Feldene

Package Leaflet: Information for the Patient

FELDENE 20 mg/ml, solution for injection
Piroxicam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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) with 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

• if the patient is allergic to piroxicam or any of the other ingredients of this medicine (listed in section 6);
• in patients with active or past stomach and/or duodenal ulcers, bleeding, or perforation in the gastrointestinal tract;
• in cases of past gastrointestinal diseases (gastritis or intestinal inflammation) that may lead to complications such as 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 redness of the skin and formation of blisters, erosions, or bleeding), and toxic epidermal necrolysis (Lyell's syndrome, a condition with blistering and peeling 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 in the third trimester.

Patients belonging to any of the above groups should not take piroxicam.

Inform your doctor immediately if any of the above circumstances apply.

Warnings and precautions

Before starting treatment with FELDENE, discuss it with your doctor or pharmacist.
Before taking FELDENE, the doctor should assess the benefit-risk ratio of side effects. 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.
Concomitant use of FELDENE with systemic NSAIDs, other than low-dose acetylsalicylic acid, should be avoided due to the increased frequency of ulcers and gastrointestinal bleeding.
If the patient experiences stomach pain or any symptoms of gastrointestinal bleeding, such as dark stools, bloody stools, bloody vomiting, or gastrointestinal ulcers, they should immediately stop taking FELDENE and consult a doctor.
If the patient experiences a rash or other skin symptoms, as well as any allergic reaction, such as facial swelling, wheezing, or difficulty breathing, they should immediately stop taking piroxicam, seek medical attention, and inform the doctor about taking this medicine.
In patients over 70 years of age, the doctor may shorten the treatment duration and order more frequent control visits during piroxicam treatment.
In patients over 70 years of age 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 along with FELDENE.
Patients taking alcohol are at 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 (the recommended dose is the smallest effective dose of piroxicam for the shortest possible duration).
Doctors and patients should be aware of the risk of cardiovascular side effects, so the doctor will inform the patient about the symptoms and/or signs of toxicity 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 conditions that may lead to fluid retention, as well as when the patient's condition may worsen due to fluid retention. Patients with congestive heart failure or hypertension should be monitored closely.
Like all NSAIDs, FELDENE may cause hypertension or worsening of existing hypertension, which may contribute to an increased risk of cardiovascular events. NSAIDs, including FELDENE, should be used with caution in patients with hypertension. Blood pressure should be closely monitored when starting FELDENE treatment and during therapy.
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 failure and other conditions 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 disease and in patients with significant dehydration. The doctor will decide on the appropriate dose adjustment and order the necessary tests.
FELDENE may cause jaundice and liver inflammation that can be fatal. Although these reactions are rare, if liver function test results are abnormal or worsen, or if symptoms indicating liver dysfunction and/or liver disease occur, or if systemic symptoms (e.g., eosinophilia, rash, etc.) occur, piroxicam treatment should be discontinued.
In patients who experience vision disturbances during piroxicam treatment, an ophthalmological examination is recommended.
Patient over 80 years old should not take this medicine.
Individuals with any diseases or allergies or those who are unsure if they can take piroxicam should consult a doctor before taking the medicine.
FELDENE may make it harder to get pregnant. If a patient is planning to get pregnant or is having trouble getting pregnant, they should inform their 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. Do not take more than the recommended dose or for longer than recommended.
If a patient has heart problems, has had a stroke, or suspects that they have conditions that increase the risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), they should discuss their treatment with their doctor or pharmacist.
If a patient is suspected or known to have reduced activity of the CYP2C9 enzyme system, caution should be exercised due to the possibility of increased blood levels of the medicine.
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, throat, nasal, genital, and conjunctival inflammation (red and swollen eyes).
These life-threatening skin rashes are often accompanied by flu-like symptoms. As the rash develops, extensive blisters or peeling of the skin may appear.
The greatest risk of serious skin reactions exists in the first few weeks of treatment.
If a patient experiences Stevens-Johnson syndrome or toxic epidermal necrolysis while taking FELDENE, they 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 a patient experiences a rash or other skin symptoms, they should immediately consult a doctor and inform them about taking this medicine.

FELDENE and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Medicines can sometimes interact with each other. The doctor may limit the use of piroxicam or other medicines or may prescribe a different medicine. It is especially important to inform the doctor:

• if the patient is taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs to reduce pain;
• if the patient is taking glucocorticosteroids, which are medications used to treat allergies and endocrine or hormonal disorders;
• if the patient is taking anticoagulant medications, such as acenocoumarol, to prevent blood clot formation;
• if the patient is taking medications used to treat depression, called selective serotonin reuptake inhibitors (SSRIs);
• if the patient is taking any medications, such as acetylsalicylic acid, to prevent platelet aggregation; FELDENE interferes with the antiplatelet effect of low-dose acetylsalicylic acid, and thus may interfere with the preventive treatment of cardiovascular diseases with acetylsalicylic acid.
• if the patient is taking antihypertensive medications, including diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (AIIA), and beta-blockers;
• if the patient is taking cardiac glycosides (digoxin and digitoxin);
• if the patient is taking cimetidine (a medication mainly used to treat stomach and duodenal ulcers);
• if the patient is taking cholestyramine (a medication that reduces cholesterol levels);
• if the patient is taking cyclosporin (an immunosuppressive medication used, among other things, in the treatment of transplant patients);
• if the patient is taking lithium and other medications that bind to plasma proteins;
• if the patient is taking methotrexate (a medication used, among other things, in the treatment of cancer and rheumatoid arthritis);
• if the patient is taking tacrolimus (an immunosuppressive medication used, among other things, in the treatment of atopic dermatitis).

Pregnancy, breastfeeding, and fertility

If a patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
FELDENE should not be taken during pregnancy.
Data from animal studies have shown that piroxicam, like other NSAIDs, may cause an increased frequency of difficult (dystocic) and delayed births 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 data 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 renal dysfunction in the fetus, which may contribute 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. The amount of amniotic fluid should be closely monitored in pregnant women taking piroxicam.
Breastfeeding
Piroxicam passes into breast milk, so FELDENE should not be taken by 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 conceiving or are undergoing fertility investigations.

Driving and using machines

The effect of piroxicam on the ability to drive and use machines has not been studied. Patients should consider 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 newborns is associated with a risk of serious side effects, including gasping syndrome. Medicines containing benzyl alcohol should not be given to newborns (up to 4 weeks of age) and should not be given to young children (under 3 years of age) for more than one week without medical advice.
Taking large amounts of FELDENE may lead to accumulation of benzyl alcohol in the body, resulting in increased blood acidity (metabolic acidosis). Patients with liver or kidney disease and 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, consult a doctor or pharmacist, especially if the child is taking other medications containing propylene glycol or alcohol.
The medicine contains 100 mg of ethanol 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 the medicine is "sodium-free".

3. How to take FELDENE

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your 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 the dose be changed without consulting a 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 duration necessary to relieve the symptoms.
Periodic assessment of the effectiveness of treatment and the patient's response to treatment should be performed, especially in patients with chronic diseases. Treatment of acute conditions should not exceed 14 days.

Adults and elderly

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

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 attack when NSAIDs are indicated. For the same reason, it should not be used in patients who are at the highest risk of serious gastrointestinal side effects.

Use in patients with renal impairment

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

Use in elderly patients

The doctor will decide on the appropriate dose adjustment for elderly patients.

Use in children and adolescents

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

Overdose of FELDENE

In case of overdose, contact a doctor.
In case of piroxicam overdose, the doctor will provide supportive and symptomatic treatment. Although no specific 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, always consult your doctor.

Missed dose of FELDENE

Take the medicine as soon as possible. However, if it is almost time for the next dose, do not take the missed dose, just take the next dose at the right time. Do not take a double dose to make up for a missed dose.

Stopping FELDENE treatment

If you have any further questions about taking this medicine, ask your 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 reports 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 doses higher than 30 mg increased the risk of gastrointestinal side effects.
Common(may affect up to 1 in 10 people):

• anemia, eosinophilia, leukopenia, thrombocytopenia
• anorexia, hyperglycemia
• dizziness, headache, drowsiness, vertigo
• tinnitus
• abdominal discomfort, abdominal pain, constipation, diarrhea, epigastric discomfort, flatulence, nausea, vomiting, dyspepsia
• pruritus, rash
• edema (mainly of the ankles)
• reversible increase in blood urea nitrogen (BUN), increased serum aminotransferase activity, weight gain
• decreased hemoglobin and hematocrit values not related to gastrointestinal bleeding

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

• hypoglycemia
• blurred vision
• palpitations
• stomatitis
• reversible increase in serum creatinine

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

• 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 disturbances, hallucinations, insomnia, disorientation, mood changes, nervousness
• aseptic meningitis, paresthesia
• eye irritation, eyelid edema
• hearing disturbances
• 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 shape of round or oval red patches and swelling of the skin), Henoch-Schönlein purpura (a condition characterized by palpable purpura, abdominal pain, and arthritis), nail separation from the nail bed, photosensitivity, pruritus, urticaria, vesicular rash
• nephrotic syndrome, 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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store FELDENE

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging (EXP).
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 pack and other information

What FELDENE contains

• The active substance is piroxicam. 1 ml of the solution for injection contains: 20 mg of piroxicam.
• The other ingredients are: sodium dihydrogen phosphate dihydrate, nicotinamide, propylene glycol (E1520), anhydrous ethanol, benzyl alcohol (E1519); sodium hydroxide and/or concentrated hydrochloric acid; water for injections (see section 2 "FELDENE contains benzyl alcohol, propylene glycol, ethanol, and sodium").

What FELDENE looks like and contents of the pack

FELDENE is packaged in ampoules (glass) placed in a cardboard box. The pack contains 6 ampoules.

Marketing authorization holder and manufacturer:

Marketing authorization holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer:
Fareva Amboise
Zone Industrielle
29 route des Industries
37530 Pocè-sur-Cisse
France
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet: