Deflazacort Normon 6 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Deflazacort NORMON 6 mg tablets EFG

Deflazacort

Read the entire 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 and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What deflazacort NORMON 6 mg tablets are and what they are used for
2. Before you take deflazacort NORMON 6 mg tablets
3. How to take deflazacort NORMON 6 mg tablets
4. Possible side effects
5. How to store deflazacort NORMON 6 mg tablets
6. Further information

1. What deflazacort NORMON 6 mg tablets are and what they are used for

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 are indicated for the treatment of:

• Rheumatic and connective tissue 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 unresponsive to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Ocular diseases: choroiditis, chorioretinitis, iritis, and iridocyclitis.
• Blood disorders: 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.

2. Before taking deflazacort NORMON 6 mg tablets

? Do not take deflazacort NORMON 6 mg tablets

• If you are allergic (hypersensitive) to deflazacort or to any of the other ingredients of this medicine.
• If you have a stomach ulcer.
• If you suffer from bacterial infections (active tuberculosis), viral infections (ocular herpes simplex, herpes zoster, varicella), or systemic fungal infections.
• If you are in a pre- or post-vaccination period.

? Take special care with deflazacort NORMON 6 mg tablets

• It is important that your doctor knows about all diseases you currently have or have had previously before advising you on this treatment. In particular, inform your doctor about cardiovascular diseases (heart failure, high blood pressure), conditions caused by blood clots (thrombosis, embolism), digestive or intestinal disorders (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 such cases. Also inform your doctor if you have recently visited tropical countries.
• With prolonged treatment, eye disorders may occur; therefore, your doctor may recommend periodic visits to an ophthalmologist.
• It may be necessary to increase the dose of the medicine in special situations (surgery, infections, and others), so your doctor must be aware of any other illness the patient may have experienced.
• In children, prolonged use of this medicine may impair growth and development.
• After long-term treatment with deflazacort NORMON 6 mg tablets, the medicine should be discontinued gradually. Do not stop taking this medicine without consulting your doctor first.

? Use in athletes

Patients should be informed that this medicine contains deflazacort, which may lead to a positive result in doping control tests.

? Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those not requiring a prescription.

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

• Medicines used to relieve pain or inflammation.
• Medicines for diabetes.
• Diuretics.
• Anti-infective agents.
• Estrogens or oral contraceptives.
• Medicines that cause muscle relaxation.
• Anticholinesterase medicines, used in myasthenia gravis.
• Medicines used to treat heart failure or coagulation disorders.
• Vaccines and toxoids.
• Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).

Do not take any of these medicines 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 medicine.

Experience in humans is limited; therefore, deflazacort NORMON 6 mg tablets should only be used if the risk/benefit assessment previously performed supports its use.

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

? Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

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

? Deflazacort NORMON 6 mg tablets contain lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take deflazacort NORMON 6 mg tablets

Follow exactly the administration instructions for deflazacort NORMON 6 mg tablets provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medicine 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 depending on the type and severity of your condition, 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 therefore essential that you fully understand your doctor's instructions regarding the administration of this medicine, and if in doubt, consult your doctor.

Your doctor will determine the duration of treatment. Do not stop treatment early or without authorization, and never discontinue it abruptly.

In special situations (stress, significant infections, severe trauma, or surgical procedures), an adjustment of the dose may be required. Consult your doctor for guidance on how to proceed in such cases.

After prolonged treatment, this medicine must never be stopped abruptly. Your doctor will instruct you on how to gradually reduce the dose. It is also important that you remain in contact with your doctor after treatment ends, so that appropriate action can be taken if symptoms reappear.

? If you take more deflazacort NORMON 6 mg tablets than you should

If you have taken more medicine than prescribed, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

? If you forget to take deflazacort NORMON 6 mg tablets

Do not take a double dose to make up for the missed dose.

? If you interrupt treatment with deflazacort NORMON 6 mg tablets

Prolonged treatments, if interrupted abruptly, may cause fever, malaise, and muscle and joint pain.

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

4. Possible adverse effects

Like all medicines, deflazacort NORMON 6 mg tablets may have adverse effects, although not everyone experiences them. In short-term treatments, this medicine is well tolerated and adverse effects are uncommon. However, in prolonged treatments, the following have been observed:

Gastrointestinal disorders: Stomach ulcer, 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 and subcutaneous tissue disorders: Thinning of the skin, stretch marks, and acne.

Cardiac and vascular disorders: Increased blood pressure, fluid retention in tissues (edema), heart failure, complications caused by blood clots (thromboembolism), decreased potassium levels, and salt retention.

Endocrine disorders: Adrenal insufficiency, weight gain, moon face (round, full face), worsening of diabetes, absence of menstruation, and growth retardation in children.

Musculoskeletal and connective tissue disorders: Muscle disturbances or muscle weakness, osteoporosis.

Eye disorders: Eye abnormalities (cataracts, increased intraocular pressure). Blurred vision has been observed with unknown frequency (frequency cannot be estimated from available data).

Laboratory findings: Decreased potassium levels and salt retention.

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

Likewise, if any of the reactions described above occur, or if you notice any other reactions not listed in this leaflet, 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 date stated on the packaging following "Exp". The expiry date refers to 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 and packaging that you no longer need. This will help protect the environment.

6. Additional information

Composition of deflazacort NORMON 6 mg tablets

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

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

Appearance of the product and contents of the pack

Deflazacort NORMON 6 mg is presented as tablets. They are whiteish, round, flat tablets with a double score on one side. Each pack 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