Febrofen

Leaflet accompanying the packaging: patient information

Febrofen, 200 mg, prolonged-release capsules

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 or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Febrofen and what is it used for

Febrofen contains ketoprofen, which belongs to a group of non-steroidal anti-inflammatory drugs with anti-inflammatory, analgesic, and antipyretic effects.
Febrofen is a form of the drug characterized by controlled release of the active substance, defined in a unit of time; the release of the active substance occurs in a alkaline environment of the small intestine. Ketoprofen is largely bound to plasma proteins, mainly albumins.
It is metabolized in the liver, excreted in 80% with urine, in the form of inactive metabolites.

Indications

Symptomatic treatment of chronic inflammatory rheumatic diseases, especially rheumatoid arthritis.
Symptomatic treatment of severe degenerative joint changes, if the necessary dose is 200 mg per day.

2. Important information before taking Febrofen

When not to take Febrofen

• if the patient has a history of hypersensitivity reactions, such as bronchospasm, asthma attack, rhinitis, angioedema, urticaria, or other types of allergic reactions after taking ketoprofen, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs), as severe, sometimes fatal anaphylactic reactions have been reported in such patients;
• if the patient is allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has active gastric or duodenal ulcer, or has a history of gastrointestinal bleeding, ulceration, or perforation;
• if the patient has severe liver or kidney failure;
• if the patient is in the third trimester of pregnancy;
• if the patient has severe heart failure;
• if the patient has a bleeding disorder.

Warnings and precautions

Before starting treatment with Febrofen, discuss it with your doctor or pharmacist.
Tell your pharmacist or doctor if you have an infection - see below, section "Infections".
It is very important to take Febrofen in the smallest effective dose for the shortest possible time necessary to alleviate symptoms - this will minimize the risk of gastrointestinal and cardiovascular side effects.
Avoid taking ketoprofen at the same time as other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors and salicylates in high doses, due to the possibility of increased side effects.
In patients with asthma, chronic rhinitis, chronic sinusitis, and/or nasal polyposis, an asthma attack, bronchospasm (especially in people with hypersensitivity to acetylsalicylic acid or other NSAIDs) may occur.
Taking ketoprofen (especially in high doses) may be associated with a high risk of harmful effects on the gastrointestinal tract. With long-term therapy with NSAIDs, there is a risk of gastrointestinal bleeding, ulcers, and perforation, which can be fatal, even without prior warning symptoms, especially in patients with a history of gastrointestinal ulcers and in the elderly.
Caution should be exercised when taking NSAIDs in patients who have had gastrointestinal diseases (gastritis, duodenitis, ulcerative colitis, Crohn's disease), due to the possibility of exacerbating symptoms.
If gastrointestinal disorders occur, especially gastrointestinal bleeding, the medicine should be discontinued and a doctor consulted. The doctor will exercise caution, recommending ketoprofen to patients who have had stomach and intestinal disorders in the past.
In the case of mild side effects related to the stomach, medications that protect the gastric mucosa (e.g., misoprostol) can be used.
Caution should be exercised in patients taking medications that may increase the risk of gastrointestinal ulcers or bleeding, such as oral corticosteroids, anticoagulant medications such as warfarin, selective serotonin reuptake inhibitors (SSRIs), or antiplatelet medications such as acetylsalicylic acid (see below, section "Febrofen and other medications").
Infections
Febrofen may mask the symptoms of an infection, such as fever and pain. Therefore, Febrofen 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 contact their doctor immediately.
Patients with a history of hypersensitivity to sunlight or phototoxicity should be closely monitored by their doctor during ketoprofen administration.
Very rarely, severe skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported with the use of NSAIDs, especially at the beginning of treatment. In case of the first symptoms that may indicate severe skin reactions or hypersensitivity: skin rash, mucosal lesions, or other hypersensitivity symptoms, the medicine should be discontinued and a doctor consulted.
Caution should be exercised in patients with systemic lupus erythematosus and mixed connective tissue disease due to the increased risk of aseptic meningitis.
The use of NSAIDs may have a toxic effect on the kidneys, which can lead to interstitial nephritis, nephrotic syndrome, and kidney failure.
In elderly patients, as well as in patients with heart failure or liver dysfunction, cirrhosis of the liver, nephrotic syndrome, chronic kidney dysfunction, and water balance disorders (e.g., dehydration due to diuretic use or other causes), ketoprofen may impair kidney function, leading to edema and increased serum nitrogen levels.
In patients with hypertension and/or heart failure, especially in the elderly, there may be fluid and sodium retention in the body, as well as edema.
Special caution is recommended when using ketoprofen in the elderly, especially with liver or kidney dysfunction. During long-term treatment with ketoprofen, the doctor will recommend blood morphology tests and monitoring of liver and kidney function and adjust the ketoprofen dose individually according to the patient's condition.
In case of vision disturbances such as blurred vision, the medicine should be discontinued.
Taking such medications as Febrofen 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.
In case of heart problems, a history of stroke, cerebrovascular diseases, peripheral artery disease, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), consult your doctor about the treatment.

Children and adolescents

The safety of ketoprofen in children has not been established.
Do not use in patients under 15 years of age.

Febrofen and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Concomitant use of ketoprofen with the following medications is not recommended:

• other pain-relieving/anti-inflammatory medications (including COX-2 inhibitors) and salicylates in high doses;
• anticoagulant medications (such as warfarin, acenocoumarol, and heparin administered parenterally);
• antiplatelet medications (such as clopidogrel or ticlopidine);
• lithium (a medication used to treat mental illnesses);
• methotrexate (a medication used to treat cancer and rheumatoid arthritis) in doses higher than 15 mg per week.

Caution should be exercised and a doctor consulted before taking ketoprofen if the patient is taking:

• diuretics;
• methotrexate (in doses less than 15 mg per week);
• pentoxifylline (a medication used to treat circulation disorders);
• quinolone antibiotics;
• antihypertensive medications (beta blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists);
• thrombolytic medications (used to dissolve blood clots);
• selective serotonin reuptake inhibitors (SSRIs) (medications used to treat depression, among other conditions);
• probenecid (a medication used to treat gout, among other conditions);
• cyclosporine (a medication used to prevent organ rejection or bone marrow transplantation);
• tacrolimus (an immunosuppressive medication);
• potassium salts (used to treat potassium deficiency);
• trimethoprim (an antibiotic used to treat urinary tract infections, among other conditions);
• oral antidiabetic medications;
• corticosteroids (anti-inflammatory medications);
• cardiac glycosides (such as digoxin);
• mifepristone (a medication used in gynecology);
• intrauterine contraceptives;

Concomitant use of antiplatelet medications (such as acetylsalicylic acid and non-steroidal anti-inflammatory medications, ticlopidine, clopidogrel) and selective serotonin reuptake inhibitors increases the risk of bleeding, as does concomitant administration of anticoagulant medications (including heparin and warfarin) and thrombolytic medications.
In patients who have received combination therapy, it is necessary to monitor the medication level and perform regular tests as recommended.
Aluminum compounds with a neutralizing effect do not reduce the absorption of ketoprofen.

Febrofen with food, drink, and alcohol

The medicine is taken during a meal, washed down with a glass of water.
The medicine may enhance the effects of alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Febrofen if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. Febrofen may cause kidney and heart problems in the unborn child. This may affect the tendency to bleed in the mother and her child and may cause delayed or prolonged labor.
Do not take Febrofen during the first 6 months of pregnancy, unless your doctor considers it absolutely necessary. If you need treatment during this period or during breastfeeding, consult your doctor.

and consult your doctor.

Driving and using machines

If you experience drowsiness, dizziness, seizures, fatigue, or vision disturbances while taking ketoprofen, do not drive or operate machinery.

Febrofen contains sucrose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Febrofen

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
The medicine is taken orally. The capsules should be taken during a meal. Swallow the capsule whole, washed down with a glass of water.
To minimize the risk of side effects, take the smallest effective dose for the shortest possible time necessary to alleviate symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Recommended dose
Adults
One 200 mg capsule once a day.
In case of mild gastrointestinal disorders, it may be advisable to take medications that neutralize or protect the gastric mucosa. Aluminum compounds with a neutralizing effect do not reduce the absorption of ketoprofen.
The maximum daily dose of ketoprofen is 200 mg (one capsule).
Children and adolescents
The safety of ketoprofen in children has not been established.
Do not use in patients under 15 years of age.

Taking a higher dose of Febrofen than recommended

If you have taken more than the recommended dose of the medicine, consult your doctor or pharmacist immediately.
Symptoms observed after an overdose of ketoprofen include: lethargy, headache, drowsiness, nausea, vomiting, diarrhea, abdominal pain, disorientation, agitation, coma, dizziness, tinnitus, fainting, seizures, hypotension, breathing difficulties, gastrointestinal bleeding. In case of an overdose of high doses of ketoprofen, acute kidney failure and liver damage may occur.
In case of an overdose, stop taking the medicine immediately and consult a doctor. The medical staff will take appropriate action.

Missing a dose of Febrofen

Do not take a double dose to make up for a missed dose.
Return to the dosing schedule prescribed by your doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Febrofen can cause side effects, although not everybody gets them.
The most common side effects are related to the gastrointestinal system. Especially in the elderly, stomach ulcers, perforation, or gastrointestinal bleeding may occur, sometimes with a fatal outcome. Ketoprofen taken orally in a dose of 200 mg per day increases the risk of gastrointestinal bleeding; the risk increases with increasing dose.
Side effects are listed according to their frequency:

• Common (may affect up to 1 in 10 people): indigestion, nausea, abdominal pain, vomiting.

Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, drowsiness, constipation, diarrhea, bloating, gastritis, rash, itching, fatigue, edema.

Rare (may affect up to 1 in 1,000 people):

• changes in blood test results (anemia, bleeding anemia, leukopenia with possible agranulocytosis), anaphylactic reactions (including anaphylactic shock), paresthesia (tingling, burning, numbness of limbs), vision disturbances such as blurred vision, tinnitus, asthma, asthma attacks, oral mucositis, gastric ulcer and/or duodenal ulcer, hepatitis, increased liver enzyme activity, increased bilirubin levels in the blood associated with hepatitis, weight gain.

Very rare (may affect up to 1 in 10,000 people):

• pancreatitis.

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

• changes in blood test results (agranulocytosis, thrombocytopenia, neutropenia) bone marrow suppression, mood changes, depression, confusion, hallucinations, optic neuritis, seizures, taste disturbances, vertigo of labyrinthine origin, heart failure, vasodilation, hypertension, bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), dyspnea, non-specific allergic reactions, exacerbation of colitis and Crohn's disease, gastrointestinal bleeding and perforation (sometimes fatal, especially in the elderly), abdominal pain, heartburn, black stools, bloody vomiting, liver dysfunction, jaundice, reddening, hypersensitivity to light, hair loss, urticaria, blistering skin diseases (including toxic epidermal necrolysis and Stevens-Johnson syndrome), exfoliative dermatitis, purpura, angioedema, acute kidney failure (especially in patients with pre-existing kidney dysfunction and/or dehydration), interstitial nephritis, nephrotic syndrome, abnormal kidney function test results, malaise, rhinitis, hyperkalemia.

Cases of aseptic meningitis (especially in patients with systemic lupus erythematosus and mixed connective tissue disease) with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation.
Based on clinical trials and epidemiological data, the use of some NSAIDs (especially long-term and in high doses) is associated with a small increased risk of arterial thrombosis (e.g., myocardial infarction or stroke).
In any case of serious side effects, stop taking Febrofen immediately.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Febrofen

Store in a temperature below 25°C. Protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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 Febrofen contains

• The active substance of the medicine is ketoprofen. Each capsule contains 200 mg of ketoprofen.
• The other ingredients are: macrogol 4000, ethylcellulose, stearic acid, ammonium methacrylate copolymer (type B) - Eudragit RS, shellac, talc, neutral pellets (sucrose, cornstarch), erythrosine (E 127), titanium dioxide (E 171), gelatin.

What Febrofen looks like and contents of the pack

Febrofen is a hard gelatin capsule with a transparent base and pink cap, containing white or almost white spherical microgranules.
The medicine is available in blisters of aluminum/PVC foil in a cardboard box containing 20, 30, 60, or 90 capsules.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz
Polpharma S.A.
Production Plant in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet: