DEFLAZACORT ALTER 30 mg TABLETS

2. Before taking Deflazacort Alter 30 mg Tablets

Do not take DEFLAZACORT ALTER 30 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 infections (ocular herpes simplex), or fungal infections.

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

Be cautious when taking DEFLAZACORT ALTER 30 mg Tablets:

• It is essential that your doctor knows about all the diseases you have or have had before advising you on this treatment. Especially, you should inform your doctor about cardiovascular diseases (heart failure, high blood pressure), blood clot-related diseases (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 advise you on what to do in these cases. Also, inform your doctor 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 30 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,
• medicines for heart failure or blood clotting disorders,
• medicines for epilepsy and those used in psychiatric treatments.

Do not take any of these medicines at the same time as DEFLAZACORT ALTER 30 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; therefore, DEFLAZACORT ALTER 30 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 ALTER 30 mg Tablets are excreted in breast milk, so their use is not recommended during breast-feeding.

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 30 mg Tablets:

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

3. How to take Deflazacort Alter 30 mg Tablets

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

The tablets or their parts 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, in case of doubt, 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 at the end of the treatment so that they can act in case of symptom recurrence.

If you take more DEFLAZACORT ALTER 30 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 30 mg Tablets:

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

Effects that occur when treatment with DEFLAZACORT ALTER 30 mg Tablets is interrupted:

Prolonged treatments, if 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 30 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, blood clot-related complications (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 test 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 listed 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 30 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 medicines in the SIGRE Collection Point (or any other pharmaceutical waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition of DEFLAZACORT ALTER 30 mg Tablets

The active ingredient is deflazacort.

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

Appearance of the product and packaging content

Oral tablets, circular, cross-scored, and white-ivory in color.

Deflazacort Alter 30 mg Tablets are available in packs containing 10 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/