Leaflet: information for the user

DEFLAZACORT ALTER 6 mg tablets EFG

1. What DEFLAZACORT ALTER 6 mg tablets are and what they are used for

2. Before taking DEFLAZACORT ALTER 6 mg tablets

3. How to take DEFLAZACORT ALTER 6 mg tablets

4. Possible side effects

5. Storage of DEFLAZACORT ALTER 6 mg tablets

6. Additional information

DEFLAZACORT ALTER 6 mg tablets belongs to a group of medicines called systemic corticosteroids.

DEFLAZACORT ALTER 6 mg tablets is indicated for the treatment of:

• Rheumatic and collagen diseases.

• Skin diseases.

• Allergic diseases.

• Pulmonary diseases.

• Eye diseases

• Hematological diseases.

• Gastrointestinal and liver diseases.

• Renal diseases.

Do not take DEFLAZACORT ALTER 6 mg tablets:

• If you are allergic to deflazacort or any of the other components of the preparation.

• If you have a stomach ulcer, bacterial infections (active tuberculosis), viral infections (herpes simplex eye infection), or fungal infections.

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

Be especially careful with DEFLAZACORT ALTER 6 mg tablets:

• It is essential that your doctor knows all the diseases you have or have had before they can advise you on this treatment. You must especially inform them of cardiovascular diseases (heart failure, high blood pressure), those caused by blood clots (thrombosis, embolism), digestive or intestinal diseases (stomach ulcer, intestinal inflammation, chronic diarrhea), significant liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections.

• Do not vaccinate during treatment with this medication. Your doctor will inform you of the conduct to follow in these cases. Also, inform them if you have recently been to tropical countries.

• In prolonged treatments, ocular alterations may appear, so your doctor may advise you to visit an ophthalmologist periodically.

• In children, prolonged use of this medication may stop their growth and development.

• Contact your doctor if you experience blurred vision or other visual alterations.

Taking other medications:

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those acquired without a prescription.

• Some medications may increase the effects of Deflazacort Alter 6 mg tablets, so your doctor will perform thorough controls if you are taking these medications (including some for HIV: ritonavir, cobicistat).

In particular, inform your doctor or pharmacist if you are taking:

• Pain or anti-inflammatory medications,
• Diuretics,
• Antibiotics,
• Contraceptives,
• Medications for heart failure or coagulation disorders,
• Medications for epilepsy and those used in psychiatric treatments.

Do not take any of these medications at the same time as DEFLAZACORT ALTER 6 mg tablets without your doctor's knowledge.

Use in athletes:

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

Pregnancy:

Consult your doctor or pharmacist before taking a medication.

Human experience is limited, so DEFLAZACORT ALTER 6 mg tablets should only be used in cases where a risk-benefit assessment recommends their use.

Breastfeeding:

Consult your doctor or pharmacist before taking a medication.

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

Driving and operating machinery:

No effects on the ability to drive and operate machinery have been described.

Important information about some of the components of DEFLAZACORT ALTER 6 mg tablets:

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow these instructions unless your doctor has given you different instructions. Remember to take the medication.

The tablets should be swallowed whole, without chewing, with a little liquid.

Adults:

The dose should 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 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 understand your doctor's instructions 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 it before, nor without authorization, and never do 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 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 ALTER 6 mg tablets than you should:

If you have taken more medication than you should, 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 ALTER 6 mg tablets:

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

Effects that occur when treatment with DEFLAZACORT ALTER 6 mg tablets is interrupted:

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 product, ask your doctor or pharmacist.

Like all medicines, DEFLAZACORT ALTER 6 mg tablets may cause side effects, although not everyone will experience them.

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

• Gastrointestinal disorders:Stomach ulcers, bleeding, heavy digestion, acute pancreatitis (especially in children).

• Neurological disorders:Headache, dizziness, agitation, insomnia, mood changes (depression, euphoria) and increased intracranial pressure.

• Dermatological 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).

• Endocrine disorders:Adrenal insufficiency, weight gain and moon face, worsening of diabetes, loss of menstruation and delayed growth in children.

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

• Ocular disorders:Cataracts, increased intraocular pressure.

• Laboratory results:Decreased potassium and sodium retention.

The following side effects have also been reported at an unknown frequency: Blurred vision.

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

Similarly, if any of the reactions described above appear or you observe any other not described in this leaflet, consult your doctor or pharmacist.

Reporting side effects

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

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

No special storage conditions are required.

Expiration Date:

This medication should not be used after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point(or any other medication waste collection system) at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of DEFLAZACORT ALTER 6 mg tablets

The active ingredient is deflazacort.

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

Appearance of the product and contents of the package

Oral tablets, circular and off-white in color.

Deflazacort Alter 6 mg tablets are presented in packages containing 20 or 500 tablets.

Holder of the marketing authorization

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Responsible for manufacturing

LACER, S.A. ; C/ Boters 5. Parc Tecnologic del Vallés (Cerdanyola del Vallés) -08290-Spain

Date of the last review of this leaflet: September 2017

The 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/