Profenid

Leaflet accompanying the packaging: information for the user

Profenid, 100 mg, suppositories

Ketoprofen

Read the leaflet carefully before using 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 as yours.
• If the patient experiences any side effects, including those 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 Profenid and what is it used for
• 2. Important information before using Profenid
• 3. How to use Profenid
• 4. Possible side effects
• 5. How to store Profenid
• 6. Contents of the packaging and other information

1. What is Profenid and what is it used for

Profenid contains 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 based on the inhibition of prostaglandin synthesis.
Profenid is used for:
the symptomatic treatment of rheumatic diseases, including:

• rheumatoid arthritis,
• osteoarthritis. In the symptomatic treatment of acute inflammatory conditions of the musculoskeletal system (tendinitis, injuries). In mild to moderate musculoskeletal pain, regardless of origin.

2.

Important information before using Profenid

When not to use Profenid

• if the patient has a known hypersensitivity to ketoprofen or any of the other ingredients of this medicine (listed in section 6), aspirin-induced asthma or other hypersensitivity reactions to non-steroidal anti-inflammatory drugs (NSAIDs). In patients who have experienced 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 in the past,
• 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.

Suppositories are contraindicated in people with proctitis or rectal bleeding in their medical history.

Warnings and precautions

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

• asthma, chronic rhinitis, chronic sinusitis, nasal polyps. The administration of ketoprofen may cause an asthma attack, bronchospasm, especially in people with hypersensitivity to acetylsalicylic acid or non-steroidal anti-inflammatory drugs;
• ulcers or bleeding while taking oral corticosteroids, anticoagulant medications (such as warfarin), selective serotonin reuptake inhibitors, antiplatelet agents (such as aspirin), and nicorandil. The use of Profenid may increase the risk of ulcers or gastrointestinal bleeding in these patients;
• a history of gastrointestinal disease (previous peptic ulcer disease of the stomach and/or duodenum, 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). The use of 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 will 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 their medical 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 use.

The use of 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 those being treated with medications that increase potassium levels in the blood, the use of 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, 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 during an infection, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
In women taking ketoprofen long-term, 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. Do not use higher doses or longer treatment than recommended.
If the patient has heart disease (heart failure, coronary heart disease), peripheral artery disease, and/or cerebrovascular disease, or has had a stroke, or suspects that they are at 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 Profenid may be associated with a small increased risk of atrial fibrillation.
If the patient experiences vision disturbances, they should stop using 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 on discontinuing the medicine.
• Symptoms of gastrointestinal bleeding, such as: vomiting blood, blood in stool, black stool. Gastrointestinal ulcers or perforation may occur. In this case, the patient should contact their doctor immediately, who will decide on discontinuing the medicine.
• Severe skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis). In this case, the patient should contact their doctor immediately, who will decide on discontinuing 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.

Patients 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.
Warning
Profenid contains a non-steroidal anti-inflammatory drug: ketoprofen.
It is not recommended to use other medicines that contain non-steroidal anti-inflammatory drugs, including acetylsalicylic acid or selective cyclooxygenase-2 inhibitors - COX-2.
Always read the patient information leaflet of any other medicine being taken at the same time to ensure it does not contain a non-steroidal anti-inflammatory drug.
Using 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

Tell your doctor about all medicines you are taking, or have recently taken, and those you plan to take, even those available without a prescription.
It is not recommended to use ketoprofen with the following medicines:

• other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 inhibitors - COX-2) and salicylates in high doses. Concurrent use leads to an increased risk of adverse effects (especially the risk of gastrointestinal ulcers 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 an increased risk of bleeding, especially gastrointestinal. It is not recommended to use 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. Non-steroidal 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 use ketoprofen with lithium salts. If such treatment is necessary, the doctor's instructions should be followed, and regular tests should be performed during and after non-steroidal 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 risk of hematologic toxicity.

Caution should be exercised when using the following medicines:

• medicines that increase potassium levels in the blood. In patients taking potassium-sparing diuretics, potassium supplements, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, other non-steroidal anti-inflammatory drugs, low molecular weight or unfractionated heparin, cyclosporine, tacrolimus, and trimethoprim, potassium levels in the blood may increase.
• diuretics, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers. Patients who will be taking these medicines at the same time as ketoprofen should be hydrated before starting treatment. After starting treatment, the doctor's instructions regarding kidney function monitoring should be followed.
• methotrexate (in doses less than 15 mg per week). During the first 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 ulcers and bleeding.
• pentoxifylline. Increased risk of bleeding when used with ketoprofen. The doctor's instructions should be followed when using these medicines at the same time.
• tenofovir. Increased risk of kidney failure when tenofovir disoproxil fumarate is used with ketoprofen.
• nicorandil. In patients taking nicorandil and non-steroidal anti-inflammatory drugs at the same time, there is an increased risk of severe complications, such as ulcers, perforation, and gastrointestinal bleeding (see section 4.4).
• cardiac glycosides. Non-steroidal anti-inflammatory drugs may exacerbate heart failure and increase cardiac glycoside levels in the blood. Caution is recommended, especially in patients with kidney dysfunction, as non-steroidal anti-inflammatory drugs may impair kidney function and reduce the renal clearance of cardiac glycosides.
• cyclosporine. Increased risk of nephrotoxicity, especially in elderly patients.
• tacrolimus. Increased risk of nephrotoxicity, especially in elderly patients.
• quinolone antibiotics. Increased risk of seizures in patients taking non-steroidal anti-inflammatory drugs and quinolone antibiotics at the same time.

Special attention should be paid to the use of ketoprofen 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 non-steroidal 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.
During long-term use of ketoprofen, general blood tests and liver and kidney function tests should be performed.

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 using this medicine.
Using 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 longer or more difficult delivery than expected.
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 when trying to conceive, the smallest dose should be used for the shortest possible time. Profenid used for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child, which can lead to low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If the patient requires treatment for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

If the patient is breastfeeding, they should consult their doctor before using this medicine.
It is not recommended to use ketoprofen 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 using machines until their doctor determines that there are no obstacles to performing these activities.

3. How to use Profenid

This medicine should always be used as directed by the doctor. If you have any doubts, consult your doctor.
The maximum daily dose is 200 mg. Using higher doses is not recommended.
Use the smallest effective dose for the shortest necessary period to alleviate symptoms. If the patient has an infection and the symptoms of the infection (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:

For long-term symptomatic treatment: 1 to 2 suppositories per day, i.e., 100 to 200 mg per day, in two divided doses.
For short-term symptomatic treatment of acute conditions: 1 to 2 suppositories per day, i.e., 100 to 200 mg per day, in 2 divided doses.

Using a higher than recommended dose of Profenid

During proper dosing, overdosing of this medicine administered rectally is unlikely.
Symptoms observed after taking a higher dose of ketoprofen include: lethargy, drowsiness, nausea, vomiting, and abdominal pain. In case of overdosing with high doses of ketoprofen, the following may occur: hypotension, respiratory arrest, gastrointestinal bleeding.
There is no specific antidote.
If a higher dose of the medicine than recommended is taken, the patient should contact their doctor immediately. The doctor will take symptomatic and supportive treatment measures.

Missing a dose of Profenid

The patient should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If the patient has any further doubts about using this medicine, they should consult their 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 reported below is defined as follows:
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).
• vision disturbances (blurred vision).
• tinnitus.
• shortness of breath, possibility of an asthma attack.
• stomatitis, gastric ulcers.
• hepatitis, increased liver enzyme 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 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 non-steroidal anti-inflammatory drugs), rhinitis.
• exacerbation of ulcerative colitis and Crohn's disease, gastrointestinal bleeding, perforation, 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), 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 the patient experiences any side effects, including those 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, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Profenid

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Profenid contains

• The active substance of the medicine is ketoprofen. Each suppository contains 100 mg of ketoprofen.
• The other ingredients are: hydrophobic silica, semi-synthetic glycerides.

What Profenid looks like and what the packaging contains

The suppositories are packaged in a cardboard box. The packaging contains 10 suppositories.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France
Manufacturer
Unither Liquid Manufacturing
1-3 Allée de la Neste
Z.I. d’en Sigal
31770 Colomiers
France
Haupt Pharma Livron
1, rue Comte de Sinard
26250 Livron
France
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00
Date of last update of the leaflet:December 2024