DEFLAZACORT FG 6 MG Tabletki

Treść ulotki

1. DEFLAZACORT FG 6 mg tablets, 30 mg tablets
   1. What is DEFLAZACORT FG and what is it used for
   2. What you need to know before taking DEFLAZACORT FG
   3. How to take DEFLAZACORT FG
   4. Possible side effects
   5. How to store DEFLAZACORT FG
   6. Package Contents and Other Information

DEFLAZACORT FG 6 mg tablets, 30 mg tablets

Equivalent Medicinal Product

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DEFLAZACORT FG is and what it is used for
• 2. What you need to know before you take DEFLAZACORT FG
• 3. How to take DEFLAZACORT FG
• 4. Possible side effects
• 5. How to store DEFLAZACORT FG
• 6. Contents of the pack and other information

1. What is DEFLAZACORT FG and what is it used for

This medicine contains the active ingredient deflazacort, which belongs to a group of medicines
called glucocorticoids with anti-inflammatory activity.
DEFLAZACORT FG is indicated for the treatment of:

• reduced adrenal function (primary and secondary adrenocortical insufficiency), alone or in combination with hormones (mineralcorticoids);
• rheumatic diseases (psoriatic arthropathy, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis, post-traumatic osteoarthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis);
• collagen diseases: (systemic lupus erythematosus, acute rheumatic carditis, systemic dermatomyositis);
• dermatological diseases (pemphigus, bullous herpetiform dermatitis, severe polymorphic 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);
• respiratory diseases (symptomatic sarcoidosis, berylliosis, fulminant or disseminated pulmonary tuberculosis, aspiration pneumonia);
• severe eye allergies and inflammation, acute and chronic, (marginal corneal allergic ulcers, herpes zoster ophthalmicus, inflammation of the anterior segment of the eyeball, choroiditis and diffuse posterior uveitis, sympathetic ophthalmitis, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis);
• blood diseases (secondary thrombocytopenia in adults, autoimmune hemolytic anemia, erythroblastopenia, congenital hypoplastic anemia, Hodgkin's disease, non-Hodgkin's lymphomas, chronic lymphocytic leukemia, acute leukemia in childhood);
• edematous states: idiopathic nephrotic syndrome (kidney disease) or secondary to Systemic Lupus Erythematosus;
• diseases of the stomach and intestines (ulcerative colitis, regional enteritis).

2. What you need to know before taking DEFLAZACORT FG

Do not take DEFLAZACORT FG

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

Warnings and precautions
Talk to your doctor or pharmacist before taking DEFLAZACORT FG.

Take this medicine with caution and always under the control of your doctor in the following cases:

• if you are in stressful situations. The doctor in this case will establish the appropriate dose according to your condition;
• if you have a reduction in hormones produced by the thyroid (hypothyroidism) or if you have a serious liver problem (hepatic cirrhosis);
• if you have mood and personality disorders (euphoria, depression, psychosis) or if you have sleep disorders (insomnia), as these may worsen;
• if you have a lung infection (latent tuberculosis) or if a test called a tuberculin test is positive. Close medical monitoring is recommended as the disease may become active. If you have tuberculosis, take this medicine only if the disease is in a severe stage (fulminant disease) or if it has spread to other organs (disseminated disease). In addition, antibiotics are necessary in this case;
• if you have an inflammatory bowel disease with a risk of perforation (ulcerative colitis), if you have pus collections (abscesses) and skin infections (pyogenic infections), if you have a problem with your intestines (diverticulitis, intestinal anastomoses), if you have kidney problems (renal insufficiency), 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 (myasthenia gravis);
• if you are taking medicines to eliminate fluids with urine (thiazide diuretics, furosemide) or medicines for the treatment of asthma (beta agonists) such as reproterol. Talk to your doctor because it is necessary to check the potassium and pH of the blood.

Tell your doctorif the following situations occur during treatment with this medicine:

• the onset of infections. In this case, specific antibiotic therapy is necessary;
• decreased production of cortisol, a hormone produced by the adrenal gland (secondary adrenal insufficiency). In this case, the doctor may decide to reduce the dose or prescribe specific hormonal therapy (mineralocorticoids);
• changes in the levels of salts present in the blood (electrolyte balance), especially if you have taken DEFLAZACORT FG for a prolonged period and at high doses. In this case, adequate intake of sodium and potassium is necessary. In addition, DEFLAZACORT FG may increase the elimination of calcium with urine.

During treatment with DEFLAZACORT FG, if you have not had chickenpox in the past, avoid contact with people who have chickenpox or an infection caused by the herpes zostervirus. Also, use caution if you come into contact with people who have measles. If you come into contact with these people, inform your doctor immediately. Be careful if your child has measles.
If you are taking this medicine, you should not be given the smallpox vaccine or other types of vaccines (immunizing procedures), as a decrease in the immune system response (antibody response) and neurological problems (neurological complications) may occur.
Contact your doctor if you experience blurred vision or other visual disturbances.
For athletes: the use of this medicine without a therapeutic need constitutes doping and may still result in a positive doping test.

Children
In children, DEFLAZACORT FG must be taken under strict medical supervision. Children who have taken corticosteroids for prolonged periods must be closely monitored by the doctor from the point of view of growth and development (see section 4 “Additional undesirable effects in children and adolescents”).

Other medicines and DEFLAZACORT FG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can increase the effects of DEFLAZACORT FG and your doctor may want to keep you under close observation 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 because specific checks are necessary (prothrombin time or INR);
• ephedrine a medicine used as a bronchodilator
• aminoglutethimide a medicine used to reduce the production of steroid hormones. In these cases, it is necessary to increase the maintenance dose of DEFLAZACORT FG.
• medicines for the treatment of bacterial infections (erythromycin, troleandomycin) or ketoconazole used for fungal infections. In this case, it is necessary to reduce the dose of DEFLAZACORT FG;
• acetylsalicylic acid (an anti-inflammatory medicine). Consult your doctor if you suffer from a blood disease called hypoprothrombinemia;
• medicines used to eliminate stomach acidity (antacids), because they reduce the absorption of DEFLAZACORT FG at the level of the intestine;
• quetiapine a medicine used for mental disorders;
• female hormones (estrogens) taken orally. The simultaneous use of oral contraceptives may increase the levels of DEFLAZACORT FG;
• 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 problems (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 because an increase in potassium loss from the blood may occur;
• medicines used to relax muscles (non-depolarizing muscle relaxants). The use of these medicines together with DEFLAZACORT FG may cause prolonged relaxation and muscle problems (acute myopathy).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take DEFLAZACORT FG only if absolutely necessary and under the direct supervision of your doctor, as it may cause harm to the fetus and newborn.

Driving and operating machinery
No data are available to establish the effects on the ability to alter driving or operating machinery

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

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

3. How to take DEFLAZACORT FG

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
It is recommended to take the daily dose in a single dose, in the morning and together with small amounts of food
orally.
The tablets cannot be divided. Therefore, if the necessary dose cannot be obtained with the available dosages
it is necessary to take another medicine.
The recommended initial dose in adults is between 6 mg and 90 mg per day. The doctor will determine the necessary dose
and the duration of treatment depending on your condition and therapeutic response. If the dose
needs to be reduced, this must happen gradually.

If you take more DEFLAZACORT FG than you should
In case of accidental intake of an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.

If you forget to take DEFLAZACORT FG
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you stop taking DEFLAZACORT FG
If you have any doubts about the use of 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, disorders of sugar metabolism (decreased glucose tolerance), latent diabetes mellitus, need to increase hypoglycemic medicines in diabetics;
• alterations of salt levels in the blood (electrolyte imbalance), which can rarely lead to heart problems (hypertension and congestive heart failure);
• increased infections without manifestation of symptoms, lung infection caused by a bacterium (latent tuberculosis), fungal infection (candidiasis);
• problems with bones (osteoporosis), bone fragility, muscle problems (myopathies), fractures of the vertebrae and long bones, death of bone tissue (avascular necrosis), tendon inflammation (tendinitis), tendon rupture in case of administration with quinolones (medicines for the treatment of infections caused by bacteria);
• dizziness, headache, increased pressure in the brain (intracranial pressure), worsening of epilepsy;
• mental disorders such as: irritability, feelings of worry or fear (anxiety), suicidal thoughts, obsessive thoughts and behaviors (mania), delusion, hallucinations, worsening of schizophrenia, feeling of well-being (euphoria), sleep disorders (insomnia), changes in mood or

personality, severe depression, memory disorders (amnesia) and attention disorders (cognitive disorders)
including confusion;

• delayed wound healing (cicatrization processes), thinning and fragility of the skin, increased hair growth in areas of the body not normally present (hirsutism), appearance of “pimples” (acne), stretch marks (striae), bruises (ecchymoses), dilation of small superficial blood vessels (telangiectasia), swelling in different parts of the body due to fluid accumulation in the body (edema);
• vision disorders (posterior subcapsular cataract), increased pressure in the eye (intraocular pressure), inflammation of the inner membrane of the eye (chorioretinopathy), thinning of the white part of the eye (sclera) or the membrane lining 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), blood loss (hemorrhage), nausea;
• irregular menstrual cycle;
• heart problems (heart failure);
• increased protein loss (negative nitrogen balance);
• alteration of the connection between the brain and the adrenal gland (interference with the function of the pituitary-adrenal axis) particularly in moments of stress, hormonal disorders (alteration of endocrine function), 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 with a tendency to thrombosis, increased pressure around the brain (benign intracranial hypertension).

Side effects with rare frequency (which may affect up to 1 in 1,000 people):

• blurred vision.

Side effects with unknown frequency (frequency cannot be defined on the basis of available data):

• hiccups.

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

• growth disorders.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DEFLAZACORT FG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 DEFLAZACORT FG 6 mg tablets contain

• The active ingredient is deflazacort: 1 tablet contains 6 mg of deflazacort.
• The other ingredients are: lactose monohydrate, magnesium stearate, pregelatinized starch, microcrystalline cellulose, sucrose, anhydrous colloidal silica.

What DEFLAZACORT FG 30 mg tablets contain

• The active ingredient is deflazacort: 1 tablet contains 30 mg of deflazacort.
• The other ingredients are: lactose monohydrate, magnesium stearate, pregelatinized starch, microcrystalline cellulose, anhydrous colloidal silica.

Description of the appearance of DEFLAZACORT FG and package contents
Blister containing 10 tablets

Marketing Authorisation Holder
FG S.r.l. - Via San Rocco, 6 - 85033 - Episcopia (Potenza)

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 - Cortemaggiore (Piacenza)