Bi-profenid

Leaflet attached to the packaging: information for the user

Bi-Profenid, 150 mg, tablets with modified release

Ketoprofen

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• 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 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 Bi-Profenid and what is it used for
• 2. Important information before taking Bi-Profenid
• 3. How to take Bi-Profenid
• 4. Possible side effects
• 5. How to store Bi-Profenid
• 6. Contents of the packaging and other information

1. What is Bi-Profenid and what is it used for

Bi-Profenid tablets with modified release 150 mg contain the active substance ketoprofen. Ketoprofen is a medicine with anti-inflammatory, analgesic, and antipyretic effects (it belongs to the group of nonsteroidal anti-inflammatory drugs - NSAIDs). The mechanism of action of ketoprofen is probably based on the inhibition of prostaglandin synthesis. Bi-Profenid is a medicine with modified release. The tablets consist of two layers: one with rapid release and one with slow release of the active substance. Bi-Profenid is used for:

• symptomatic treatment of:
• rheumatic diseases, including rheumatoid arthritis,
• arthritis of other origin,
• extra-articular inflammatory conditions, such as tendon sheath inflammation or shoulder pain syndrome,
• degenerative joint disease with significant pain and significantly impaired patient mobility.

2.

Important information before taking Bi-Profenid

When not to take Bi-Profenid:

• if the patient has a known allergy to ketoprofen or any of the other ingredients of this medicine (listed in section 6), aspirin asthma, or other hypersensitivity reactions to nonsteroidal anti-inflammatory drugs (NSAIDs). In these patients, who have had a history of hypersensitivity reactions such as: bronchospasm, asthma attacks, rhinitis, urticaria, or other allergic reactions, severe, rarely life-threatening anaphylactic reactions have been observed,
• if the patient has active gastric or duodenal ulcer, or has had gastrointestinal bleeding, ulcers, or perforations,
• if the patient has severe liver or kidney failure,
• if the patient has severe heart failure,
• if the patient has a bleeding disorder,
• if the patient has a diagnosed gluten intolerance (the tablets contain wheat starch),
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting treatment with Bi-Profenid, the patient should inform their doctor if they have:

• asthma, chronic rhinitis, chronic sinusitis, nasal polyps; Taking ketoprofen may cause an asthma attack, bronchospasm, especially in people with hypersensitivity to acetylsalicylic acid or nonsteroidal anti-inflammatory drugs;
• ulcer or bleeding while taking oral corticosteroids, anticoagulant medications (such as warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents (such as aspirin) and nicorandil. Taking Bi-Profenid may increase the risk of ulceration or gastrointestinal bleeding in these patients;
• a history of gastrointestinal disease (previous gastric or duodenal ulcer, ulcerative colitis, Crohn's disease), due to the possibility of exacerbating the disease;
• hypersensitivity to sunlight or UV radiation;
• heart disease (heart failure), liver disease (liver dysfunction), or kidney disease (chronic kidney dysfunction), as well as water metabolism disorders (e.g., dehydration due to diuretic use or recent surgery). Taking Bi-Profenid may reduce renal blood flow, leading to renal dysfunction, especially in elderly patients. At the start of treatment, these patients should be closely monitored for renal function. In patients with liver dysfunction, the doctor may consider reducing the dose of the medicine. Very rare cases of jaundice and liver inflammation have been reported during ketoprofen treatment. The doctor may recommend performing appropriate tests;
• infection - see below, section entitled "Infections";
• erythema multiforme in the medical history (circular or oval redness and swelling of the skin, which usually recur in the same place (places), blisters, urticaria, and itching of the skin), if it has ever occurred while taking ketoprofen.

Taking ketoprofen, especially in high doses, may be associated with a higher risk of serious gastrointestinal toxicity compared to other NSAIDs. In patients with diabetes, kidney failure, and (or) taking medications that increase potassium levels in the blood, taking ketoprofen may lead to increased potassium levels in the blood. Infections Bi-Profenid may mask the symptoms of infection, such as fever and pain. Therefore, Bi-Profenid may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should consult their doctor immediately. In women taking ketoprofen for a long time, secondary infertility without ovulation may occur. Ketoprofen, like other NSAIDs, may make it more difficult to become pregnant. If the patient is planning to become pregnant or is having trouble becoming pregnant, they should inform their doctor. Taking nonsteroidal anti-inflammatory drugs other than acetylsalicylic acid, such as Bi-Profenid, may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not take higher doses or use the medicine for longer than recommended. If the patient has heart disease (heart failure, coronary artery disease), peripheral artery disease, and (or) cerebrovascular disease, has had a stroke, or suspects they are at increased risk of cardiovascular disease (e.g., high blood pressure, diabetes, high cholesterol, smoking), they should discuss their treatment with their doctor or pharmacist. Patients with heart disease who have reported edema and fluid retention should be properly monitored and their treatment adjusted individually. The patient should inform their doctor if they have recently undergone coronary artery bypass grafting. Taking such medicines as Bi-Profenid may be associated with a small increased risk of atrial fibrillation. If vision disturbances occur, the patient should stop taking the medicine and consult their doctor. During treatment with the medicine, the patient should inform their doctor if they experience:

• Symptoms of hypersensitivity to the medicine, especially: shortness of breath, urticaria, skin rash, mucosal damage, sudden itching of the face and neck. In this case, the patient should contact their doctor immediately, who will decide whether to discontinue the medicine.
• Symptoms of gastrointestinal bleeding, such as: vomiting blood, blood in stool, black stool. Gastrointestinal ulceration or perforation may occur. In this case, the patient should contact their doctor immediately, who will decide whether to discontinue the medicine.
• Severe skin reactions (in the form of exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis). In this case, the patient should contact their doctor immediately, who will decide whether to discontinue the medicine.The highest risk of these disorders occurs at the beginning of treatment. In most cases, these skin reactions occur during the first month of treatment.

Patient with severe gastrointestinal diseases in their medical history, especially the elderly, should inform their doctor about all unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial treatment period. WarningBi-Profenid contains a nonsteroidal anti-inflammatory drug: ketoprofen. It is not recommended to take other medicines that contain nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid or selective cyclooxygenase 2 inhibitors - COX-2. Always read the patient information leaflet for any other medicine taken at the same time to ensure it does not contain a nonsteroidal anti-inflammatory drug. Using Bi-Profenid in children and adolescentsBi-Profenid should not be used in children and adolescents under 15 years of age.

Bi-Profenid and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, even those available without a prescription. It is not recommended to take ketoprofen with the following medicines:

• other nonsteroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors - COX-2) and salicylates in high doses. Concurrent use leads to increased adverse effects (especially the risk of gastrointestinal ulceration and bleeding).
• anticoagulant medications, such as: heparin, vitamin K antagonists (e.g., warfarin), antiplatelet agents (e.g., clopidogrel, ticlopidine), thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitors (e.g., apixaban, rivaroxaban, edoxaban)

Ketoprofen inhibits platelet aggregation and irritates the gastric mucosa, leading to increased risk of bleeding, especially from the gastrointestinal tract. It is not recommended to take these medicines at the same time as ketoprofen. If concurrent use is necessary, the patient should be closely monitored for clinical symptoms and periodic laboratory tests should be performed. Nonsteroidal anti-inflammatory drugs should not be used for more than a few days.

• lithium Ketoprofen inhibits lithium excretion, increasing its blood levels (even to toxic values). It is not recommended to take ketoprofen with lithium salts. If such treatment is necessary, the patient should strictly follow their doctor's instructions and regularly undergo laboratory tests ordered by their doctor during and after nonsteroidal anti-inflammatory drug treatment.
• methotrexate (in doses greater than 15 mg per week) Concurrent use of methotrexate in high doses (greater than 15 mg per week) increases the likelihood of hematologic toxicity.

Caution should be exercised when taking the following medicines with Bi-Profenid:

• medicines that increase potassium levels in the blood. In patients taking potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, other nonsteroidal anti-inflammatory drugs, low molecular weight or unfractionated heparin, cyclosporine, tacrolimus, and trimethoprim, increased potassium levels in the blood may occur.
• diuretics, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers. Patients who will take these medicines at the same time as ketoprofen should be hydrated before starting treatment. After starting treatment, they should follow their doctor's instructions for monitoring kidney function.
• methotrexate (in doses less than 15 mg per week) During the first few weeks of concurrent use of ketoprofen and methotrexate in doses less than 15 mg per week, regular full blood counts should be performed.
• corticosteroids Increased risk of gastrointestinal ulceration and bleeding.
• pentoxifylline Concurrent use with ketoprofen increases the risk of bleeding. The patient should follow their doctor's instructions when taking these medicines at the same time.
• tenofovir Concurrent use of tenofovir disoproxil fumarate with ketoprofen increases the risk of kidney failure.
• nicorandil In patients taking nicorandil and nonsteroidal anti-inflammatory drugs at the same time, there is an increased risk of severe complications, such as ulceration, perforation, and gastrointestinal bleeding (see section 4.4).
• digitalis glycosides Nonsteroidal anti-inflammatory drugs may exacerbate heart failure and increase digitalis glycoside levels in the blood. Caution is advised, especially in patients with kidney dysfunction, as nonsteroidal anti-inflammatory drugs may impair kidney function and reduce the renal clearance of digitalis glycosides.

Special attention should be paid to the use of ketoprofen with:

• antihypertensive medicines (beta-adrenergic receptor blockers, angiotensin-converting enzyme inhibitors, diuretics) - risk of reduced efficacy of these medicines (inhibition of vasodilating prostaglandins by nonsteroidal anti-inflammatory drugs);
• thrombolytic agents - increased risk of bleeding;
• probenecid - reduced excretion of ketoprofen by the kidneys;
• selective serotonin reuptake inhibitors (SSRIs) - increased risk of gastrointestinal bleeding.

Ketoprofen may reduce the effectiveness of intrauterine contraceptives.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Taking Bi-Profenid in the last 3 months of pregnancy is contraindicated, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect the patient's and child's tendency to bleed and cause delayed or prolonged labor. Bi-Profenid should not be used during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or while trying to conceive, the lowest dose should be used for the shortest possible time. Bi-Profenid taken for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child, leading to low amniotic fluid levels or narrowing of the ductus arteriosus in the child's heart. If the patient requires treatment for a longer period, their doctor may recommend additional monitoring.

Breastfeeding

If the patient is breastfeeding, they should consult their doctor before taking this medicine. Ketoprofen is not recommended for use in breastfeeding women. There is no data on the penetration of ketoprofen into breast milk.

Fertility

See "Warnings and precautions" section.

Driving and using machines

If the patient experiences dizziness, drowsiness, or seizures while taking ketoprofen, they should refrain from driving and operating machines until their doctor determines that there are no obstacles to performing these activities.

Important information about some ingredients of Bi-Profenid

Bi-Profenid contains gluten

This medicine contains very small amounts of gluten (from wheat starch) and is considered "gluten-free". It is very unlikely to cause any problems in patients with celiac disease. One tablet contains no more than 3.8 micrograms of gluten. Patients with a wheat allergy (other than celiac disease) should not take this medicine.

Bi-Profenid contains lactose

The medicine also contains lactose, so if the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Bi-Profenid contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Bi-Profenid

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor. The maximum daily dose is 200 mg. Taking higher doses is not recommended. The patient should take the lowest effective dose for the shortest necessary period to alleviate symptoms. If the patient has an infection and its symptoms (such as fever and pain) persist or worsen, they should consult their doctor immediately (see section 2).

Dosage and administration: Adults and adolescents over 15 years:

• 150 mg per day, i.e., 1 tablet with modified release once a day. The tablets should be taken during meals, with a glass of water. The tablet should be swallowed whole, without chewing.

In case of mild gastrointestinal disorders, it may be advisable to take medicines that neutralize stomach acid or protect the gastric mucosa. Aluminum compounds with a neutralizing effect do not reduce the absorption of ketoprofen.

Taking a higher dose of Bi-Profenid than recommended

Observed symptoms after taking a higher dose of ketoprofen included: lethargy, drowsiness, nausea, vomiting, and abdominal pain. In case of overdose with high doses of ketoprofen, the following may occur: hypotension, respiratory arrest, gastrointestinal bleeding. There is no specific antidote. If the patient has taken a higher dose of the medicine than recommended, they should contact their doctor immediately. The doctor will take symptomatic and supportive treatment measures.

Missing a dose of Bi-Profenid

The patient should take the next dose at the usual time. They should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bi-Profenid can cause side effects, although not everybody gets them. The frequency of side effects is defined as follows: The following side effects may occur: Common (affects 1 to 10 patients in 100):

• indigestion, nausea, abdominal pain, vomiting.

Uncommon (affects 1 to 10 patients in 1000):

• headaches and dizziness of central origin, drowsiness.
• constipation, diarrhea, bloating, gastritis.
• rash, redness, itching.
• edema, fatigue.

Rare (affects 1 to 10 patients in 10,000):

• anemia caused by bleeding or hemorrhage.
• paresthesia (sensory disturbances).
• visual disturbances (blurred vision).
• tinnitus.
• shortness of breath, possible asthma attack.
• stomatitis, gastric ulcer.
• hepatitis, increased transaminase activity, increased bilirubin levels in the blood due to hepatitis.
• weight gain.

Frequency not known (frequency cannot be estimated from available data):

• agranulocytosis (decrease in the number of a certain type of granulocytes in the blood), thrombocytopenia (decrease in platelet count in the blood), bone marrow suppression, hemolytic anemia, leukopenia (decrease in white blood cell count in the blood).
• anaphylactic reactions (including anaphylactic shock).
• depression, hallucinations, disorientation, mood disorders.
• aseptic meningitis, seizures, taste disorders, dizziness of peripheral origin.
• heart failure, atrial fibrillation, hypertension, vasodilation, vasculitis.
• bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs), rhinitis.
• worsening of ulcerative colitis and Crohn's disease, gastrointestinal bleeding, perforations, pancreatitis.
• hypersensitivity to light, alopecia, urticaria, angioedema, bullous eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis.
• erythema multiforme, which recurs in the same place (places) after re-exposure to the medicine and may have the form of circular or oval redness and swelling of the skin, blisters (urticaria), itching of the skin.
• acute kidney failure, especially in patients with pre-existing kidney dysfunction and (or) dehydration, tubulointerstitial nephritis, nephrotic syndrome, abnormal kidney function test results.
• hyponatremia, hyperkalemia.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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, 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 or its representative in Poland. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Bi-Profenid

The medicine should be stored out of sight and reach of children. Store at a temperature below 25°C. Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Bi-Profenid contains

• The active substance of the medicine is ketoprofen. Each tablet contains 150 mg of ketoprofen.
• Other ingredients are: White coating:lactose monohydrate, wheat starch, silica colloidal anhydrous, gelatin, magnesium stearate. Yellow coating:hydroxyethylcellulose, calcium hydrogen phosphate dihydrate, sodium riboflavin phosphate, magnesium stearate.

What Bi-Profenid looks like and contents of the pack

Bi-Profenid tablets are tablets with modified release, divisible. The tablets are packaged in blisters and a cardboard box. The packaging contains 20 or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder Sanofi Winthrop Industrie 82, Avenue Raspail 94250 Gentilly France Manufacturer Famar Lyon 29, avenue du General de Gaulle 69230 Saint Genis Laval France Opella Healthcare International SAS 56, route de Choisy 60200 Compiègne France For more information, please contact the local representative of the marketing authorization holder: Sanofi Sp. z o.o. ul. Marcina Kasprzaka 6 01-211 Warsaw Tel.: +48 22 280 00 00 Date of last revision of the leaflet:December 2024