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 attack, nasal mucosa swelling (rhinitis), skin reactions (hives) or other allergic reactions after taking ketoprofen, acetylsalicylic acid or other non-steroidal 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 an active peptic ulcer (gastric and/or duodenal ulcer) or a history of gastrointestinal bleeding, ulceration or perforation,
• 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, the patient should discuss it with their doctor or pharmacist.
Patients should inform their pharmacist or doctor if they 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, patients should contact their 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)
Patients should avoid taking Ketoprofen-SF with other NSAIDs (non-steroidal anti-inflammatory drugs), including so-called selective cyclooxygenase-2 inhibitors.
Elderly patients
When taking NSAIDs, 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 gastrointestinal events.
Epidemiological data indicate that ketoprofen may be associated with an increased, compared to other NSAIDs, toxic effect on the gastrointestinal tract, especially when taking higher doses.
The risk of gastrointestinal bleeding, ulcers, or perforations increases with the dose of NSAIDs 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, treatment should therefore be started with the lowest available dose.
It is recommended to consider the use of concomitant protective therapy (e.g., with 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.
Patient monitoring
Patient monitoring is required in the following cases:

• in patients with previously 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

Anaphylactic reactions (e.g., anaphylactic shock) are very rare.
In case of the first symptoms of severe hypersensitivity reactions after taking Ketoprofen-SF, the patient should stop taking 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 blood coagulation disorders should be closely monitored.
If the patient is taking anticoagulant medications (blood thinners) or diabetes medications, they should be closely monitored for blood sugar and 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, liver enzyme activity should be periodically monitored, especially during long-term treatment.
There have been rare reports of jaundice and liver inflammation associated with ketoprofen use.
During prolonged use of Ketoprofen-SF, regular monitoring of liver enzyme activity, kidney function, and blood morphology is required.
Patient should inform their 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 patients allergic 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, the patient should consult their doctor.
Essentially, habitual use of painkillers, especially when taking several painkillers at the same time, can lead to permanent kidney damage, including kidney failure (analgesic nephropathy).

Ketoprofen-SF and other medicines

Patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
Concomitant use of Ketoprofen-SF and digoxin (used to strengthen heart muscle) may increase the risk of heart failure and increase 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 levels of lithium 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 diuretics (water pills), beta-blockers, and medicines used to treat high blood pressure.
Ketoprofen-SF may reduce the effect of angiotensin-converting enzyme inhibitors (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 diuretics) 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 (preventing 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 (used to treat cancer and autoimmune diseases) may lead to increased methotrexate levels and increased side effects.
When Ketoprofen-SF is used concomitantly with cyclosporin or tacrolimus, there is a risk of additive toxic effects on the kidneys, especially in elderly patients.
Medicines containing probenecid and sulfinpyrazone (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 drugs (used to treat diabetes). However, as a precaution, blood sugar levels should be monitored during concomitant treatment.
Concomitant use of loop diuretics (used to treat high blood pressure) may increase the frequency of kidney function disorders.
Antacids may reduce the absorption of ketoprofen in the intestine.
Concomitant use of pentoxifylline (used to treat intermittent claudication) with Ketoprofen-SF may increase the risk of bleeding.
Administration of antibiotics (used to treat 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

Alcohol should not be consumed during treatment with Ketoprofen-SF.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Ketoprofen-SF should not be taken if the patient is in the last three 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 or delay of labor.
During the first six months of pregnancy, Ketoprofen-SF should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used 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 a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
There is no data on the passage of ketoprofen into breast milk. Ketoprofen-SF should not be taken by breastfeeding women.
Ketoprofen-SF may make it more difficult to become pregnant. Women who are trying to conceive or who have difficulty becoming pregnant should inform their doctor.

Driving and using machines

As Ketoprofen-SF may cause side effects related to the central nervous system (e.g., fatigue, dizziness), reaction time may be slowed down, and the ability to drive vehicles or operate machinery may be impaired. This is especially true when consuming alcohol.
Patient should be informed about the possibility of drowsiness, dizziness, or seizures and advised not to drive vehicles or operate machinery if such symptoms occur.

Ketoprofen-SF contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Ketoprofen-SF

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Adults
The patient should take 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, the patient should consult their 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 regimen is recommended:
The recommended daily dose is 1-4 capsules of Ketoprofen-SF (corresponding to 50-200 mg of ketoprofen) taken in 1-2 single doses.
Dose of 100 mg:
Unless otherwise prescribed, the following dosing regimen is recommended:
The recommended daily dose is 1-2 capsules (corresponding to 100-200 mg of ketoprofen) taken 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

The patient should always take Ketoprofen-SF as directed by their doctor. In case of doubts, they should consult their doctor or pharmacist.
Ketoprofen-SF should be swallowed whole (not chewed), with a large amount of liquid, during or after meals.

Duration of treatment

The 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 (blue discoloration of the skin and mucous membranes) may occur.
In case of suspected overdose, the patient should inform their doctor. The doctor, considering the severity of the poisoning, will decide on the necessary measures.
There is no specific antidote.

Missed dose of Ketoprofen-SF

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Ketoprofen-SF

The patient should inform their doctor.
In case of any further doubts about taking this medicine, the patient should consult their 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. 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 medicines like 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, indigestion, abdominal pain, gastrointestinal ulcers with bleeding and perforation in some cases, fluid retention in the 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 (hematemesis), black stools (melena), oral mucosa inflammation, stomach inflammation.
If moderate to severe abdominal pain, vomiting blood, blood in the stool, and/or black stools occur, the patient should stop taking Ketoprofen-SF and consult their doctor immediately.
Liver function disorders, hypersensitivity to light, rash, itching, fluid retention, excessive protein loss in the urine (nephrotic syndrome), kidney tissue inflammation (interstitial nephritis), kidney function disorders.
A decrease in urine production, fluid retention, and general poor health may be symptoms of kidney function disorders, even kidney failure.
Rare (may affect up to 1 in 1,000 people)
Hemorrhagic anemia, paresthesia, asthma, liver inflammation, increased bilirubin levels in the blood due to liver disorders, increased body weight.
Very rare (may affect up to 1 in 10,000 people)
There have been reports of worsening infectious conditions (e.g., development of necrotizing fasciitis) associated with the use of NSAIDs, including Ketoprofen-SF. Therefore, the patient should immediately consult their doctor if they experience any signs of infection (e.g., redness, swelling, overheating, pain, fever) while taking 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, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and bleeding into the skin. In such cases, the patient should stop taking Ketoprofen-SF and consult their doctor immediately. The patient should not treat these symptoms with painkillers or antipyretics.
During long-term treatment, the patient should have regular blood morphology tests.
Anaphylactic reactions. The 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.
The patient should immediately consult their doctor if they experience any of these symptoms, which may occur after the first dose of Ketoprofen-SF.
Heart failure, myocardial infarction, high blood pressure, pancreatitis, intestinal stricture, liver 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 - Lyell's syndrome), kidney damage (renal papillary necrosis), especially during long-term treatment, as well as increased uric acid levels.
After several months of taking the medicine without complications, the skin may become sensitive to light, showing signs of redness, itching, blistering, and nodules on areas of skin 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 disturbances, vasodilation, bronchial spasm (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs), nasal mucosa inflammation, worsening of ulcerative colitis and Crohn's disease, hives, angioedema, abnormal kidney function test results, confusion, aseptic meningitis.
The patient should have regular kidney function tests.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their 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, more information can be collected on the safety of the medicine.

5. How to store Ketoprofen-SF

The medicine should be stored out of 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. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack 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 blisters of PVC/PVDC/Aluminum 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 blisters of PVC/PVDC/Aluminum 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