Feldene Flas 20 mg oral lyophilisate

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Feldene Flas 20 mg lyophilisate for oral use

piroxicam

Read the entire 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Feldene Flas 20 mg lyophilisate for oral use is and what it is used for
2. What you need to know before taking Feldene Flas 20 mg lyophilisate for oral use
3. How to take Feldene Flas 20 mg lyophilisate for oral use
4. Possible side effects
5. How to store Feldene Flas 20 mg lyophilisate for oral use
6. Contents of the pack and other information

1. What Feldene Flas 20 mg oral lyophilisate is and what it is used for

Feldene Flas 20 mg oral lyophilisate is a medicine presented as an oral lyophilisate that dissolves instantly upon contact with saliva.

Before prescribing piroxicam, your doctor should evaluate the benefits of this medicine against the risk of developing adverse reactions. Due to treatment with piroxicam, your doctor may require periodic monitoring and will inform you of how often these checks should be performed.

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

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

2. What you need to know before starting Feldene Flas 20 mg oral lyophilisate

Do not take piroxicam

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• If you have had stomach or intestinal ulcer, bleeding, or perforation.
• If you currently have or have previously had stomach or intestinal ulcer, bleeding, or perforation.
• 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, or diverticulitis (inflammation or infection of pouches/diverticula in the colon).
• If you are taking other NSAIDs, including COX-2 selective NSAIDs and acetylsalicylic acid, a substance found in many medications used to relieve pain and reduce fever.
• If you are taking anticoagulants such as warfarin, coumarins, or newer oral anticoagulants including apixaban, dabigatran, and rivaroxaban, used to prevent blood clots.
• If you have previously experienced a severe allergic reaction to piroxicam, other NSAIDs, or other medications, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense skin redness with peeling in layers or scales), vesiculobullous reactions (Stevens-Johnson syndrome characterized by reddish blisters, erosion, and crusted or bleeding skin), or toxic epidermal necrolysis (a condition causing peeling and blisters in the superficial layers of the skin), or if you have experienced other allergy symptoms such as asthma attacks, severe nasal congestion, or other allergic reactions such as skin itching, rash, swelling of the face, lips, or tongue causing difficulty breathing or wheezing.
• If you suffer from severe liver or kidney disease.
• If you suffer from severe heart failure.
• If you have coagulation disorders.
• If you are in your third trimester of pregnancy.

If any of these conditions apply to you, you must not take piroxicam. Consult your doctor immediately.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with Feldene.

Gastrointestinal risks

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Feldene may cause serious stomach and intestinal reactions such as pain, bleeding, ulceration, and perforation.

Administering doses higher than 20 mg per day increases the risk of gastrointestinal adverse effects.

You must stop treatment with piroxicam and consult your doctor immediately if you experience stomach pain or any signs of gastrointestinal bleeding, such as black or bloody stools or vomiting blood.

Skin risks

Serious, potentially life-threatening skin reactions (DRESS syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported with the use of Feldene. These initially appear as red spots or circular patches, often with a central blister.

Other additional symptoms may include mouth sores, throat or nasal ulcers, genital lesions, and conjunctivitis (swollen, red eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

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

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis while using Feldene, you must never use Feldene again.

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

Cardiovascular and cerebrovascular risks

Medicines such as Feldene may be associated with a moderate increase in the risk of heart attacks ("myocardial infarction") or strokes. This risk is more likely when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, elevated cholesterol, or are a smoker), discuss this treatment with your doctor or pharmacist.

These types of medicines may also cause fluid retention, particularly 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 monitoring while you are taking piroxicam.

If you are over 70 years old or 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 stomach-protecting medication alongside Feldene.

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

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

Ensure your doctor is informed about all medications you are taking, including those obtained without a prescription.

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

• You have mild or moderate liver or kidney disease
• You have an infection, as this medicine may mask fever and give a false impression that you are improving or that the infection is not serious
• You experience eye discomfort during treatment with piroxicam; you should consult an ophthalmologist
• You suffer from asthma

Use of Feldene with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine.

Certain medicines may interact with each other. Your doctor may limit the use of piroxicam and/or other medicines, or may need to switch you to a different 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 (NSAIDs) used to relieve pain
• Corticosteroids, medicines used to treat a wide range of conditions such as allergies, hormonal disorders, and inflammatory diseases
• Anticoagulants such as warfarin, coumarins, or newer oral anticoagulants (apixaban, dabigatran, and rivaroxaban) used to prevent blood clots
• Antidepressants known as selective serotonin reuptake inhibitors (SSRIs)
• Medicines used 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 certain cancers)
• Ticlopidine (an antiplatelet medicine)
• Quinolones (antibacterial medicines)
• Certain diuretics (medicines used to treat fluid retention in high blood pressure)
• Sulfonylureas (oral antidiabetic medicines)
• Cyclosporine, tacrolimus (medicines used in transplant patients)
• Antihypertensives (medicines used to treat high blood pressure)
• Digoxin: concomitant treatment with digoxin and piroxicam does not affect plasma levels of either drug.

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

Taking Feldene Flas 20 mg oral lyophilisate with food, drinks, and alcohol

Taking Feldene Flas 20 mg oral lyophilisate with food may delay its onset of action; therefore, it is recommended to take it between meals.

Do not consume alcoholic beverages during treatment with this medicine, 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

From week 20 of pregnancy, NSAIDs may cause kidney problems in the fetus if taken for more than a few days, which 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 for longer than a few days is needed, your doctor may recommend additional monitoring. In such cases, the dose and duration of treatment should be limited to the minimum possible.

Administration of Feldene is contraindicated during the third trimester of pregnancy.

For women of childbearing age, it should be noted that medicines like Feldene have been associated with a reduced ability to conceive.

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Feldene is not recommended in breastfeeding mothers, as clinical safety has not been established.

Driving and use of machines:

If you experience dizziness, vertigo, vision disturbances, or drowsiness while taking Feldene, do not drive or operate dangerous machinery until these symptoms resolve or until you have assessed how you tolerate the medicine.

Excipients with known effect:

This medicine contains 0.25 mg of aspartame per oral lyophilisate.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Feldene Flas 20 mg oral lyophilisate

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

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

Do not increase the dose:

If you consider the medicine 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 of age, your doctor may prescribe a lower daily dose and reduce the duration of treatment.

Use in children:

Use in children is not recommended.

Instructions for use

Due to the special characteristics of Feldene Flas 20 mg oral lyophilisate, the following instructions must be followed to remove the lyophilisates from the packaging:

1. Do not extract the oral lyophilisates by pressing on them, as is usually done.
2. Open the compartment containing each oral lyophilisate by gently pulling the tab provided for this purpose.
3. Remove 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 immediately or go to the emergency department of your hospital.

In case of overdose or accidental ingestion, contact 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 until your next scheduled dose. Do not take a double dose to make up for a missed dose. If you have any further 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 everyone experiences them. Piroxicam is generally well tolerated.

The adverse effects of Feldene vary in intensity from individual to individual and are 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 blood; increase in the number of certain white blood cells (eosinophilia)
• Loss of appetite, elevated blood sugar levels
• Dizziness, headache, drowsiness, vertigo
• Tinnitus (ringing in the ears)
• Abdominal discomfort or pain, constipation, diarrhoea, upper abdominal discomfort, flatulence, nausea, vomiting, indigestion
• Itching of the skin, rash
• Swelling of ankles (oedema)
• Reversible increase in blood nitrogen levels (BUN), changes in blood tests (decrease in haemoglobin and haematocrit), or increased liver enzymes (transaminases) which may affect certain medical tests, weight gain

Uncommon: may affect up to 1 in 100 people

• Low blood sugar levels
• Blurred vision
• Palpitations
• Gum inflammation
• Reversible increase in creatinine levels which may affect certain 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 in mucous membranes

Frequency not known: cannot be estimated from available data

• Decrease in the number of red blood cells due to failure in their production process or premature destruction
• Severe allergic reaction affecting the whole body (anaphylaxis), rash accompanied by fever, swollen 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 sensations in the limbs
• Eye irritation or inflammation
• Hearing disturbances
• Inflammation of blood vessels, high blood pressure
• Bronchospasm preventing air passage to the lungs, breathing difficulty, nosebleeds
• Reaction to suppositories with pain, burning, pruritus in the anorectal area or urgent need to defecate, accompanied by colicky pain and, rarely, rectal bleeding; inflammation of the stomach lining, gastrointestinal bleeding which may include vomiting blood or black stools due to bleeding, pancreatitis, ulcers or perforations in the intestinal wall
• Life-threatening liver inflammation, yellowing of the skin and mucous membranes (jaundice)
• Hair loss, severe skin reactions which may be life-threatening (exfoliative dermatitis, erythema multiforme, non-thrombocytopenic purpura), nail detachment, skin reactions due to light allergy, urticaria, skin reactions with blister or vesicle formation
• Fixed drug eruption (may appear as round or oval-shaped patches with redness and swelling of the skin), blisters (urticaria), itching
• Kidney disorders such as nephrotic syndrome and interstitial glomerulonephritis (often manifested by kidney swelling and protein excretion in urine), and renal failure
• Decreased female fertility
• Changes in laboratory tests (positive antinuclear antibody (ANA) test), 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Feldene Flas 20 mg, oral lyophilisate

Keep out of the sight and reach of children.

Do not store above 30°C.

Keep the container tightly closed to protect it from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of FeldeneFlas 20mg oral lyophilisate

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

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

Appearance of the medicinal product and contents of the pack

Feldene Flas 20 mg oral lyophilisate is a medicine presented in the form of tablets (or liotabs) that are white in colour and dissolve instantly upon contact with saliva. The pack contains 20 oral lyophilisates.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent review of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/