FELDENE 20 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Feldene, 20 mg/ml, Solution for Injection
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Feldene and what is it used for
5. Important information before taking Feldene
   1. When not to take Feldene
   2. Inform your doctor immediately if any of the above circumstances apply.
   3. Warnings and precautions
   4. Feldene and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Feldene contains benzyl alcohol, propylene glycol, alcohol (ethanol), and sodium
6. How to take Feldene
   1. Adults and elderly
   2. The doctor may recommend taking piroxicam with another medicine that protects the stomach and intestinal lining to prevent potential side effects.
   3. Dosage
   4. Rheumatoid arthritis, osteoarthritis (degenerative joint disease), ankylosing spondylitis
   5. Use in patients with renal impairment
   6. Use in elderly patients
   7. Use in children
   8. Overdose of Feldene
   9. Do not increase the dose of the medicine
   10. Missed dose of Feldene
   11. Discontinuation of Feldene treatment
7. Possible side effects
   1. Reporting side effects
8. How to store Feldene
9. Contents of the pack and other information
   1. What Feldene contains
   2. What Feldene looks like and contents of the pack
   3. Marketing authorization holder in Spain, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Feldene, 20 mg/ml, Solution for Injection

Piroxicam

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 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, tell your doctor or pharmacist. 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) 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 ulcer, bleeding, or perforation in the gastrointestinal tract;
• in cases of past gastrointestinal diseases (gastritis or colitis) that favor the occurrence of complications in the form of bleeding, including ulcerative colitis, Crohn's disease, gastrointestinal tumors, or diverticulitis (inflamed or infected pockets and/or pouches in the colon);
• in patients taking other NSAIDs, including selective COX-2 inhibitors and aspirin 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 with a history of severe skin reactions (regardless of severity), such as exfoliative dermatitis (intense redness of the skin with scaling), blistering reactions (Stevens-Johnson syndrome, a condition with redness of the skin and formation of blisters, ulcers, 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 postoperative pain during coronary artery bypass grafting.

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 Feldene treatment, discuss it with your doctor or pharmacist.
Before taking Feldene, the doctor will assess the risk of side effects. Like all nonsteroidal anti-inflammatory drugs, Feldene may cause serious gastrointestinal side effects, such as pain, bleeding, ulcers, and perforation.
Concomitant use of Feldene with systemic NSAIDs, other than low-dose aspirin, 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, stools with blood, or bloody vomiting, or gastrointestinal ulcers, Feldene treatment should be discontinued immediately and a doctor consulted.
If the patient experiences a rash or other skin symptoms, as well as any allergic reaction, such as facial swelling, wheezing, or difficulty breathing, Feldene treatment should be discontinued immediately, medical advice sought, and the doctor informed about the use of 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 aspirin, the doctor may recommend taking a medicine that protects the stomach and intestines in combination with Feldene.
Patients taking alcohol have an increased risk of gastrointestinal complications.
To minimize the potential risk of cardiovascular side effects, the doctor will decide on the appropriate dose adjustment (the smallest effective dose of piroxicam is recommended for the shortest possible duration).
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 using 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 fluid retention. Patients with congestive heart failure or hypertension should be monitored closely.
Like all NSAIDs, Feldene may cause hypertension or exacerbate 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.
Some patients taking NSAIDs, including Feldene, have experienced fluid retention and edema. Therefore, caution should be exercised when using Feldene in patients with heart failure 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 order the necessary tests.
Feldene may cause jaundice and liver failure leading to death. Although these reactions are rare, if abnormal liver function test results persist or worsen, or if symptoms indicating liver dysfunction and/or liver disease occur, or if systemic symptoms (e.g., eosinophilia, rash, etc.) occur, Feldene 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 individuals who are unsure if they can take piroxicam should consult a doctor before using the medicine.
Feldene may make it harder to get pregnant. If a patient plans to get pregnant or is having trouble getting pregnant, they should tell 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 of the medicine. Do 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), discuss your treatment with your doctor or pharmacist.
If it is suspected or confirmed that the patient has reduced activity of the so-called CYP2C9 enzyme system, caution should be exercised due to the possibility of increased blood levels of the medicine.

Feldene and other medicines

Tell your doctor or pharmacist about all medicines you are 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:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Feldene should not be used 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 advanced 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 amniotic fluid volume 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 conceiving or are undergoing fertility tests.

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, alcohol (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 one week without medical advice.
A large amount of Feldene may cause accumulation of benzyl alcohol in the body, resulting in an increase in blood acid levels (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 using 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 medicines containing propylene glycol or alcohol.
The medicine contains 100 mg of alcohol (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 that the medicine is considered "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 used. The doctor will adjust the treatment to the smallest effective dose. Under no circumstancesshould the dose be changed without consulting a doctor.
Feldene, 20 mg/ml solution for intramuscular injection, 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 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 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 duration.

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

Dosage

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 NSAID use 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 elderly patients

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

Use in children

The dosage and indications for use in children have not been established, so the use of Feldene in children 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 of the medicine

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 of the medicine to make up for the missed dose.

Discontinuation of Feldene treatment

If you have any further doubts about the use of this medicine, consult 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.
Gastrointestinal side effects, such as ulcers, hypertension, and heart failure, have been reported with NSAID use.
Taking medicines like Feldene 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.
Prolonged use of the medicine at 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, stomach 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 1,000 patients):

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

Rare side effects(occurring in less than 1 out of 10,000 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, perforations, ulcers,
• jaundice, liver failure leading to death,
• 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 (palpable purpura), nail detachment, photosensitivity, urticaria, blistering skin lesions, pruritus,
• nephrotic syndrome, nephritis, interstitial nephritis, renal failure,
• reduced fertility in women,
• local side effects (burning sensation) or tissue damage (formation of sterile abscesses, fat tissue necrosis) at the injection site, malaise, transient pain during injection,
• positive antinuclear antibody titers (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, 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, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 this medicine.

5. How to store Feldene

Keep the 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.
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 of the medicine 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, ethanol, benzyl alcohol, sodium hydroxide, hydrochloric acid, and water for injections (see section 2 "Feldene contains benzyl alcohol, propylene glycol, alcohol (ethanol), and sodium").

What Feldene looks like and contents of the pack

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

Marketing authorization holder in Spain, the country of export:

Pfizer, S.L.
Avda. de Europa, 20 B
Parque Empresarial La Moraleja
28108 Alcobendas, Madrid, Spain

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Spanish marketing authorization number:983866.9
Parallel import authorization number:641/12
Date of leaflet approval: 12.10.2022
[Information about the trademark]