Piroxicam jelfa

Patient Information Leaflet

Piroxicam Jelfa, 10 mg, coated tablets
Piroxicam Jelfa, 20 mg, coated tablets
(Piroxicamum)
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Piroxicam Jelfa is and what it is used for
2. Important information before taking Piroxicam Jelfa
3. How to take Piroxicam Jelfa
4. Possible side effects
5. How to store Piroxicam Jelfa
6. Contents of the pack and other information

1. What Piroxicam Jelfa is and what it is used for

The active substance in this medicine is piroxicam, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Before prescribing Piroxicam Jelfa, 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 these visits are necessary while taking piroxicam.

Indications
Piroxicam Jelfa is used to relieve symptoms caused by:

• osteoarthritis,
• rheumatoid arthritis,
• ankylosing spondylitis (spinal rheumatism), such as joint swelling, stiffness, and pain.

This medicine does not cure joint inflammation 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 Piroxicam Jelfa

When not to use Piroxicam Jelfa:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking other medicines from the NSAID group, including selective COX-2 inhibitors, and acetylsalicylic acid (a substance present in many pain-relieving and antipyretic medicines),
• if the patient has experienced a severe allergic reaction to piroxicam, other NSAIDs, or other drugs, especially with severe skin reactions (regardless of severity), such as: exfoliative dermatitis (intense redness of the skin with peeling in scales or sheets), bullous-bullous reactions (Stevens-Johnson syndrome, a condition with redness of the skin and formation of blisters, erosions, hemorrhagic crusts or scabs), and toxic epidermal necrolysis (Lyell’s syndrome, a disease characterized by blister formation and shedding of the outer layer of the skin),
• if the patient develops a rash or other skin symptoms, treatment with Piroxicam Jelfa must be discontinued immediately, immediate medical advice must be sought, and the doctor must be informed about the use of this medicine,
• if the patient currently has or has previously had active peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding or perforation,
• if the patient has previously suffered from gastrointestinal disorders (inflammation of the mucous membrane of the stomach or intestines) predisposing to complications such as bleeding, including ulcerative colitis, Crohn’s disease, gastrointestinal tumors, or diverticulitis (inflamed or infected pouches/pits in the colon),
• if the patient is taking anticoagulant medicines, such as acenocoumarol, to prevent blood clots,
• in severe renal insufficiency,
• in severe hepatic insufficiency,
• in severe cardiac insufficiency,
• in haemorrhagic diathesis or coagulation disorders,
• in patients under 18 years of age,
• during the third trimester of pregnancy.

Patients belonging to any of the above groups should not use
piroxicam. It is essential to inform the doctor immediately if any of the above
conditions apply.
Warnings and precautions
Before starting to take piroxicam, discuss it with your doctor, pharmacist, or
nurse.
Piroxicam Jelfa should be used under continuous medical supervision. Before taking
Piroxicam Jelfa, always inform your doctor. Like all non-steroidal anti-inflammatory drugs, Piroxicam Jelfa may cause serious gastrointestinal reactions such as: stomach pain, bleeding, ulceration, and perforation.
Particular caution should be exercised when using Piroxicam Jelfa:

• if the patient experiences stomach pain or any signs of gastrointestinal bleeding, such as: black stools, stools containing blood, or vomiting blood, piroxicam use must be stopped immediately and the patient should consult a doctor,

• if the patient experiences any allergic reaction, such as skin rash, facial swelling, wheezing or difficulty breathing, piroxicam intake must be stopped immediately and the doctor must be informed about this reaction and the use of this medicine. After administration of piroxicam, potentially life-threatening skin rashes may occur (Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing as erythematous, target-like patches or circular lesions, often with central blisters on the
  torso. Additional symptoms to watch for include: oral, throat, nasal, and genital mucosal erosions, and conjunctivitis (red, swollen eyes). These potentially life-threatening rashes are often accompanied by flu-like symptoms. The rash may progress to extensive blistering or skin peeling.
  The highest risk of severe skin reactions occurs during the first weeks of treatment.
  Patients with any medical conditions or allergies, or those unsure whether they can use
  piroxicam, should consult their doctor before using the medicine.

• if visual disturbances occur during piroxicam treatment, an ophthalmological examination is recommended.

Patients with impaired renal function
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.
Patients with impaired cardiac function
Taking medicines such as Piroxicam Jelfa 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. Doses higher than recommended or longer treatment duration than advised should not be used.
In case of heart problems, previous stroke, or suspected risk of such conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), the treatment approach should be discussed with a doctor or pharmacist.
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 cardiovascular toxicity and the actions to take if such symptoms occur.
Piroxicam may cause fluid retention and edema; therefore, caution is required when using Piroxicam Jelfa in patients with impaired cardiac function and other conditions 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.
Elderly patients
For patients over 70 years of age, the doctor may minimize the duration of treatment and recommend more frequent follow-up visits 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 acetylsalicylic acid for anticoagulation prophylaxis, the doctor may prescribe a gastroprotective agent alongside Piroxicam Jelfa.
Patients over 80 years of age should not take this medicine.
Children and adolescents
This medicine should not be used in patients under 18 years of age.
Piroxicam Jelfa and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently used, or planned for use.
The doctor may restrict the use of piroxicam or other medicines, or may recommend an alternative medicine.
The patient should inform the doctor if taking:

• acetylsalicylic acid or other non-steroidal anti-inflammatory drugs for pain relief,
• corticosteroids, medicines used to treat, for example, allergies and endocrine/hormonal disorders,
• anticoagulant medicines such as acenocoumarol, to prevent blood clots,
• medicines used to treat depression, known as selective serotonin reuptake inhibitors (SSRIs),
• any medicines, such as acetylsalicylic acid, to prevent platelet aggregation,
• antihypertensive medicines (angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, -adrenergic blockers) or diuretics (furosemide, thiazides),
• cardiac glycosides (e.g. digoxin and digitoxin),
• cyclosporine (an immunosuppressive medicine used, among others, in transplant patients),
• lithium and other protein-bound medicines,
• methotrexate (a medicine used, among others, in oncological diseases and rheumatoid arthritis),
• tacrolimus (an immunosuppressive medicine used, among others, in atopic dermatitis),
• potassium-containing medicines and potassium-sparing diuretics,
• cimetidine,
• quinolones (bactericidal antibiotics).

If any of the above apply to the patient, the doctor should be informed immediately.
Piroxicam Jelfa and alcohol
Alcohol should not be consumed during treatment. Alcohol increases the risk of adverse effects. Piroxicam may increase blood alcohol concentration.
Piroxicam Jelfa 20 mg contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning pregnancy, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Due to the lack of established safety of piroxicam use in pregnant women, piroxicam should not be used during pregnancy if possible. Piroxicam Jelfa should not be used during the last three months of pregnancy, as it may cause fetal developmental abnormalities and delivery complications. Piroxicam Jelfa may cause kidney and heart problems in the unborn child. It may increase bleeding tendency in both the mother and the child and may delay or prolong labor. Piroxicam Jelfa should not be used during the first six months of pregnancy unless the doctor considers its use absolutely necessary.
If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. From week 20 of pregnancy, Piroxicam Jelfa may cause impaired renal function in the unborn child if used for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Piroxicam passes into breast milk; therefore, use of Piroxicam Jelfa is not recommended in breastfeeding women.
Effect on fertility
Piroxicam may impair fertility. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
This medicine may affect physical performance; therefore, caution is advised when performing activities requiring quick reflexes, such as driving vehicles or operating machinery.
Patients should consider the possibility of adverse effects (e.g.: drowsiness, blurred vision (see also section 4. "Possible side effects")) that may affect the ability to drive and operate machinery.

3. How to use Piroxicam Jelfa

This medicine should always be used exactly as prescribed by your doctor. If you have any doubts,
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.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms
reduces the risk of adverse effects (see section 4).

Recommended dose
Adults and elderly patients:
The maximum daily dose is 20 milligrams of piroxicam, taken as a single daily dose.
For patients over 70 years of age, the doctor may recommend a lower daily dose and shorten the duration of treatment.
The doctor may also recommend using piroxicam together with another medicine that protects the stomach and intestinal mucosa from potential adverse effects.

Taking the medicine with food and drink
The medicine should be taken orally during a meal.

Use in children and adolescents
This medicine should not be used in patients under 18 years of age.

Use in patients with impaired kidney function
The doctor will decide on the appropriate dose adjustment for patients with impaired kidney function.
The clinical condition of such patients should be closely monitored.

Use in patients with impaired heart function
The doctor will decide on the appropriate dose adjustment for patients with impaired heart function.

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

Taking more than the recommended dose of Piroxicam Jelfa
If you take more than the recommended dose of Piroxicam Jelfa, contact your doctor immediately.
In case of overdose, the doctor will provide supportive and symptomatic treatment.

Do not increase the dose
If you feel the medicine is not effective enough, always consult your doctor.

Missed dose of Piroxicam Jelfa
Take the missed dose as soon as possible. However, if it is almost time for the next dose, do not take the missed dose.
Take the next dose at the scheduled time.
Do not take a double dose of the medicine.

If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Piroxicam is generally well tolerated. The most commonly occurring adverse effects are gastrointestinal.
Adverse effects may occur with the following frequency:
Very common: more than 1 in 10 people
Common: 1 to 10 in 100 people
Uncommon: 1 to 10 in 1,000 people
Rare: 1 to 10 in 10,000 people
Very rare: less than 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data

During long-term treatment, the following may occur:

Gastrointestinal disorders
Very common: inflammation of the oral mucosa, anorexia, epigastric discomfort, gastric mucosal inflammation, gastritis, nausea, vomiting, constipation or diarrhoea, abdominal discomfort, abdominal pain, bloating, dyspepsia. In most cases, adverse effects did not affect the course of treatment.
Very rare: gastrointestinal bleeding (including haematemesis and melaena) associated with piroxicam use.
Rare: gastrointestinal perforations and ulcers (see section 4.4), pancreatitis.
Long-term administration of doses of 30 mg or higher increases the risk of gastrointestinal adverse effects.

Vascular disorders
Frequency not known: oedema, mainly in the ankle area.
Exacerbation of congestive heart failure should be considered in elderly patients or patients with impaired cardiac function.
Vasculitis.

Nervous system disorders
Frequency not known: aseptic meningitis, vertigo.
Rare: dizziness, headache, somnolence, paraesthesia.

Psychiatric disorders
Frequency not known: depression, sleep disorders, hallucinations, insomnia, disorientation, mood changes, nervousness.

Immune system disorders
Rare: anaphylaxis, bronchospasm, rash, serum sickness.

Skin and subcutaneous tissue disorders
Frequency not known: rash and itching, angioedema, exfoliative dermatitis, erythema multiforme, non-thrombocytopenic purpura (Henoch-Schoenlein purpura), blisters (urticaria), fixed drug eruption (may present as round or oval red spots and swellings on the skin).
Rare: potentially life-threatening skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2).
Nail detachment from the nail bed, alopecia, photosensitivity, bullous skin lesions.

Renal and urinary disorders
Rare: interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis.

Blood and lymphatic system disorders
Frequency not known: decreased haemoglobin concentration and haematocrit values, anaemia, aplastic anaemia, leukopenia, eosinophilia, haemolytic anaemia.
Rare: thrombocytopenia, petechiae, bone marrow suppression.

Hepatobiliary disorders
Frequency not known: hepatitis resulting in death, jaundice.
Although the above reactions are rare, if abnormal liver function test results persist or worsen, or if symptoms or signs indicating liver dysfunction/liver disease occur, or if systemic symptoms occur (e.g. eosinophilia, rash, etc.), treatment with piroxicam should be discontinued.

Metabolism and nutrition disorders
Frequency not known: hyperglycaemia (increased blood sugar level), hypoglycaemia (decreased blood sugar level).

Eye disorders
Frequency not known: blurred vision, eye irritation, swollen eyelids.

Ear and labyrinth disorders
Frequency not known: hearing disturbances, tinnitus.

Cardiac disorders
Frequency not known: palpitations.

Respiratory, thoracic and mediastinal disorders
Frequency not known: bronchospasm, dyspnoea, epistaxis.

General disorders and administration site conditions
Frequency not known: oedema (mainly in the ankles), malaise.

Investigations
Positive antinuclear antibody (ANA) titres, reversible increase in blood urea nitrogen (BUN) and serum creatinine, decreased haemoglobin concentration and decreased haematocrit not related to gastrointestinal bleeding, increased serum aminotransferase activity, decreased or increased body weight.

Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Piroxicam Jelfa

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (month and year) stated on the cardboard
pack after: Expiry date (EXP). 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 required. This will help protect
the environment.

6. Contents of the pack and other information

What Piroxicam Jelfa contains
The active substance is piroxicam. One coated tablet contains 10 mg or 20 mg of piroxicam.
Other components of the medicine are:
Piroxicam Jelfa, 10 mg, coated tablets
tablet core: calcium hydrogen phosphate dihydrate, potato starch, gelatin, magnesium stearate;
coating: hypromellose (15 cP), Macrogol 6000, hydroxypropylcellulose, titanium dioxide (E 171),
quinoline yellow, lac (E 104), simethicone emulsion.
Piroxicam Jelfa, 20 mg, coated tablets
tablet core: calcium hydrogen phosphate dihydrate, potato starch, hydroxypropylcellulose, sodium lauryl sulfate, magnesium stearate;
coating: hypromellose (15 cP), Macrogol 6000, hydroxypropylcellulose, titanium dioxide (E 171),
iron oxide red (E 172), talc, simethicone emulsion.
What Piroxicam Jelfa looks like and contents of the pack
Piroxicam Jelfa, 10 mg, coated tablets – yellow, round, biconvex coated tablets. The tablet break shows a white core.
Piroxicam Jelfa, 20 mg, coated tablets – light brown, round, biconvex coated tablets. The tablet break shows a white core.
Blister pack in a cardboard box.
20 tablets
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: + 48 17 865 51 00
Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
tel. (75) 643 31 02
fax: (075) 752 44 55
e-mail: [email protected]