DEFLAZACORT TARBIS 30 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Deflazacort TARBIS 30 mg tablets EFG

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 of the side effects, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Contents of the package leaflet:

1. What is Deflazacort TARBIS 30 mg and what is it used for
2. Before taking Deflazacort TARBIS 30 mg
3. How to take Deflazacort TARBIS 30 mg
4. Possible side effects
5. Storage of Deflazacort TARBIS 30 mg
6. Further information

1. What is Deflazacort TARBIS 30 mg and what is it used for

Deflazacort TARBIS 30 mg is a medicine that belongs to a group of medicines known as corticosteroids, which have anti-inflammatory and anti-allergic properties.

Deflazacort TARBIS 30 mg is indicated for the treatment of:

• Rheumatic and collagen diseases: such as rheumatoid arthritis, psoriatic arthritis, and systemic lupus erythematosus.
• Skin diseases: such as pemphigus, generalized exfoliative dermatitis, and severe psoriasis.
• Allergic diseases: bronchial asthma that does not respond to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Ocular diseases: choroiditis, chorioretinitis, iritis, and iridocyclitis.
• Blood diseases: idiopathic thrombocytopenia, hemolytic anemias, and palliative treatment of leukemias and lymphomas.
• Gastrointestinal and hepatic diseases: ulcerative colitis, Crohn's disease, and chronic active hepatitis.
• Kidney diseases: nephrotic syndrome.

2. Before taking Deflazacort TARBIS 30 mg

Do not take Deflazacort TARBIS 30 mg:

• If you are allergic (hypersensitive) to deflazacort or any of the other components of this medicine.
• If you have a stomach ulcer.
• If you have bacterial infections (active tuberculosis) and viral infections (simple ocular herpes, herpes zoster, chickenpox) or generalized fungal infections.
• If you are in a pre- or post-vaccination period.

Be careful with Deflazacort TARBIS 30 mg:

• 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), gastrointestinal or intestinal diseases (stomach ulcers, intestinal inflammation, chronic diarrhea), significant liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, 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.
• It is necessary to increase the dose of corticosteroids in special situations (surgery, infections, and others), and therefore, the doctor should know if the patient has suffered from any other disease.
• In children, prolonged use of this medicine can stop their growth and development.
• After a long treatment with Deflazacort TARBIS 30 mg, it should be gradually discontinued. Do not stop taking this medicine without consulting your doctor first.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

Patients should be warned that this medicine contains deflazacort, which can produce a positive result in doping tests.

Use of other medicines

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines, as Deflazacort TARBIS 30 mg may interact with them:

• Pain or inflammation medicines.
• Diabetes medicines.
• Diuretics.
• Antibiotics.
• Estrogens or oral contraceptives.
• Muscle relaxants.
• Anticholinesterase medicines used in myasthenia gravis.
• Medicines for heart failure or blood clotting disorders.
• Vaccines and toxoids.
• Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).

Do not take any of these medicines at the same time as Deflazacort TARBIS 30 mg without consulting your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Human experience is limited, so Deflazacort TARBIS 30 mg will only be used in cases where the risk-benefit assessment advises its use.

Deflazacort TARBIS 30 mg is excreted in breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

No data are available, but it is advisable not to perform tasks that require special attention, such as driving vehicles or operating hazardous machinery, until the response to treatment is satisfactory.

Important information about some of the components of Deflazacort TARBIS 30 mg

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

3. How to take Deflazacort TARBIS 30 mg

Follow the instructions for administration of Deflazacort TARBIS 30 mg exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medicine is administered orally. The tablets should be swallowed without chewing, with a little liquid.

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, and in children from 0.25 to 1.15 mg/kg. 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 treatment. Do not stop it before, or without authorization, and never stop it abruptly.

In special situations (stress, significant infections, severe trauma, or surgical interventions), it may be necessary to adjust the dose. Consult your doctor to explain the procedure 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 remain in contact with your doctor after completing treatment so that they can act in case of symptom recurrence.

If you take more Deflazacort TARBIS 30 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Deflazacort TARBIS 30 mg

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

If you interrupt treatment with Deflazacort TARBIS 30 mg

Prolonged treatments that are interrupted abruptly can cause: fever, discomfort, and muscle and joint pain.

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

4. Possible side effects

Like all medicines, Deflazacort TARBIS 30 mg tablets can cause side effects, although not everybody gets them.

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

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

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

• Skin and subcutaneous tissue disorders: Thinning of the skin, stretch marks, and acne.

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

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

• Musculoskeletal and connective tissue disorders: Muscle disorders or weakness, osteoporosis.

• Ocular disorders: Eye disorders (cataracts, increased intraocular pressure), blurred vision.

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

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

5. Storage of Deflazacort TARBIS 30 mg

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Deflazacort TARBIS 30 mg after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Deflazacort TARBIS 30 mg

The active ingredient is deflazacort.

The other components are: lactose monohydrate, cornstarch, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and package contents:

Oral tablets, circular, cross-scored, and white.

Deflazacort TARBIS 30 mg tablets are available in packages containing 10 or 500 tablets.

Marketing authorization holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Manufacturer

LACER, S.A.

C/ Boters nº 5, 08290 Cerdanyola del Vallès

Barcelona (Spain)

This leaflet was approved in:

September 2017

Other sources of information

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.es/