Defal 6 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Defal 6 mg tablets EFG

deflazacort

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Defal is and what it is used for

Defal is a medicine belonging to a group of medicines known as corticosteroids, which have anti-inflammatory and antiallergic properties.

This medicine can be used for the treatment of conditions whose severity requires immediate systemic treatment with glucocorticoids. These include:

• Rheumatic and collagen diseases: treatment of rheumatoid arthritis and psoriatic arthritis when conservative treatments have proven ineffective; polymyalgia rheumatica; acute rheumatic fever; systemic lupus erythematosus; severe dermatomyositis; polyarteritis nodosa; giant cell arteritis and Wegener's granulomatosis.
• Skin diseases: pemphigus, bullous pemphigoid, generalized exfoliative dermatitis, erythema multiforme, erythema nodosum and severe psoriasis.
• Allergic diseases: bronchial asthma refractory to conventional therapy.
• Pulmonary diseases: sarcoidosis with pulmonary involvement, extrinsic allergic alveolitis (organic dust pneumoconiosis), desquamative interstitial pneumonia (idiopathic pulmonary fibrosis).
• Inflammatory eye diseases: choroiditis, chorioretinitis, iritis and iridocyclitis.
• Hematological diseases: idiopathic thrombocytopenia, hemolytic anemias and palliative treatment of leukemias and lymphomas.
• Gastrointestinal and liver diseases: ulcerative colitis, Crohn's disease and chronic active hepatitis.
• Renal diseases: nephrotic syndrome.

2. What you need to know before starting to take Defal

Do not take Defal

• If you are allergic (hypersensitive) to deflazacort or to any of the other components of this medicine (listed in section 6).
• If you are receiving vaccines containing live viruses.
• If you have a systemic infection without specific treatment.
• If you have a stomach ulcer.
• If you suffer from bacterial (active tuberculosis), viral (ocular herpes simplex, herpes zoster, chickenpox) or systemic fungal infections.
• If you are in a pre- or post-vaccination period.

Warnings and precautions

Consult your doctor before starting to take this medicine.

• It is important that your doctor knows about all diseases you currently have or have previously had before advising you on this treatment. In particular, inform your doctor of cardiovascular diseases (heart failure, high blood pressure), conditions caused by blood clots (thrombosis, embolism), digestive or intestinal disorders (stomach ulcer, intestinal inflammation, chronic diarrhea), significant liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections. A history of severe affective disorders or such disorders in first-degree relatives (depressive or manic-depressive illnesses and psychosis) should also be reported.
• The use of corticosteroids beyond replacement therapy or short-term emergency treatment is contraindicated in the following cases: peptic ulcer, bacterial and viral infections such as active tuberculosis, ocular herpes simplex, herpes zoster (viremic phase), systemic fungal infections, and during the pre- and post-vaccination periods.
• With prolonged treatment, ocular disorders may occur; therefore, your doctor may recommend regular check-ups with an ophthalmologist.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• It may be necessary to adjust corticosteroid dosage in special situations (surgery, infections, and others). Inform your doctor if any of these conditions occur during treatment with Defal.
• Treatment with deflazacort may cause irregular menstruation and leukocytosis.
• You should take special care to avoid exposure to measles and chickenpox; seek medical advice immediately if exposed.
• In children, prolonged use of this medicine may impair growth and development.
• Contact a doctor if concerning psychological symptoms appear, especially if depressive mood or suicidal thoughts are suspected. Be alert to possible psychiatric disorders that may occur during or immediately after dose reduction/withdrawal of the medicine, although such reactions have been reported infrequently.
• After long-term treatment with Defal, the medicine should be discontinued gradually. Do not stop taking this medicine without first consulting your doctor.

Use in athletes

Patients should be informed that this medicine contains deflazacort, which may result in a positive doping test.

Other medicines and Defal

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

Some medicines may increase the effects of Defal 6 mg tablets, so your doctor will perform careful monitoring if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

In particular, inform your doctor or pharmacist if you are taking any of the following medicines, as Defal may interact with them:

• Medicines used to relieve pain or inflammation.
• Medicines for diabetes: dosage adjustments may be necessary.
• Antihypertensives and diuretics: dosage adjustments may be necessary.
• Anti-infectives (rifampicin): as they may reduce the effect of Defal.
• Estrogens or oral contraceptives: as the effect of Defal may be increased.
• Medicines that cause muscle relaxation: the relaxing effect may be prolonged.
• Anticholinesterase medicines, used in myasthenia gravis.
• Medicines used to treat heart failure or coagulation disorders.
• Vaccines and toxoids: corticosteroids reduce immune response.
• Medicines for epilepsy and psychiatric treatments (carbamazepine, phenytoin, phenobarbital): as they may reduce the effect of Defal.
• Anticoagulant medicines: corticosteroids may increase or decrease their effects.
• Antacid medicines: as they may reduce bioavailability.

Do not take any of these medicines at the same time as Defal without consulting your doctor.

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. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Human experience is limited; therefore, deflazacort should only be used when a prior risk/benefit assessment justifies its use.

Defal is excreted in breast milk; therefore, its use during breastfeeding is not recommended. The use of deflazacort requires that the benefits of breastfeeding be weighed against the potential risks.

Driving and use of machines

No data are available; however, until the response to treatment is satisfactory, it is advisable to avoid tasks requiring special attention, such as driving vehicles or operating dangerous machinery.

Defal contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Defal

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine is administered orally. The tablets should be swallowed whole, with the help of a little liquid.

The dose must be individualized. Therefore, the number and frequency of tablets you should take will be determined by your doctor according to the type and severity of your condition, as well as your response to treatment.

The tablet may be divided into equal doses.

In adults, the dose may range from 6 to 90 mg per day, and in children from 0.25 to 1.5 mg/kg. It is therefore essential that you fully understand your doctor's instructions regarding administration of the medicine, and if in doubt, do not hesitate to consult them.

In special situations (stress, significant infections, severe trauma, or surgical interventions), a dose adjustment may be required. Consult your doctor for guidance on how to proceed in such cases.

Your doctor will indicate the duration of treatment. Do not stop it prematurely without authorization, and never stop abruptly.

After prolonged treatment, administration of this medicine must never be interrupted suddenly. Your doctor will instruct you on how to gradually reduce the dose. It is also important that you remain in contact with your doctor at the end of treatment, so they can act promptly if symptoms reappear.

If you take more Defal than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested, and go immediately to a hospital center for appropriate treatment.

If you forget to take Defal

Do not take a double dose to make up for forgotten doses.

If you stop taking Defal

Prolonged treatments, if interrupted abruptly, may cause: fever, malaise, and muscle and joint pain.

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

4. Possible adverse effects

Like all medicines, Defal may cause adverse effects, although not everyone experiences them.

In short-term treatments, this medicine is well tolerated and adverse effects are uncommon. However, in prolonged treatments, the following have been observed:

Frequent: may affect up to 1 in 10 people

• Weight gain.

Uncommon: may affect up to 1 in 100 people

• Allergy or hypersensitivity to deflazacort.
• Abdominal pain or discomfort, stomach ulcer, bleeding, nausea, indigestion.
• Headache, dizziness.
• Depressed and unstable mood.
• Behavioral disturbances, mood changes (depression, euphoria).
• Hirsutism (excessive hair growth in women), striae, and acne.
• Suppression of the hypothalamic-pituitary-adrenal axis (may cause impaired response to stress and inadequate defense against infections), cushingoid face (moon face).
• Increased blood glucose (with onset or worsening of diabetes), sodium and water retention (with elevated blood pressure), potassium loss in urine when administered concomitantly with beta-agonist or xanthine medications (salbutamol, isoprenaline, fluticasone, theophylline).
• Increased susceptibility to infections due to reduced immune system activity.
• Osteoporosis, vertebral and long bone fractures.
• Edema (swelling caused by fluid accumulation in body tissues).

Rare: may affect up to 1 in 1,000 people

• Bruising.
• Loss of muscle mass.

Frequency not known (cannot be estimated from available data):*

• Leukocytosis (increase in the number of white blood cells in the blood).
• Blood clot formation, particularly in patients with pre-existing conditions associated with a higher tendency to thrombosis.
• Perforation of gastroduodenal peptic ulcer, acute pancreatitis (especially in children), candidiasis (a fungal infection of the skin and mucous membranes).
• Restlessness, increased intracranial pressure in children (usually after discontinuation of treatment), worsening of epilepsy.
• Irritability, suicidal thoughts.
• Mania, delusions, hallucinations, worsening of schizophrenia.
• Anxiety, sleep disorders, and cognitive dysfunction (impairment of higher brain functions such as language, orientation, memory, interpretation of reality, or social behavior).
• Blurred vision, increased intraocular pressure, glaucoma, papilledema, cataracts (especially in children), chorioretinopathy (retinal disorder that may affect vision), corneal thinning, worsening of viral or fungal eye infections.
• Skin thinning, appearance of small blood vessels on the skin (spider veins).
• Heart failure, hypertrophic cardiomyopathy in premature newborns.
• Growth retardation in children.
• Increased loss of protein and calcium, increased appetite.
• Avascular necrosis of bone (bone destruction due to inadequate blood supply), tendinitis and tendon rupture when taken concomitantly with quinolone-type antibiotics (ciprofloxacin, ofloxacin, levofloxacin), muscle weakness or disturbances.
• Menstrual irregularities.
• Impaired wound healing.
• Too rapid reduction of the dose of this medicine after prolonged treatment may lead to acute adrenal insufficiency (a potentially life-threatening condition occurring when cortisol levels are insufficient), hypotension, and death.

The use of Defal together with medications that cause muscle relaxation, especially when administered at high doses and for long periods, may result in severe muscle disorders.

During treatment with this medicine, your susceptibility to infections may increase. If you notice any symptoms of illness that could be related to its use, you should contact your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Defal

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Defal

The active substance is deflazacort. Each tablet contains 6 mg of deflazacort.

The other components are: monohydrate lactose, corn starch, microcrystalline cellulose and magnesium stearate.

Appearance of Defal and package contents:

Round, uncoated white tablets, biconvex on one side and bearing the number 6 on the other.

The tablets are packaged in PVC-aluminum blisters and presented in packs containing 20 or 500 tablets.

Other presentations

Defal 30 mg tablets: packs containing 10 or 500 tablets.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the most recent revision of this leaflet: April 2025

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