Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Feldene, 20 mg/ml, solution for injection
Piroxicam
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Feldene is and what it is used for
Important information before using Feldene
How to use Feldene
Possible side effects
How to store Feldene
Contents of the pack and other information

1. What Feldene is and what it is used for

Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) which also has analgesic and antipyretic properties.
Before prescribing piroxicam, your doctor will assess the benefits the medicine may provide you against the risk of adverse effects. Your doctor may recommend periodic check-ups and inform you how often follow-up visits are necessary while taking piroxicam.
Feldene is used to relieve symptoms caused by osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis (rheumatism of the spine), such as joint swelling, stiffness, and pain. The medicine does not cure arthritis and works only during the period it is taken.
Your doctor may prescribe piroxicam only if other non-steroidal anti-inflammatory drugs (NSAIDs) have not provided sufficient symptom relief.

2. Important Information Before Using Feldene

When not to use 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 a history of peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding or perforation;
in patients with a history of gastrointestinal disorders (such as inflammation of the gastric or intestinal mucosa) predisposing 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 non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors and acetylsalicylic acid at analgesic doses;
in patients taking anticoagulant medicines such as acenocoumarol to prevent blood clots;
in patients with a history of severe allergic reactions to piroxicam, other NSAIDs, or other drugs, especially severe skin reactions (regardless of severity), such as exfoliative dermatitis (intense redness of the skin with flaking or peeling), bullous reactions (Stevens-Johnson syndrome, characterized by red skin with blisters, erosions, hemorrhagic crusts), or toxic epidermal necrolysis (Lyell’s syndrome, a condition involving blistering and peeling of the superficial skin layer);
in patients with severe hepatic impairment;
in patients with severe renal impairment;
in patients with severe heart failure;
in patients with bleeding disorders or coagulation abnormalities;
in premature infants and newborns;
for perioperative pain management during coronary artery bypass graft surgery.

Patients belonging to any of the above groups should not use piroxicam.
If any of the above conditions apply, you must immediately inform your doctor.
Warnings and precautions

Before starting treatment with Feldene, discuss this with your doctor or pharmacist.
Before using Feldene, your doctor should assess the benefit-risk ratio regarding the potential for adverse effects. Like all non-steroidal anti-inflammatory drugs, Feldene may cause serious gastrointestinal adverse reactions such as pain, bleeding, ulceration, and perforation.
Concomitant use of Feldene with systemic NSAIDs, other than low-dose acetylsalicylic acid, should be avoided due to an increased risk of gastrointestinal ulcers and bleeding.
If the patient experiences stomach pain or any signs of gastrointestinal bleeding, such as black stools, blood in the stool, or bloody vomiting, or if gastrointestinal ulceration occurs, treatment with Feldene must be stopped immediately and medical advice sought.
If a rash or other skin symptoms appear, or any allergic reaction occurs, such as facial swelling, wheezing, or difficulty breathing, piroxicam must be discontinued immediately, medical advice sought urgently, and the doctor informed about the use of this medicine.
For patients over 70 years of age, the doctor may minimize the duration of treatment and recommend more frequent monitoring during piroxicam therapy.
In patients over 70 years of age or those taking other medicines such as corticosteroids, certain antidepressants known as selective serotonin reuptake inhibitors (SSRIs), or low-dose acetylsalicylic acid, the doctor may recommend concomitant use of a gastroprotective agent alongside Feldene.
Patients who consume alcohol have an increased risk of gastrointestinal complications.
To minimize the potential risk of cardiovascular adverse effects, the doctor will decide on appropriate dose adjustment (the lowest effective dose of piroxicam for the shortest possible duration is recommended).
Doctors and patients should remain vigilant for cardiovascular adverse effects; therefore, the doctor will inform the patient about symptoms and/or signs of toxicity and the actions to take if such symptoms occur.
Piroxicam may cause fluid retention and edema; therefore, caution is required when using Feldene in patients with impaired cardiac function or other conditions that may lead to fluid retention, or when the patient's condition could worsen due to fluid accumulation. Patients with congestive heart failure or hypertension should undergo appropriate monitoring.
As with all NSAIDs, Feldene may lead to the development or worsening of pre-existing hypertension, which may contribute to an increased frequency of cardiovascular events. NSAIDs, including Feldene, should be used with caution in patients with hypertension. Blood pressure should be closely monitored when starting treatment with Feldene and during therapy.
Fluid retention and edema have been observed in some patients taking NSAIDs, including Feldene. Therefore, caution is required when using Feldene in patients with cardiac disorders or other diseases causing or exacerbating fluid retention. Patients with congestive heart failure or hypertension should be carefully observed.
Caution is required when initiating piroxicam treatment in patients with kidney disease or significant dehydration. The doctor will decide on appropriate dose adjustment and necessary tests.
Feldene may cause jaundice and hepatitis leading to death. Although such 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 [increased number of eosinophils or acidophilic granulocytes in blood], rash, etc.) appear, Feldene must be discontinued.
Patients experiencing visual disturbances during piroxicam treatment should undergo an ophthalmological examination.
Patients over 80 years of age should not take this medicine.
Individuals with any medical conditions or allergies, or those unsure whether they can use piroxicam, should consult their doctor before using the medicine.
Feldene may impair fertility. If a patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.
Taking medicines such as Feldene may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses. Doses higher than recommended or longer treatment duration than advised should not be used.
In case of heart problems, history of stroke, or suspicion of conditions increasing the risk of these disorders (e.g., elevated blood pressure, diabetes, increased cholesterol, smoking), treatment should be discussed with a doctor or pharmacist.
If reduced activity of the CYP2C9 enzyme system is suspected or confirmed in a patient, caution is required due to the possibility of increased blood levels of the drug.
During treatment with Feldene, potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been observed, initially presenting as concentric erythematous lesions or round spots, often with centrally located blisters.
Additional symptoms may include oral, pharyngeal, nasal, or genital ulcers, and conjunctivitis (red, swollen eyes).
These life-threatening skin reactions are often accompanied by flu-like symptoms. As the condition progresses, extensive blisters or epidermal detachment may occur.
The highest risk of serious skin reactions occurs during the first weeks of treatment.
If Stevens-Johnson syndrome or toxic epidermal necrolysis occurs during treatment with Feldene, re-administration of this medicine must never be attempted.
Concomitant use of Feldene with oral anticoagulants [warfarin and/or coumarin derivatives, and new oral anticoagulants (e.g., apixaban, dabigatran, rivaroxaban)] increases the risk of gastrointestinal and non-gastrointestinal bleeding.
If a rash or other skin symptoms occur, immediate medical consultation is required, and the doctor must be informed about the use of this medicine.

Feldene and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Medicines may interact with each other. The doctor may limit the use of piroxicam or other medicines or may recommend an alternative medicine. It is particularly important to inform the doctor:

if the patient is taking acetylsalicylic acid or other NSAIDs for pain relief;
if the patient is taking glucocorticosteroids used in the treatment of, for example, allergies and endocrine and/or hormonal disorders;
if the patient is taking anticoagulants such as acenocoumarol to prevent blood clots;
if the patient is taking medicines used to treat depression, known as selective serotonin reuptake inhibitors (SSRIs);
if the patient is taking any medicines such as acetylsalicylic acid to prevent platelet aggregation. Feldene interferes with the antiplatelet effect of low-dose acetylsalicylic acid and may therefore interfere with acetylsalicylic acid prophylactic treatment for cardiovascular diseases;
if the patient is taking antihypertensive medicines, including diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (AIIA), and β-blockers;
if the patient is taking cardiac glycosides (digoxin and digitoxin);
if the patient is taking cimetidine (a medicine primarily used in the treatment of peptic ulcer disease);
if the patient is taking cholestyramine (a medicine that reduces cholesterol levels);
if the patient is taking cyclosporine (an immunosuppressive medicine used, among others, in transplant patients);
if the patient is taking lithium or other protein-bound medicines;
if the patient is taking methotrexate (a medicine used, among others, in cancer and rheumatoid arthritis);
if the patient is taking tacrolimus (an immunosuppressive medicine used, among others, in atopic dermatitis).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Feldene should not be used during pregnancy.
Animal studies have shown that piroxicam, like other NSAIDs, may increase the incidence of difficult labor (cervical dystocia) and delayed delivery in pregnant animals when treatment is continued into late 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 adversely affect pregnancy. Epidemiological data indicate that use of prostaglandin synthesis inhibitors in early pregnancy increases the risk of spontaneous abortion. Animal studies have shown that administration of prostaglandin synthesis inhibitors leads to loss of embryos before or after implantation.
NSAIDs used during the second or third trimester of pregnancy may cause renal dysfunction in the fetus, potentially leading to reduced amniotic fluid volume or, in severe cases, oligohydramnios. These effects may occur soon after starting treatment and are usually reversible. Amniotic fluid volume should be closely monitored in pregnant women taking piroxicam.

Breastfeeding

Piroxicam passes into breast milk; therefore, use of Feldene is not recommended in breastfeeding women.

Fertility

Due to its mechanism of action, NSAIDs, including piroxicam, may delay or prevent ovulation by inhibiting follicular rupture, leading to reversible infertility in some women. Discontinuation of NSAIDs, including piroxicam, should be considered in women experiencing difficulty conceiving or undergoing fertility investigations.

Driving and operating machinery

The effect of piroxicam on the ability to drive and operate machinery has not been studied.
Patients should consider the possibility of adverse effects (such as drowsiness, blurred vision; see also section 4 "Possible side effects") that may affect their ability to drive and operate machinery.

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 young children is associated with a risk of severe adverse effects, including respiratory disorders (so-called gasping syndrome). Medicines containing benzyl alcohol should not be administered to newborns (up to 4 weeks of age) or young children (under 3 years) for longer than one week without medical advice.
High doses 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, as well as pregnant or breastfeeding women, must exercise particular caution and consult their 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, contact 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 cause noticeable effects.
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning the medicine is considered "sodium-free".

3. How to use Feldene

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will schedule regular check-ups to ensure that the optimal dose of piroxicam is being used.
The doctor will adjust the treatment to the lowest effective dose. Under no circumstances should you
change the dose without first consulting your doctor.
Feldene, injection solution for intramuscular injection 20 mg/ml, is recommended for initial treatment
of acute conditions and exacerbations of chronic disorders. Intramuscular injections of piroxicam should
be administered into large muscles, observing aseptic technique.
The recommended injection site is the upper outer quadrant of the buttock (i.e. the gluteus maximus muscle).
As with all intramuscularly administered drugs, aspiration should be performed before injection to ensure
that the needle tip is not located within a blood vessel.
Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary
to relieve symptoms. The effectiveness of treatment and the patient's response should be periodically
evaluated, especially in chronically ill patients. Treatment of acute conditions should not exceed 14 days.
Adults and elderly patients
The maximum daily dose is 20 milligrams of piroxicam, administered as a single daily dose.
In patients over 70 years of age, the doctor may recommend a lower daily dose and shorter treatment duration.
The doctor may recommend concomitant use of piroxicam with a gastroprotective agent to protect the
gastrointestinal mucosa in order to prevent potential adverse 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 daily.
In a small group of patients, a maintenance dose of 10 mg daily may be sufficient.
Due to the gastrointestinal safety profile, Feldene should not be used as first-line treatment when NSAIDs
are indicated. For the same reason, it should not be used in patients at highest risk of serious gastrointestinal
adverse effects.
Use in patients with renal impairment
The doctor will decide on appropriate dose adjustment in patients with impaired renal function.
The clinical condition of patients should be closely monitored.
Use in elderly patients
The doctor will decide on appropriate dose adjustment in elderly patients.
Use in children
Dosage and indications in children have not been established; therefore, use of this medicine in children
is not recommended.
Use of a higher than recommended dose of Feldene
If an overdose of Feldene is taken, contact your doctor immediately.
In cases of piroxicam overdose, the doctor will provide supportive and symptomatic treatment. Although
appropriate studies have not been conducted, hemodialysis is unlikely to accelerate piroxicam elimination
because the drug is highly protein-bound.
Study results indicate that administration of activated charcoal may reduce absorption and reabsorption
of piroxicam, thereby reducing the total amount of drug available.
Do not increase the dose of the medicine
If you feel the medicine's effect is too strong or too weak, you should always consult your doctor.
Missed dose of Feldene
Take the missed dose as soon as possible. However, if it is almost time for the next dose, do not take the
missed dose; instead, take the next dose at the scheduled time. Do not take a double dose to make up
for a missed dose.
Stopping treatment with Feldene
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Feldene is generally well tolerated. The most commonly occurring adverse effects are related to the
gastrointestinal tract.
Edema, hypertension, and heart failure have been reported with NSAID therapy. Use of medicines such as Feldene may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Long-term use of the medicine at doses higher than 30 mg increases the risk of gastrointestinal adverse effects.

Common adverse effects (occur in 1 to 10 out of 100 patients):

anemia, eosinophilia, leukopenia, thrombocytopenia,
loss of appetite, hyperglycemia,
dizziness, headache, somnolence, dizziness due to vestibular disorders,
tinnitus,
abdominal discomfort, abdominal pain, constipation, diarrhea, epigastric disturbances, flatulence, nausea, vomiting, dyspepsia,
itching, skin rash,
edema (mainly of the ankles),
reversible increase in blood urea nitrogen (BUN), increased serum aminotransferase activity, weight gain.

Uncommon adverse effects (occur in 1 to 10 out of 1,000 patients):

hypoglycemia,
blurred vision,
palpitations,
inflammation of the oral mucosa,
reversible increase in blood creatinine concentration.

Very rare adverse effects (occur 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 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, swollen eyelids,
hearing disturbances,
vasculitis, hypertension,
bronchospasm, dyspnea, epistaxis,
gastritis, gastrointestinal bleeding (including hematemesis and melena), pancreatitis, perforations, ulcers,
jaundice, fatal hepatitis,
alopecia, angioedema, exfoliative dermatitis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), fixed drug eruption (may present as round or oval red patches and swelling on the skin), non-thrombocytopenic purpura (Henoch-Schoenlein purpura), nail detachment from the nail bed, photosensitivity, urticaria, vesicular lesions, pruritus,
nephrotic syndrome, glomerulonephritis, interstitial nephritis, renal failure,
decreased fertility in women,
local adverse 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 (ANA) titers, weight loss, decreased hemoglobin concentration, and decreased hematocrit not related to gastrointestinal bleeding.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Feldene

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 injection solution contains 20 mg of piroxicam.
Other components are: disodium dihydrogen phosphate dihydrate, nicotinamide, propylene glycol, ethanol, benzyl alcohol, sodium hydroxide, concentrated hydrochloric acid, 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 packed in 1 ml ampoules made of brown type I glass, placed in a cardboard box.
The pack contains 6 ampoules of 1 ml each.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, 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, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in Spain, country of export: 983866.9
Parallel import authorisation number: 641/12