PATIENT INFORMATION LEAFLET

Defal 30 mg tablets EFG

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 their symptoms are the same. 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.

1.What isDefal30 mg tablets and what it is used for

2.Before takingDefal30 mg tablets

3.How to takeDefal30 mg tablets

4.Possible side effects

5.Storage ofDefal30 mg tablets

6.Further information

Defal30 mg tablets is a medication belonging to a group of medications known as corticosteroids, which has anti-inflammatory and antiallergic properties.

Defal30 mg tablets 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.
• 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 takeDefal30 mg tablets:

Be especially careful withDefal30 mg tablets:

•Your doctor should know 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.

•You should not be vaccinated during treatment with this medication. Your doctor will tell you what to do in these cases. Also inform them if you have recently been to tropical countries.

•In prolonged treatments, eye changes may occur, so your doctor may advise you to visit an ophthalmologist periodically.

•Contact your doctor if you experience blurred vision or other visual changes.

•You need to increase the dose of corticosteroids in special situations (surgery, infections, and others) and therefore your doctor should know if you have had any other disease.

•Prolonged use of this medication in children may stop their growth and development.

•After a long treatment withDefal30 mg tablets, it should be gradually discontinued. Do not stop taking this medication without consulting your doctor first.

Use in athletes

You should 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.

• Some medications may increase the effects ofDefal30 mg tablets, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Especially inform your doctor or pharmacist if you are taking any of the following medications, asDefal30 mg tablets 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 asDefal30 mg tablets without your doctor's knowledge.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Human experience is limited, soDefal30 mg tablets should only be used in cases where a previous risk-benefit assessment recommends its use.

Defal30 mg tablets are excreted in breast milk, so it is not recommended to use it during breastfeeding.

Driving and operating machinery

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 treatment response is satisfactory.

Important information about one of the components ofDefal30 mg tablets

This medication contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for Defal 30 mg tablets 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 set 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 given by your doctor regarding the administration of the medication, and in case of doubt, do not hesitate to consult them.

Your doctor will inform you of 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 your doctor to explain the course of action to follow in these cases.

After prolonged treatment, the administration of this medication should never be stopped abruptly. Your doctor will inform you 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 Defal 30 mg tablets 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 Defal 30 mg tablets

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

If you interrupt treatment with Defal 30 mg tablets

Prolonged treatments that are stopped 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.

Like all medications,Defal30 mg tablets may have adverse effects, although not everyone will experience them.

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

• Gastrointestinal disorders:Stomach ulcers, hemorrhage, heavy digestion, 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: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 (failure of the adrenal gland), weight gain and moon face, worsening of diabetes, cessation of menstruation and delayed growth in children.
• Musculoskeletal and connective tissue disorders:Muscle weakness or alterations, osteoporosis.
• Eye disorders:Eye changes (cataracts, increased intraocular pressure).

With an unknown frequency (cannot be estimated from available data): 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, contact your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No requires special conditions for conservation.

Keep out of reach and sight of children.

Do not useDefal30 mg tablets 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 drain or in the trash. Dispose of the packaging and medicines that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition ofDefal30 mg tablets

The active ingredient is deflazacort.

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

Appearance of the product and content of the packaging:

Round, non-coated tablets, white, with a cross engraved on one face and the number 30 on the other.

The tablet can be divided into equal parts.

Defal30 mg tablets are packaged in PVC blisters and aluminum-PVC laminates and are presented in containers containing 10 or 500 tablets.

Other presentations

Defalis also marketed in 6 mg tablets.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet: January 2025

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