Package Leaflet: Information for the User

Piroxicam Cinfa 20 mg Dispersible Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Piroxicam is an anti-inflammatory medication that belongs to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).

Piroxicam is used to relieve some symptoms caused by arthritis (degenerative joint disease), rheumatoid arthritis, and ankylosing spondylitis (spinal rheumatism), such as joint inflammation, stiffness, and pain. It does not cure arthritis, but it helps to relieve some symptoms only while continuing treatment.

The doctor will evaluate, before prescribing piroxicam, the benefits of this medication against the risk of developing adverse reactions. Due to piroxicam treatment, the doctor may require periodic checks and will inform you of their frequency.

Your doctor will prescribe piroxicam only when treatment with other nonsteroidal anti-inflammatory drugs (NSAIDs) has not relieved your symptoms.

Do not take piroxicam cinfa

• If you are allergic to piroxicam or any of the other ingredients in this medicine (listed in section 6)
• If you have had a stomach or intestinal ulcer, bleeding, or perforation.
• If you have a stomach or intestinal ulcer, bleeding, or perforation.
• If you have a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to hemorrhagic disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers, diverticulitis (inflammation or infection of the pouches/diverticula in the colon).
• If you are taking other NSAIDs, including COX-2 selective NSAIDs and acetylsalicylic acid, a substance that contains many medications used to relieve pain and reduce fever.
• If you are taking anticoagulants, such as warfarin, coumarins, or new oral anticoagulants, including apixaban, dabigatran, and rivaroxaban, to prevent blood clots.
• If you have had a severe allergic reaction to piroxicam, other NSAIDs, and other medications, especially severe skin reactions (regardless of severity) such as exfoliative dermatitis (intense redness of the skin, with peeling in layers or scales), vesiculobullous reactions (Stevens-Johnson syndrome that presents with red blisters, erosion, and skin with crusts or bleeding), and toxic epidermal necrolysis, (a disease that presents with peeling and blisters on the superficial layers of the skin), or if you have presented other allergy symptoms such as asthma attacks, severe nasal congestion, or other allergic reactions such as itching, rash, facial swelling, lip or tongue swelling that caused difficulty breathing or wheezing in the chest.
• If you present a skin rash or symptoms on the skin, stop taking piroxicam immediately, seek urgent medical advice, and inform your doctor that you are taking this medication.
• If you have a severe liver or kidney disease.
• If you have severe heart failure.
• If you have bleeding disorders.
• If you are in your third trimester of pregnancy.

If you present any of these situations, do not take piroxicam. Consult your doctor immediately.

Warnings and precautions

Consult your doctor or pharmacist before starting to take piroxicam.

Gastrointestinal risks

Like other nonsteroidal anti-inflammatory drugs, piroxicam can cause severe reactions in the stomach and intestines, such as pain, bleeding, ulceration, and perforation. The administration of doses above 20 mg per day increases the risk of adverse gastrointestinal effects. Adverse effects can be minimized by using the minimum effective doses for the shortest possible period.

You should interrupt treatment with piroxicam and consult your doctor if you have stomach pain or any sign of bleeding in the stomach or intestines, such as black or bloody stools or vomiting with blood.

If you present any new abdominal symptoms or gastrointestinal complications during treatment, interrupt the treatment and consult your doctor immediately.

Cutaneous risks

Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of piroxicam. Initially, they appear as red spots or circular patches, often with a central blister.

Other additional signs that may appear are mouth sores, throat, nose, genital, and conjunctivitis (swollen and red eyes).

These life-threatening skin reactions, often accompanied by flu-like symptoms, can progress to the formation of generalized blisters or skin peeling.

The highest risk period for severe skin reactions is during the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of piroxicam, do not use piroxicam again at any time.

If you develop these skin reactions or symptoms, stop taking piroxicam, go to a doctor immediately, and inform them that you are taking this medication.

Cardiovascular and cerebrovascular risks

Medications like piroxicam can be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) you should consult this treatment with your doctor or pharmacist.

These types of medications can also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Other risks

If you are over 70 years old, your doctor may reduce the treatment duration and perform more frequent checks while taking piroxicam.

If you are taking other medications, such as corticosteroids or certain antidepressants called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clots, your doctor may prescribe a medication to protect your stomach or intestines along with piroxicam.

Do not take this medication if you are over 80 years old.

If you have or have had any medical problems or any type of allergy or if you are unsure if you can take piroxicam, consult your doctor before taking this medication.

Make sure your doctor is informed about all the medications you are taking, including those purchased without a prescription.

You should also use piroxicam with caution, following your doctor's instructions in the following circumstances:

• You have a moderate or mild liver or kidney disease
• You have severe dehydration
• You have an infection, as it may mask fever and make you think, by mistake, that you are better or that the infection is not serious
• You present eye discomfort during treatment with piroxicam, you should go to an ophthalmologist
• You have asthma
• You are taking anticoagulants

Other medications and piroxicam cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Certain medications may interact with each other. Your doctor may limit the use of piroxicam and/or other medications or may need to change you to another medication. It is especially important to inform your doctor if you are taking any of the following medications:

• Aspirin or other nonsteroidal anti-inflammatory drugs to relieve pain.
• Corticosteroids, which are medications used to treat a multitude of diseases such as allergies, hormonal imbalances, and inflammatory diseases.
• Anticoagulants such as warfarin, coumarins, or new oral anticoagulants (apixaban, dabigatran, and rivaroxaban) to prevent blood clots.
• Antidepressants called selective serotonin reuptake inhibitors (SSRIs).
• Medications to prevent platelet aggregation such as acetylsalicylic acid.
• Lithium (medication used in bipolar depression).
• Methotrexate (medication used in rheumatoid arthritis and in the treatment of some cancers).
• Ticlopidine (antiplatelet medication).
• Quinolones (antibiotics).
• Certain diuretics (medications used to treat fluid retention in high blood pressure).
• Sulfonilureas (oral antidiabetic medications).
• Ciclosporina, tacrolimus (medications used in transplant patients).
• Antihypertensives (medications used to treat high blood pressure).
• Trombolitics (medications used for stroke or heart attack)
• Digoxina: the combined treatment with digoxina and piroxicam does not affect the plasma levels of either of these medications.

If you present any of these situations, consult your doctor immediately.

Taking piroxicam cinfa with food, drinks, and alcohol

If you take piroxicam with food, it may take a little longer to take effect, so it is recommended to take it between meals.

You should not ingest alcoholic beverages during treatment with this medication, as this may increase the risk of adverse effects.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take piroxicam if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Since the administration of medications of the type piroxicam has been associated with an increase in the risk of congenital anomalies/abortions, loss of amniotic fluid, it is not recommended to administer it during the first and second trimesters of pregnancy, except if it is strictly necessary and as your doctor indicates. In these cases,

If you need treatment during this period or while trying to become pregnant, the dose and duration will be limited to the minimum possible. From week 20 of pregnancy, the use of piroxicam may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) of the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

For fertile women, it should be taken into account that medications of the type piroxicam have been associated with a decrease in the ability to conceive.

Inform your doctor if you are breastfeeding your child or plan to start doing so. Piroxicam is not recommended for use in mothers who are breastfeeding, as the clinical safety has not been established.

Driving and operating machines

If you notice any dizziness, vertigo, visual disturbances, or sleepiness while taking piroxicam, do not drive or operate hazardous machinery until these symptoms disappear or check how you tolerate the medication.

Piroxicam contains sodium.This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Piroxicam cinfa tablets can be swallowed whole with a little liquid or taken by dispersing them first in a glass of water.

Your doctor will perform regular checks to ensure you are taking the appropriate dose of piroxicam. Your doctor will adjust the treatment to the lowest dose that effectively controls your symptoms. Under no circumstances should you modify the dose without consulting your doctor first.

Your doctor may prescribe piroxicam with another medication to protect your stomach and intestines from potential adverse reactions.

Do not increase the dose:

If you consider the medication to be ineffective, consult with your doctor.

Adults and elderly patients:

The maximum daily dose is 20 mg of piroxicam as a single daily dose.

If you are over 70 years old, your doctor may prescribe a lower daily dose and reduce the treatment duration.

Use in children:

It is not recommended for use in children.

If you take more piroxicam cinfa than you should

Contact your doctor or pharmacist immediately or your hospital's emergency service.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take piroxicam cinfa

Take it as soon as you remember. If it is almost time to take the next dose, do not take the one you missed, wait for the next scheduled dose. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them. Piroxicam is generally well tolerated.

The side effects of piroxicam vary in intensity from one individual to another, being generally mild and transient.

The following is a list of side effects. It is essential to inform your doctor if you notice any discomfort.

Frequent side effects:may affectup to 1 in 10 patients

Rare side effects:mayaffect up to 1 in 100 patients

Very rare side effects:mayaffect up to 1 in 10,000 patients

Side effects of unknown frequency:cannot be estimated from available data

• Inflammation of the membranes covering the brain and spinal cord caused by viruses, numbness or tingling in the extremities
• Irritation or inflammation of the eyes
• Alteration of hearing
• Inflammation of blood vessels, high blood pressure
• Spasms in the bronchi that prevent airflow to the lungs, difficulty breathing, nasal bleeding
• Reaction to suppositories with pain, burning, itching in the anal-rectal area or urgent need to defecate, accompanied by colic pain and in rare cases with rectal bleeding, inflammation of the stomach mucosa, gastrointestinal bleeding that may include vomiting with blood or black stools due to bleeding, inflammation of the pancreas, intestinal wounds or perforations

• Inflammation of the liver leading to death, yellow discoloration of the skin and mucous membranes
• Loss of hair, severe skin reactions that can be fatal (dermatitis exfoliativa, erythema multiforme, non-thrombocytopenic purpura)
• Renal disorders such as nephrotic syndrome and interstitial glomerulonephritis (often presenting with kidney swelling and proteinuria), and renal failure
• Decreased female fertility
• Alterations in analytical tests, weight loss
• Fixed drug eruption (may appear as rounded or oval plaques with redness and swelling of the skin), blisters (urticaria), itching

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Piroxicam cinfa composition

• The active ingredient is piroxicam. Each tablet contains 20 mg of piroxicam.
• The other components are: microcrystalline cellulose (E-460), dihydrated calcium phosphate, cornstarch, sodium carboxymethylcellulose (type A) (from potato), sodium stearoyl fumarate, magnesium stearate (E-470b), and talc (E-553b).

Appearance of the product and contents of the packaging

Piroxicam cinfa is presented in the form of dispersible, oblong, biconvex tablets, white-yellowish in color, with a notch on one face and marked with “P20C” on the other. It is presented in PVC-PVDC/Aluminum blisters. Each package contains 20 tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa, S.A. Laboratories

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:May 2023

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/62418/P_62418.html

QR code to:https://cima.aemps.es/cima/dochtml/p/62418/P_62418.html.