FELDENE FLAS 20 mg ORAL LYOPHILIZED

2. What you need to know before you take Feldene Flas 20 mg Oral Lyophilisate

Do not take piroxicam

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have had an ulcer, bleeding, or perforation of the stomach or intestine.
• If you have an ulcer, bleeding, or perforation of the stomach or intestine.
• If you have or have had a history of gastrointestinal disorders (inflammation of the stomach or intestine) 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 selective COX-2 inhibitors and acetylsalicylic acid, a substance found in many medicines used to relieve pain and lower 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 previously had a severe allergic reaction to piroxicam, other NSAIDs, and other medicines, especially severe skin reactions (regardless of severity) such as exfoliative dermatitis (intense redness of the skin, with scaling in layers or flakes), vesiculobullous reactions (Stevens-Johnson syndrome with reddish blisters, erosion, and skin with crusts or bleeding) and toxic epidermal necrolysis (a disease that progresses with scaling and blisters on the superficial layers of the skin), or if you have presented other symptoms of allergy such as asthma attacks, severe nasal congestion, or other allergic reactions such as skin itching, rash, swelling of the face, lips, or tongue that cause difficulty breathing or wheezing in the chest.
• If you have severe liver or kidney disease.
• If you have severe heart failure.
• If you have coagulation 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 the rest of non-steroidal anti-inflammatory drugs, Feldene can cause serious reactions in the stomach and intestine, such as pain, bleeding, ulcers, and perforation.

Administration of doses higher than 20 mg per day carries an increased risk of presenting gastrointestinal adverse effects.

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

Skin 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 patches, often with a central blister.

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

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

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

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

If you develop 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 medicine.

Cardiovascular and Cerebrovascular Risks

Medicines like Feldene may 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 duration of treatment.

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 your doctor or pharmacist about this treatment.

Similarly, this type of medicine may 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 duration of treatment and perform more frequent checks while you are taking piroxicam.

If you are over 70 years old or are taking other medicines such as corticosteroids or certain antidepressants called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clots, your doctor may prescribe a medicine to protect your stomach or intestine along with Feldene.

Do not take this medicine 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 not sure if you can take piroxicam, consult your doctor before taking this medicine.

Make sure your doctor is informed about all the medicines 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 moderate or mild liver or kidney disease.
• You have an infection, as it could mask fever and make you mistakenly believe that you are better or that the infection is not serious.
• You experience eye discomfort during treatment with Piroxicam; you should consult an ophthalmologist.
• You have asthma.

Using Feldene with Other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

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

• Aspirin or other non-steroidal anti-inflammatory drugs to relieve pain.
• Corticosteroids, which are medicines used in the treatment of numerous diseases such as allergies, hormonal disorders, and inflammatory diseases.
• Anticoagulants such as warfarin, coumarins, or new oral anticoagulants (apixaban, dabigatran, and rivaroxaban) to prevent blood clots.
• Medicines for depression called selective serotonin reuptake inhibitors (SSRIs).
• Medicines to prevent platelet aggregation such as acetylsalicylic acid.
• Lithium (a medicine used in bipolar depression).
• Methotrexate (a medicine used in rheumatoid arthritis and in the treatment of some cancers).
• Ticlopidine (an antiplatelet medicine).
• Quinolones (antibiotic medicines).
• Certain diuretics (medicines used to treat fluid retention in high blood pressure).
• Sulfonylureas (oral antidiabetic medicines).
• Cyclosporin, tacrolimus (medicines used in transplanted patients).
• Antihypertensives (medicines used in the treatment of high blood pressure).
• Digoxin: combined treatment with digoxin and piroxicam does not affect the plasma levels of either of these drugs.

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

Taking Feldene Flas 20 mg Oral Lyophilisate with Food, Drinks, and Alcohol

If you take Feldene Flas 20 mg Oral Lyophilisate with food, it may take a little longer to take effect; therefore, it is recommended to take it between meals.

You should not drink alcoholic beverages during treatment with this medicine, as this can 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 medicine.

NSAIDs can cause kidney and heart problems in the fetus. NSAIDs can affect the tendency of mothers and their babies to bleed and delay or prolong labor more than expected.

From the 20th week of pregnancy, NSAIDs can cause kidney problems in the fetus if taken for more than a few days, which can lead to low levels of the amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductal artery) 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, the administration of Feldene is contraindicated.

For patients of childbearing age, it should be noted that medicines of the Feldene type have been associated with a decrease in fertility.

Tell your doctor if you are breastfeeding or plan to start breastfeeding. The use of Feldene is not recommended in breastfeeding mothers, as clinical safety has not been established.

Driving and Using Machines

If you notice any dizziness, drowsiness, vision changes, or sleepiness while taking Feldene, do not drive or operate hazardous machinery until these symptoms disappear or until you have checked how you tolerate the medicine.

Excipients with Known Effects

This medicine contains 0.25 mg of aspartame in each oral lyophilisate.

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.

3. How to Take Feldene Flas 20 mg Oral Lyophilisate

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

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

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

Do not increase the dose:

If you consider that the medicine is not effective, 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 duration of treatment.

Use in Children:

Its use is not recommended in children.

Method of Use

Due to the special characteristics of Feldene Flas 20 mg Oral Lyophilisate, to extract the lyophilisates from the package, follow these instructions:

1. Do not extract the oral lyophilisates by pressing on them, as is usually done.
2. Open the cell that contains each oral lyophilisate by gently pulling the tab provided for this purpose.
3. Extract the oral lyophilisate with dry fingers, without pressing it, and place 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 Oral Lyophilisate Than You Should

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

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

If You Forget 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 make up for missed doses. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Piroxicam is generally well tolerated.

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

Below is a list of adverse effects. It is important that you 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 the number of certain white blood cells (eosinophilia)
• Lack of appetite, high blood sugar levels
• Dizziness, headache, drowsiness, vertigo
• Ringing in the ears
• Abdominal discomfort or pain, constipation, diarrhea, discomfort in the upper abdominal area, flatulence, nausea, vomiting, indigestion
• Itching of the skin, rash
• Swelling of the ankles (edema)
• Reversible increase in blood nitrogen levels (BUN), alterations in analytical tests (decrease in hemoglobin and hematocrit) or increase in liver enzymes (transaminases) that may affect some medical tests, weight gain

Uncommon: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 ulcers on the mucous membranes

Frequency Not Known:cannot be estimated from the available data

• Decrease in the number of red blood cells in the blood due to a failure in their formation process or premature destruction of these cells
• Severe allergic reaction that affects the whole 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 that cover the brain and spinal cord caused by a virus, numbness or tingling sensation in the limbs
• Irritation or inflammation of the eyes
• Hearing impairment
• Inflammation of blood vessels, high blood pressure
• Spasms in the bronchi that prevent air from passing into 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, pancreatitis, wounds or perforations in the intestinal wall
• Life-threatening liver inflammation, yellowish color of the skin and mucous membranes
• Hair loss, severe skin reactions that can be life-threatening (exfoliative dermatitis, erythema multiforme, non-thrombocytopenic purpura), nail separation, skin reactions due to allergy to light, urticaria, skin reactions with vesicle or blister formation
• Fixed drug eruption (may appear as rounded or oval plaques with redness and swelling of the skin), blisters (urticaria), itching
• Kidney disorders such as nephrotic syndrome and interstitial glomerulonephritis (which often manifest with kidney inflammation and protein elimination in the urine), and kidney failure
• Decreased female fertility
• Alterations in analytical tests (positive antinuclear antibody test (ANA)), weight loss

Reporting of Adverse Effects

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

5. Storage of Feldene Flas 20 mg, Oral Lyophilisate

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 moisture.

Do not use this medicine 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 thrown away through the sewers or in the trash. Deposit the containers and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Feldene Flas 20 mg Oral 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 Package Contents

Feldene Flas 20 mg oral lyophilisate is a medicine that comes in the form of tablets (or lyotabs) that are white in color and dissolve instantly in contact with saliva. The container contains 20 oral lyophilisates.

Marketing Authorization Holder and Manufacturer

Holder:

Pfizer, S.L.

Avda. de Europa, 20 B,

Parque Empresarial La Moraleja

28108 Alcobendas, Madrid.

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

Date of the Last Revision of this Prospectus: March 2024

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