DEFLAZACORT VIR 6 mg TABLETS

Introduction

Package Leaflet: Information for the User

DEFLAZACORT VIR 6 mg tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

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

• If you have any doubts, consult your doctor or pharmacist.

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

• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

1. What is DEFLAZACORT VIR 6 mg tablets and what is it used for
2. Before taking DEFLAZACORT VIR 6 mg tablets
3. How to take DEFLAZACORT VIR 6 mg tablets
4. Possible side effects
5. Storage of DEFLAZACORT VIR 6 mg tablets

1. Additional Information

1. What is DEFLAZACORT VIR 6 mg tablets and what is it used for

It belongs to the group of medications called systemic corticosteroids.

It 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 VIR 6 mg tablets

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 (herpes simplex ocular) or fungal infections

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

Be 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. 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 medication. Your doctor will indicate 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. Contact your doctor if you experience blurred vision or other visual disturbances.

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

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

Human experience is limited, so Deflazacort will only be used in cases where the risk/benefit assessment advises its use.

Deflazacort VIR 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 machinery have been described.

Important Information about Some of the Components of Deflazacort VIR:

This medication contains lactose. If your doctor has indicated 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.

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

• medications to combat pain or inflammation,
• diuretics,
• antibiotics,
• contraceptives

, • those intended for the treatment of 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 VIR without your doctor's knowledge.

3. How to Take DEFLAZACORT VIR 6 mg tablets

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

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 the response to treatment. In adults, the dose can range from 6 to 90 mg per day. 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 the treatment. Do not suspend it before, nor without authorization, and never do it abruptly.

In special situations (stress, important 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 medication 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 VIR 6 mg tablets than you should:

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

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

If you forget to take DEFLAZACORT VIR 6 mg tablets:

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

If you interrupt the treatment with DEFLAZACORT VIR 6 mg tablets:

Prolonged treatments, if interrupted abruptly, can 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 medications, Deflazacort VIR can have side effects, although not all people experience them.

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

• Gastrointestinal: stomach ulcer, hemorrhage, heavy digestions, acute pancreatitis (especially in children).

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

• Dermatological: skin thinning, stretch marks, and acne.

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

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

• Musculoskeletal: muscle alterations or weakness, osteoporosis.

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

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

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of DEFLAZACORT VIR 6 mg tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

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

Medications should not be thrown away through the sewers or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Additional Information

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 Packaging Contents:

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

Marketing authorization holder and manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

This package leaflet was approved in February 2017