Piroxicam Ielfa

Leaflet accompanying the packaging: patient information

Piroxicam Jelfa 10 mg, coated tablets
Piroxicam Jelfa 20 mg, coated tablets
(Piroxicam)

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• -You should keep this leaflet, so that you can read it again if necessary.
• -If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• -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.
• -If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

The active substance of the medicine is piroxicam, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).
Before prescribing Piroxicam Jelfa, 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 in connection with taking piroxicam.
Indications for use
Piroxicam Jelfa is used to alleviate symptoms caused by:

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

The medicine does not cure arthritis and only works during the period it is taken.
The doctor may prescribe piroxicam only when other nonsteroidal anti-inflammatory drugs (NSAIDs) have not provided sufficient relief from symptoms.

2. Important information before using Piroxicam Jelfa

When not to use Piroxicam Jelfa:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking other NSAIDs, including selective COX-2 inhibitors, and acetylsalicylic acid (a substance found in many painkillers and antipyretics),
• if the patient has had a severe allergic reaction to piroxicam, other NSAIDs, and other medicines, especially with a history of severe skin reactions (regardless of severity), such as: exfoliative dermatitis (intensive redness of the skin with its peeling in flakes or plates), blistering reactions (Stevens-Johnson syndrome, a condition with redness of the skin and the formation of blisters, erosions, hemorrhages, or scabs) and toxic epidermal necrolysis (Lyell's syndrome, a disease with the formation of blisters and peeling of the top layer of skin),
• if the patient develops a rash or other skin symptoms, they should immediately stop using Piroxicam Jelfa, seek immediate medical attention, and tell their doctor about taking this medicine,
• if the patient has or has had active stomach or duodenal ulcer, gastrointestinal bleeding, or perforation,
• if the patient has a history of gastrointestinal diseases (gastritis or enteritis) that may lead to complications in the form of bleeding, including ulcerative colitis, Crohn's disease, gastrointestinal tumors, or diverticulitis (inflamed or infected pouches/pockets in the colon),
• if the patient is taking anticoagulant medications, such as acenocoumarol, to prevent blood clot formation,
• in severe renal impairment,
• in severe hepatic impairment,
• in severe heart failure,
• in hemorrhagic diathesis or coagulation disorders,
• in patients under 18 years of age,
• in the third trimester of pregnancy.

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

Warnings and precautions

Before starting to take piroxicam, you should discuss it with your doctor, pharmacist, or nurse.
Piroxicam Jelfa should be used under constant medical supervision. Before taking Piroxicam Jelfa, you should always inform your doctor. Like all nonsteroidal anti-inflammatory drugs, Piroxicam Jelfa may cause serious gastrointestinal reactions, such as: pain, bleeding, ulcers, and perforation.
You should be particularly careful when using Piroxicam Jelfa:

• if the patient experiences stomach pain or any symptoms of gastrointestinal bleeding, such as: dark stools, stools with blood, or bloody vomiting, they should immediately stop using piroxicam and consult a doctor,
• if the patient experiences any allergic reaction, such as skin rash, facial swelling, wheezing, or difficulty breathing, they should immediately stop taking piroxicam and inform their doctor about this reaction and the use of this medicine.After using piroxicam, potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) may occur, in the form of reddish target-like spots or circular eruptions, often with blisters in the center on the torso. Additional symptoms to pay attention to include: mouth ulcers, throat, nose, and genital ulcers, as well as conjunctivitis (red and swollen eyes). These potentially life-threatening rashes are often accompanied by flu-like symptoms. The rash may develop into extensive blisters or skin peeling.
  The highest risk of severe skin reactions occurs in the first few weeks of treatment.
  People with any diseases or allergies or people who are not sure if they can use piroxicam should consult a doctor before using the medicine,

If the patient experiences vision disturbances during piroxicam treatment, an ophthalmological examination is recommended.

• if the patient experiences vision disturbances during piroxicam treatment, an ophthalmological examination is recommended.

Patients with renal impairment

Care should be taken when starting piroxicam treatment in patients with kidney disease and in patients with significant dehydration. The doctor will decide on the appropriate dose adjustment and order the necessary tests.

Patients with heart impairment

Taking such medicines as Piroxicam Jelfa may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not use higher doses or longer treatment than recommended.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, increased cholesterol levels, smoking), you should discuss the treatment with your doctor or pharmacist.
To minimize the potential risk of cardiovascular side effects, the doctor will decide on the appropriate dose adjustment (it is recommended to use the smallest effective dose of piroxicam for the shortest possible period).
Doctors and patients should pay attention to the occurrence of cardiovascular side effects, so the doctor will inform the patient about the symptoms and/or signs of toxic effects on the cardiovascular system and the actions to be taken in case of such symptoms.
Piroxicam may cause fluid retention and edema, so care should be taken when using Piroxicam Jelfa 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 as a result of their retention. Patients with congestive heart failure or hypertension should be subject to appropriate control tests.

Patients in old age

In the case of patients over 70 years of age, the doctor may shorten the duration of treatment and order more frequent control visits during the use of piroxicam.
In patients over 70 years of age or taking other medicines, such as corticosteroids, certain antidepressants called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid as a blood clot prevention, the doctor may prescribe a medicine that protects the stomach and intestines along with Piroxicam Jelfa.
Patient over 80 years of age should not use this medicine.

Children and adolescents

The medicine should not be used in patients under 18 years of age.

Piroxicam Jelfa and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as medicines you plan to take.
The doctor may limit the use of piroxicam or other medicines or may recommend taking another medicine.
You should inform your doctor if you are taking:

• acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs to reduce pain,
• corticosteroids, which are medicines used to treat, for example, allergies and endocrine/hormonal disorders,
• anticoagulant medications, such as acenocoumarol, to prevent blood clot formation,
• medicines used to treat depression, called selective serotonin reuptake inhibitors (SSRIs),
• any medicines, such as acetylsalicylic acid, to prevent blood clotting,
• medicines that lower blood pressure (angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, beta-blockers) or diuretics (furosemide, thiazides),
• cardiac glycosides (e.g., digoxin and digitoxin),
• cyclosporine (an immunosuppressive medicine used, among other things, in the treatment of transplant patients),
• lithium and other medicines that bind to plasma proteins,
• methotrexate (a medicine used, among other things, in the treatment of cancer and rheumatoid arthritis),
• tacrolimus (an immunosuppressive medicine used, among other things, in the treatment of atopic dermatitis),
• medicines containing potassium and potassium-sparing diuretics,
• cimetidine,
• quinolones (bactericidal antibiotics).

If any of the above statements apply to you, you should immediately inform your doctor.

Piroxicam Jelfa and alcohol

You should not consume alcohol while using the medicine. Alcohol increases the risk of side effects. Piroxicam may increase the blood alcohol level.

Piroxicam Jelfa 20 mg contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Due to the fact that the safety of using piroxicam in pregnant women has not been established, unless necessary, the use of piroxicam during pregnancy is not recommended. Piroxicam Jelfa should not be used in the last three months of pregnancy, as it may cause fetal developmental abnormalities and complications during delivery. Piroxicam Jelfa may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first six months of pregnancy, Piroxicam Jelfa should not be used unless the doctor considers its use absolutely necessary.
If treatment is necessary during this period or during attempts to become pregnant, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Piroxicam Jelfa may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If treatment is required for a longer period than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Piroxicam passes into breast milk, so Piroxicam Jelfa should not be used in breastfeeding women.
Fertility
Piroxicam may make it difficult to become pregnant. If you plan to become pregnant or have problems becoming pregnant, you should inform your doctor.

Driving and using machines

This medicine may affect your ability to drive or use machines, so caution is recommended when performing tasks that require quick reflexes, such as driving vehicles or operating machinery.
Patient should consider the possibility of side effects (including: drowsiness, blurred vision (see also section 4 "Possible side effects")) that may affect the ability to drive vehicles or operate machinery.

3. How to use Piroxicam Jelfa

This medicine should always be used as directed by your doctor. If you are unsure, you should consult 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 modify the treatment to the smallest effective dose.
Under no circumstancesshould you change the dose without consulting your doctor first.
Taking the medicine in the smallest effective dose for the shortest possible time necessary to alleviate symptoms reduces the risk of side effects (see section 4).
Recommended dose

Adults and elderly:

The maximum daily dose is 20 milligrams of piroxicam, taken as a single daily dose.
In patients over 70 years of age, the doctor may recommend a lower daily dose and shorten the treatment period.
The doctor may recommend taking piroxicam with another medicine that protects the stomach and intestines from potential side effects.

Using the medicine with food and drink

The medicine should be taken orally during a meal.

Using the medicine in children and adolescents

The medicine should not be used in patients under 18 years of age.

Using the medicine 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.

Using the medicine in patients with heart impairment

The doctor will decide on the appropriate dose adjustment of the medicine in patients with heart impairment.

Using the medicine in elderly patients

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

Taking a higher dose of Piroxicam Jelfa than recommended

In case of taking a higher dose of Piroxicam Jelfa than recommended, you should contact your doctor.
In case of overdose, the doctor will provide supportive and symptomatic treatment.

Do not increase the dose

If you feel that the medicine is not effective enough, you should always consult your doctor.

Missing a dose of Piroxicam Jelfa

You should take the medicine as soon as possible. However, if it is close to the time of the next dose, you should not take the missed dose. You should take the next dose at the right time.

Do not take a double dose of the medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Piroxicam is generally well-tolerated. The most common side effects are related to the gastrointestinal tract.
Side effects may occur with the following frequency:
very common: more than 1 in 10 people
common: 1 in 10 to 1 in 100 people
uncommon: 1 in 100 to 1 in 1,000 people
rare: 1 in 1,000 to 1 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:oral mucosal inflammation, anorexia, upper abdominal discomfort, gastritis, dyspepsia, nausea, vomiting, constipation or diarrhea, abdominal discomfort, abdominal pain, bloating, dyspepsia. In most cases, side effects did not affect the course of treatment.
Very rare: gastrointestinal bleeding (including bloody vomiting and black stools) associated with the use of piroxicam,
Rare:perforations and ulcers (see section 4.4), pancreatitis.
Long-term administration of doses of 30 mg or higher increases the risk of gastrointestinal side effects.

Vascular disorders

Frequency not known: edema, mainly in the ankles.
It should be remembered that there is a possibility of worsening congestive heart failure in elderly patients or patients with impaired heart function.
Vasculitis.

Nervous system disorders

Frequency not known: aseptic meningitis, dizziness.
Rare:headache, drowsiness, paresthesia.

Psychiatric disorders

Frequency not known: depression, sleep disturbances, 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, Henoch-Schönlein purpura (a condition characterized by the deposition of immune complexes in small blood vessels), blisters (urticaria), fixed drug eruption (may have the form of round or oval reddened spots and swelling on the skin).
Rare: potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), (see section 2).
Onycholysis (separation of the nail from the nail bed), alopecia, photosensitivity, blistering skin eruptions.

Renal and urinary disorders

Rare: interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis.

Blood and lymphatic system disorders

Frequency not known: decreased hemoglobin and hematocrit values, anemia, aplastic anemia, leukopenia, eosinophilia, hemolytic anemia.
Rare:thrombocytopenia, purpura, bone marrow depression.

Hepatobiliary disorders

Frequency not known: liver inflammation leading to death, jaundice.
Although the above reactions are rare, in case of persistent abnormal test results or worsening of test results, or in case of symptoms or signs indicating liver dysfunction/disease, or in case of systemic symptoms (e.g., eosinophilia, rash, etc.), piroxicam treatment should be discontinued.

Metabolic and nutritional disorders

Frequency not known: hyperglycemia (elevated blood sugar level), hypoglycemia (low blood sugar level).

Eye disorders

Frequency not known: blurred vision, eye irritation, eyelid edema.

Ear and labyrinth disorders

Frequency not known: hearing impairment, tinnitus.

Cardiac disorders

Frequency not known: palpitations.

Respiratory, thoracic, and mediastinal disorders

Frequency not known: bronchospasm, dyspnea, epistaxis.

General disorders and administration site conditions

Frequency not known: edema (mainly ankles), malaise.

Investigations

Positive antinuclear antibody titers, reversible increased blood urea nitrogen (BUN) and creatinine levels, decreased hemoglobin and hematocrit values not related to gastrointestinal bleeding, increased serum aminotransferase activity, weight loss or gain.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Piroxicam Jelfa

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date (month and year) stated on the carton after: Expiry date. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Piroxicam Jelfa contains

The active substance of the medicine is piroxicam. One coated tablet contains 10 mg or 20 mg of piroxicam.
The other ingredients 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, hydroxypropyl cellulose, titanium dioxide (E 171), quinoline yellow, lake (E 104), simethicone emulsion.
Piroxicam Jelfa, 20 mg, coated tablets
tablet core:calcium hydrogen phosphate dihydrate, potato starch, hydroxypropyl cellulose, sodium lauryl sulfate, magnesium stearate;
coating:hypromellose (15 cP), Macrogol 6000, hydroxypropyl cellulose, 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.
Tablet break line is white.
Piroxicam Jelfa, 20 mg, coated tablets - light brown, round, biconvex coated tablets. Tablet break line is white.
Blister pack in a carton box.
20 tablets

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
phone: (75) 643 31 02
fax: (075) 752 44 55
e-mail: [email protected]

Date of last revision of the leaflet: