Deflazacort Tarbis 30 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Deflazacort TARBIS 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 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 severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

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

Deflazacort TARBIS 30 mg is a medicine belonging to a group of medicines known as corticosteroids, which have anti-inflammatory and antiallergic 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 unresponsive to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Ocular diseases: choroiditis, chorioretinitis, iritis, and iridocyclitis.
• Blood disorders: idiopathic thrombocytopenia, hemolytic anemias, and palliative treatment of leukemias and lymphomas.
• Gastrointestinal and hepatic diseases: ulcerative colitis, Crohn's disease, and active chronic 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 to any of the other ingredients of this medicine.
• If you have a stomach ulcer.
• If you have bacterial infections (active tuberculosis), viral infections (ocular herpes simplex, herpes zoster, varicella), or systemic fungal infections.
• If you are in a pre- or post-vaccination period.

Take special care with Deflazacort TARBIS 30 mg:

• It is important that your doctor knows about all the medical conditions you currently have or have had in the past before prescribing this treatment. In particular, inform your doctor about cardiovascular diseases (heart failure, high blood pressure), conditions caused by blood clots (thrombosis, embolism), gastrointestinal or intestinal disorders (stomach ulcer, 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 the appropriate course of action 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.
• The dose of corticosteroids may need to be increased in special situations (surgery, infections, and others), so your doctor must be aware if you have suffered from any other illness.
• In children, prolonged use of this medicine may impair growth and development.
• After long-term treatment with Deflazacort TARBIS 30 mg, the medicine should be discontinued gradually. Do not stop taking this medicine without first consulting your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Use in athletes

Patients should be informed that this medicine contains deflazacort, which may result in a positive finding in doping control tests.

Use of other medicines

Inform your doctor or pharmacist if you are currently 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 any of the following medicines, as Deflazacort TARBIS 30 mg may interact with them:

• Medicines used to relieve pain or inflammation.
• Medicines for diabetes.
• Diuretics.
• Anti-infective agents.
• Estrogens or oral contraceptives.
• Medicines that cause muscle relaxation.
• Anticholinesterase medicines, used in myasthenia gravis.
• Medicines used to treat heart failure or coagulation disorders.
• Vaccines and toxoids.
• Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).

Do not take any of these medicines concurrently with Deflazacort TARBIS 30 mg without your doctor's knowledge.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Human experience is limited; therefore, Deflazacort TARBIS 30 mg should only be used when a previous risk/benefit assessment justifies its use.

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

Driving and use of machines

There are no available data; however, until your response to treatment is satisfactory, it is advisable to avoid tasks requiring special alertness such as driving vehicles or operating dangerous machinery.

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

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

3. How to take Deflazacort TARBIS 30 mg

Follow exactly the administration instructions for Deflazacort TARBIS 30 mg provided by your physician. If you have any doubts, consult your doctor or pharmacist.

This medicine is administered orally. The tablets should be swallowed whole, 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 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, and in children from 0.25 to 1.15 mg/kg. It is therefore essential that you fully understand your doctor's instructions regarding administration of the medicine, and if in doubt, consult your doctor.

Your doctor will determine the duration of treatment. Do not stop the treatment prematurely, without authorization, or abruptly.

In special situations (stress, significant infections, severe trauma, or surgical procedures), dose adjustments may be required. Consult your doctor for guidance on how to proceed 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 after treatment ends, so that appropriate action can be taken if symptoms reappear.

If you take more Deflazacort TARBIS 30 mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 missed doses.

If you stop treatment with Deflazacort TARBIS 30 mg

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 TARBIS 30 mg tablets can cause adverse effects, although not everyone experiences them.

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

• Gastrointestinal disorders: Stomach ulcer, 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.

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

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

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

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

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.

Likewise, if you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed 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 expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Deflazacort TARBIS 30 mg

The active substance is deflazacort.

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

Appearance of the product and contents of the pack:

White, circular, orally administered tablets, cross-scored.

Deflazacort TARBIS 30 mg tablets are available in packs 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 last approved in:

September 2017

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/