Deflazacort Cinfa 6 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

deflazacort cinfa 6 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

deflazacort cinfa is a medicine belonging to a group of medicines known as corticosteroids, which have anti-inflammatory and antiallergic properties. It has a different safety profile compared to other corticosteroids due to its lower 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 unresponsive to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Ocular diseases: choroiditis, chorioretinitis, iritis, and iridocyclitis.
• Blood disorders: 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 taking deflazacort cinfa

Do not take deflazacort cinfa

• If you are allergic to deflazacort or to any of the other ingredients of this medicine (listed in section 6).
• If you have a stomach ulcer.
• If you suffer from bacterial infections (active tuberculosis), viral infections (ocular herpes simplex, herpes zoster, varicella), or systemic fungal infections.
• If you are in a 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 heart disease, congestive heart failure, high blood pressure, thromboembolic disorders (those caused by blood clots), diseases of the esophagus, stomach or intestine, diabetes mellitus, emotional disorders, psychosis, epilepsy, glaucoma, hypothyroidism (underactive thyroid gland) and/or cirrhosis.
• It is necessary to adjust corticosteroid dosage in special situations (such as surgery, infections, and others), so your doctor must be aware of any other medical conditions you may have had.
• In children, prolonged use of this medicine may impair growth and development.
• After long-term treatment with deflazacort, the medication should be discontinued gradually. Do not stop taking this medicine without first consulting your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

Patients should be advised that this medicine contains deflazacort, which may result in a positive outcome in doping control tests.

Taking deflazacort cinfa with other medicines

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

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

• Medicines for diabetes: because a dosage adjustment may be necessary.
• Anti-infectives (rifampicin): because they may reduce the effect of deflazacort.
• Estrogens or oral contraceptives: because the effect of deflazacort may be increased.
• Medicines that cause muscle relaxation: because the relaxing effect may be prolonged.
• Anticholinesterase medicines, used in myasthenia gravis.
• Vaccines and toxoids: because corticosteroids reduce the immune response.
• Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital): because they may reduce the effect of deflazacort.
• Some medicines may increase the effects of deflazacort, so your doctor will perform careful monitoring 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 become pregnant, consult your doctor or pharmacist before using this medicine.

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

Taking medicines during pregnancy may be harmful 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 using machines

There are no available data; however, until the response to treatment is satisfactory, it is advisable to avoid tasks requiring special attention, such as driving vehicles or operating dangerous machinery.

deflazacort cinfa contains lactose

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

deflazacort cinfa contains sodium

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

3. How to take deflazacort cinfa

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

This medicine is administered orally. The tablets should be swallowed whole, with a little liquid.

The tablet may be divided into equal doses. The dose must be individualized. Therefore, the number and frequency of tablets you should take will be determined by your doctor according to the type and severity of your illness, 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 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.

Your doctor will tell you how long the treatment should last. Do not stop it earlier or without authorization, and never stop abruptly. In special situations (stress, significant infections, severe trauma, or surgical procedures), it may be necessary to adjust the dose. Consult your doctor to find out how to proceed in such cases.

After prolonged treatment, administration of this medicine must never be stopped abruptly. Your doctor will instruct you on how to gradually reduce the dose. It is also important that you remain in contact with your doctor after finishing treatment, so they can act promptly if symptoms reappear.

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 at telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take deflazacort cinfa

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

If you stop treatment with deflazacort cinfa

After long-term treatment with deflazacort, discontinuation should be gradual. Prolonged treatments interrupted abruptly 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, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects of deflazacort observed mainly during long-term treatment are the following:

• Gastrointestinal disorders: gastrointestinal ulcer.

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

• Skin and subcutaneous tissue disorders: impaired wound healing, skin lesions.

• Cardiac and vascular disorders: increased blood pressure (hypertension), fluid retention in tissues (edema).

• Endocrine disorders: weight gain, worsening of diabetes mellitus, absence of menstruation.

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

• Eye disorders: ocular disturbances.

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

The use of deflazacort together with medications that cause muscle relaxation, especially when administered at high doses and for prolonged periods, may lead to severe muscle disorders.

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 can 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 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of deflazacort cinfa

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

The other components 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 cylindrical, uncoated white tablets, with a cross-shaped double score on one side and the number 6 on the other.

It is 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 the most recent review of this leaflet: July 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You may 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