DEFLAZACORT EFARMES 30 mg TABLETS

Introduction

Package Leaflet: Information for the User

Deflazacort Efarmes 30 mg Tablets EFG

Deflazacort

Read this entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Deflazacort Efarmes 30 mg and what is it used for
2. What you need to know before taking Deflazacort Efarmes 30 mg
3. How to take Deflazacort Efarmes 30 mg
4. Possible side effects
5. Storage of Deflazacort Efarmes 30 mg
6. Package Contents and Additional Information

1. What is Deflazacort Efarmes 30 mg and what is it used for

Deflazacort Efarmes 30 mg is a medication belonging to a group of medications known as corticosteroids, which have anti-inflammatory and anti-allergic properties.

Deflazacort Efarmes 30 mg 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.

??Eye diseases: choroiditis, chorioretinitis, iritis, and iridocyclitis

??Blood diseases: idiopathic thrombocytopenia, hemolytic anemias, and palliative treatment of leukemias and lymphomas.

??Gastrointestinal and hepatic diseases: ulcerative colitis, Crohn's disease, and chronic active hepatitis.

??Kidney diseases: nephrotic syndrome.

2. What you need to know before taking Deflazacort Efarmes 30 mg

Do not take Deflazacort Efarmes 30 mg:

??If you are allergic (hypersensitive) to deflazacort or 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 (simple ocular herpes, herpes zoster, chickenpox) or generalized fungal infections.

??If you are in a pre- or post-vaccination period.

Warnings and Precautions

??It is essential that your doctor knows about all the diseases you have or have had before they can advise you on this treatment. Especially, you should inform them about cardiovascular diseases (heart failure, high blood pressure), blood clotting disorders (thrombosis, embolism), digestive or intestinal diseases (stomach ulcers, intestinal inflammation, chronic diarrhea), significant liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections.

??You should not be vaccinated during treatment with this medication. Your doctor will advise you on what to do in these cases. Also, inform them if you have recently been to tropical countries.

??In prolonged treatments, eye disorders may appear, so your doctor may advise you to visit an ophthalmologist periodically.

??It is necessary to increase 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 medication can stop their growth and development.

??After a long treatment with Deflazacort Efarmes 30 mg, it should be gradually discontinued. Do not stop this medication 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 medication contains deflazacort, which can produce a positive result in doping tests.

Taking Deflazacort Efarmes with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. In particular, inform your doctor or pharmacist if you are taking any of the medications listed below, as Deflazacort Efarmes 30 mg may interact with them:

• Pain or inflammation medications.
• Diabetes medications.
• Diuretics.
• Antibiotics.
• Estrogens or oral contraceptives.
• Muscle relaxants.
• Anticholinesterase medications used in myasthenia gravis.
• Medications for heart failure or coagulation disorders.
• Vaccines and toxoids.
• Medications for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).

Do not take any of these medications at the same time as Deflazacort Efarmes 30 mg without consulting your doctor.

Pregnancy, Breastfeeding, and Fertility

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

Human experience is limited, so Deflazacort Efarmes 30 mg will only be used in cases where the risk-benefit assessment advises its use.

Deflazacort Efarmes 30 mg is excreted in breast milk, so its use is not recommended during breastfeeding.

Driving and Using Machines

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

Deflazacort Efarmes contains lactose

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

3. How to take Deflazacort Efarmes 30 mg

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

The dose must 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 can 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 medication, and if you have any doubts, 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 medication should never be interrupted abruptly. Your doctor will indicate how to gradually decrease the dose. It is also important that you remain in contact with your doctor after completing the treatment so that they can act in case of symptom recurrence.

If you take more Deflazacort Efarmes 30 mg 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 medication and the amount ingested.

If you forget to take Deflazacort Efarmes 30 mg

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

If you interrupt treatment with Deflazacort Efarmes 30 mg

Prolonged treatments that are interrupted abruptly can cause: fever, malaise, and muscle and joint pain.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In short-term treatments, this medication is well-tolerated, and side effects are rare. However, in prolonged treatments, the following have been observed:

??Gastrointestinal disorders: Stomach ulcers, bleeding, indigestion, acute pancreatitis (especially in children).

??Nervous system disorders: Headache, dizziness, agitation, insomnia, mood changes (depression, euphoria), and increased intracranial pressure.

??Skin and subcutaneous tissue disorders: Thinning of the skin, stretch marks, and acne.

??Cardiovascular and vascular disorders: Increased blood pressure, fluid retention in tissues (edema), heart failure, complications caused by blood clots (thromboembolism), decreased potassium, and salt retention.

??Endocrine disorders: Adrenal insufficiency, weight gain, and moon face, worsening of diabetes, disappearance of menstruation, and growth retardation in children.

??Musculoskeletal and connective tissue disorders: Muscle weakness or disorders, osteoporosis.

??Eye disorders: Eye disorders (cataracts, increased intraocular pressure), blurred vision.

During treatment with this medication, your tendency to infections may increase, so if you notice any symptoms of disease that may be related to taking this medication, you should contact your doctor.

Similarly, if you consider that any of the side effects you experience is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Deflazacort Efarmes 30 mg

No special storage conditions are required.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE Point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Deflazacort Efarmes 30 mg

The active ingredient is deflazacort.

The other components are: lactose monohydrate, cornstarch, microcrystalline cellulose, and magnesium stearate.

Appearance of the Product and Package Contents:

Oral tablets, circular, cross-scored, and white.

Deflazacort Efarmes 30 mg tablets are available in packages containing 10 or 500 tablets.

Marketing Authorization Holder and Manufacturer

LACER, S.A.

C/ Boters, 5

08290 Parc Tecnològic del Vallès (Cerdanyola del Vallès) - Barcelona

Spain

Date of the Last Revision of this Leaflet: February 2017

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/