DEFLAZACORT KERN PHARMA 6 mg TABLETS

2. Before taking Deflazacort Kern Pharma 6 mg tablets EFG

Do not take Deflazacort Kern Pharma 6 mg tablets EFG:

• 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 (ocular herpes simplex) or fungal infections

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

Be careful withDeflazacort Kern Pharma6 mg tablets EFG:

• It is essential that your doctor knows all the diseases you have or have had before they can advise you on this treatment. Especially, you should 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.

• You should not be vaccinated during treatment with this medicine. Your doctor will indicate what 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 medicine can 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 medicine, including those obtained without a prescription.

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

• medicines to combat pain or inflammation,
• diuretics,
• antibiotics,
• contraceptives,
• those intended 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 Kern Pharma 6 mg tablets EFG without your doctor's knowledge.

Some medicines may increase the effects of Deflazacort Kern Pharma, so your doctor will perform thorough checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Use in athletes

Patient 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 a medicine.

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

Breastfeeding:

Consult your doctor or pharmacist before taking a medicine.

Deflazacort Kern Pharma 6 mg tablets EFG is excreted in breast milk, so its use is not recommended during breastfeeding.

Driving and using machines:

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

Important information about some of the components ofDeflazacort Kern Pharma 6 mg tablets EFG:

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

3. How to take Deflazacort Kern Pharma 6 mg tablets EFG

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

The tablets or their parts should be swallowed whole, without chewing, with the help of 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 you have any doubts, do not hesitate to consult them.

Your doctor will indicate the duration of the treatment. Do not stop it before, nor 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 conduct 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 moreDeflazacort Kern Pharma6 mg tablets EFG 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 takeDeflazacort Kern Pharma6 mg tablets EFG:

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

Effects that occur when treatment withDeflazacort Kern Pharma6 mg tablets EFG is interrupted:

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

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

4. Possible side effects

Like all medicines, Deflazacort Kern Pharma 6 mg tablets EFG can have side effects, although not everyone 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 ulcer, hemorrhage, 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.

• Cardiac 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, disappearance of menstruation, and growth retardation in children.

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

• Ocular disorders: Cataracts, increased intraocular pressure, blurred vision.

• Laboratory test results: Decreased potassium and salt retention.

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 it, you should contact your doctor.

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 Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Deflazacort Kern Pharma 6 mg tablets EFG

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

No special storage conditions are required.

Expiry date:

This medicine should not be used after the expiry date indicated 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. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Deflazacort Kern Pharma 6 mg tablets

The active ingredient is deflazacort.

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

Appearance of the product and packaging content

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

Deflazacort Kern Pharma 6 mg tablets are presented in packs containing 20 or 500 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol.Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

LACER, S.A.

C/Sardenya, 350

08025 Barcelona

Spain

Date of the last revision of this leaflet: September 2017

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