PATIENT INFORMATION LEAFLET

Deflazacort TARBIS 30 mg tablets EFG

Deflazacort

Read this 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. Do not pass it on to others even if they have the same symptoms, as it may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Deflazacort TARBIS 30 mg is a medication belonging to a group of medications 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: severe asthma that does not respond to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Eye diseases: choroiditis, chororetinitis, iritis, and iridocyclitis.
• Blood diseases: idiopathic thrombocytopenia, hemolytic anemias, and palliative treatment of leukemias and lymphomas.
• Gastrointestinal and liver diseases: ulcerative colitis, Crohn's disease, and active chronic hepatitis.
• Kidney diseases: nephrotic syndrome.

Do not take Deflazacort TARBIS 30 mg :

• If you are allergic (hypersensitive) to deflazacort or to any of the other components of this medication.
• If you have a stomach ulcer.
• If you suffer from bacterial infections (active tuberculosis) and viral infections (herpes simplex eye, herpes zoster, varicella) or generalized infections caused by fungi.
• If you are in the pre or post-vaccination period.

Be especially careful with Deflazacort TARBIS 30 mg :

• It is essential that your doctor knows all the diseases you have or have had before they can advise you on this treatment. You must especially inform them of cardiovascular diseases (heart failure, high blood pressure), those caused by blood clots (thrombosis, embolism), digestive or intestinal diseases (stomach ulcer, intestinal inflammation, chronic diarrhea), important liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections.
• Do not get vaccinated during treatment with this medication. Your doctor will indicate what you should do in these cases. Inform them also if you have recently been to tropical countries.
• In prolonged treatments, ocular alterations 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 must know if the patient has suffered any other disease.
• In children, the prolonged use of this medication may stop their growth and development.
• After a long treatment with Deflazacort TARBIS 30 mg, it should be gradually discontinued. Do not stop this medication without consulting your doctor first.
• Contact your doctor if you experience blurred vision or other visual alterations.

Use in athletes

Inform patients that this medication contains deflazacort, which may produce a positive result in doping control tests.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, even those purchased without a prescription.

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

• Pain or anti-inflammatory medications.
• Diabetes medications.
• Diuretics.
• Antibiotics.
• Estradiol or oral contraceptives.
• Medications that cause muscle relaxation.
• Anticholinesterase medications, used in myasthenia gravis.
• Medications for heart failure or coagulation disorders.
• Vaccines and toxoids.
• Medications for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The experience in humans is limited, so Deflazacort TARBIS 30 mg should only be used in cases where the risk-benefit assessment recommends its use.

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

Driving and operating machinery

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

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

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

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

This medication 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 that 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 perfectly the instructions provided by your doctor regarding the administration of the medication, and in case of doubt, do not hesitate to consult them.

Your doctor will indicate the duration of treatment. Do not stop taking it before, nor without authorization, and never discontinue it abruptly.

In special situations (stress, major infections, severe trauma, or surgical interventions), it may be necessary to adjust the dose. Consult with your doctor to explain the course of action to follow in these cases.

After prolonged treatment, the administration of this medication should never be discontinued abruptly. Your doctor will indicate how to gradually reduce the dose. It is also essential that you maintain contact with your doctor at the end of treatment to act in case of reappearance of symptoms.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Deflazacort TARBIS 30 mg

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Deflazacort TARBIS 30 mg

Prolonged treatments that are discontinued abruptly may cause: fever, discomfort, and muscle and joint pain.

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

Like all medications, Deflazacort TARBIS 30 mg tablets may produce adverse effects, although not everyone will experience them.

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

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

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

• Disorders of the skin and subcutaneous tissue: Skin thinning, 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 sodium retention.

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

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

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

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

Similarly, if you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

No requires special conditions for conservation.

Keep out of the reach and sight of children.

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

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

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 contents of the packaging:

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

Deflazacort TARBIS 30 mg tablets are presented in containers containing 10 or 500 tablets.

Holder of the marketing authorization

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

(Spain)

Responsible for manufacturing

LACER, S.A.

C/ Boters nº 5, 08290 Cerdanyola del Vallès

Barcelona (Spain)

This leaflet has been approved in:

September 2017

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/