Feldene

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

FELDENE

20 mg/ml, solution for injection Piroxicam

You should carefully read the leaflet before taking 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 doubts, you should consult a 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 as yours.
• If you experience any side effects, including those 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 FELDENE and what is it used for
• 2. Important information before taking FELDENE
• 3. How to take FELDENE
• 4. Possible side effects
• 5. How to store FELDENE
• 6. Contents of the pack and other information

1. What is FELDENE and what is it used for

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) that also has analgesic and antipyretic properties. Before prescribing piroxicam, the doctor will assess the benefits that the medicine may provide to the patient, compared to the risk of side effects. The doctor may order control tests and inform how often control visits will be necessary during piroxicam treatment. FELDENE is used to relieve symptoms caused by degenerative joint disease, rheumatoid arthritis, and ankylosing spondylitis (spinal rheumatism), such as swelling, stiffness, and joint pain. The medicine does not cure arthritis and only works while it is being taken. The doctor may prescribe piroxicam only when other nonsteroidal anti-inflammatory drugs (NSAIDs) have not provided sufficient relief of symptoms.

2. Important information before taking FELDENE

When not to take FELDENE

• in patients with active or past stomach and/or duodenal ulcer, bleeding or perforation in the gastrointestinal tract;
• in cases of a history of gastrointestinal diseases (gastritis or enteritis) that favor the occurrence of complications in the form of bleeding, including ulcerative colitis, Crohn's disease,

gastrointestinal tumors or diverticulitis (inflamed or infected pouches and/or diverticula in the colon);

• in patients taking other NSAIDs, including selective COX-2 inhibitors and acetylsalicylic acid in analgesic doses;
• in patients taking anticoagulant medications, such as acenocoumarol, to prevent blood clot formation;
• in patients with a history of severe allergic reactions to piroxicam, other NSAIDs, and other medications, especially those with a history of severe skin reactions (regardless of severity), such as exfoliative dermatitis (intensive redness of the skin with scaling or flaking), blistering reactions (Stevens-Johnson syndrome - a condition with skin redness and blistering), and toxic epidermal necrolysis (Lyell's syndrome - a disease with blistering and scaling of the skin);
• in patients with severe liver failure;
• in patients with severe kidney failure;
• in patients with severe heart failure;
• in patients with bleeding disorders or coagulation disorders;
• in premature infants and newborns;
• for the treatment of perioperative pain during coronary artery bypass grafting;
• in pregnant women during the third trimester.

Patients belonging to any of the above groups should not take piroxicam. You should immediately inform your doctor if any of the above circumstances occur.

Warnings and precautions

Before starting treatment with FELDENE, you should discuss it with your doctor or pharmacist. Before taking FELDENE, the doctor will assess the benefit-risk ratio of the treatment. Like all nonsteroidal anti-inflammatory drugs, FELDENE may cause serious side effects related to the stomach and intestines, such as pain, bleeding, ulcers, and perforation. You should avoid taking FELDENE with other systemic NSAIDs, except for low-dose acetylsalicylic acid, due to the increased frequency of ulcers and gastrointestinal bleeding. If you experience stomach pain or any signs of gastrointestinal bleeding, such as dark stools, stools with blood, bloody vomiting, or gastrointestinal ulcers, you should stop taking FELDENE and consult a doctor. If you experience a rash or other skin symptoms, as well as any allergic reaction, such as facial swelling, wheezing, or difficulty breathing, you should stop taking piroxicam, seek immediate medical attention, and tell your doctor about taking this medicine. In patients over 70 years old, the doctor may shorten the treatment duration and order more frequent control visits during piroxicam treatment. In patients over 70 years old or taking other medications, such as corticosteroids, certain antidepressants called selective serotonin reuptake inhibitors (SSRIs), or low-dose acetylsalicylic acid, the doctor may recommend taking a medicine that protects the stomach and intestines at the same time as FELDENE. In patients taking alcohol, there is an increased risk of gastrointestinal complications. To minimize the potential risk of side effects related to the cardiovascular system, the doctor will decide on the appropriate dose adjustment (it is recommended to use the smallest effective dose of piroxicam for the shortest possible period). Doctors and patients should be aware of the occurrence of cardiovascular side effects, so the doctor will inform the patient about the symptoms and/or signs of toxic effects and the actions to be taken in case of such symptoms. Piroxicam may cause fluid retention and edema, so caution should be exercised when taking FELDENE in patients with impaired heart function and other diseases that may lead to fluid retention, as well as when the patient's condition may worsen due to their retention. Patients with congestive heart failure or hypertension should be subject to appropriate control tests. Like all NSAIDs, FELDENE may cause hypertension or exacerbate existing hypertension, which can contribute to an increased risk of cardiovascular events. NSAIDs, including FELDENE, should be used with caution in patients with hypertension. During the initiation of FELDENE treatment and during therapy, blood pressure should be closely monitored. In some patients taking NSAIDs, including FELDENE, fluid retention and edema have been observed. Therefore, caution should be exercised when taking FELDENE in patients with heart function disorders and other diseases that cause or exacerbate fluid retention. Patients with congestive heart failure or hypertension should be closely monitored. Caution should be exercised when starting piroxicam treatment in patients with kidney diseases and in patients with significant dehydration. The doctor will decide on the appropriate dose adjustment and perform the necessary tests. FELDENE may cause jaundice and liver inflammation that can be fatal. Although these reactions are rare, in case of persistent abnormal test results or worsening liver function tests, as soon as symptoms indicating liver dysfunction and/or liver disease occur, or in case of systemic symptoms [e.g., eosinophilia (increased number of eosinophils, i.e., acidophilic granulocytes in the blood), rash, etc.], you should stop taking FELDENE. In patients who experience vision disturbances during piroxicam treatment, an ophthalmological examination is recommended. Patients over 80 years old should not take this medicine. People with any diseases or allergies or people who are not sure if they can take piroxicam should consult a doctor before taking the medicine. FELDENE may make it harder to get pregnant. If you are planning to get pregnant or are having trouble getting pregnant, you should tell your doctor. Taking medicines like FELDENE may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses. You should not take higher doses or longer treatment than recommended. If you have heart problems, have had a stroke, or suspect that you have conditions that increase the risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), you should discuss your treatment with your doctor or pharmacist. If you suspect or have been diagnosed with reduced activity of the so-called CYP2C9 enzyme system, you should exercise caution due to the possibility of increased drug concentration in the blood. During FELDENE treatment, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been observed, which initially have the shape of concentric red patches or round spots, often with centrally located blisters. Additional symptoms may occur, such as oral ulcers, throat ulcers, nose ulcers, genital ulcers, and conjunctivitis (red and swollen eyes). These life-threatening skin rashes are often accompanied by flu-like symptoms. In the further development of the rash, extensive blisters or skin peeling may appear. The greatest risk of serious skin reactions exists in the first few weeks of treatment. If you experience Stevens-Johnson syndrome or toxic epidermal necrolysis while taking FELDENE, you should never take this medicine again. Concomitant use of FELDENE with oral anticoagulants [warfarin and/or acenocoumarol and new oral anticoagulants (e.g., apixaban, dabigatran, rivaroxaban)] increases the risk of gastrointestinal bleeding and bleeding from other sources. If you experience a rash or other skin symptoms, you should immediately consult a doctor and tell them about taking this medicine.

FELDENE and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Medicines can sometimes interact with each other. Your doctor may limit the use of piroxicam or other medicines or may recommend taking a different medicine. It is especially important to inform your doctor:

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. Pregnancy FELDENE should not be taken during pregnancy. Animal studies have shown that piroxicam, like other NSAIDs, may increase the frequency of difficult (dystocic) and delayed labor in pregnant animals, in which the medicine was continued until the advanced stage of pregnancy. NSAIDs may also cause premature closure of the ductus arteriosus in newborns. Piroxicam is contraindicated during the third trimester of pregnancy. Inhibition of prostaglandin synthesis may have a negative effect on pregnancy. Epidemiological studies suggest that the use of prostaglandin synthesis inhibitors in early pregnancy increases the risk of spontaneous abortion. Animal studies have shown that the administration of prostaglandin synthesis inhibitors leads to embryo loss before or after implantation. NSAIDs used in the second or third trimester of pregnancy may cause fetal renal dysfunction, which may lead to a decrease in the amount of amniotic fluid or, in severe cases, to oligohydramnios. These effects may occur soon after the start of treatment and are usually reversible. Amniotic fluid volume should be closely monitored in pregnant women taking piroxicam. Breastfeeding Piroxicam passes into breast milk, so FELDENE is not recommended for use in breastfeeding women. Fertility Due to its mechanism of action, NSAIDs, including piroxicam, may delay or prevent ovulation, which is associated with reversible infertility in some women. Discontinuation of NSAIDs, including piroxicam, should be considered in women who have difficulty getting pregnant or are undergoing fertility testing.

Driving and using machines

The effect of piroxicam on the ability to drive and use machines has not been studied. Patients should take into account the possibility of side effects (drowsiness, blurred vision, see also section 4 "Possible side effects") that may affect the ability to drive and use machines.

FELDENE contains benzyl alcohol, propylene glycol, ethanol, and sodium

The medicine contains 20 mg of benzyl alcohol in each 1 ml ampoule. Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to small children is associated with a risk of serious side effects, including respiratory disorders (so-called gasping syndrome). Medicines containing benzyl alcohol should not be given to newborns (up to 4 weeks of age) or small children (under 3 years of age) for more than a week without a doctor's recommendation. Taking a large amount of FELDENE may cause accumulation of benzyl alcohol in the body, resulting in an increased amount of acid in the blood (so-called metabolic acidosis). Patients with liver or kidney disease, as well as pregnant or breastfeeding women, should exercise caution and consult a doctor before taking the medicine. The medicine contains 400 mg of propylene glycol in each 1 ml ampoule. Before administering the medicine to a child under 4 weeks of age, you should consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol. The medicine contains 100 mg of ethanol (alcohol) in each 1 ml ampoule. The amount of alcohol in each 1 ml ampoule of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects. The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means that the medicine is considered "sodium-free".

3. How to take FELDENE

This medicine should always be taken according to the doctor's or pharmacist's instructions. If you have any doubts, you should consult a doctor or pharmacist. The doctor will order regular control visits to ensure that the optimal dose of piroxicam is being taken. The doctor will adjust the treatment to the smallest effective dose. Under no circumstancesshould you change the dose without consulting your doctor. FELDENE, solution for intramuscular injection, 20 mg/ml is recommended for initial treatment of acute conditions and exacerbations of chronic diseases. Intramuscular injections of piroxicam should be administered in large muscles while maintaining asepsis. The proposed injection site is the upper outer quadrant of the buttock (i.e., the gluteus maximus muscle). As with all intramuscularly administered medicines, aspiration should be performed before injection to ensure that the needle tip is not in a blood vessel. Side effects can be minimized by using the smallest effective dose for the shortest period necessary to relieve symptoms. The effectiveness of the treatment and the patient's response to the treatment should be periodically evaluated, especially in patients with chronic diseases. Treatment of acute conditions should not exceed 14 days.

Adults and the elderly

The maximum daily dose is 20 milligrams of piroxicam, taken as a single daily dose. In patients over 70 years old, the doctor may recommend a lower daily dose and shorten the treatment period.

The doctor may recommend taking piroxicam with another medicine that protects the stomach and intestinal lining to prevent potential side effects.

Dosing for Rheumatoid arthritis, osteoarthritis (degenerative joint disease), ankylosing spondylitis

The recommended initial dose is 20 mg once daily. In most patients, the maintenance dose is 20 mg once daily. In a small group of patients, a maintenance dose of 10 mg once daily may be sufficient. Due to the gastrointestinal safety profile, FELDENE should not be used for the treatment of the first episode of a condition when an NSAID is indicated. For the same reason, it should not be used in patients who are most at risk of serious gastrointestinal side effects.

Use in patients with renal impairment

The doctor will decide on the appropriate dose adjustment of the medicine in patients with renal impairment. The patient's clinical condition should be closely monitored.

Use in the elderly

The doctor will decide on the appropriate dose adjustment of the medicine in elderly patients.

Use in children

Dosing and indications for use in children have not been established, so the use of the medicine in children is not recommended.

Overdose of FELDENE

In case of overdose, you should contact a doctor. In case of piroxicam overdose, the doctor will provide supportive and symptomatic treatment. Although no relevant studies have been conducted, hemodialysis is unlikely to accelerate the elimination of piroxicam, as the medicine is strongly bound to plasma proteins. Studies have shown that the administration of activated charcoal may reduce the absorption and reabsorption of piroxicam, thereby reducing the total amount of the medicine available.

Do not increase the dose

If you feel that the effect of the medicine is too strong or too weak, you should always consult a doctor.

Missed dose of FELDENE

You should take the medicine as soon as possible. However, if it is almost time for the next dose, you should not take the missed dose, but take the next dose at the right time. You should not take a double dose to make up for the missed dose.

Stopping FELDENE treatment

If you have any further doubts about taking this medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, FELDENE can cause side effects, although not everybody gets them. FELDENE is generally well tolerated. The most common side effects are related to the gastrointestinal tract. NSAID treatment has been associated with the occurrence of edema, hypertension, and heart failure. Taking medicines like FELDENE may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Long-term use of the medicine in doses higher than 30 mg increased the risk of gastrointestinal side effects. Common side effects(occurring in 1 to 10 out of 100 patients):

• anemia, eosinophilia, leukopenia, thrombocytopenia;
• anorexia, hyperglycemia;
• dizziness, headache, drowsiness, vertigo due to balance disorders;
• tinnitus;
• abdominal discomfort, abdominal pain, constipation, diarrhea, epigastric disorders, flatulence, nausea, vomiting, dyspepsia;
• pruritus, skin rash;
• edema (mainly of the ankles);
• reversible increase in blood urea nitrogen (BUN), increased serum aminotransferase activity, weight gain.

Uncommon side effects(occurring in 1 to 10 out of 1000 patients):

• hypoglycemia;
• blurred vision;
• palpitations;
• stomatitis;
• reversible increase in serum creatinine levels.

Rare side effects(occurring in less than 1 out of 10000 patients):

• Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

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

• aplastic anemia, hemolytic anemia;
• anaphylaxis, serum sickness;
• fluid retention;
• depression, sleep disorders, hallucinations, insomnia, disorientation, mood changes, nervousness;
• aseptic meningitis, paresthesia;
• eye irritation, eyelid edema;
• hearing disorders;
• vasculitis, hypertension;
• bronchospasm, dyspnea, epistaxis;
• gastritis, gastrointestinal bleeding (including bloody vomiting and melena), pancreatitis, perforation, ulcers;
• jaundice, liver failure;
• alopecia, angioedema, exfoliative dermatitis, erythema multiforme, drug rash with eosinophilia and systemic symptoms (DRESS), fixed drug eruption (may have the form of round or oval red patches and swelling on the skin), Henoch-Schönlein purpura (a condition characterized by the appearance of purpura, joint pain, and abdominal pain), nail detachment, photosensitivity, urticaria, blistering changes;
• nephrotic syndrome, glomerulonephritis, interstitial nephritis, renal failure;
• reduced fertility in women;
• local side effects (burning sensation) or tissue damage (formation of sterile abscesses, fat necrosis) at the injection site, malaise, transient pain during injection;
• positive antinuclear antibodies (ANA), weight loss, decreased hemoglobin levels, and decreased hematocrit not related to gastrointestinal bleeding.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 (22) 49 21 301, fax: +48 (22) 49 21 309, website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store FELDENE

The medicine should be stored out of sight and reach of children. Store at a temperature below 30°C. Do not use this medicine after the expiry date stated on the packaging. 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 FELDENE contains

• The active substance of the medicine is piroxicam. 1 ml of the solution for injection contains: 20 mg of piroxicam.
• The other ingredients are: disodium phosphate dihydrate, nicotinamide, propylene glycol, ethanol, benzyl alcohol, sodium hydroxide, and/or hydrochloric acid, water for injections.

What FELDENE looks like and contents of the pack

The medicine is packaged in ampoules (type I glass) placed in a cardboard box. The packaging contains 6 ampoules of 1 ml each. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Pfizer S.L. Avenida de Europa 20-B Parque empresarial La Moraleja 28108 Alcobendas Madrid, Spain

Manufacturer:

Fareva Amboise Zone Industrielle, 29 Route des Industries 37530 Poce-sur-Cisse France Pfizer Manufacturing Belgium NV Rijksweg, 12 B-2870 Puurs Belgium

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Spanish marketing authorization number: 983866.9

Parallel import authorization number: 349/11 Date of leaflet approval: 07.01.2022

[Information about the trademark]