DEZACOR 6 mg TABLETS

Introduction

Package Leaflet: Information for the User

Dezacor 6 mg Tablets

deflazacort

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Dezacor and what is it used for

Dezacor is a medicine that belongs to a group of medicines known as corticosteroids, which have anti-inflammatory and anti-allergic properties.

This medicine can be used to treat diseases 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 been shown to be ineffective; polymyalgia rheumatica; acute rheumatic fever; systemic lupus erythematosus; severe dermatomyositis; polyarteritis nodosa; cranial arteritis and Wegener's granulomatosis.
• Skin diseases: 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 anemia, and palliative treatment of leukemia and lymphoma.
• Diseases of the digestive system and liver: ulcerative colitis, Crohn's disease, and chronic active hepatitis.
• Kidney diseases: nephrotic syndrome.

2. What you need to know before you take Dezacor

Do not take Dezacor

• If you are allergic (hypersensitive) to deflazacort or any of the other ingredients of this medicine (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 (ocular herpes simplex, herpes zoster, chickenpox) or generalized fungal infections.
• If you are in the pre- or post-vaccination period.

Warnings and precautions

Consult your doctor before starting to take this medicine.

• It is essential that your doctor knows all the diseases you have or have had before they can advise you on this treatment. Especially, you must inform them of cardiovascular diseases (heart failure, high blood pressure), those produced by blood clots (thrombosis, embolism), digestive or intestinal diseases (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. Previous or existing 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 during treatment with Dezacor you present any of these processes.
• 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 in case of exposure.
• In children, prolonged use of this medicine may stop their 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/stopping the dose of the medicine, although such reactions have been reported with low frequency.
• After a long treatment with Dezacor, 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 medicine contains deflazacort, which may produce a positive result in doping tests.

Other medicines and Dezacor

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

Some medicines may increase the effects of Dezacor 6 mg tablets, so your doctor will perform thorough checks 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 Dezacor may interact with them.

• Medicines to combat pain or inflammation.
• Medicines for diabetes: because a dose change may be necessary.
• Antihypertensives and diuretics: because a dose change may be necessary.
• Antibiotics (rifampicin): because they may decrease the effect of Dezacor.
• Estrogens or oral contraceptives: because the effect of Dezacor may be increased.
• Medicines that produce muscle relaxation: because the relaxing effect may be prolonged.
• Anticholinesterase medicines used in myasthenia gravis.
• Medicines intended for the treatment of heart failure or coagulation disorders.
• Vaccines and toxoids: because corticosteroids decrease the immune response.
• Medicines for epilepsy and those used in psychiatric treatments (carbamazepine, phenytoin, phenobarbital): because they may decrease the effect of Dezacor.
• Anticoagulant medicines: because corticosteroids may increase or decrease their effects.
• Antacid medicines: because they may reduce their bioavailability.

Do not take any of these medicines at the same time as Dezacor 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 medicine. Taking medicines during pregnancy can be hazardous for 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 previously advises its use.

Dezacor is excreted in breast milk; therefore, its use is not recommended during breastfeeding. The use of deflazacort requires weighing the benefits of breastfeeding against the possible 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, handling hazardous machinery, etc.

Dezacor contains lactose

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

3. How to take Dezacor

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

This medicine is administered orally. The tablets should be swallowed without chewing, 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 based on the type and severity of your disease, as well as the 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 the administration of the medicine, and in case of doubt, do not hesitate to consult them.

In special situations (stress, significant infections, severe trauma, or surgical interventions), it may be necessary to adjust the dose. Consult your doctor so that they can explain the procedure to follow 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 a prolonged treatment, the administration of this medicine 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 Dezacor 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 medicine and the amount ingested, and go immediately to a hospital for appropriate treatment.

If you forget to take Dezacor

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

If you stop taking Dezacor

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

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

4. Possible side effects

Like all medicines, Dezacor can cause side effects, although not everybody gets them.

In short-term treatments, this medicine is well tolerated, and side 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, indigestion.
• Headache, dizziness.
• Depressed or unstable mood.
• Behavioral changes, mood swings (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 together with beta-agonist and xanthine-type medications (salbutamol, isoprenaline, fluticasone, theophylline).
• Increased susceptibility to infections due to the reduction of the immune system's action.
• 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 the 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 optic disc, cataracts (especially in children), chorioretinopathy (retinal alteration that can cause vision problems), corneal thinning, worsening of viral or fungal eye infections.
• Thinning of the skin, appearance of small blood vessels in the skin (spider veins).
• Heart failure, hypertrophic cardiomyopathy in premature newborns.
• Growth retardation 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.
• Worsening of wound healing.
• A too rapid reduction in the dose of this medicine 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 Dezacor together with muscle relaxant medicines, especially when administered at high doses and for extended periods, may cause severe muscle alterations.

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

Reporting of side effects

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

5. Storage of Dezacor

Keep out of 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 should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. 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 6 mg of deflazacort.

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

Appearance of Dezacor and pack contents:

Round, uncoated, white tablets, birranurated on one face and with the number 6 on the other.

The tablets are packaged in PVC-Aluminum blisters and come in packs containing 20 tablets.

Other presentations

Dezacor 30 mg tablets: pack with 10 tablets of 30 mg of 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.

Bizkaia Science and Technology Park

Ibaizabal Bidea, Building 901

48160 Derio (Bizkaia)

Spain

Date of last revision of this leaflet:April 2025

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