Package Insert: Information for the User

Feldene Flas 20 mg lyophilized oral

piroxicam

Read this package insert carefully before starting to take this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• Ifyouexperienceadverse effects, consult your doctor, pharmacist or nurse,eveniftheydo not appearin this package insert. See section 4.

Feldene Flas 20 mg lyophilized oral is a medication that is presented as a lyophilized oral that is characterized by dissolving instantly in contact with saliva.

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

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

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

Do not take piroxicam

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you have had stomach ulcers, bleeding, or perforation.
• If you have stomach ulcers, bleeding, or perforation.
• If you have a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose you 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 contained in 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, characterized by red blisters, erosion, and skin with crusts or bleeding), and toxic epidermal necrolysis, 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 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, pharmacist, or nurse before starting to take Feldene.

Gastrointestinal risks

Like other nonsteroidal anti-inflammatory drugs, Feldene 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 presenting adverse gastrointestinal effects.

You should interrupt the 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.

Cutaneous risks

Severe skin reactions that can be life-threatening (DRESS syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been described with the use of Feldene. 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 the appearance of 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 Feldene, do not use Feldene again at any time.

If you present a skin rash or symptoms on the skin, stop taking Feldene immediately, seek urgent medical advice, and inform your doctor that you are taking this medication.

Cardiovascular and cerebrovascular risks

Medications like Feldene 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) 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 (hypertension).

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 over 70 years old or 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 Feldene.

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

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

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

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

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

Use of Feldene with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• Aspirin or other anti-inflammatory medications 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 (antibacterial medications).
• Certain diuretics (medications used to treat fluid retention in hypertension).
• Sulfonilureas (oral antidiabetic medications).
• Ciclosporin, tacrolimus (medications used in transplant patients).
• Antihypertensives (medications used to treat high blood pressure).
• Digoxin: the combined treatment with digoxin 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 Feldene Flas 20 mg, lyophilized oral with food, drinks, and alcohol

If you take Feldene Flas 20, lyophilized oral with food, it may take a little longer to take effect, so it is recommended to take it between meals.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

NSAIDs can cause kidney and heart problems in the fetus. NSAIDs can affect the mother's and baby's tendency to bleed and delay or prolong labor more than expected.

From week 20 of pregnancy, NSAIDs can cause kidney problems in the fetus if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (arterial duct) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, administration of Feldene is contraindicated.

For fertile women, it should be noted that medications like Feldene 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. It is not recommended to use Feldene in mothers who are breastfeeding, as the clinical safety has not been established.

Driving and operating machinery

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

Excipients with known effect

This medication contains 0.25 mg of aspartame in each lyophilized oral.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

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.

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 your doctor.

Adults and elderly:

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.

Method of use:

Due to the special characteristics of Feldene Flas 20 mg Lyophilized oral, to extract the lyophilizates from the packaging, follow these instructions:

1. Do not extract the oral lyophilizates by pressing on them, as is usually done.
2. Open the blister pack containing each oral lyophilizate by gently pulling the tab provided for this purpose.
3. Extract the oral lyophilizate with dry fingers, without pressing it, and deposit it on the tongue, where it will dissolve almost instantly in the presence of water or saliva.

If you take more Feldene Flas 20 mg lyophilized oral than you should:

Contact your doctor or pharmacist immediately or the emergency service of your hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Feldene:

Take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Wait for the next scheduled dose. Do not take a double dose to compensate for the missed dose. 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 Feldene 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:may affect up to 1 in 10 people

• Decrease in the number of red blood cells, white blood cells, and platelets in the blood, elevation of certain white blood cells (eosinophilia)
• Loss of appetite, elevated blood sugar levels
• Dizziness, headache, drowsiness, vertigo
• Tinnitus
• Abdominal discomfort or pain, constipation, diarrhea, upper abdominal discomfort, flatulence, nausea, vomiting, indigestion
• Itching on the skin, rash
• Swelling of the ankles (edema)
• Reversible increase in blood nitrogen levels (BUN), alterations in laboratory tests (decreased hemoglobin and hematocrit) orincreasein liver enzymes(transaminases) thatmayaffect somemedical tests, weight gain

Rare::may affect up to 1 in 100 people

• Low blood sugar levels
• Blurred vision
• Palpitations
• Gingivitis
• Reversible increase in creatinine levels that may affect some medical tests

Very rare:may affect up to 1 in 10,000 people

• Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's disease) characterized by skin peeling,fever, pain, skin rash, and blisters and sores on themucous membranes

Frequency not known::cannot be estimated from available data

• Decrease in the number of red blood cells in the blood due to failure in their formation or premature destruction
• Severe allergic reaction affecting the entire body (anaphylaxis), rash accompanied by fever, inflammation of the lymph nodes, and joint pain (serum sickness)
• Fluid retention
• Depression, sleep disturbances, hallucinations, insomnia, confusion, mood changes, nervousness
• 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 the blood vessels, high blood pressure
• Spasms in thebronchithat prevent air from passing to thelungs, 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
• Fatal liver inflammation, yellow discoloration of the skin and mucous membranes
• Hair loss, severe skin reactions that can be fatal (dermatitis exfoliativa, erythema multiforme, non-thrombocytopenic purpura),separation of the nail, light-induced allergic skin reactions, urticaria, vesicular or blistering skin reactions
• Fixed drug eruption (may appear as rounded or oval plaques with redness and swelling of the skin), blisters (urticaria), itching.
• Renal disorders such as nephrotic syndrome and interstitial glomerulonephritis (often manifested with swelling of the kidney and proteinuria), and renal failure
• Decreased female fertility
• Alterations in laboratory tests (positive antinuclear antibodies (ANA) test), weight loss

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not store at a temperature above 30°C.

Keep the container perfectly closed to protect it from humidity.

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

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Feldene CompositionFlas 20mgoral lyophilisate

The active ingredient is piroxicam. Each oral lyophilisate contains 20 mg of piroxicam.

The other components are: gelatin, anhydrous citric acid, aspartame, and mannitol.

Appearance of the product and contents of the packaging

FeldeneFlas 20mgoral lyophilisateis a medication that is presented in the form oftablets (or liotabs)that are white in color and dissolve instantlyupon contact with saliva. The packaging contains 20 oral lyophilisates.

Holder of the marketing authorization and responsible manufacturer

Holder:

Pfizer, S.L.

Avda. de Europa, 20 B,

Parque Empresarial La Moraleja

28108 Alcobendas, Madrid.

Responsible manufacturer:

Haupt Pharma Latina S.r.l.

Strada Statale 156 km 47,600

04100 Borgo San Michele

Latina, Italy.

or

FARMASIERRA MANUFACTURING S.L.

Ctra. Irún, km.26,200., San Sebastián de los Reyes 28700 (Madrid) – Spain

Last review date of thisleaflet: March 2024

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