Package leaflet: Information for the user

Profenid, 100 mg, suppositories
Ketoprofenum
Please read all of this leaflet carefully before using this medicine, because 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 ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions 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 using Profenid
How to use 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 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 due to inhibition of prostaglandin synthesis.
Profenid is used for symptomatic treatment of rheumatic diseases, including:

rheumatoid arthritis,
degenerative joint disease. For symptomatic treatment of acute inflammatory conditions of the musculoskeletal system (tendonitis, injuries). For mild to moderate bone and muscular 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 these patients, severe, rarely fatal anaphylactic reactions have been observed when hypersensitivity reactions such as bronchospasm, asthma attacks, rhinitis, urticaria or other allergic-type reactions occurred in the past,
if the patient has active gastric or duodenal ulceration, or a history of 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.

Suppositories are contraindicated in individuals with a history of proctitis or rectal bleeding.
Warnings and precautions
Before starting treatment with Profenid, inform your doctor if the patient has:

bronchial asthma, chronic rhinitis, chronic sinusitis, nasal polyps. Administration of ketoprofen may provoke an asthma attack or bronchospasm, especially in individuals with hypersensitivity to acetylsalicylic acid or other NSAIDs;
ulceration or bleeding while concurrently taking oral corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors, antiplatelet agents (such as aspirin) or nicorandil. Use of Profenid may increase the risk of gastrointestinal ulceration or bleeding in these patients;
a history of gastrointestinal disease (past gastric or duodenal ulcer, ulcerative colitis, Crohn's disease), due to the possibility of exacerbation of the disease;
photosensitivity or UV radiation sensitivity;
heart disease (heart failure), liver disease (liver function disorders) or kidney disease (chronic kidney function disorders), and 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, the doctor may consider reducing the dose. Very rare cases of jaundice and hepatitis have been reported during ketoprofen treatment. The doctor may recommend appropriate tests;
infection – see below, section titled “Infections”;
recurrent erythema (circular or oval redness and swelling of the skin, which usually recur in the same location(s)), blisters, urticaria and skin itching, if 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 concurrently taking drugs that increase blood potassium levels, concomitant use of ketoprofen may lead to increased blood potassium levels.
Infections
Profenid may mask signs of infection such as fever and pain. Therefore, Profenid may delay appropriate treatment of infection and consequently lead to an 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 existing infection and infection symptoms persist or worsen, immediate consultation with a doctor is necessary.
In women taking ketoprofen long-term, secondary anovulatory infertility may occur.
Ketoprofen, like other NSAIDs, may impair fertility. If a woman plans pregnancy or has difficulty conceiving, she should inform her doctor.
The use of 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 drug. Do not use higher doses or longer treatment duration than recommended.
If the patient has heart disease (heart failure, ischemic heart disease), peripheral arterial disease and/or cerebrovascular disease, has had a stroke, or suspects he/she is at risk of cardiovascular disease (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss the treatment approach with a doctor or pharmacist. Patients with heart disease who report edema and fluid retention should be appropriately monitored and treatment individually adjusted.
Inform your doctor if the patient recently underwent coronary artery bypass grafting.
The use of drugs such as Profenid may be associated with a small increased risk of atrial fibrillation.
In case of visual disturbances, discontinue the medicine and contact a doctor.
During treatment, inform your doctor if any of the following occur:

Signs of hypersensitivity to the medicine, especially: dyspnea, urticaria, skin rash, mucosal damage, sudden itching of the face and neck. In such cases, contact a doctor immediately, who will decide whether to discontinue the medicine.
Signs of gastrointestinal bleeding, such as: vomiting blood, blood in stool, tarry stools. Gastrointestinal ulceration or perforation may occur. In such cases, contact a doctor immediately, who will decide whether to discontinue the medicine.
Severe skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal necrolysis). In such cases, contact a doctor immediately, who will decide whether to discontinue 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 a history of severe gastrointestinal diseases, especially elderly individuals, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial period of treatment.
Warning
Profenid contains a 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 read the patient leaflet of any other concurrently used medicine 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 and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, even those available without a prescription.
Concomitant use of ketoprofen with the following medicines is not recommended:

other non-steroidal anti-inflammatory drugs (including selective cyclooxygenase-2 (COX-2) inhibitors) and high-dose salicylates. Concomitant use leads to an increased risk of adverse effects (especially risk of gastrointestinal ulceration and gastrointestinal 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, leading to an increased risk of bleeding, especially gastrointestinal bleeding. Concomitant use of these medicines with ketoprofen is not recommended. If concomitant use is essential, carefully monitor clinical symptoms and perform periodic laboratory tests. Do not use NSAID treatment for longer than a few days.
lithium. Ketoprofen inhibits 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 the doctor's instructions and regularly perform appropriate tests ordered by the doctor during and after NSAID treatment.
methotrexate (at doses greater than 15 mg per week). Concomitant 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 concurrently using 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 who will use these medicines concomitantly with ketoprofen should be adequately hydrated before starting treatment. After starting treatment, follow the 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 (CBC) ordered by the doctor should be performed.
corticosteroids. Increased risk of gastrointestinal ulceration and bleeding.
pentoxifylline. Concomitant use with ketoprofen increases the risk of bleeding. Follow the doctor's recommendations when using these medicines together.
tenofovir. Concomitant use of tenofovir disoproxil fumarate with ketoprofen increases the risk of kidney failure.
nicorandil. In patients taking nicorandil and NSAIDs simultaneously, there is an increased risk of severe complications such as ulceration, perforation and gastrointestinal bleeding (see section 4.4).
cardiac glycosides. Non-steroidal anti-inflammatory drugs may exacerbate heart failure and increase blood levels 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 likelihood of nephrotoxic effects, especially in elderly patients.
tacrolimus. Increased likelihood of nephrotoxic effects, especially in elderly patients.
quinolone antibiotics. In patients concurrently using non-steroidal anti-inflammatory drugs and a quinolone antibiotic, the risk of seizures is increased.

Special 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 (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 oral contraceptives.
During long-term use of ketoprofen, regular blood tests and monitoring of liver and kidney function parameters should be performed.
Pregnancy, breastfeeding and effects on fertility
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Use of Profenid during 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 function disorders in the unborn child. It may affect bleeding tendency in both the patient and the child and may cause delivery to be later or longer than expected.
Profenid should not be used during the first 6 months of pregnancy unless absolutely necessary and recommended 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 duration. Use of Profenid for longer than a few days during the period from the 20th week of pregnancy may cause kidney disorders in the unborn child, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If the patient requires treatment for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
If the patient is breastfeeding, she should consult a doctor before using this medicine.
Use of ketoprofen is not recommended in breastfeeding women. There are no data on the passage of ketoprofen into breast 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 the doctor confirms there are no obstacles to performing these activities.

3. How to use Profenid

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your doctor.
The maximum daily dose is 200 mg. Higher doses are not recommended.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If symptoms of an infection (such as fever and pain) persist or worsen, medical advice should be
sought immediately (see section 2).
Dosage and method of administration:
Adults and adolescents over 15 years of age:
For symptomatic long-term treatment: 1 to 2 suppositories per day, i.e. 100 to 200 mg per day,
divided into two doses.
For symptomatic short-term treatment of acute conditions: 1 to 2 suppositories per day, i.e. 100 to 200 mg per day, divided into two doses.
Use of a higher than recommended dose of Profenid
When administered rectally at the recommended dosage, overdose of this medicine is unlikely.
Symptoms observed after taking an excessive dose of ketoprofen include: lethargy, drowsiness, nausea,
vomiting, and abdominal pain. In cases of severe ketoprofen overdose, arterial hypotension, respiratory depression, and gastrointestinal bleeding may occur.
There is no specific antidote.
If a higher than recommended dose has been taken, contact your 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 a missed dose.
If you have any further questions about 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 occurrence 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 mucositis.
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.
Stomatitis, gastric ulceration.
Hepatitis, increased aminotransferase activity, increased plasma bilirubin concentration due to hepatitis.
Weight gain.

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

Agranulocytosis (decreased number of certain types of granulocytes in blood), thrombocytopenia (reduced platelet count in blood), bone marrow suppression, haemolytic anaemia, leukopenia (reduced white blood cell count in blood).
Anaphylactic reactions (including anaphylactic shock).
Depression, hallucinations, disorientation, mood disturbances.
Aseptic meningitis, convulsions, taste disturbances, peripheral dizziness.
Heart failure, atrial fibrillation, arterial hypertension, vasodilation, vasculitis.
Bronchospasm (especially in patients with diagnosed hypersensitivity to acetylsalicylic acid or other NSAIDs), rhinitis.
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 medicine and which may present as circular or oval skin redness and swelling, blisters (urticaria), skin itching.
Acute renal failure, especially 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 of 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 the medicine Profenid

Keep the medicine out of the sight and reach of children.
Store below 25 °C.
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 must not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Profenid contains

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

What Profenid looks like and contents of the pack
Suppositories are packed in a cardboard box. The pack contains 10 suppositories.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
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