Package Leaflet: Information for the User

DEFLAZACORT VIR 6 mg tablets EFG

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you personally and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you think you are having a serious side effect or if any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

6. Additional Information

It belongs to a group of medicines called systemic corticosteroids.

It is indicated for the treatment of:

• Rheumatic and collagen diseases.
• Skin diseases.
• Allergic diseases.
• Pulmonary diseases.
• Eye diseases.

• Hematological diseases.
• Gastrointestinal and hepatic diseases
• Renal diseases.

Do not take Deflazacort VIR:

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

• 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 VIR:

• 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, inflammatory bowel disease, chronic diarrhea), important liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, thyroid insufficiency, muscle weakness, and certain acute or chronic infections.

• Do not get vaccinated 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, eye alterations may appear, so your doctor may advise you to visit an ophthalmologist periodically. Contact your doctor if you experience blurry vision or other visual alterations.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Human experience is limited, so Deflazacort should only be used in cases where a risk-benefit assessment advises its use.

Deflazacort VIR 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 use machinery have been described.

Important information about some of the components of Deflazacort VIR:

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Particularly inform your doctor or pharmacist if you are taking:

• pain or anti-inflammatory medications,

• diuretics,

• antibiotics,

• contraceptives,

• medications for heart failure or coagulation disorders,

• epilepsy medications, and those used in psychiatric treatments.

Do not take any of these medications at the same time as Deflazacort VIR without your doctor's knowledge.

Follow exactly the administration instructions for Deflazacort VIR 6mg tablets as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take the medication.

The tablets or their parts will be swallowed whole, without chewing, with a little liquid.

Adults:

The dose must be individualized. Therefore, the number and frequency of tablets that you should take will be set 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. It is essential that you understand perfectly the instructions from your doctor 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 taking it before, nor without authorization, and never discontinue 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 how to proceed 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 VIR 6 mg tablets than you should:

If you have taken more than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Deflazacort VIR 6 mg tablets:

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

If you interrupt treatment with Deflazacort VIR 6 mg tablets:

Prolonged treatments that are stopped 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

Like all medications, Deflazacort VIR may have adverse effects, although not everyone will experience them.

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

• Gastrointestinal:Stomach ulcer, hemorrhage, heavy digestion, acute pancreatitis (especially in children).

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

• Dermatological:Thinning of the skin, stretch marks, and acne.

• Cardiovascular:Increased blood pressure, fluid retention in tissues (edema), heart failure, complications caused by blood clots (thromboembolism), decreased potassium, and sodium retention.

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

• Musculoskeletal:Muscle weakness or alterations, osteoporosis.

• Others:Eye alterations (cataracts, increased intraocular pressure, blurred vision of unknown frequency).

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

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.. .

Keep out of reach and sight of children.

No special storage conditions are required.

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

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment..

Composition of Deflazacort VIR 6 mg tablets:

The active ingredient is deflazacort. Each tablet contains 6mg of deflazacort.

The other excipients are lactose, microcrystalline cellulose, cornstarch and magnesium stearate.

Appearance of the product and contents of the package:

Deflazacort VIR 6 mg tablets are presented in the form of oral tablets. Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

This leaflet was approved in February 2017