Dezacor 30 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dezacor 30 mg tablets

deflazacort

Read the entire leaflet carefully before you start taking this medicine, as 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 must not give it to other people, 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 these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Dezacor is and what it is used for

Dezacor 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 granulomatosis with polyangiitis (Wegener's granulomatosis).
• Skin diseases: pemphigus, bullous pemphigoid, generalized exfoliative dermatitis, erythema multiforme, erythema nodosum, and severe psoriasis.
• Allergic diseases: refractory bronchial asthma not responding 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 Dezacor

Do not take Dezacor

• 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), viral (ocular herpes simplex, herpes zoster, chickenpox), or systemic fungal infections.
• If you are in a pre- or post-vaccination period.

Warnings and precautions

Talk to your doctor before starting this medicine.

• It is important that your doctor knows about any medical conditions you currently have or have had in the past 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), 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 of any personal or family history (first-degree relatives) of severe affective disorders (depressive or manic-depressive illness and psychosis).
• 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, eye 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 you experience any of these conditions during treatment with Dezacor.
• 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.
• Consult a doctor if you experience concerning psychological symptoms, 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 Dezacor, 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 Dezacor

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 Dezacor 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 Dezacor may interact with them:

• Medicines for 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 Dezacor.
• Estrogens or oral contraceptives: because the effect of Dezacor 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 Dezacor.
• Anticoagulant medicines: because corticosteroids may increase or decrease their effects.
• Antacid medicines: because they may reduce bioavailability.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning 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.

Dezacor 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 using 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.

Dezacor contains lactose

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

3. How to take Dezacor

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

This medicine is administered orally. The tablets should be swallowed whole 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 depending on the type and severity of your illness, 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; 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 these cases.

Your doctor will determine the duration of treatment. Do not stop treatment early without authorization, and never discontinue it 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 at the end of treatment, so they can act promptly if symptoms reappear.

If you take more Dezacor 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 Dezacor

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

If you interrupt treatment with Dezacor

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, Dezacor 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 drugs 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

• 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 treatment withdrawal), worsening of epilepsy
• Irritability, suicidal thoughts
• Mania, delusions, hallucinations, worsening of schizophrenia
• Anxiety, sleep disorders, and cognitive dysfunction (impairment in higher brain functions such as language, orientation, memory, interpretation of reality, or social behavior)
• Blurred vision, increased intraocular pressure, glaucoma, optic disc edema, cataracts (especially in children), chorioretinopathy (retinal disorder that may cause visual disturbances), corneal thinning, worsening of viral or fungal ocular 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 together 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 there is insufficient cortisol), hypotension, and death

The use of Dezacor together with drugs 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 its use, you should contact your doctor.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Dezacor

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 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 unused medicines and their containers at the SIGRE Point in 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 Dezacor

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 Dezacor and pack contents:

Uncoated round 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 tablets.

Other presentations

Dezacor 6 mg tablets: pack with 20 tablets of 6 mg deflazacort.

Dezacor 22.75 mg/ml oral drops in suspension: bottle with 13 ml of suspension and dropper.

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 review of this leaflet: April 2025

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