DEZACOR 22.75 MG/ML ORAL SUSPENSION DROPS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dezacor 22.75 mg/ml oral drops, suspension

deflazacort

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they 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 Wegener's granulomatosis.
• Skin diseases: pemphigus, bullous pemphigoid, generalized exfoliative dermatitis, erythema multiforme, erythema nodosum and severe psoriasis.
• Allergic diseases: bronchial asthma refractory to conventional therapy.
• Lung 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 active chronic hepatitis.
• Kidney diseases: nephrotic syndrome.

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

Do not take Dezacor

• If you are allergic (hypersensitive) to deflazacort or to any of the other components 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 have bacterial (e.g. active tuberculosis), viral (e.g. ocular herpes simplex, herpes zoster, varicella), or systemic 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 important that your doctor knows about any diseases you currently have or have previously had before advising you on this treatment. In particular, inform your doctor about cardiovascular diseases (heart failure, high blood pressure), conditions caused by blood clots (thrombosis, embolism), digestive 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 about any personal or family history (in first-degree relatives) of severe affective disorders (depressive disorders, bipolar disorder, or psychosis).
• The use of corticosteroids for longer than replacement 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 (e.g. 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 varicella; seek immediate medical attention if exposed.
• In children, prolonged use of this medicine may impair growth and development.
• Contact 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, although such reactions have been infrequently reported.

After long-term treatment with Dezacor, the medicine should be gradually discontinued. 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 22.75 mg/ml oral suspension drops, 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 used to relieve pain or inflammation.
• Medicines for diabetes: because a dose adjustment may be necessary.
• Antihypertensives and diuretics: because a dose 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 enhanced.
• 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 your doctor's knowledge.

Pregnancy, breastfeeding, and fertility

If you are pregnant or 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 your response to treatment is satisfactory, it is advisable to avoid tasks requiring special attention, such as driving vehicles or operating dangerous machinery.

Dezacor 22.75 mg/ml oral suspension drops contains sorbitol (E-420), sodium, and benzyl alcohol.

This medicine contains sorbitol. If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; thus, it is essentially “sodium-free”.

This medicine contains 10.45 mg of benzyl alcohol (0.01 ml) in each ml of product. Benzyl alcohol may cause allergic reactions. Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis), especially in pregnant or breastfeeding women and in patients with hepatic or renal insufficiency. In these cases, consult your doctor or pharmacist.

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome"), in children.

This medicine must not be administered to newborns (up to 4 weeks of age) unless recommended by your doctor.

This medicine should not be used for longer than one week in children under 3 years of age unless recommended by your doctor.

3. How to take Dezacor

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, please consult your doctor or pharmacist again.

Your doctor will determine the daily dose. The dosage is individual for each patient, depending on the type and severity of the disease, as well as on the response to treatment.

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 important that you fully understand your doctor's instructions regarding administration of the medicine, and if in doubt, do not hesitate to consult them.

In special situations (stress, severe infections, serious trauma, or surgical procedures), a dose adjustment may be required. Consult your doctor for advice on how to proceed in such cases.

Instructions for correct administration

This medicine is administered orally. Shake the bottle well before use.

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

Use of the container

1. To release the dropper from its protective cap, hold A and simultaneously pull B upwards.
2. Unscrew the metal cap from the bottle and place and screw the dropper in place.
3. To open the bottle containing the dropper, press down firmly on the cap while simultaneously unscrewing it.

CHILD-RESISTANT SAFETY CAP.

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

After prolonged treatment, this medicine must never be discontinued abruptly. Your doctor will advise you how to gradually reduce the dose. It is also important that you remain in contact with your doctor at the end of treatment, so that appropriate action can be taken 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 name of the medicine and the amount ingested, and go immediately to a hospital facility so that appropriate treatment can be administered.

If you forget to take Dezacor

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

If you stop taking Dezacor

Abruptly stopping prolonged treatment 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 can cause adverse effects, although not everyone will experience them.

This medicine is generally well tolerated during short-term treatment, and adverse effects are uncommon. However, the following effects have been observed during prolonged treatment:

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, gastric ulcer, bleeding, nausea, indigestion.
• Headache, dizziness.
• Depressed and unstable mood.
• Behavioural disturbances, mood changes (depression, euphoria).
• Hirsutism (excessive hair growth in women), striae, and acne.
• Suppression of the hypothalamic-pituitary-adrenal axis (which may impair the response to stress and reduce resistance to infections), Cushingoid facies (moon face).
• Increased blood glucose (with onset or worsening of diabetes), sodium and water retention (leading to elevated blood pressure), potassium loss in urine when administered concomitantly with beta-agonist or xanthine medications (salbutamol, isoprenaline, fluticasone, theophylline).
• Increased susceptibility to infections due to reduced immune system activity.
• Osteoporosis, vertebral and long bone fractures.
• Edema (swelling due to 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):

• Leucocytosis (increase in the number of white blood cells).
• Blood clot formation, particularly in patients with pre-existing conditions associated with a higher risk of 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 of higher brain functions such as language, orientation, memory, reality interpretation, or social behaviour).
• Blurred vision, increased intraocular pressure, glaucoma, optic disc edema, cataracts (especially in children), chorioretinopathy (retinal disorder that may affect vision), corneal thinning, worsening of viral or fungal eye infections.
• Skin thinning, appearance of small blood vessels on the skin (telangiectasias).
• 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 concomitantly with quinolone antibiotics (ciprofloxacin, ofloxacin, levofloxacin), muscle weakness or disturbances.
• Menstrual irregularities.
• Impaired wound healing.
• Too rapid reduction of the dose after prolonged treatment may lead to acute adrenal insufficiency (a potentially life-threatening condition caused by cortisol deficiency), hypotension, and death.

The use of Dezacor together with medications that cause muscle relaxation, especially when administered at high doses and for long periods, may cause 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 taking this medicine, you should contact your doctor.

Reporting of 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 leaflet. You may also report them directly through 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 carton after EXP. The expiry date is the last day of the month indicated.

Discard the container 1 month after opening.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dezacor

The active substance 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: sorbitol 70% solution, sodium carboxymethylcellulose, magnesium aluminium silicate, polysorbate 80, benzyl alcohol, sucralose, tropical fruit flavour, monohydrate citric acid, sodium hydroxide and purified water.

Appearance of Dezacor and contents of the container:

Homogeneous white-tinged suspension.

It is presented in 20 ml amber glass bottles with an aluminium cap, including a glass dropper. The container holds 13 ml.

Other presentations

Dezacor is also marketed as 6 mg and 30 mg 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.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of latest revision 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/