Package leaflet: Information for the patient

DECOR 6 mg tablets, 30 mg tablets

Equivalent Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DECOR is and what it is used for
What you need to know before taking DECOR
How to take DECOR
Possible side effects
How to store DECOR
Contents of the pack and other information

1. What DECOR is and what it is used for

This medicinal product contains the active substance deflazacort, which belongs to a group of medicines called glucocorticoids with anti-inflammatory activity.
DECOR is indicated for the treatment of:

reduced adrenal function (primary and secondary adrenocortical insufficiency), alone or in combination with hormones (mineralocorticoids);
rheumatic diseases (psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis, post-traumatic osteoarthritis, acute and subacute bursitis, acute non-specific tenosynovitis, epicondylitis);
collagen diseases: (systemic lupus erythematosus, acute rheumatic carditis, systemic dermatomyositis);
dermatological diseases (pemphigus, bullous herpetiform dermatitis, severe polymorphous erythema, Stevens-Johnson syndrome, exfoliative dermatitis, mycosis fungoides such as cutaneous lymphoma, severe psoriasis, severe seborrheic dermatitis);
allergic conditions (seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity);
severe acute and chronic eye inflammation and allergies, (marginal corneal allergic ulcers, ocular herpes zoster, inflammation of the anterior segment of the eyeball, posterior diffuse choroiditis and uveitis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis);
blood disorders (secondary thrombocytopenia in adults, autoimmune hemolytic anemia, erythroblastopenia, congenital hypoplastic anemia, Hodgkin's disease, non-Hodgkin lymphomas, chronic lymphocytic leukemia, acute leukemia in childhood);
edematous states: idiopathic (kidney disease) or secondary nephrotic syndrome due to Systemic Lupus Erythematosus;
gastrointestinal diseases (ulcerative colitis, regional enteritis).

2. What you need to know before taking DECOR

Do not take DECOR

if you are allergic to deflazacort or to any of the other ingredients of this medicine (listed in section 6);
if you have a lung infection (active tuberculosis);
if you have a stomach or intestinal problem called peptic ulcer;
if you have an eye infection caused by the Herpes simplex virus;
if you have fungal infections (systemic mycotic infections);
if you have mental disorders (psychosis);
if you have been administered a live attenuated vaccine.

Warnings and precautions
Talk to your doctor or pharmacist before taking DECOR.
Take this medicine with caution and always under medical supervision in the following cases:

if you are under physical or emotional stress. In this case, your doctor will determine the appropriate dose according to your condition;
if you have reduced hormone production by the thyroid gland (hypothyroidism) or a serious liver problem (hepatic cirrhosis);
if you have mood or personality disorders (euphoria, depression, psychosis) or sleep disorders (insomnia), as these may worsen;
if you have a latent lung infection (latent tuberculosis) or if you test positive on a test called the tuberculin test. Close medical monitoring is recommended, as the disease may become activated. If you have tuberculosis, take this medicine only if the disease is in an advanced stage (fulminant disease) or has spread to other organs (disseminated disease). In such cases, antibiotic treatment is also required;
if you have an inflammatory bowel disease with risk of perforation (non-specific ulcerative colitis), if you have collections of pus (abscesses) or skin infections (pyogenic infections), if you have a bowel problem (diverticulitis, intestinal anastomoses), if you have kidney problems (renal failure), if you suffer from high blood pressure (hypertension), if you have diabetes, if you have a bone disease (osteoporosis), or if you have a muscle disease (severe myasthenia);
if you are taking medicines to eliminate fluids through urine (thiazide diuretics, furosemide) or medicines for the treatment of asthma (beta agonists) such as reproterol. Consult your doctor, as it is necessary to monitor potassium levels and blood pH.

Inform your doctor if any of the following occur during treatment with this medicine:

onset of infections. In this case, specific antibiotic therapy is required;
decreased production of cortisol, a hormone produced by the adrenal glands (secondary adrenal insufficiency). In this case, your doctor may decide to reduce the dose or prescribe specific hormone replacement therapy (mineralocorticoid hormones);
changes in blood electrolyte levels, especially if DECOR has been taken for a prolonged period and at high doses. In this case, adequate intake of sodium and potassium is necessary. Furthermore, DECOR may increase calcium excretion in urine.

During treatment with DECOR, if you have never had chickenpox, avoid contact with people who have chickenpox or an infection caused by the herpes zoster virus. Also, use caution if you come into contact with people who have measles. If you are exposed to such individuals, inform your doctor immediately. Be cautious if your child has measles.
If you are taking this medicine, you must not be given the smallpox vaccine or other types of vaccines (immunization procedures), as this may lead to a reduced immune response (antibody response) and nervous system problems (neurological complications).
Contact your doctor if you experience blurred vision or other visual disturbances.
For those engaged in sports: the use of this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children
DECOR should be taken by children only under strict medical supervision. Children who have taken corticosteroids for prolonged periods must be closely monitored with regard to growth and development (see section 4 “Additional undesirable effects in children and adolescents”).

Other medicines and DECOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may increase the effects of DECOR, and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
Take this medicine with caution and consult your doctor if you are taking any of the following medicines:

medicines used to reduce seizures (phenobarbital, diphenylhydantoin, carbamazepine, phenytoin, primidone), some medicines used to treat bacterial infections (rifampicin, rifabutin), medicines used to thin the blood (coumarin anticoagulants, e.g. warfarin). Consult your doctor, as specific monitoring (prothrombin time or INR) is required;
ephedrine, a medicine used as a bronchodilator;
aminoglutethimide, a medicine used to reduce steroid hormone production. In these cases, the maintenance dose of DECOR may need to be increased;
medicines for the treatment of bacterial infections (erythromycin, troleandomycin) or ketoconazole used for fungal infections. In this case, the dose of DECOR may need to be reduced;
acetylsalicylic acid (an anti-inflammatory medicine). Consult your doctor if you suffer from a blood disorder called hypoprothrombinemia;
medicines used to reduce stomach acidity (antacids), as they reduce the intestinal absorption of DECOR;
quetiapine, a medicine used for mental disorders;
oral female hormones (estrogens). Concurrent use of oral contraceptives may increase levels of DECOR;
medicines for the treatment of infections (anti-infectives);
medicines for the treatment of diabetes (oral agents and insulin);
medicines for controlling blood pressure or heart conditions (antihypertensives, loop diuretics, thiazide diuretics), medicines used for the treatment of asthma (xanthines and beta2-agonists), and carbenoxolone, a medicine used for stomach problems. Consult your doctor, as increased potassium loss from the blood may occur;
medicines used to relax muscles (non-depolarizing muscle relaxants). Concurrent use of these medicines with DECOR may cause prolonged muscle relaxation and muscle problems (acute myopathy).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take DECOR only when strictly necessary and under direct medical supervision, as it may cause harm to the fetus or newborn.

Driving and using machines
There are no available data to determine the effects on the ability to drive vehicles or operate machinery.

DECOR 6 mg tablets contain lactose and sucrose
This medicine contains lactose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
It may be harmful to teeth.

DECOR 30 mg tablets contain lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take DECOR

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is recommended to take the daily dose as a single dose in the morning, with a small amount of food, orally.
The tablets cannot be divided. Therefore, if the required dose cannot be achieved with the available strengths, another medicine must be used.
The recommended initial dose in adults ranges from 6 mg to 90 mg daily. Your doctor will determine the necessary dose and duration of treatment according to your condition and therapeutic response. If the dose needs to be reduced, this should be done gradually.
If you take more DECOR than you should
If you accidentally take an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take DECOR
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you stop taking DECOR
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

weight gain, increased appetite, disturbances in sugar metabolism (reduced carbohydrate tolerance), latent diabetes mellitus, need to increase antidiabetic medications in diabetics;
changes in blood electrolyte levels (electrolyte imbalance), which may rarely lead to heart problems (hypertension and congestive heart failure);
increased risk of infections without symptoms, lung infection caused by a bacterium (latent tuberculosis), fungal infections (candidiasis);
bone problems (osteoporosis), bone fragility, muscle problems (myopathies), fractures of the vertebrae and long bones, death of bone tissue (avascular necrosis), tendon inflammation (tendinitis), tendon rupture when administered with quinolones (medicines used to treat bacterial infections);
dizziness, headache (cephalalgia), increased pressure in the brain (intracranial pressure), worsening of epilepsy;
mental disturbances such as: irritability, feelings of worry or fear (anxiety), suicidal thoughts, obsessive ideas and behaviors (mania), depression, hallucinations, worsening of schizophrenia, feeling of well-being (euphoria), sleep disturbances (insomnia), mood or personality changes, severe depression, memory problems (amnesia) and attention disorders (cognitive disorders), including confusion;
delayed wound healing, thinning and fragility of the skin, increased hair growth in areas not normally hairy (hirsutism), appearance of pimples (acne), stretch marks (striae), bruising (ecchymosis), dilation of small superficial blood vessels (telangiectasia), swelling in various parts of the body due to fluid retention (edema);
eye disorders (posterior subcapsular cataract), increased eye pressure (intraocular pressure), inflammation of the inner membrane of the eye (chorioretinopathy), thinning of the white part of the eye (sclera) or of the membrane covering the eye (cornea), worsening of eye diseases caused by viruses or fungi (viral or fungal ophthalmic diseases);
stomach and intestinal disorders (peptic ulcer), digestive difficulties (dyspepsia), bleeding, nausea;
irregular menstrual cycle;
heart problems (heart failure);
increased loss of protein (negative nitrogen balance);
disruption of the connection between the brain and adrenal gland (interference with hypothalamic-pituitary-adrenal axis function), especially during periods of stress, hormonal disturbances (endocrine dysfunction), changes in facial appearance ("moon face");
increased number of white blood cells in the blood (leukocytosis);
allergic reactions (hypersensitivity);
formation of blood clots in the veins (thromboembolism) in patients predisposed to thrombosis, increased pressure around the brain (benign intracranial hypertension).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

blurred vision;
hiccups.

Additional side effects in children and adolescents
The following side effect may occur:

growth disorders.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DECOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DECOR 6 mg tablets contains

The active substance is deflazacort: each tablet contains 6 mg of deflazacort.
The other ingredients are: monohydrate lactose, magnesium stearate, pregelatinized starch, microcrystalline cellulose, sucrose, anhydrous colloidal silica.

What DECOR 30 mg tablets contains

The active substance is deflazacort: each tablet contains 30 mg of deflazacort.
The other ingredients are: monohydrate lactose, magnesium stearate, pregelatinized starch, microcrystalline cellulose, anhydrous colloidal silica.

Description of the appearance of DECOR and contents of the pack
Blister pack containing 10 tablets
Marketing Authorization Holder
Laboratorio Chimico Deca Dr. Capuani s.r.l.
Via Giotto, 1
30172 – Venice
Italy
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 - Cortemaggiore (Piacenza)