DEFLAZACORT PENSA 30 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

deflazacort pensa 30 mg tablets EFG

Deflazacort

Contents of the pack:

1. What deflazacort pensa 30 mg tabletsare and what they are used for
2. Before taking deflazacort pensa 30 mg tablets
3. How to take deflazacort pensa 30 mg tablets
4. Possible side effects
5. Storage of deflazacort pensa 30 mg tablets
6. Further information

1. What deflazacort pensa 30 mg tablets are and what they are used for

deflazacort pensa 30 mg tabletsare a medicine belonging to a group of medicines known as corticosteroids, which have anti-inflammatory and anti-allergic properties.

deflazacort pensa 30 mg tabletsare 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 anemia, and palliative treatment of leukemia and lymphoma.
• Gastrointestinal and hepatic diseases: ulcerative colitis, Crohn's disease, and chronic active hepatitis.
• Kidney diseases: nephrotic syndrome.

2. Before taking deflazacort pensa 30 mg tablets

Do not take deflazacort pensa 30 mg tablets

• If you are allergic (hypersensitive) to deflazacort or any of the other ingredients of deflazacort pensa 30 mg tablets.
• If you have a stomach ulcer.
• If you have active bacterial (tuberculosis) or viral (herpes simplex ocular, herpes zoster, chickenpox) infections or generalized fungal infections.
• If you are in a pre- or post-vaccination period.

Be careful with deflazacort pensa 30 mg tablets

• 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), digestive or intestinal diseases (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 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.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• 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 may stop their growth and development.
• After a long treatment with deflazacort pensa 30 mg tablets, it should be gradually discontinued. Do not stop taking this medicine without consulting your doctor first.

Use in athletes

Patients should be warned that this medicine contains deflazacort, which may 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 pensa 30 mg tabletsmay interact with them:

• Pain or anti-inflammatory medicines.
• Diabetes medicines.
• Diuretics, medicines used to increase urine production.
• Antibiotics.
• Estrogens or oral contraceptives.
• Muscle relaxants.
• Anticholinesterase medicines used in myasthenia gravis.
• Medicines for the treatment of heart failure or blood coagulation disorders.
• Vaccines and toxoids.
• Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).
• Some medicines may increase the effects of deflazacort Pensa 30 mg tablets, so your doctor will closely monitor you if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Do not take any of these medicines at the same time as deflazacort pensa 30 mg tabletswithout your doctor's knowledge.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy:Human experience is limited, so deflazacort pensa 30 mg tabletswill only be used in cases where the risk/benefit assessment advises its use.

Breastfeeding: deflazacort pensa 30 mg tabletsare excreted in breast milk, so their use is not recommended during breastfeeding.

Driving and using machines

No effects on the ability to drive and use machines have been described.

Important information about some of the ingredients of deflazacort pensa 30 mg tablets

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 pensa 30 mg tablets

Follow the administration instructions of deflazacort pensa 30 mg tabletsindicated 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 tablet can be divided into equal parts. The dose should 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 fully 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 the treatment. Do not stop it before, or without authorization, and never stop it abruptly. In special situations (stress, significant infections, severe trauma, or surgery), 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 at the end of the treatment so that they can act in case of symptom recurrence.

If you take more deflazacort pensa 30 mg tablets than you should

If you have taken more medicine than you should (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 pensa 30 mg tablets

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

If you stop treatment with deflazacort pensa 30 mg tablets

After prolonged treatment with deflazacort pensa 30 mg tablets, it should be gradually discontinued. Prolonged treatments that are interrupted abruptly may cause: fever, discomfort, and muscle and joint pain.

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

4. Possible side effects

Like all medicines, deflazacort pensa 30 mg tabletscan cause side effects, although not everyone 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 (bleeding), indigestion, acute pancreatitis (inflammation of the pancreas), especially in children.
• Nervous system disorders: headache, dizziness, agitation, insomnia, mood changes (depression, euphoria), and increased intracranial pressure.
• Skin disorders: thinning of the skin, stretch marks, and acne.
• Cardiovascular and vascular disorders: high blood pressure, fluid retention in tissues (edema), heart failure (difficulty pumping blood), complications caused by blood clots (thromboembolism), low potassium levels, and salt retention.
• Endocrine disorders: adrenal insufficiency (adrenal gland failure), weight gain, and moon face, worsening of diabetes, disappearance of menstruation, and delayed growth in children.
• Musculoskeletal and connective tissue disorders: muscle weakness or disorders, osteoporosis.
• Eye disorders: eye disorders (cataracts, increased intraocular pressure). Blurred vision (frequency not known - cannot be estimated from available data).
• Laboratory test result: low potassium levels and salt retention.

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 are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of deflazacort pensa 30 mg tablets

No special storage conditions are required.

Keep out of the reach and sight of children.

Expiry date

Do not take deflazacort pensa 30 mg tabletsafter the expiry date stated on the packaging after "EXP". The expiry date is 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 no longer required. This will help protect the environment.

6. Further information

Composition of deflazacort pensa 30 mg tablets

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

The other ingredients are: lactose monohydrate, microcrystalline cellulose (E-460), sodium croscarmellose, cornstarch, polysorbate 80 (E-433), and magnesium stearate.

Appearance of the product and packaging contents

deflazacort pensa 30 mg tabletsare oral tablets, round, uncoated, white, with a double score line in the shape of a cross on one side and the number 30 on the other, and are presented in packages containing 10 tablets. The tablet can be divided into equal parts.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

LABORATORIOS CINFA, S.A.

Olaz-Chipi, 10. Poligono Industrial Areta

31620 Huarte-Pamplona (Navarra), Spain

This leaflet was approved in September 2017

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