Leaflet: information for the user

deflazacort cinfa 6 mg tablets EFG

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, and you should 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.See section 4.

1. What is deflazacort cinfa and what it is used for

2. What you need to know before taking deflazacort cinfa

3. How to take deflazacort cinfa

4. Possible side effects

5. Storage of deflazacort cinfa

6. Contents of the pack and additional information

deflazacort cinfa 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 corticosteroids due to its lower activity on sugars and bone.

deflazacort cinfais indicated for the treatment of:

• Rheumatic and collagen diseases: such as rheumatoid arthritis, psoriatic arthritis, and systemic lupus erythematosus.
• Skin diseases: such as pemphigus, generalized exfoliative dermatitis, and severe psoriasis.
• Allergic diseases: bronchial asthma that does not respond to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Eye diseases: choroiditis, chororetinitis, iritis, and iridocyclitis.
• Blood 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.

Do not take deflazacort cinfa

• If you are allergic to deflazacort or any of the other ingredients 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

Consult your doctor or pharmacist before starting to take deflazacort cinfa.

• 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.
• The dose of corticosteroids needs to be adjusted in special situations (surgery, infections, and others) and your doctor must know if you have had any other diseases.
• In children, prolonged use of this medication may stop their growth and development.
• After a long treatment with deflazacort, 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.

Use in athletes

Inform patients that this medication contains deflazacort, which may produce a positive result in doping control tests.

Taking deflazacort cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

• Diabetes medications: as the dose may need to be changed.
• Antibiotics (rifampicin): as they may reduce the effect of deflazacort.
• Estrogens or oral contraceptives: as the effect of deflazacort 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 deflazacort.
• Some medications may increase the effects of deflazacort, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Consuming medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

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

Driving and operating machines

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

Deflazacort cinfa contains lactose

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

Deflazacort cinfa contains sodium

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

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

This medication is administered orally. The tablets will be swallowed without chewing, with the help of a little liquid.

The tablet can be divided into equal doses. The dose must be individualized. Therefore, the number and frequency of tablets that you should take will be determined by your doctor based on the type and severity of your disease, as well as your response to treatment.

In adults, the dose may range from 6 to 90 mg per day, and in children from 0.25 to 1.15 mg/kg. It is essential that you understand perfectly the instructions given by your doctor regarding the administration of the medication, and in case of doubt, do not hesitate to consult them.

Your doctor will indicate the duration of treatment. Do not stop taking it before, nor without authorization, and never discontinue it abruptly. In special situations (stress, major infections, severe trauma, or surgical interventions), it may be necessary to adjust the dose. Consult with your doctor to explain the course of action to follow in these cases.

After a prolonged treatment, the administration of this medication should never be stopped abruptly. Your doctor will indicate how to gradually reduce the dose. It is also essential that you maintain contact with your doctor at the end of treatment to act in case of reappearance of symptoms.

If you take more deflazacort cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take deflazacort cinfa

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

If you interrupt treatment with deflazacort cinfa

After a long treatment with deflazacort, it should be gradually discontinued. Prolonged treatments that are stopped abruptly may cause: fever, discomfort, and muscle and joint pain.

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

Like all medications,this medicationcan produce adverse effects, although not all people experience them.

The adverse effects of deflazacort that have been observed primarily in long-term treatments are the following:

• Gastrointestinal disorders:gastrointestinal ulcer.
• Central 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, loss of menstruation.

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

-Eye disorders:eye alterations.

Unknown frequency (cannot be estimated from available data): blurred vision.

The use ofdeflazacortwith 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 theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash.Deposit empty packaging and unused medications at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of deflazacort cinfa

The active ingredient is deflazacort. Each tablet contains 6 mg of deflazacort.

The other components are: lactose monohydrate, microcrystalline cellulose (E-460), sodium croscarmellose, cornstarch, polisorbate 80 (E-433) and magnesium stearate.

Appearance of the product and contents of the packaging

deflazacort cinfa 6 mgare non-coated, white, cylindrical tablets with a double cross-score on one face and the number 6 on the other.

They are presented in blister packs containing 20 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet: July 2020

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

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/73872/P_73872.html

QR code to:https://cima.aemps.es/cima/dochtml/p/73872/P_73872.html