DEFLAZACORT VIR 30 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

DEFLAZACORT VIR 30 mg tablets EFG

Deflazacort

Read the entire 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 you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

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

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

It belongs to the 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 liver diseases.
• Renal diseases.

2. Before taking DEFLAZACORT VIR

Do not take Deflazacort VIR:

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

• If you have stomach ulcer, bacterial infections (active tuberculosis), viral infections (ocular herpes simplex), or fungal infections.

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

Take special care with Deflazacort VIR:

• It is important that your doctor is aware of all diseases you currently have or have previously had before prescribing this treatment. In particular, you must inform your doctor about cardiovascular diseases (heart failure, high blood pressure), conditions caused by blood clots (thrombosis, embolism), digestive or intestinal disorders (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 advise you on what to do in these cases. Also inform your doctor if you have recently traveled to tropical countries.

• With prolonged treatment, eye disorders may occur, so your doctor may recommend regular check-ups with an ophthalmologist. Contact your doctor if you experience blurred vision or other visual disturbances.

• In children, prolonged use of this medicine may impair growth and development.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Experience in humans is limited; therefore, Deflazacort should only be used when a previous risk/benefit assessment justifies its use.

Deflazacort VIR is excreted in breast milk; therefore, its use during breastfeeding is not recommended.

Driving and use of machines:

No effects on the ability to drive or operate machinery have been reported.

Important information about some of the components of Deflazacort VIR:

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

Use of other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

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

• Medicines for pain or inflammation,

• Diuretics,

• Anti-infective agents,

• Contraceptives,

• Medicines 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 for Deflazacort VIR provided by your doctor. If you have any doubts, consult your doctor or pharmacist. Remember to take the medication as prescribed.

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

Adults:

The dose should be individualized. Therefore, the number and frequency of tablets you need to take will be determined by your doctor according to the type and severity of your illness, as well as your response to treatment. In adults, the dose may range from 6 to 90 mg per day. It is therefore essential that you fully understand your doctor's instructions regarding administration of the medication, and if in doubt, do not hesitate to consult your doctor.

Your doctor will determine the duration of treatment. Do not stop it prematurely or without authorization, and never discontinue it abruptly.

In special situations (stress, severe infections, major trauma, or surgical procedures), an adjustment of the dose may be required. Consult your doctor to find out what you should do in such cases.

After prolonged treatment, this medication must never be stopped abruptly. Your doctor will instruct you how to gradually reduce the dose. It is also important that you continue to stay in contact with your doctor after treatment ends, so that appropriate action can be taken if symptoms reappear.

If you take more Deflazacort VIR than you should:

If you have taken more than the prescribed amount, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 915 62 04 20, indicating the medication and the amount taken.

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

If you forget to take Deflazacort VIR:

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

If you stop taking Deflazacort VIR:

Prolonged treatments, if interrupted abruptly, may cause fever, malaise, and muscle and joint pain.

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

4. Possible adverse effects

Like all medicines, Deflazacort VIR may cause adverse effects, although not everyone experiences them.

This medicine is generally well tolerated during short-term treatment, and adverse effects are very rare. However, the following effects have been observed during prolonged treatment:

• Gastrointestinal: Stomach ulcer, bleeding, indigestion, acute pancreatitis (especially in children).

• Nervous system: Headache, dizziness, agitation, insomnia, and mood changes (depression, euphoria), 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 levels, and salt retention.

• Endocrine: Adrenal insufficiency, weight gain and moon face, worsening of diabetes, cessation of menstruation, and growth retardation in children.

• Musculoskeletal: Muscle disorders or weakness, osteoporosis.

• Other: Eye disorders (cataracts, increased intraocular pressure, blurred vision, frequency not known).

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of DEFLAZACORT VIR:

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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

6. Additional information

Composition of Deflazacort VIR:

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

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

Appearance of the product and contents of the pack:

Deflazacort VIR is available as scored tablets for oral use. Each pack 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