DEFLAZACORT CINFA 6 mg TABLETS

Introduction

Package Leaflet: Information for the User

deflazacort cinfa 6 mg tablets EFG

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

deflazacort cinfa is a medicine that belongs to a group of medicines known as corticosteroids, which have anti-inflammatory and anti-allergic properties. It has a distinct safety profile compared to other corticosteroids, with less activity on sugars and bone.

deflazacort cinfa is 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.
• Ocular diseases: choroiditis, chorioretinitis, iritis, and iridocyclitis.
• Blood diseases: idiopathic thrombocytopenia, hemolytic anemia, and palliative treatment of leukemia and lymphoma.
• Gastrointestinal and hepatic diseases: ulcerative colitis, Crohn's disease, and chronic active hepatitis.
• Kidney diseases: nephrotic syndrome.

2. What you need to know before you take deflazacort cinfa

Do not take deflazacort cinfa

• If you are allergic to deflazacort or any of the other ingredients of this medicine (listed in section 6).
• If you have a stomach ulcer.
• If you have bacterial infections (active tuberculosis) and viral infections (simple ocular herpes, herpes zoster, chickenpox) or generalized fungal infections.
• If you are in the pre- or post-vaccination period.

Warnings and precautions

Talk to your doctor or pharmacist before taking deflazacort cinfa.

• Tell 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.
• It is necessary to adjust the dose of corticosteroids in special situations (surgery, infections, and others) and therefore the doctor should know if the patient has suffered from any other disease.
• In children, prolonged use of this medicine may stop their growth and development.
• After long-term treatment with deflazacort, it should be gradually discontinued. Do not stop taking this medicine without consulting your doctor first.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

Patients should be warned that this medicine contains deflazacort, which may produce a positive result in doping tests.

Taking deflazacort cinfa with other medicines

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

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as deflazacort may interact with them.

• Diabetes medicines: because a dose change may be necessary.
• Anti-infectives (rifampicin): because they may decrease the effect of deflazacort.
• Estrogens or oral contraceptives: because the effect of deflazacort may be increased.
• Muscle relaxants: because the relaxing effect may be prolonged.
• Anticholinesterase medicines used in myasthenia gravis.
• Vaccines and toxoids: because corticosteroids decrease the immune response.
• Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital): because they may decrease the effect of deflazacort.
• Some medicines may increase the effects of deflazacort, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Deflazacort should not be used during the first trimester of pregnancy unless the doctor considers the benefits to outweigh the potential risks.

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

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

Driving and using machines

There are no available data, although it is advisable that, until the response to treatment is satisfactory, you should not perform tasks that require special attention, such as driving vehicles, operating hazardous machinery, etc.

deflazacort cinfa contains lactose

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

deflazacort cinfa contains sodium

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

3. How to take deflazacort cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, 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 tablet can be divided into equal doses. The dose should 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 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 fully understand your doctor's instructions regarding the administration of the medicine and, if in doubt, do not hesitate to consult them.

Your doctor will indicate the duration of the treatment. Do not stop it before, or without authorization, and never stop it abruptly. In special situations (stress, significant infections, severe trauma, or surgical interventions), it may be necessary to adjust the dose. Consult your doctor to explain the procedure to follow in these cases.

After prolonged treatment, the administration of this medicine should never be stopped abruptly. Your doctor will indicate how to gradually decrease the dose. It is also important 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 deflazacort cinfa 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 taken.

If you forget to take deflazacort cinfa

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

If you stop taking deflazacort cinfa

After long-term treatment with deflazacort, it should be gradually discontinued. Abrupt interruption of prolonged treatments can cause: fever, malaise, and muscle and joint pain.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The side effects of deflazacort that have been observed, mainly in long-term treatments, are the following:

• Gastrointestinal disorders:gastrointestinal ulcer.
• Nervous system disorders:headache, dizziness, agitation, sleep disorders.
• Skin and subcutaneous tissue disorders:healing problems, skin lesions.
• Cardiac 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 disturbances.

Frequency not known (cannot be estimated from the available data): blurred vision.

The use of deflazacort together with muscle relaxants, especially when administered at high doses and for long periods, may produce severe muscle disorders.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects 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 deflazacort cinfa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of deflazacort cinfa

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

The other ingredients are: lactose monohydrate, microcrystalline cellulose (E-460), sodium croscarmellose, corn starch, polysorbate 80 (E-433), and magnesium stearate.

Appearance of the product and contents of the pack

deflazacort cinfa 6 mg are tablets, cylindrical, uncoated, white, with a double score line in the shape of a cross on one side and the number 6 on the other.

They are available in blister packs containing 20 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of last revision of this package leaflet: July 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the package 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