DEFLAZACORT ALTER 6 mg TABLETS

Introduction

Package Leaflet: Information for the User

DEFLAZACORT ALTER 6 mg tablets EFG

Contents of the package leaflet:

1. What is DEFLAZACORT ALTER 6 mg tablets and what is it 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. Further information

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

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.

• Ocular diseases

• Hematological diseases.

• Gastrointestinal and hepatic diseases.

• Renal diseases.

2. Before taking Deflazacort Alter 6 mg tablets

Do not take DEFLAZACORT ALTER 6 mg tablets:

• If you are allergic to deflazacort or any of the other ingredients of this medicine.

• If you have stomach ulcers, bacterial infections (active tuberculosis), viral (ocular herpes simplex) or fungal infections.

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

Be careful with DEFLAZACORT ALTER 6 mg tablets:

• It is essential that your doctor knows about all the diseases you have or have had before he can advise you on this treatment. Especially, you should inform him about cardiovascular diseases (heart failure, high blood pressure), those caused by blood clots (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, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections.

• You should not be vaccinated during treatment with this medicine. Your doctor will tell you what to do in these cases. Also, inform him 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.

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

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

Taking other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

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

• medicines for pain or inflammation,
• diuretics,
• antibiotics,
• contraceptives,
• those for the treatment of heart failure or coagulation disorders,
• medicines for epilepsy and those used in psychiatric treatments.

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

Use in athletes

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

Pregnancy:

Consult your doctor or pharmacist before taking any medicine.

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

Breast-feeding:

Consult your doctor or pharmacist before taking any medicine.

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

Driving and using machines:

No effects on the ability to drive or use machines have been described.

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

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

3. How to take Deflazacort Alter 6 mg tablets

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

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

Adults:

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 in doubt, do not hesitate to consult him.

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 at the end of the treatment so that he can act in case of symptom recurrence.

If you take more DEFLAZACORT ALTER 6 mg tablets than you should:

If you have taken more medicine than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take DEFLAZACORT ALTER 6 mg tablets:

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

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

Prolonged treatments that are interrupted abruptly may cause: fever, discomfort, and muscle and joint pain.

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

4. Possible side effects

Like all medicines, DEFLAZACORT ALTER 6 mg tablets can cause side effects, although not everybody gets 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 digestions, 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 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, disappearance of menstruation, and growth retardation in children.

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

• Ocular disorders: Cataracts, increased intraocular pressure.

• Laboratory results: Decreased potassium and salt retention.

The following side effects have also been reported with an unknown frequency: 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 any of the reactions described above or any other not described in this leaflet appear, consult your doctor or pharmacist.

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 leaflet. You can also report them 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 Alter 6 mg tablets

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

No special storage conditions are required.

Expiry date:

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Collection Point (or any other medicine waste collection system) at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of DEFLAZACORT ALTER 6 mg tablets

The active ingredient is deflazacort.

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

Appearance of the product and packaging content

Oral tablets, circular, and ivory white in color.

Deflazacort Alter 6 mg tablets are available in packs containing 20 or 500 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Manufacturer

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

Date of the last revision of this leaflet: September 2017

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/