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 this 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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 side effects. Your doctor may recommend regular check-ups and inform you how often follow-up visits are needed while taking piroxicam.
FELDENE is used to relieve symptoms caused by osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis (rheumatic spine disease), such as joint swelling, stiffness, and pain. FELDENE does not cure arthritis and only works while it is being 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 previous peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding or perforation;
in patients with a history of gastrointestinal disorders (such as gastritis or enteritis) predisposing to complications such as bleeding, including ulcerative colitis, Crohn's disease, gastrointestinal tumours, or diverticulitis (inflamed or infected pouches and/or recesses in the colon);
in patients taking other 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 – a condition with redness of the skin and formation of blisters, erosions, haemorrhagic crusts or scabs), or toxic epidermal necrolysis (Lyell's syndrome – a disease with blistering and shedding of the outer layer of the skin);
in patients with severe hepatic insufficiency;
in patients with severe renal insufficiency;
in patients with severe heart failure;
in patients with haemorrhagic diathesis or coagulation disorders;
in premature infants and newborns;
in the treatment of perioperative pain during coronary artery bypass graft (CABG) surgery;
in pregnant women during the third trimester.

Patients belonging to any of the above groups should not use piroxicam. You must immediately inform your doctor if any of the above conditions apply.

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 occurrence of adverse effects. Like all nonsteroidal anti-inflammatory drugs (NSAIDs), FELDENE may cause serious gastrointestinal adverse reactions such as pain, bleeding, ulceration and perforation.

Avoid concomitant use of FELDENE with other systemic NSAIDs, except low-dose acetylsalicylic acid, due to increased risk of gastrointestinal ulcers and bleeding.

If the patient experiences stomach pain or any signs of gastrointestinal bleeding such as black stools, bloody stools, vomiting blood, or gastrointestinal ulceration, treatment with FELDENE must be stopped immediately and medical advice sought.

If a rash or other skin symptoms appear, or any allergic reaction occurs (e.g. facial swelling, wheezing or breathing difficulties), piroxicam should be discontinued immediately, medical advice sought without delay, and the doctor informed about the use of this medicine.

For patients over 70 years of age, the doctor may shorten the duration of treatment and recommend more frequent check-ups 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 with FELDENE.

Patients who consume alcohol have an increased risk of gastrointestinal complications.

To reduce 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 be 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 oedema; therefore, caution is advised when using FELDENE in patients with impaired cardiac function or other diseases that may lead to fluid retention, as well as 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 onset 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 oedema have been observed in some patients taking NSAIDs, including FELDENE. Therefore, caution is advised when using FELDENE in patients with cardiac dysfunction or other diseases causing or exacerbating fluid retention. Patients with congestive heart failure or hypertension should be carefully observed.

Caution is advised when initiating piroxicam therapy in patients with renal disease or significant dehydration. The doctor will decide on appropriate dose adjustment and necessary investigations.

FELDENE may cause jaundice and hepatitis leading to death. Although these reactions are rare, treatment with FELDENE should be discontinued if abnormal liver function test results persist or worsen, if symptoms indicating liver dysfunction and/or liver disease occur, or if systemic symptoms (e.g. eosinophilia [increased number of eosinophils, i.e. acidophilic granulocytes in blood], rash, etc.) appear.

Patients who develop visual disturbances during piroxicam treatment should undergo an ophthalmological examination.

Patients over 80 years of age should not take this medicine.

Patients 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 myocardial infarction or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended.

If the patient has heart problems, a history of stroke, or suspects conditions increasing the risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking), the treatment approach should be discussed with the doctor or pharmacist.

If reduced activity of the CYP2C9 enzyme system is suspected or confirmed in the patient, caution is advised due to the possibility of increased drug concentration in blood.

Life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been observed during FELDENE treatment. These initially appear as concentric red lesions or round spots, often with centrally located blisters.

Additional symptoms may include oral, pharyngeal, nasal or genital ulceration and conjunctivitis (red, swollen eyes).

These life-threatening skin rashes are often accompanied by influenza-like symptoms. As the condition progresses, extensive blisters or epidermal detachment may occur.

The greatest risk of serious skin reactions occurs during the first weeks of treatment.

If Stevens-Johnson syndrome or toxic epidermal necrolysis occurs during FELDENE treatment, 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, the patient should consult a doctor immediately and inform them 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 restrict 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 nonsteroidal anti-inflammatory drugs for pain relief;
if the patient is taking glucocorticosteroids, medicines used to treat conditions such as allergies and endocrine and/or hormonal disorders;
if the patient is taking anticoagulant medicines 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 prophylactic acetylsalicylic acid treatment for cardiovascular diseases;
if the patient is taking antihypertensive medicines, including diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor type 1 (AT1) antagonists (AIIA), and β-blockers;
if the patient is taking cardiac glycosides (digoxin and digitoxin);
if the patient is taking cimetidine (a medicine mainly used to treat peptic ulcer disease);
if the patient is taking cholestyramine (a medicine that lowers 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 medicines bound to plasma proteins;
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 or 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 frequency of difficult labour (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, which may lead 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 ovarian follicle rupture, which may result in 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 vehicles 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 or 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 the 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.

Large amounts of FELDENE may lead to accumulation of benzyl alcohol in the body, resulting in increased acid levels in the blood (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 according to the instructions given 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. Your doctor will adjust
the treatment to the lowest effective dose. Under no
circumstances should you change the dose without first 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 into large muscles, maintaining aseptic technique.
The recommended injection site is the upper outer quadrant of the buttock (i.e. the gluteus maximus muscle). As with all drugs administered intramuscularly, aspiration should be performed before injection to ensure that the needle tip is not located within a blood vessel.
Adverse effects can 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 patients with chronic conditions. Treatment of acute conditions should not exceed 14 days.
Adults and elderly patients
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 shorter treatment duration.
The doctor may recommend concomitant use of piroxicam with a gastroprotective agent to protect the gastric and intestinal 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 per day. In a small group of patients, a maintenance dose of 10 mg per day may be sufficient.
Due to its gastrointestinal safety profile, FELDENE should not be used as a 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 status 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 in children is not recommended.
Taking more than the recommended dose of FELDENE
If you take more FELDENE than you should, contact your doctor immediately.
In case of piroxicam overdose, the doctor will provide supportive and symptomatic treatment. Although adequate studies have not been conducted, hemodialysis is unlikely to accelerate piroxicam elimination because the drug is highly protein-bound.
Research findings indicate that administration of activated charcoal may reduce absorption and reabsorption of piroxicam, thereby decreasing the total amount of drug available.
Do not increase the dose of the medicine
If you feel the effect of the medicine 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, skip the missed dose and 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 reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
FELDENE is generally well tolerated. The most commonly occurring adverse reactions
involve the gastrointestinal tract.
Edema, hypertension, and heart failure have been reported with the use of NSAIDs.
The 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 drug at doses higher than 30 mg increases the risk of gastrointestinal
adverse reactions.
Common adverse reactions (occur in 1 to 10 out of 100 patients):

anemia, eosinophilia, leukopenia, thrombocytopenia;
loss of appetite, hyperglycemia;
dizziness, headache, drowsiness, vertigo due to labyrinthine disorders;
tinnitus;
abdominal discomfort, abdominal pain, constipation, diarrhea, dyspepsia, flatulence with passage of gas, nausea, vomiting, indigestion;
itching, skin rash;
edema (mainly of the ankles);
reversible increase in blood urea nitrogen (BUN), increased serum aminotransferase activity, weight gain.

Uncommon adverse reactions (occur in 1 to 10 out of 1000 patients):

hypoglycemia;
blurred vision;
palpitations;
stomatitis;
reversible increase in blood creatinine concentration.

Very rare adverse reactions (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, arterial hypertension;
bronchospasm, dyspnea, epistaxis;
gastric mucositis, gastrointestinal bleeding (including hematemesis and melena), pancreatitis, perforations, ulcers;
jaundice, hepatitis leading to fatal outcome;
alopecia, angioedema, exfoliative dermatitis, erythema multiforme, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), persistent drug-induced erythema (may present as round or oval red patches and swelling on the skin), non-thrombocytopenic purpura (Henoch-Schönlein purpura), onycholysis, photosensitivity, urticaria, bullous lesions, pruritus;
nephrotic syndrome, glomerulonephritis, interstitial nephritis, renal failure;
decreased fertility in women;
local adverse reactions (burning sensation) or tissue damage (formation of sterile abscesses, fat necrosis) at the injection site, malaise, transient pain during injection;
positive antinuclear antibody (ANA) titers, weight loss, decreased hemoglobin concentration, and decreased hematocrit unrelated to gastrointestinal bleeding.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 reactions helps to obtain 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What FELDENE contains

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

What FELDENE looks like and contents of the pack
The medicine is packed in ampoules (made of 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.
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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Spain, country of export: 983866.9
Parallel Import Authorisation Number: 349/11

Feldene