DEFLAZACORT NORMON 6 mg TABLETS

Introduction

Package Leaflet: Information for the User

Deflazacort NORMON 6 mg Tablets EFG

Deflazacort

Read this entire leaflet carefully before starting to take this medication.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet

1. What Deflazacort NORMON 6 mg Tablets are and what they are used for
2. Before taking Deflazacort NORMON 6 mg Tablets
3. How to take Deflazacort NORMON 6 mg Tablets
4. Possible side effects
5. Storage of Deflazacort NORMON 6 mg Tablets
6. Additional information

1. What Deflazacort NORMON 6 mg Tablets are and what they are used for

Deflazacort NORMON 6 mg Tablets are a medication belonging to a group of medications known as corticosteroids, which have anti-inflammatory and anti-allergic properties.

Deflazacort NORMON 6 mg Tablets are 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 NORMON 6 mg Tablets

Do not take Deflazacort NORMON 6 mg Tablets

• If you are allergic (hypersensitive) to deflazacort or any of the other components of this medication.
• 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 the pre- or post-vaccination period.

Be cautious with Deflazacort NORMON 6 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 must inform them about cardiovascular diseases (heart failure, high blood pressure), blood clotting disorders (thrombosis, embolism), digestive 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 medication. Your doctor will indicate the course of action 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 medication in special situations (surgery, infections, and others), and therefore, the doctor must know if the patient has suffered from any other disease.
• In children, prolonged use of this medication can stop their growth and development.
• After a long treatment with Deflazacort NORMON 6 mg Tablets, it should be gradually discontinued. Do not discontinue this medication without consulting your doctor first.

Use in Athletes

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

Use of Other Medications

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

In particular, inform your doctor or pharmacist if you are taking any of the medications listed below, as deflazacort NORMON may interact with them:

• Pain or inflammation medications.
• Diabetes medications.
• Diuretics.
• Antibiotics.
• Estrogens or oral contraceptives.
• Muscle relaxants.
• 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 NORMON 6 mg Tablets without your doctor's knowledge.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

Human experience is limited; therefore, Deflazacort NORMON 6 mg Tablets will only be used in cases where the risk-benefit assessment advises their use.

Deflazacort NORMON 6 mg Tablets are excreted in breast milk; therefore, their use is not recommended during breastfeeding.

Driving and Using Machines

No effects on the ability to drive or use machinery have been described.

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

Deflazacort NORMON 6 mg Tablets contain Lactose

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

3. How to take Deflazacort NORMON 6 mg Tablets

Follow the administration instructions for Deflazacort NORMON 6 mg Tablets indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication is administered orally. The tablets should be swallowed whole, 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 medication administration and do not hesitate to consult them if you have any doubts.

Your doctor will indicate the duration of treatment. Do not discontinue treatment before the indicated time or without authorization, and never do so 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 course of action in these cases.

After prolonged treatment, the administration of this medication 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 NORMON 6 mg Tablets than you should

If you have taken more medication than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Deflazacort NORMON 6 mg Tablets

Do not take a double dose to compensate for the forgotten dose.

If you interrupt treatment with Deflazacort NORMON 6 mg Tablets

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

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

4. Possible Side Effects

Like all medications, Deflazacort NORMON 6 mg Tablets can have side effects, although not everyone experiences them. In short-term treatments, this medication 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:Skin thinning, stretch marks, and acne.

Cardiovascular disorders:Increased blood pressure, fluid retention in tissues (edema), heart failure, blood clot complications (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). With an unknown frequency (cannot be estimated from available data), blurred vision has been observed.

Laboratory results:Decreased potassium and salt retention.

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

Similarly, if any of the reactions described above or any other not mentioned in this leaflet appear, consult your doctor or pharmacist.

5. Storage of Deflazacort NORMON 6 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiry date: Do not use Deflazacort NORMON 6 mg Tablets after the expiry date stated on the packaging after "Cad". The expiry date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Additional Information

Composition of Deflazacort NORMON 6 mg Tablets

The active ingredient is deflazacort. Each tablet contains 6 mg of deflazacort.

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

Appearance of the Product and Packaging Contents

Deflazacort NORMON 6 mg is presented in the form of tablets. They are white, round, flat tablets with a double score on one side. Each package contains 20 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Deflazacort NORMON 30 mg Tablets EFG

This leaflet was approved in April 2011