DEFLAZACORT EFARMES 6 mg TABLETS

Introduction

Package Leaflet: Information for the User

Deflazacort Efarmes 6 mg Tablets EFG

Deflazacort

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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Deflazacort Efarmes 6 mg and what is it used for

Deflazacort Efarmes 6 mg is a medicine that belongs to a group of medicines known as corticosteroids, which have anti-inflammatory and anti-allergic properties.

Deflazacort Efarmes 6 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 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 Efarmes 6 mg

Do not take Deflazacort Efarmes 6 mg:

?If you are allergic (hypersensitive) to deflazacort or any of the other ingredients of this medicine (listed in section 6).

?If you have stomach ulcers

?If you have bacterial infections (active tuberculosis) and viral infections (ocular herpes simplex, herpes zoster, chickenpox) or generalized fungal infections.

?If you are in the 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), gastrointestinal or intestinal diseases (stomach ulcers, intestinal inflammation, chronic diarrhea), severe 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 medicine. 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 must know if the patient has suffered from any other disease.

?In children, prolonged use of this medicine can stop their growth and development.

?After a long treatment with Deflazacort Efarmes 6 mg, 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 can produce a positive result in doping tests.

Taking Deflazacort Efarmes with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines, as Deflazacort Efarmes 6 mg may interact with them:

• Pain or anti-inflammatory medicines.
• Diabetes medicines.
• Diuretics.
• Antibiotics.
• Estrogens or oral contraceptives.
• Muscle relaxants.
• Anticholinesterase medicines used in myasthenia gravis.
• Medicines for the treatment of heart failure or coagulation disorders.
• Vaccines and toxoids.
• Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).

Do not take any of these medicines at the same time as Deflazacort Efarmes 6 mg without consulting your doctor.

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.

Human experience is limited, so Deflazacort Efarmes 6 mg will only be used in cases where the risk/benefit assessment advises its use.

Deflazacort Efarmes 6 mg is excreted in breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

No data are available, but 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 some sugars, consult them before taking this medicine.

3. How to take Deflazacort Efarmes 6 mg

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 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 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 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 medicine 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 6 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 medicine and the amount taken.

If you forget to take Deflazacort Efarmes 6 mg

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

If you stop taking Deflazacort Efarmes 6 mg

Prolonged treatments that are stopped abruptly can cause: fever, discomfort, and muscle and joint pain.

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

4. Possible side effects

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

In short-term treatments, this medicine 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 medicine, your tendency to infections may increase, so if you notice any symptoms of disease that may be related to taking this medicine, you should contact your doctor.

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Deflazacort Efarmes 6 mg

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the pack and any unused medicine in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the pack and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Deflazacort Efarmes 6 mg

The active substance is deflazacort.

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

Appearance of the product and pack contents:

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

Deflazacort Efarmes 6 mg tablets are available in packs containing 20 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 package leaflet: September 2018

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