PATIENT INFORMATION LEAFLET

Dezacor 22.75 mg/ml Oral Suspension

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 (those caused by blood clots), esophageal, stomach, or intestinal diseases, diabetes mellitus, emotional disorders, psychosis, epilepsy, glaucoma, hypothyroidism (thyroid gland insufficiency), and/or cirrhosis.
• The dose of corticosteroids needs to be adjusted in special situations (surgery, infections, and others) and therefore your doctor must know if you have suffered any other disease.
• In children, the prolonged use of this medication 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 blurry vision or other visual disturbances.

Consult your doctor before starting to take this medication.

Use in athletes

Inform patients 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 reduce the effect of Dezacor.
• Estrogens 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 reduce the immune response.
• Medications for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital): as they may reduce the effect of Dezacor.
• Some medications may increase the effects of Dezacor 22.75 mg/ml oral suspension, 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 intend to become pregnant, consult your doctor or pharmacist before using this medication. The consumption of medications during pregnancy can 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, although it is advisable that, until the treatment response is satisfactory, do not perform tasks that require special attention, such as driving vehicles, operating hazardous machinery, etc.

Dezacor 22.75 mg/ml oral suspension contains sorbitol (E-420)

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

This medication contains less than 23 mg of sodium (1 mmol) per mL; it is essentially "sodium-free".

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

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

Instructions for Correct Administration

This medication is administered orally. The bottle should be shaken before use.

The drops to be administered may be diluted immediately before taking, in sugar water or non-carbonated beverages.

Use of the Container

1.To release the dropper from its protection, hold A and, at the same time, pull B upwards.

2.Remove the metal cap from the bottle and place Y to screw on the dropper.

3.To open the bottle containing the dropper, press the cap firmly and, at the same time, unscrew.

CHILD-RESISTANT SAFETY DEVICE.

If You Take More Dezacor Than You Should

In case of overdose or accidental ingestion, call the Toxicology 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 doubts 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.

•Nervous system disorders: headache, dizziness, agitation, sleep disorders.

•Skin and subcutaneous tissue disorders: 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, cessation of menstruation.

•Musculoskeletal and connective tissue disorders:muscle weakness, osteoporosis.

•Eye disorders: eye alterations.

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

The use of Dezacor with medications that produce 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.

Dispose of the packaging 1 month after opening.

Medicines should not be thrown down the drain or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medicines if you are unsure. By doing so, you will help protect the environment.

Composition of Dezacor 22.75 mg/ml oral suspension drops

The active ingredient is deflazacort. Each ml of suspension contains 22.75 mg of deflazacort or each drop of suspension contains 1 mg of deflazacort.

The other components are: 70% sorbitol solution, sodium carboxymethylcellulose, aluminium magnesium silicate, polisorbate 80, benzyl alcohol, sucralose, tropical fruit aroma, citric acid monohydrate, sodium hydroxide and purified water.

Appearance of the product and content of the container:

Dezacor drops, is a homogeneous suspension of a whitish color.

This medicine is presented in amber glass vials of 20 ml including an aluminium cap and a glass dropper. The content of the container is 13 ml.

Other presentations

Dezacor is also marketed in tablets of 6 mg and 30 mg.

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