DEFLAZACORT VIR 30 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

DEFLAZACORT VIR 30 mg tabletsEFG

Deflazacort

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What DEFLAZACORT VIR is and what it is used for
2. Before taking DEFLAZACORT VIR
3. How to take DEFLAZACORT VIR
4. Possible side effects
5. Storing DEFLAZACORT VIR
6. Further information

1. What DEFLAZACORT VIR is and what it is used for

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

2. Before taking DEFLAZACORT VIR

Do not take Deflazacort VIR:

• If you are allergic to deflazacort or any of the other ingredients of DEFLAZACORT VIR.

• If you have stomach ulcers, bacterial infections (active tuberculosis), viral infections (simple ocular herpes), 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 about all the diseases you have or have had before they can advise you on this treatment. Especially, you should inform them about cardiovascular diseases (heart failure, high blood pressure), blood clotting disorders (thrombosis, embolism), digestive or intestinal diseases (stomach ulcers, intestinal inflammation, chronic diarrhea), severe 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 them 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. Contact your doctor if you experience blurred vision or other visual disturbances.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Human experience is limited; therefore, 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 machines have been described.

Important information about some of the ingredients of DEFLAZACORT VIR

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

Using other medicines

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

Especially, inform your doctor or pharmacist if you are taking:

• Medicines for 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 VIR without your doctor's knowledge.

3. How to take DEFLAZACORT VIR

Follow exactly the administration instructions of DEFLAZACORT VIR indicated by your doctor. Consult your doctor or pharmacist if you have doubts. Remember to take the 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. It is essential that you 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, nor without authorization, and never stop 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 medicine should never be interrupted abruptly. Your doctor will indicate how to gradually decrease the dose. It is also important that you stay in contact with your doctor at the end of the treatment to act in case of symptom recurrence.

If you take more DEFLAZACORT VIR 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 medicine and the amount taken.

It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take DEFLAZACORT VIR:

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

If you interrupt treatment with DEFLAZACORT VIR:

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 medicines, DEFLAZACORT VIR 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: stomach ulcers, bleeding, 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 disorders or weakness, osteoporosis.

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

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

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storing DEFLAZACORT VIR

Keep out of the reach and sight of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Further information

Composition of DEFLAZACORT VIR:

The active ingredient is deflazacort. Each tablet contains 30 mg of deflazacort.

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

Appearance of the product and package contents:

DEFLAZACORT VIR is presented in the form of scored tablets for oral use. Each package contains 10 tablets.

Marketing authorization holder and manufacturer

INDUSTRIA QUIMICA Y FARMACEUTICA VIR, S.A.

C/Laguna, 66-68-70. Poligono Industrial Urtinsa II

28923– Alcorcón (Madrid)

Spain

This leaflet was approved in January 2011