Deflazacort Vir 6 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

DEFLAZACORT VIR 6 mg tablets EFG

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 must not give it to others, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

1. What DEFLAZACORT VIR 6 mg tablets are and what they are used for

2. Before taking DEFLAZACORT VIR 6 mg tablets

3. How to take DEFLAZACORT VIR 6 mg tablets

4. Possible side effects

5. How to store DEFLAZACORT VIR 6 mg tablets

6. Further information

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

It belongs to the group of medicines known as 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 to any of the other ingredients of Deflazacort VIR.

• If you have stomach ulcers, 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 knows about all medical conditions you currently have or have previously had before advising you on this treatment. You must especially inform your doctor of 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 such cases. Also inform your doctor if you have recently visited tropical countries.

• With prolonged treatment, eye disorders may occur; therefore, 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 prior 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 with your doctor before taking this medicine.

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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-infectives,
• contraceptives,

• medicines used to treat 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 6 mg TABLETS

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

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

Adults:

The dose should be individually adjusted. Therefore, the number and frequency of tablets you must 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 the administration of the medicine, and if in doubt, do not hesitate to consult them.

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

In special situations (stress, significant infections, severe trauma, or surgical procedures), an adjustment of the dose may be required. Consult your doctor to explain the recommended course of action in such cases.

After prolonged treatment, administration of this medicine must never be stopped abruptly. Your doctor will instruct you on how to gradually reduce the dose. It is also important that you remain in contact with your doctor at the end of treatment, so they can act promptly if symptoms reappear.

If you take more Deflazacort VIR 6 mg tablets than you should:

If you have taken more than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 915 62 04 20, stating the name of the medicine and the amount taken.

It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Deflazacort VIR 6 mg tablets:

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

If you stop taking Deflazacort VIR 6 mg tablets:

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 have adverse effects, although not everyone will experience them.

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

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

• Nervous system: Headache, dizziness, agitation, insomnia, 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 levels, and salt retention.

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

• Musculoskeletal: Muscle disorders or muscle weakness, osteoporosis.

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

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 6 mg tablets

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

6. ADDITIONAL INFORMATION

Composition of Deflazacort VIR 6 mg tablets:

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

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

Appearance of the medicinal product and contents of the pack:

Deflazacort VIR 6 mg tablets are presented as tablets for oral use. Each pack 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 leaflet was approved in February 2017