Profenid

Leaflet attached to the packaging: information for the user

Profenid, 100 mg, coated tablets

Ketoprofen

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Profenid and what is it used for

Profenid 100 mg coated tablets contain the active substance ketoprofen. Ketoprofen is an anti-inflammatory, analgesic, and antipyretic (belonging to the group of non-steroidal anti-inflammatory drugs - NSAIDs). The mechanism of action of ketoprofen is probably based on the inhibition of prostaglandin synthesis.
Profenid is used for:

• Symptomatic treatment of:
• rheumatic diseases, including rheumatoid arthritis,
• degenerative joint disease, with significant pain and limited patient mobility. For pain of various origins with mild to moderate severity. For painful menstruation.

2.

Important information before taking Profenid

When not to take Profenid

• if the patient has a known hypersensitivity to ketoprofen or any of the other ingredients of this medicine (listed in section 6), has aspirin-induced asthma or other hypersensitivity reactions to non-steroidal anti-inflammatory drugs (NSAIDs). In patients who have had a history of hypersensitivity reactions such as: bronchospasm, asthma attacks, rhinitis, urticaria, or other allergic reactions, severe, sometimes life-threatening anaphylactic reactions have been observed,
• if the patient has active peptic ulcer disease of the stomach and/or duodenum, 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 is in the third trimester of pregnancy.

Warnings and precautions

Before starting treatment with Profenid, you should inform your doctor if you have:

• asthma, chronic rhinitis, chronic sinusitis, nasal polyps; Administration of ketoprofen may cause an asthma attack, bronchospasm, especially in people with hypersensitivity to acetylsalicylic acid or non-steroidal 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 Profenid may increase the risk of ulceration or bleeding in the gastrointestinal tract in these patients;
• a history of gastrointestinal disease (previous stomach 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 balance disorders (e.g., dehydration due to diuretic use or recent surgery). Taking Profenid may reduce renal blood flow, leading to kidney dysfunction, especially in elderly patients. At the start of treatment, these patients should be closely monitored for kidney 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 titled "Infections";
• chronic erythema in history (circular or oval redness and swelling of the skin, which usually recur in the same place (places), blisters, urticaria, and skin itching), if it has ever occurred during ketoprofen treatment.

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 being treated with medications that increase potassium levels in the blood, taking ketoprofen may lead to increased potassium levels in the blood.
Infections
Profenid may mask the symptoms of infection, such as fever and pain. Therefore, Profenid may delay the use of appropriate infection treatment, and consequently, 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 during an infection, and the symptoms of the infection persist or worsen, they should immediately consult a doctor.
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 difficulty becoming pregnant, they should inform their doctor.
Taking non-steroidal anti-inflammatory drugs other than acetylsalicylic acid, such as 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. You should not take higher doses or use the medicine for longer than recommended.
If you have heart disease (heart failure, coronary artery disease), peripheral artery disease, and/or cerebrovascular disease, or have had a stroke or suspect that you are at increased risk of cardiovascular disease (e.g., high blood pressure, diabetes, high cholesterol, smoking), you should discuss your treatment with your doctor or pharmacist. Patients with heart disease who have reported edema and fluid retention should be properly monitored and their treatment adjusted individually.
You should inform your doctor if you have recently undergone coronary artery bypass grafting.
Taking such medicines as Profenid may be associated with a small increased risk of atrial fibrillation.
If you experience vision disturbances, you should stop taking the medicine and contact your doctor.
During treatment with the medicine, you should inform your doctor if you experience:

• Symptoms of hypersensitivity to the medicine, especially: shortness of breath, urticaria, skin rash, mucosal damage, sudden itching of the face and neck. You should then contact your doctor immediately, who will decide on discontinuation of the medicine.
• Symptoms of gastrointestinal bleeding, such as: vomiting blood, blood in stool, black stool. Gastrointestinal ulceration or perforation may occur. You should then contact your doctor immediately, who will decide on discontinuation of the medicine.
• Severe skin reactions (in the form of exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis). You should then contact your doctor immediately, who will decide on discontinuation of the medicine.The greatest 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 history, especially the elderly, should inform about all unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial treatment period.
Warning
Profenid contains a non-steroidal anti-inflammatory drug: ketoprofen.
It is not recommended to take other medicines that contain non-steroidal anti-inflammatory drugs, including acetylsalicylic acid or selective cyclooxygenase 2 inhibitors - COX-2.
You should always read the patient information leaflet of any other medicine you are taking at the same time to make sure it does not contain a non-steroidal anti-inflammatory drug.
Use of Profenid in children and adolescents
It is not recommended to use the medicine in children and adolescents under 15 years of age.

Profenid and other medicines

You should tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take, even those that are available without a prescription.
It is not recommended to take ketoprofen with the following medicines:

• other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase 2 inhibitors - COX-2) and salicylates in high doses. Concomitant 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 use these medicines concomitantly with ketoprofen. If concomitant use is necessary, you should be closely monitored for clinical symptoms and periodic laboratory tests.
• 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, you should strictly follow your doctor's instructions and regularly perform the tests ordered by your doctor during and after NSAID treatment.
• methotrexate (in doses greater than 15 mg per week). Concomitant use of methotrexate in high doses (greater than 15 mg per week) increases the likelihood of hematologic toxicity.

You should exercise caution when taking the following medicines concomitantly:

• medicines that increase potassium levels in the blood. In patients taking potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, other NSAIDs, 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 be taking these medicines concomitantly with ketoprofen should be hydrated before starting treatment. After starting treatment, you should follow your doctor's instructions for monitoring kidney function.
• methotrexate (in doses less than 15 mg per week). During the first weeks of concomitant use of ketoprofen and methotrexate in doses less than 15 mg per week, you should regularly perform complete blood count tests.
• corticosteroids. Increased risk of gastrointestinal ulceration and bleeding.
• pentoxifylline. Concomitant use with ketoprofen increases the risk of bleeding. You should follow your doctor's instructions when taking these medicines concomitantly.
• tenofovir. Concomitant use of tenofovir disoproxil fumarate with ketoprofen increases the risk of kidney failure.
• nicorandil. In patients taking nicorandil and NSAIDs concomitantly, there is an increased risk of severe complications, such as ulceration, perforation, and gastrointestinal bleeding (see section 4.4).
• digitalis glycosides. Non-steroidal anti-inflammatory drugs may exacerbate heart failure and increase digitalis glycoside levels in the blood. Caution is recommended, especially in patients with kidney dysfunction, as NSAIDs may impair kidney function and reduce the renal clearance of digitalis glycosides.
• cyclosporine. Increased likelihood of nephrotoxicity, especially in elderly patients.
• tacrolimus. Increased likelihood of nephrotoxicity, especially in elderly patients.
• quinolone antibiotics. In patients taking non-steroidal anti-inflammatory drugs and quinolone antibiotics concomitantly, there is an increased risk of seizures.

You should pay special attention to taking ketoprofen concomitantly with:

• antihypertensive medications (beta-adrenergic receptor blockers, angiotensin-converting enzyme inhibitors, diuretics) - risk of reduced efficacy of these medications (inhibition of prostaglandins that dilate blood vessels by NSAIDs);
• 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.
During long-term use of ketoprofen, you should perform general blood tests and monitor liver and kidney function tests.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice before taking this medicine.
Taking 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 tendency to bleed in the mother and child and cause the delivery to be later or longer than expected.
Profenid should not be taken 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 during attempts to conceive, the lowest effective dose should be used for the shortest possible time. Profenid taken for more than a few days during the period from the 20th week of pregnancy may cause kidney problems in the unborn child, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If you require treatment for a longer period, your doctor may recommend additional monitoring.

Breastfeeding

If you are breastfeeding, you should ask your doctor for advice before taking this medicine.
It is not recommended to take ketoprofen while breastfeeding. There is no data on the penetration of ketoprofen into breast milk.

Fertility

See section "Warnings and precautions".

Driving and using machines

If you experience dizziness, drowsiness, or seizures while taking ketoprofen, you should refrain from driving and using machines until your doctor determines that there are no obstacles to performing these activities.

Profenid contains lactose

The medicine contains lactose and therefore, if you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Profenid contains sodium

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

3. How to take Profenid

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor.
The maximum daily dose is 200 mg. Taking higher doses is not recommended.
You should take the lowest effective dose for the shortest possible time to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should immediately consult your doctor (see section 2).

Dosage and administration: Adults and adolescents over 15 years of age:

For long-term symptomatic treatment: 1 or 2 tablets per day, i.e., 100 to 200 mg per day in 1 or 2 divided doses.
For short-term symptomatic treatment of acute conditions: 2 tablets per day, i.e., 200 mg per day in 2 divided doses.
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 medications 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 Profenid than recommended

The observed symptoms after taking a higher dose of ketoprofen were: 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 you have taken a higher dose of the medicine than recommended, you should immediately contact your doctor. Your doctor will take symptomatic and supportive treatment measures.

Missing a dose of Profenid

You should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:

• Frequent (affects 1 to 10 patients in 100):
• indigestion, nausea, abdominal pain, vomiting.

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

• headache 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, possibility of 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 depression, hemolytic anemia, leukopenia (decrease in white blood cell count in the blood).
• anaphylactic reactions (including anaphylactic shock).
• depression, hallucinations, disorientation, mood disturbances.
• aseptic meningitis, seizures, taste disturbances, dizziness of peripheral origin.
• heart failure, atrial fibrillation, hypertension, vasodilation, vasculitis.
• bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid or other NSAIDs), rhinitis.
• worsening of ulcerative colitis and Crohn's disease, gastrointestinal bleeding, perforations, pancreatitis.
• hypersensitivity to light, alopecia, urticaria, angioedema, blistering eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis.
• chronic erythema, 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), skin itching.
• acute kidney failure, especially in patients with pre-existing kidney dysfunction and/or dehydration, interstitial nephritis, nephrotic syndrome, abnormal kidney function test results.
• hyponatremia, hyperkalemia.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should 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:
Jerozolimskie Avenue 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 or its representative in Poland.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Profenid

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Do not use this medicine after the expiry date stated on the carton after: Expiry date. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Profenid contains

• The active substance of the medicine is ketoprofen. Each tablet contains 100 mg of ketoprofen.
• The other ingredients are: lactose monohydrate, corn starch, corn starch paste, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 6000.

What Profenid looks like and contents of the pack

Profenid tablets are coated tablets.
Tablets are packaged in blisters and a cardboard box. The pack contains 30 tablets.

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
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
Sanofi Sp. z o.o.
Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00
Date of last revision of the leaflet:December 2024