PATIENT INFORMATION LEAFLET

Dezacor 6 mg tablets

Deflazacort

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1.What is Dezacor and what it is used for

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

3.How to take Dezacor

4.Possible side effects

5.Storage of Dezacor

6.Contents of the pack and additional information

Dezacor is a medication belonging to a group of medications known as corticosteroids, which has anti-inflammatory and antiallergic properties. It has a distinct safety profile compared to other corticoids due to its lower activity on sugars and bone.

Dezacor is indicated for the treatment of:

• Rheumatic and collagen diseases.
• Skin diseases.
• Allergic diseases: bronchial asthma that does not respond to conventional treatment.
• Respiratory system diseases.
• Eye diseases.
• Blood diseases.
• Digestive system diseases.
• Renal diseases.
• Liver diseases.

Do not take Dezacor

• If you are allergic (hypersensitive) to deflazacort or to any of the other components of this medication (listed in section 6).
• If you have a stomach ulcer.
• If you have bacterial infections (active tuberculosis) and viral infections (herpes simplex eye, herpes zoster, varicella) or generalized infections caused by fungi.
• If you are in the pre- or post-vaccination period.

Warnings and precautions

Be especially careful with Dezacor

• Inform your doctor if you have any heart disease, congestive heart failure, high blood pressure, thromboembolic diseases (caused by blood clots), esophageal, stomach, or intestinal diseases, diabetes mellitus, emotional disorders, psychosis, epilepsy, glaucoma, hypothyroidism (thyroid gland insufficiency), and/or cirrhosis.

You may need to adjust the dose of corticosteroids in special situations (surgery, infections, and others) and your doctor should know if you have had any other diseases.

• Long-term use of this medication in children may stop their growth and development.

• After a long treatment with Dezacor, it should be gradually discontinued. Do not stop taking this medication without consulting your doctor first.

• Contact your doctor if you experience blurred vision or other visual disturbances.

Consult your doctor before starting to take this medication.

Use in athletes

You should be aware that this medication contains deflazacort, which may produce a positive result in doping control tests.

Use of Dezacor with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

• Diabetes medications: as the dose may need to be changed.
• Antibiotics (rifampicin): as they may decrease the effect of Dezacor.
• Estradiol or oral contraceptives: as the effect of Dezacor may be increased.
• Medications that cause muscle relaxation: as the relaxing effect may be prolonged.
• Anticholinesterase medications, used in myasthenia gravis.
• Vaccines and toxoids: as corticosteroids decrease the immune response.
• Medications for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital): as they may decrease the effect of Dezacor.
• Some medications may increase the effects of Dezacor 6 mg tablets, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

Dezacor should not be used during the first trimester of pregnancy unless your doctor considers the benefits greater than the potential risk.

IMPORTANT FOR WOMEN:

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. The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

Dezacor passes into breast milk, so its use is not recommended during breastfeeding.

Driving and operating machinery

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

Dezacor 6 mg tablets contain lactose

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

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

This medication is administered orally.

Your doctor will establish the number and frequency of tablets. The dosage is individual for each patient, and may be modified by your doctor based on the response to treatment.

If you take more Dezacor than you should

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

If you forget to take Dezacor

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dezacor

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

Like all medications, Dezacor can produce adverse effects, although not everyone will experience them.

The adverse effects of Dezacor that have been observed primarily in long-term treatments are as follows:

• Gastrointestinal disorders: gastrointestinal ulcer.
• Central nervous system disorders: headache, dizziness, agitation, sleep disorders.
• Disorders of the skin and subcutaneous tissue: wound healing problems, skin lesions.
• Cardiovascular and vascular disorders: increased blood pressure (hypertension), water retention in tissues (edema).
• Endocrine disorders: weight gain, worsening of diabetes mellitus, disappearance of menstruation.
• Musculoskeletal and connective tissue disorders: muscle weakness, osteoporosis.
• Eye disorders: eye alterations.

With an unknown frequency (cannot be estimated from available data): blurred vision.

The use of Dezacor with medications that cause muscle relaxation, especially when administered at high doses and for long periods of time, may produce severe muscle alterations.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keep out of sight and reach of children.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Dezacor 6 mg tablets

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 the product and content of the packaging:

Round, non-coated, white, beveled tablets on one side and the number 6 on the other.

The tablet can be divided into equal parts.

Dezacor 6 mg tablets are packaged in PVC-Aluminum blisters and are presented in containers containing 20 tablets.

Other presentations

Dezacor 30 mg tablets: container 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

Responsible for manufacturing

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

Last review date of this leaflet:January 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/