Defal 30 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Defal 30 mg tablets EFG

deflazacort

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because 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.

Contents of the leaflet

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 may 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; temporal 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 taking Defal

Do not take Defal

• If you are allergic (hypersensitive) to deflazacort or to any of the other ingredients 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) or viral infections (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 about cardiovascular diseases (heart failure, high blood pressure), conditions caused by blood clots (thrombosis, embolism), gastrointestinal or intestinal disorders (stomach ulcer, intestinal inflammation, chronic diarrhea), serious liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections. Also inform your doctor about any personal or family history (in first-degree relatives) of severe affective disorders (depressive or manic-depressive illnesses and psychosis).
• The use of corticosteroids for durations exceeding 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 periodic visits to an ophthalmologist.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• It may be necessary to adjust the corticosteroid dose 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 vigilant for possible psychiatric disorders that may occur during or immediately after dose reduction/withdrawal of the medicine, although such reactions have been infrequently reported.
• After long-term treatment with Defal, the medicine should be discontinued gradually. Do not stop taking this medicine without consulting your doctor first.

Use in athletes

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

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 30 mg tablets, so your doctor will perform careful monitoring if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

In particular, inform your doctor or pharmacist if you are taking any of the following medicines, as Defal 30 mg tablets may interact with them:

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Defal

Follow exactly the instructions for administering 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, without chewing, with 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 important 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, serious infections, severe trauma, or surgical procedures), a dose adjustment may be required. Consult your doctor to discuss the appropriate course of action in such cases.

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

After prolonged treatment, administration of this medicine must never be stopped abruptly. Your doctor will instruct you on how to gradually reduce the dose. It is also important that you remain in contact with your doctor after completing treatment, so they can intervene 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 name of 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 missed doses.

If you interrupt treatment with 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 (which may cause impaired response to stress and inadequate defense against infections), Cushingoid facies (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 and 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, reality interpretation, 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 ocular infections.
• Skin thinning, appearance of small blood vessels on the skin (telangiectasias).
• 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 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 is 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. Therefore, if you notice any symptoms of illness that could be related to taking this medicine, 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 carton 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 at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Defal

The active substance is deflazacort. Each tablet contains 30 mg of deflazacort.

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

Appearance of Defal and contents of the pack:

Round, uncoated white tablets, biconvex on one side and the number 30 on the other.

The tablets are packaged in PVC-aluminum blisters and presented in packs containing 10 or 500 tablets.

Other presentations

Defal 6 mg tablets: packs containing 20 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.

Scientific and Technological Park of Bizkaia

Ibaizabal Bidea, Building 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/