DEFAL 6 mg TABLETS

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

Do not take Defal

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

Warnings and precautions

Consult your doctor before starting to take this medication.

• It is essential that your doctor knows about all the diseases you have or have had before they can advise you on this treatment. Especially, you must inform them about cardiovascular diseases (heart failure, high blood pressure), blood clotting disorders (thrombosis, embolism), digestive or intestinal diseases (stomach ulcer, intestinal inflammation, chronic diarrhea), severe liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections. History of severe affective disorders or in first-degree relatives (depressive or manic-depressive illnesses and psychosis).
• The use of corticosteroids whose duration exceeds that of a short-term replacement or emergency treatment is contraindicated in the following cases: peptic ulcer, bacterial and viral infections such as active tuberculosis, herpes simplex ocular, herpes zoster (viremic phase), as well as in systemic mycotic infections and in the pre- and post-vaccination period.
• In prolonged treatments, ocular alterations may appear, so your doctor may advise you to visit an ophthalmologist periodically.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• It may be necessary to adjust the dose of corticosteroids in special situations (surgery, infections, and others). Inform your doctor if you experience any of these processes during treatment with Defal.
• Treatment with deflazacort may cause irregular menstruation and leukocytosis.
• You should be especially careful to avoid exposure to measles and chickenpox; consult your doctor immediately if you are exposed.
• In children, prolonged use of this medication can stop growth and development.
• Consult a doctor if you experience worrying psychological symptoms, especially if you suspect a depressive mood or suicidal ideas. You should be aware of possible psychiatric disorders that may appear during or immediately after reducing or withdrawing the medication, although such reactions have been reported with low frequency.
• After a long treatment with Defal, it should never be stopped abruptly. Your doctor will indicate how to gradually decrease the dose. It is also essential that you remain in contact with your doctor at the end of the treatment so that they can act in case of symptom recurrence.

Use in athletes

Patients should be warned that this medication contains deflazacort, which may produce a positive result in doping tests.

Other medications and Defal

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

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

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

• Pain or inflammation medications.
• Diabetes medications: as a dose change may be necessary.
• Antihypertensives and diuretics: as a dose change may be necessary.
• Antibiotics (rifampicin): as they may decrease the effect of Defal.
• Estrogens or oral contraceptives, as the effect of Defal may be increased.
• Muscle relaxants, as the relaxing effect may be prolonged.
• Anticholinesterase medications used in myasthenia gravis.
• Medications for heart failure or coagulation disorders.
• Vaccines and toxoids, as corticosteroids decrease the immune response.
• Medications for epilepsy and those used in psychiatric treatments (carbamazepine, phenytoin, phenobarbital), as they may decrease the effect of Defal.
• Anticoagulant medications: as corticosteroids may increase or decrease their effects.
• Antacids: as they may reduce the bioavailability of Defal.

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

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. Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Human experience is limited; therefore, deflazacort will only be used in cases where the risk-benefit assessment advises its use.

Defal is excreted in breast milk, so its use is not recommended during breastfeeding. The use of deflazacort requires weighing the benefits of breastfeeding against the potential risks.

Driving and using machines

No data are available, although it is advisable that, until the response to treatment is satisfactory, you do not perform tasks that require special attention, such as driving vehicles or operating hazardous machinery.

Defal contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

3. How to take Defal

Follow your doctor's instructions for administering this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

This medication is administered orally. The tablets should be swallowed 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 based on the type and severity of your disease, as well as your response to treatment.

The tablet can 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 essential that you fully understand your doctor's instructions regarding medication administration, and if you have any doubts, do not hesitate to consult them.

In special situations (stress, significant infections, severe trauma, or surgery), it may be necessary to adjust the dose. Consult your doctor to explain the procedure in these cases.

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

After prolonged treatment, the administration of this medication should never be interrupted abruptly. Your doctor will indicate how to gradually decrease the dose. It is also essential that you remain in contact with your doctor at the end of the treatment so that they can act in case of symptom recurrence.

If you take more Defal than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, and go to a hospital for appropriate treatment.

If you forget to take Defal

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

If you interrupt treatment with Defal

Prolonged treatments that are interrupted abruptly can cause fever, discomfort, and muscle and joint pain.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, Defal can cause adverse effects, although not everyone will experience them.

In short-term treatments, this medication is well tolerated, and adverse effects are rare. 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.
• Pain or discomfort in the abdomen, stomach ulcer, bleeding, nausea, heavy digestion.
• Headache, dizziness.
• Depressed or unstable mood.
• Behavioral changes, mood changes (depression, euphoria).
• Hirsutism (excessive hair growth in women), stretch marks, and acne.
• Suppression of the hypothalamic-pituitary-adrenal axis (can cause impaired response to stress and inadequate defense against infections), Cushingoid face (moon face).
• Elevation of blood glucose (with onset or worsening of diabetes), sodium and water retention (with increased blood pressure), potassium loss in the urine when administered with beta-agonist medications and xanthines (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

• Bruises.
• Muscle mass loss.

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

• Leukocytosis (increase in the number of white blood cells in the blood).
• Clot formation, particularly in patients with pre-existing conditions associated with a higher tendency to develop thrombi.
• Perforation of peptic ulcer, acute pancreatitis (especially in children), candidiasis (fungal infection of the skin and mucous membranes).
• Restlessness, increased intracranial pressure in children (usually after treatment withdrawal), worsening of epilepsy.
• Irritability, euphoria, suicidal thoughts.
• Mania, delirium, hallucinations, worsening of schizophrenia.
• Anxiety, sleep disorders, and cognitive dysfunction (alteration in higher brain functions such as language, orientation, memory, interpretation of reality, or social behavior).
• Blurred vision, increased intraocular pressure, glaucoma, edema of the papilla, cataracts (especially in children), chorioretinopathy (retinal alteration that can cause vision changes), corneal thinning, worsening of ocular infections by viruses or fungi.
• Thinning of the skin, appearance of small blood vessels in the skin (spider veins).
• Heart failure, hypertrophic cardiomyopathy in premature newborns.
• Growth delay in children.
• Greater loss of proteins and calcium, increased appetite.
• Avascular necrosis of bone (bone destruction due to insufficient blood supply), tendinitis, and tendon rupture when taken with quinolone-type antibiotics (ciprofloxacin, ofloxacin, levofloxacin), muscle alterations or weakness.
• Menstrual irregularity.
• Impaired wound healing.
• A too rapid reduction in the dose of this medication after prolonged treatment can lead to acute adrenal insufficiency (a potentially life-threatening condition that occurs when there is a lack of cortisol), hypotension, and death.

The use of Defal along with muscle relaxant medications, especially when administered at high doses and for extended periods, can cause severe muscle alterations.

During treatment with this medication, your tendency to infections may increase, so if you notice any symptoms of disease that may be related to taking it, you should contact your doctor.

Reporting 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Defal

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Defal

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

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

Appearance of Defal and package contents:

Round, uncoated, white tablets, scored on one side and with the number 6 on the other.

The tablets are packaged in PVC-aluminum blisters and come in containers containing 20 or 500 tablets.

Other presentations

Defal 30 mg tablets: containers with 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.

Bizkaia Science and Technology Park

Ibaizabal Bidea, Building 901

48160 Derio (Bizkaia)

Spain

Date of last revision of this prospectus:April 2025

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