Prospecto: information for the user

Deflazacort NORMON 6 mg tablets EFG

Deflazacort

Read this prospectus carefully before starting to take this medication.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you must not give it to others even if they have the same symptoms, as it may harm them.
• 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.

1. What is deflazacort NORMON 6 mg tablets and what is it used for

2. Before taking deflazacort NORMON 6 mg tablets

3. How to take deflazacort NORMON 6 mg tablets

4. Possible adverse effects

5. Storage of deflazacort NORMON 6 mg tablets

6. Additional information

Deflazacort NORMON 6 mg tablets is a medicine belonging to a group of medicines known as corticosteroids, which have anti-inflammatory and antiallergic properties.

Deflazacort NORMON 6 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: 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.
• Renal diseases: nephrotic syndrome.

?Do not take deflazacort NORMON 6 mg tablets

• 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 have 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 NORMON 6 mg tablets

• 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 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, eye alterations may appear, so your doctor may advise you to visit an ophthalmologist periodically.
• It is necessary to increase the medication dose in special situations (surgery, infections, and others) and therefore the doctor must know if the patient has had any other disease.
• In children, the prolonged use of this medication may stop their growth and development.
• After a long treatment with deflazacort NORMON6 mg tablets, this should be gradually discontinued. Do not stop this medication without consulting your doctor first.

?Use in athletes

Inform the 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 NORMON may interact with them:

• Pain or anti-inflammatory medications.
• Diabetes medications.
• Diuretics.
• Antibiotics.
• Estrogens 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 NORMON 6 mg tablets without your doctor's knowledge.

?Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

The experience in humans is limited, so deflazacort NORMON6 mg tabletsshould only be used in cases where the risk-benefit assessment previously advises its use.

Deflazacort NORMON6 mg tabletsare excreted in breast milk, so it is not recommended to use it during breastfeeding.

?Driving and operating machinery

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

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

?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.

Follow exactly the administration instructions for Deflazacort NORMON 6 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 whole, 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 your doctor's instructions regarding the administration of the medication, and if you have any doubts, do not hesitate to consult them.

Your doctor will indicate the duration of treatment. Do not suspend treatment 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 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 Toxicological 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 missed dose.

?If you interrupt treatment with Deflazacort NORMON 6 mg tablets

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 medication, ask your doctor or pharmacist.

Like all medications,deflazacort NORMON 6 mg tabletsmay have 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, hemorrhage, heavy digestion, acute pancreatitis (especially in children).

Central Nervous System Disorders:Headache, dizziness, agitation, insomnia, mood changes (depression, euphoria) and increased intracranial pressure.

Skin and Subcutaneous Tissue Disorders:Thinning of the skin, striae, 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 changes (cataracts, increased intraocular pressure). With an unknown frequency (the frequency cannot be estimated from available data), blurred vision has been observed.

Laboratory Results:Decreased potassium and sodium retention.

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

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

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiration date: Do not use deflazacort NORMON 6 mg tablets after the expiration date that appears on the packaging after “Cad”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

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 Contents of the Package

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

Holder of the Marketing Authorization and Responsible for Manufacturing

LABORATORIOS NORMON, S.A.

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

OTHER PRESENTATIONS

Deflazacort NORMON 30 mg Tablets EFG

This prospectus was approved in April 2011