Package leaflet: Information for the user

Profenid, 100 mg, coated tablets
Ketoprofen
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Profenid is and what it is used for
Important information before taking Profenid
How to take Profenid
Possible side effects
How to store Profenid
Contents of the pack and other information

1. What Profenid is and what it is used for

Profenid 100 mg coated tablets contain the active substance ketoprofen. Ketoprofen is a medicine with anti-inflammatory, analgesic, and antipyretic effects (it belongs to the group of non-steroidal anti-inflammatory drugs – NSAIDs). The mechanism of action of ketoprofen is probably due to inhibition of prostaglandin synthesis.
Profenid is used for symptomatic treatment of:

rheumatic diseases, including rheumatoid arthritis,
degenerative joint disease with severe pain and significantly impaired patient function,
mild to moderate pain of various origins,
painful menstruation.

2. Important information before taking Profenid

When not to take Profenid

if you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6), have aspirin-induced asthma, or other hypersensitivity reactions after non-steroidal anti-inflammatory drugs (NSAIDs). In such patients with a history of hypersensitivity reactions such as bronchospasm, asthma attacks, rhinitis, urticaria, or other allergic-type reactions, severe, rarely fatal anaphylactic reactions have been observed,
if you have active gastric or duodenal ulceration or a history of gastrointestinal bleeding, ulcers, or perforations,
if you have severe liver or kidney failure,
if you have severe heart failure,
if you have a bleeding disorder,
if you are in the third trimester of pregnancy.

Warnings and precautions
Before starting Profenid, inform your doctor if you have:

bronchial asthma, chronic rhinitis, chronic sinusitis, nasal polyps; administration of ketoprofen may provoke asthma attacks or bronchospasm, especially in individuals hypersensitive to acetylsalicylic acid or other NSAIDs;
ulcers or bleeding while taking oral corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors, antiplatelet agents (such as aspirin), or nicorandil. The use of Profenid may increase the risk of gastrointestinal ulceration or bleeding in these patients;
a history of gastrointestinal disease (past gastric or duodenal ulceration, ulcerative colitis, Crohn’s disease), due to the possibility of exacerbating the condition;
photosensitivity or UV radiation sensitivity;
heart disease (heart failure), liver disease (liver function disorders), kidney disease (chronic kidney function disorders), or fluid balance disorders (e.g., dehydration due to diuretic use or after recent surgery). Use of Profenid may reduce renal blood flow, leading to kidney function disorders, especially in elderly patients. Kidney function should be closely monitored at the beginning of treatment in these patients. In patients with liver function disorders, your doctor may consider reducing the dose. Very rare cases of jaundice and hepatitis have been reported during ketoprofen treatment. Your doctor may recommend appropriate tests;
infection – see below, section titled “Infections”;
a history of erythema multiforme (circular or oval redness and swelling of the skin, which usually recur in the same location(s), blisters, urticaria, and skin itching), if it ever occurred during ketoprofen use.

The use of ketoprofen, especially at 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 those taking drugs that increase blood potassium levels, concomitant use of ketoprofen may lead to increased blood potassium concentration.
Infections
Profenid may mask symptoms of infection such as fever and pain. Therefore, Profenid may delay appropriate treatment of infection, thereby increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and symptoms persist or worsen, consult your doctor immediately.
In women taking ketoprofen long-term, secondary anovulatory infertility may occur.
Ketoprofen, like other NSAIDs, may impair fertility. If you are planning pregnancy or have difficulty conceiving, inform your 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. Do not use higher doses or longer treatment duration than recommended.
If you have heart disease (heart failure, ischemic heart disease), peripheral arterial disease, and/or cerebrovascular disease, have had a stroke, or suspect you have an increased risk of cardiovascular disease (e.g., high blood pressure, diabetes, elevated cholesterol, smoking), discuss treatment options with your doctor or pharmacist. Patients with heart disease who develop edema and fluid retention should be monitored appropriately and treatment individualized.
Inform your doctor if you recently underwent coronary artery bypass grafting.
Taking medicines such as Profenid may be associated with a small increased risk of atrial fibrillation.
If visual disturbances occur, discontinue the medicine and contact your doctor.
During treatment, inform your doctor if you experience:

Signs of hypersensitivity to the medicine, especially: shortness of breath, urticaria, skin rash, mucosal damage, sudden itching of the face and neck. You should contact your doctor immediately, who will decide whether to discontinue the medicine.
Symptoms of gastrointestinal bleeding, such as: vomiting blood, blood in stool, tarry stools. Gastrointestinal ulceration or perforation may occur. You should contact your doctor immediately, who will decide whether to discontinue the medicine.
Severe skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis). You should contact your 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.

Patients with a history of severe gastrointestinal diseases, especially elderly individuals, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial treatment period.
Warning
Profenid contains the non-steroidal anti-inflammatory drug: ketoprofen.
Concomitant use of other medicines containing non-steroidal anti-inflammatory drugs, including acetylsalicylic acid or selective cyclooxygenase-2 (COX-2) inhibitors, is not recommended.
Always check the patient leaflet of any other medicine you are taking concurrently to ensure it does not contain a non-steroidal anti-inflammatory drug.
Use of Profenid in children and adolescents
Use of this medicine is not recommended in children and adolescents under 15 years of age.
Profenid with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription.
Concomitant use of ketoprofen with the following medicines is not recommended:

other non-steroidal anti-inflammatory drugs (including selective COX-2 inhibitors) and high-dose salicylates. Concurrent use increases the risk of adverse effects (especially gastrointestinal ulceration and bleeding).
anticoagulants 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, increasing the risk of bleeding, especially gastrointestinal. Concomitant use of these medicines with ketoprofen is not recommended. If simultaneous use is necessary, carefully monitor clinical symptoms and perform periodic laboratory tests. Do not use NSAID treatment for longer than a few days.
lithium Ketoprofen reduces lithium excretion, increasing its blood concentration (even to toxic levels). Concomitant use of ketoprofen with lithium salts is not recommended. If such treatment is necessary, strictly follow your doctor’s instructions and regularly perform appropriate tests ordered by your doctor during and after NSAID treatment.
methotrexate (at doses greater than 15 mg per week). Concurrent use of high-dose methotrexate (greater than 15 mg per week) increases the likelihood of hematological toxicity.

Exercise caution when using concurrently with the following medicines:

medicines that increase blood potassium levels In patients taking potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, other NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim, blood potassium levels may increase.
diuretics, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers Patients taking these medicines with ketoprofen should be adequately hydrated before starting treatment. After starting treatment, follow your doctor’s recommendations regarding monitoring kidney function.
methotrexate (at doses less than 15 mg per week) During the first weeks of concomitant use of ketoprofen and methotrexate at doses less than 15 mg per week, regular complete blood counts (as ordered by your doctor) should be performed.
corticosteroids Increased risk of gastrointestinal ulceration and bleeding.
pentoxifylline Increased risk of bleeding when used concomitantly with ketoprofen. Follow your doctor’s recommendations when using these medicines together.
tenofovir Increased risk of kidney failure when tenofovir disoproxil fumarate is used concomitantly with ketoprofen.
nicorandil Patients taking nicorandil and NSAIDs have an increased risk of severe complications such as gastrointestinal ulceration, perforation, and bleeding (see section 4.4).
cardiac glycosides Non-steroidal anti-inflammatory drugs may exacerbate heart failure and increase blood concentrations of cardiac glycosides. Caution is advised, especially in patients with kidney function disorders, as NSAIDs may impair kidney function and reduce renal clearance of cardiac glycosides.
cyclosporine Increased risk of nephrotoxic effects, especially in elderly patients.
tacrolimus Increased risk of nephrotoxic effects, especially in elderly patients.
quinolone antibiotics In patients taking NSAIDs and quinolone antibiotics simultaneously, the risk of seizures is increased.

Particular attention should be paid to concomitant use of ketoprofen with:

antihypertensive medicines (β-adrenergic receptor blockers, angiotensin-converting enzyme inhibitors, diuretics) – risk of reduced effectiveness of these medicines (due to inhibition of vasodilatory prostaglandins by NSAIDs);
thrombolytic agents – increased risk of bleeding;
probenecid – reduced renal excretion of ketoprofen;
selective serotonin reuptake inhibitors (SSRIs) – increased risk of gastrointestinal bleeding.

Ketoprofen may reduce the effectiveness of hormonal contraceptives.
During long-term use of ketoprofen, regular blood tests and monitoring of liver and kidney function parameters are recommended.
Pregnancy, breastfeeding, and effects on fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Use of Profenid during the last three months of pregnancy is contraindicated, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both mother and child and may cause delivery to occur later or last longer than expected.
Profenid should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible time. Profenid use for longer than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child’s heart. If treatment for longer than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
If you are breastfeeding, consult your doctor before using this medicine.
Use of ketoprofen is not recommended in breastfeeding women. There are no data on ketoprofen excretion in human milk.
Effect on fertility
See section “Warnings and precautions”.
Driving and operating machinery
If dizziness, drowsiness, or seizures occur while taking ketoprofen, refrain from driving and operating machinery until your doctor confirms it is safe to perform these activities.
Profenid contains lactose
This medicine contains lactose; therefore, if you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
Profenid contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Profenid

This medicine should always be used as directed by a physician. In case of doubt, consult
your doctor.
The maximum daily dose is 200 mg. Higher doses are not recommended.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Dosage and method of administration:
Adults and adolescents over 15 years of age:
For symptomatic long-term treatment: 1 or 2 tablets per day, i.e. 100 to 200 mg per day
in 1 or 2 divided doses.
For symptomatic short-term treatment of acute conditions: 2 tablets per day, i.e. 200 mg per day
in 2 divided doses.
The tablets should be taken during a meal, with a glass of water. The tablet should be swallowed
whole, not chewed.
In case of mild gastrointestinal discomfort, it may be beneficial to use agents that neutralize gastric acid or protect the gastric mucosa. Aluminum-containing compounds with neutralizing action do not reduce the absorption of ketoprofen.
Use of a higher than recommended dose of Profenid
Symptoms observed after ingestion of an excessive dose of ketoprofen include: lethargy, drowsiness, nausea,
vomiting, and abdominal pain. Following large overdoses of ketoprofen, the following may occur:
hypotension, respiratory depression, and gastrointestinal bleeding.
There is no specific antidote.
In case of ingestion of a higher than recommended dose, contact a doctor immediately.
The doctor will provide symptomatic treatment and initiate supportive therapy to maintain vital functions.
Missed dose of Profenid
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 doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of the adverse effects listed below has been defined as follows:

Common (affects 1 to 10 patients in 100):

Dyspepsia, nausea, abdominal pain, vomiting.

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

Central origin headache and dizziness, drowsiness.
Constipation, diarrhoea, flatulence, gastric mucosal inflammation.
Rash, redness, itching.
Oedema, fatigue.

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

Anaemia caused by haemorrhage or bleeding.
Paraesthesia (sensory disturbances).
Visual disturbances (blurred vision).
Tinnitus.
Dyspnoea, possible asthma attack.
Oral mucosal inflammation, gastric ulceration.
Hepatitis, increased aminotransferase activity, increased plasma bilirubin concentration due to hepatitis.
Weight gain.

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

Agranulocytosis (decreased number of certain types of granulocytes in blood), thrombocytopenia (reduced number of platelets in blood), bone marrow suppression, haemolytic anaemia, leukopenia (reduced number of white blood cells in blood).
Anaphylactic reactions (including anaphylactic shock).
Depression, hallucinations, disorientation, mood disturbances.
Aseptic meningitis, convulsions, taste disturbances, peripheral origin dizziness.
Heart failure, atrial fibrillation, hypertension, vasodilation, vasculitis.
Bronchospasm (especially in patients diagnosed with hypersensitivity to acetylsalicylic acid or other NSAIDs), nasal mucosal inflammation.
Exacerbation of colitis and Crohn's disease, gastrointestinal bleeding, perforations, pancreatitis.
Photosensitivity, alopecia, urticaria, angioedema, bullous eruptions including Stevens-Johnson syndrome and toxic epidermal necrolysis, acute generalized exanthematous pustulosis.
Persistent erythema recurring in the same location(s) upon re-exposure to the drug, which may present as circular or oval skin redness and swelling, blisters (urticaria), skin itching.
Acute renal failure, particularly in individuals with pre-existing renal function disorders and (or) in dehydrated patients, tubulointerstitial nephritis, nephrotic syndrome, abnormal kidney function test results.
Hyponatraemia, hyperkalaemia.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder or the representative of the marketing authorisation holder in Poland.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Profenid

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Profenid contains

The active substance is ketoprofen. Each tablet contains 100 mg of ketoprofen.
The other ingredients are: lactose monohydrate, maize starch, pregelatinized maize starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, hypromellose, polyethylene glycol 6000.

What Profenid looks like and contents of the pack
Profenid tablets are film-coated tablets.
The tablets are packed in blisters and cardboard boxes. The pack contains 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France
Manufacturers
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 further information, please contact the local representative of the Marketing Authorisation Holder:
Sanofi Sp. z o.o.
Ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00