DEFLAN 6 mg Tablet

Зміст інструкції

1. DEFLAN 6 mg tablets, 30 mg tablets, 22.75 mg/ml oral drops, suspension
   1. What is DEFLAN and what is it used for
   2. What you need to know before taking DEFLAN
2. DEFLAN 6 mg and 30 mg tablets contain lactose. If your doctor has diagnosed you with
   1. How to take DEFLAN
   2. Possible side effects
   3. How to store DEFLAN
   4. Package Contents and Other Information

DEFLAN 6 mg tablets, 30 mg tablets, 22.75 mg/ml oral drops, suspension

Deflazacort

Read this leaflet carefully before 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 their symptoms are the same as yours, 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 DEFLAN is and what it is used for
• 2. What you need to know before you take DEFLAN
• 3. How to take DEFLAN
• 4. Possible side effects
• 5. How to store DEFLAN
• 6. Contents of the pack and other information

1. What is DEFLAN and what is it used for

DEFLAN contains the active ingredient deflazacort, a synthetic glucocorticoid with
anti-inflammatory and immunosuppressive activity (which blocks the response of the immune system).
This medicine is used in the treatment of:

• Primary and secondary insufficiency of the adrenal glands (alone or in association with mineralocorticoids which, like glucocorticoids, are corticosteroids but contribute to the regulation of water and electrolyte balance).
• Rheumatic diseases (conditions that cause disorders affecting the musculoskeletal system and supporting tissues of the body) such as psoriatic arthropathy (chronic inflammation of the joints, often associated with psoriasis), rheumatoid arthritis, ankylosing spondylitis (severe disabling rheumatic disease), acute gouty arthropathy (condition that occurs following the deposition of microcrystals near joint structures, tendons and surrounding areas), post-traumatic osteoarthritis (degenerative joint disease that occurs following trauma), acute and subacute bursitis (inflammation of the small sacs containing synovial fluid that form a cushion between bones and tendons and/or muscles surrounding a joint), acute non-specific tenosynovitis (inflammation of the anatomical structure that covers the tendon), epicondylitis (inflammation of the tendons that strain the elbow).
• Collagen diseases (structural protein present in connective and bone tissue) such as systemic lupus erythematosus (SLE, a long-lasting autoimmune disease), acute rheumatic carditis (inflammation of the heart), systemic dermatomyositis (polymyositis) (a muscle disease, with possible skin involvement, due to causes not yet fully understood, characterized by an inflammatory process affecting skeletal muscle).
• Dermatological diseases (of the skin) such as pemphigus (rare autoimmune disease affecting the skin and/or mucous membranes), bullous herpetiform dermatitis (skin inflammation that manifests with the formation of cavities within or under the epidermis), severe polymorphic erythema

(Stevens-Johnson syndrome), exfoliative dermatitis (severe inflammation of the entire
skin surface), mycosis fungoides (skin tumor), severe psoriasis (long-lasting
inflammatory skin disease), severe seborrheic dermatitis (skin inflammation
with excessive sebum production).

• Allergic conditions such as seasonal or perennial allergic rhinitis (acute and recurrent inflammatory condition affecting the nasal mucosa), bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness (reaction of the immune system to certain medications), drug hypersensitivity.
• Respiratory diseases such as symptomatic sarcoidosis (inflammatory condition that can affect all organs, particularly the lungs, lymph nodes, eyes and skin), berylliosis (condition triggered by exposure to beryllium), fulminant or disseminated pulmonary tuberculosis (in association with appropriate chemotherapy), aspiration pneumonia (inflammation of the lungs that develops due to the entry of foreign material into the bronchial tree).
• Eye diseases (severe acute and chronic inflammatory and allergic processes) such as marginal allergic corneal ulcers (lesions of the transparent surface of the eye), ocular herpes zoster (or “shingles,” eye virus), inflammation of the anterior segment of the eyeball, choroiditis (inflammation of the choroid, a thin membrane of the eye located between the sclera and the retina) and posterior diffuse uveitis (inflammation of the uvea), sympathetic ophthalmitis (continuous and severe inflammation that causes vision loss in the eye), allergic conjunctivitis (inflammation of the conjunctiva), keratitis (inflammation of the cornea), chorioretinitis (inflammation of the choroid and retina), optic neuritis (inflammation of the optic nerves), iritis (inflammation of the iris) and iridocyclitis (inflammatory process affecting the ciliary body).
• Hematological disorders (at the blood level) and hematological diseases with malignant evolution such as adult secondary thrombocytopenia (decrease in the number of platelets in the blood), autoimmune hemolytic anemia (decrease in hemoglobin levels in the blood caused by the destruction of red blood cells), erythroblastopenia (decrease in the number of red blood cells), congenital hypoplastic anemia (anemia characterized by insufficient production of blood cells in the bone marrow), Hodgkin's disease (disease characterized by a malignant tumor process affecting lymphoid tissues), non-Hodgkin's lymphomas (malignant tumors of the lymphatic system), chronic lymphocytic leukemia, acute childhood leukemia, etc.
• Edematous states (due to fluid accumulation) such as idiopathic nephrotic syndrome (a set of symptoms and clinical signs caused by alterations at the renal level) secondary to SLE.
• Gastrointestinal diseases (of the stomach and intestines) such as ulcerative colitis and regional enteritis or Crohn's disease (long-lasting inflammatory diseases of part of the intestine).

2. What you need to know before taking DEFLAN

Do not take DEFLAN

• If you are allergic to deflazacort or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from active tuberculosis (lung infection caused by mycobacteria)
• In case of peptic ulcer (erosion of the internal lining of the stomach and intestines).
• In case of ocular Herpes simplex (common eye infection).
• If you have systemic fungal infections (infections caused by fungi that affect the whole body).
• If you suffer from psychosis.
• In case of administration of a live attenuated vaccine (i.e., when live microorganisms are used for vaccination).

Warnings and precautions
Talk to your doctor or pharmacist before taking DEFLAN.
Tell your doctor before taking DEFLAN:

• If you have ever developed a severe skin rash or peeling of the skin, blisters and/or mouth ulcers after taking DEFLAN or other medicines containing deflazacort. Pay particular attention with DEFLAN:
• Severe skin reactions including toxic epidermal necrolysis, have been reported in association with treatment with DEFLAN. Stop using DEFLAN and consult your doctor immediately if you notice any of the symptoms described in section 4. If you suffer from active tuberculosis, take DEFLAN only in cases of fulminant or disseminated disease, in association with appropriate anti-tuberculosis therapy.

If you are in therapy with corticosteroids, such as glucocorticoids (DEFLAN):

• Be cautious if you are subjected to particular stress; in these circumstances, dose adjustment is essential in relation to the extent of the stressful condition.
• Keep in mind that a secondary adrenal insufficiency (reduction of the functionality of the adrenal glands), induced by cortisone, can be contained with a gradual reduction of the doses. This type of relative insufficiency can persist for months after discontinuation of therapy. Therefore, in any stressful situation that occurs during this period, adequate hormone replacement therapy should be instituted. Furthermore, in this situation, the secretion of mineralocorticoids (corticosteroids that contribute to the regulation of water-salt balance) may be compromised and therefore it would be appropriate to administer, concurrently, salt and/or mineralcorticoids.
• Know that you should not be vaccinated against smallpox and should not undergo other immunization procedures, especially if taking high doses of corticosteroids, due to an increased risk of neurological (nervous) complications and decreased antibody response.
• You should be advised to be particularly careful to avoid contact with people suffering from measles and to consult your doctor immediately if this should occur.
• Consult your doctor immediately if you come into contact with people suffering from chickenpox or Herpes zoster and have not already contracted chickenpox.
• You should be aware that corticosteroids can mask some signs of infection and infections can occur during their use. In these cases, the opportunity to institute adequate antibiotic therapy should always be evaluated.
• You should know that various types of mental alterations can occur during corticosteroid therapy, such as euphoria, insomnia, changes in mood or personality, severe depression or symptoms of real psychoses. Pre-existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Take DEFLAN with caution:

• If you suffer from nonspecific ulcerative colitis with a risk of perforation.
• If you have abscesses (accumulation of pus in a tissue) and pyogenic infections (causing purulent inflammation) in general.
• If you suffer from diverticulitis (disease of the digestive system, characterized by inflammation of one or more diverticula).
• In case of recent intestinal anastomoses (sutures that connect two blood vessels).
• In case of renal insufficiency (decreased kidney function).
• If you suffer from hypertension (high blood pressure).
• If you have diabetes (increased concentration of sugars in the blood).
• In case of osteoporosis (bone disease).
• If you suffer from myasthenia gravis (disease that affects the muscles causing progressive loss of tone and strength).
• In case of hypothyroidism (decreased thyroid function) or liver cirrhosis (chronic and degenerative liver disease); in these cases, the response to corticosteroids may be increased.
• In case of latent tuberculosis or with a positive reaction to tuberculin (test useful for testing the presence in an individual of an even latent infection caused by the tuberculosis bacillus); in these cases, close monitoring is necessary as the disease may

become activated and, in case of prolonged therapy with corticosteroids, it is
necessary to undergo specific chemoprophylaxis (disease prevention).

• In case of concomitant treatment with diuretics (i.e. medicines that increase urine production such as thiazides, furosemide, etc.) and beta-2-agonists (medicines used in the treatment of lung diseases, such as reproterol, etc.) which induce potassium loss; in these cases, it is necessary to monitor the level of potassium in the blood and the pH of the blood.

During prolonged and high-dose therapy, if an alteration of
electrolyte balance should occur, it is appropriate to adjust the intake of sodium and potassium. Corticosteroids
can increase calcium excretion, so monitoring
blood calcium levels may be necessary.
Contact your doctor if you experience blurred vision or other visual disturbances.
For those who play sports, the use of the medicine without therapeutic need constitutes doping and
may still result in a positive doping test.

Children and adolescents
DEFLAN can also be used in children due to its anti-inflammatory and
immunosuppressive properties for the treatment of conditions responsive to cortisone therapy.
However, in early infancy, the product should be administered only in cases of real need,
under the direct control of the doctor.
Children undergoing prolonged corticosteroid therapy should be closely
monitored for growth and development.
Consult your doctor immediately if your child comes into contact with people suffering from
chickenpox or Herpes zoster and has not already contracted chickenpox.

Other medicines and DEFLAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
No interactions and incompatibilities with other medicines are known with DEFLAN; however, it is necessary
to use particular precautions in the cases listed below.
It is advisable to increase the maintenance dose of DEFLAN during concomitant treatment with:

• Anticonvulsants (phenobarbital, diphenylhydantoin).
• Rifampicin and rifabutin (antibiotics of the rifamycin group).
• Anticoagulants (warfarin).
• Bronchodilators (ephedrine).
• Carbamazepine, primidone and phenytoin (anticonvulsant medicines used in the treatment of epilepsy).
• Aminoglutethimide.

It is recommended instead to reduce the dose of DEFLAN in case of association with:

• Erythromycin and troleandomycin (macrolide antibiotics).
• Estrogens (female sex hormones used as contraceptives) or preparations containing estrogens; the concomitant use of glucocorticoids and oral contraceptives should be carefully monitored as glucocorticoid levels in the blood may be increased due to a change in metabolism or binding to proteins in the blood.

Take DEFLAN with caution in association with:

• Acetylsalicylic acid (anti-inflammatory medicine) if you have hypoprothrombinemia (blood coagulation defect).
• Antacids (medicines used to reduce acidity in the stomach); if administered simultaneously to reduce dyspepsia (abdominal pain) induced by corticosteroids, they lead to a reduction in intestinal absorption of glucocorticoids, worsening the control of disease symptoms.
• Quetiapine (antipsychotic); taking deflazacort may cause a decreased concentration of quetiapine in the blood.
• Anti-infectives (medicines used in bacterial infections); since glucocorticoids such as DEFLAN can suppress the body's normal responses to bacterial infections, it is important to ensure that any anti-infective therapy is effective, therefore you should undergo careful medical monitoring.
• Medicines that inhibit liver enzymes (e.g. ketoconazole); it is recommended to reduce the maintenance dose of deflazacort.
• Some medicines may increase the effects of DEFLAN and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV (e.g. ritonavir, cobicistat).
• Hypoglycemic medicines (medicines that decrease blood sugar levels, including insulin).
• Antihypertensives and diuretics (medicines used to lower blood pressure); the activity of these medicines may be counteracted by corticosteroids and the hypokalemic effect (reduction of potassium levels in the blood) of diuretics such as acetazolamide, loop diuretics, thiazide diuretics, beta-2-agonists, xanthines (medicines used especially for lung diseases) and carbenoxolone (anti-ulcer medicine) may be increased.
• Coumarin anticoagulants (medicines that decrease blood coagulation); the effectiveness of coumarin anticoagulants may be increased with concomitant corticosteroid therapy. It is necessary to carefully monitor prothrombin time or INR (indices that allow to evaluate blood coagulation) to avoid spontaneous bleeding.
• Non-depolarizing muscle relaxants; in patients treated with systemic corticosteroids, the use of non-depolarizing muscle relaxants may cause prolonged relaxation and acute myopathy (muscle disease).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
In pregnant women, the product should be administered only in cases of real need,
under the direct control of the doctor.
Deflazacort crosses the placenta. The administration of corticosteroids in animals during pregnancy can
cause developmental abnormalities of the fetus such as cleft palate, intrauterine growth retardation and effects on brain growth and development.
There is no evidence that the use of corticosteroids results in an increase in the incidence of congenital
abnormalities, such as cleft lip/palate in humans. However, when administered for prolonged or repeated
periods during pregnancy, corticosteroids may increase the risk of
intrauterine growth retardation.
After prenatal exposure to corticosteroids, adrenal insufficiency may occur in the newborn
(decreased functionality of the adrenal glands) but usually resolves spontaneously
after birth and is rarely clinically significant.
Breastfeeding
During breastfeeding, the product should be administered only in cases of real need, under the
direct control of the doctor.
Corticosteroids are excreted in breast milk, although there is no data available for deflazacort
to establish whether this substance is eliminated in breast milk. Doses up to 50 mg per day
of deflazacort do not cause systemic effects in the infant. In infants of mothers treated with doses
higher than the indicated dosage, adrenal suppression may occur, but the benefits
of breastfeeding may outweigh any theoretical risk.

Driving and using machines
DEFLAN does not impair the ability to drive vehicles or use machinery.

DEFLAN 6 mg and 30 mg tablets contain lactose. If your doctor has diagnosed you with

an intolerance to certain sugars, contact them before taking these medicines.

DEFLAN 22.75 mg/ml oral drops, suspension contains 276.92 mg of sorbitol per dose
(considering the initial maximum daily dose of 90 mg) equivalent to 70 mg/ml.
Sorbitol is a source of fructose. If your doctor has told you (or your child) that you are intolerant to
certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare genetic
disease where patients cannot metabolize fructose, talk to your doctor before you
(or your child) take this medicine.

DEFLAN 22.75 mg/ml oral drops, suspension contains 0.04 mg of benzyl alcohol per dose
(considering the initial maximum daily dose of 90 mg) equivalent to 0.010mg/ml.Benzyl
alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects including breathing problems
(agonal respiratory syndrome) in young children.
Do not administer to infants under 4 weeks of age unless otherwise recommended by the
doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by the doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).
Ask your doctor or pharmacist for advice if you have a liver or kidney condition. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).

DEFLAN 22.75 mg/ml oral drops, suspension contains less than 1 mmol (23 mg) of sodium per
dose (considering the initial maximum daily dose of 90 mg), i.e. essentially
‘sodium-free’.

3. How to take DEFLAN

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
DEFLAN is a medicine that must be administered orally.
The initial daily dosage of deflazacort in adults may vary from 6 mg (1 tablet of 6 mg
or 6 drops) to 90 mg (3 tablets of 30 mg or 90 drops per day), considering the severity and
evolution of the specific disease to be treated.
The initial dosage should be maintained or modified until a satisfactory
clinical response is obtained. It is important to emphasize that the corticosteroid requirement is variable and therefore the
dosage must be personalized taking into account the disease and the therapeutic response of the
patient.
The maintenance dosage must always be the minimum capable of controlling the
symptoms: the dosage reduction must always be done gradually.
It is advisable to take the daily dose of DEFLAN in a single administration, in the morning,
together with small amounts of food.
DEFLAN 22.75 mg/ml oral drops, solution
The dropper of the suspension delivers on average 1 mg of deflazacort per drop.
Shake the bottle before use and dilute the suspension, immediately before
administration, in sugar water or in beverages not added with carbon dioxide (non
carbonated).

If you take more DEFLAN than you should
In case of accidental intake of an excessive dose of the medicine, immediately inform your
doctor or go to the nearest hospital.
In case of taking an excessive dose of the medicine, it is recommended to carry out, in
conjunction with the usual measures for the elimination of the unabsorbed medicine such as gastric lavage (emptying and cleaning of the stomach) and the use of activated charcoal, the clinical control
of the patient's vital functions.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking the medicine and urgently consult a doctor:
Stop using DEFLAN and consult your doctor immediately if you notice any of the following symptoms:

• reddish patches on the trunk, the patches are target or circular macules, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis) (frequency not known) within 8 weeks of starting treatment.

During corticosteroid therapy, especially for intensive and prolonged treatments, the following side effects may occur:

• Weight gain, increased appetite, decreased glucose tolerance with possible manifestation of latent diabetes mellitus (increased blood sugar levels) as well as increased need for hypoglycemic medications in diabetics, to be determined at the doctor's discretion; alterations of electrolyte balance which, rarely and in particularly predisposed patients, can lead to hypertension and congestive heart failure (the heart's inability to provide blood in an adequate quantity in relation to the body's needs).
• Increased susceptibility to infections and their severity, with suppression of clinical signs and symptoms, recurrence of latent tuberculosis, candidiasis (fungal infection).
• Osteoporosis (bone disease), bone fragility, myopathies (muscle diseases), vertebral and long bone fractures, avascular necrosis (death of bone tissue due to arrest of blood flow), tendinitis, tendon rupture in case of concomitant administration of quinolones (antibacterials).
• Dizziness, headache and increased intracranial pressure (around the brain), worsening of epilepsy (neurological condition characterized by recurrent and sudden manifestations with sudden loss of consciousness and violent convulsions of the muscles), psychiatric disorders of various kinds such as irritability, anxiety, suicidal thoughts, mania, delusion, hallucinations, worsening of schizophrenia, euphoria, insomnia, changes in mood or personality, severe depression, cognitive disorders including confusion and amnesia (memory loss).
• Delays in wound healing, thinning and fragility of the skin, hirsutism (abnormal hair growth), acne, striae cutaneae (stretch marks), ecchymosis (bruise caused by trauma), telangiectasia (dilation of some blood vessels on the surface of the skin), edema (fluid accumulation).
• Posterior subcapsular cataract (progressive loss of transparency of the lens) and increased intraocular pressure (inside the eye), chorioretinopathy (retinal disease), thinning of the cornea or sclera, worsening of viral or fungal (mycotic) ophthalmic (eye) diseases.
• Blurred vision (frequency not known).
• Peptic ulcer (erosion of the inner lining of the stomach and intestines); dyspepsia (abdominal pain), bleeding, nausea.
• Menstrual irregularities.
• Heart failure.
• Negative nitrogen balance, alterations of electrolyte balance, including hypokalemia (decreased potassium levels in the blood) and hypernatremia (increased sodium levels in the blood).
• Interference with the function of the pituitary-adrenal axis, particularly during times of stress; alteration of endocrine function (altered hormone production), changes in facial appearance ("moon face"), growth disorders in children and adolescents.
• Leukocytosis (increased number of white blood cells).
• Hypersensitivity (allergy).
• Thromboembolism (blood clot formation) particularly in patients with underlying conditions associated with an increased tendency to thrombosis, rare incidence of benign intracranial hypertension, hypertension.
• Hiccups (frequency not known).

Additional side effects in children and adolescents
Like other cortisone-based medicines, DEFLAN can cause growth disorders in children and adolescents.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 DEFLAN

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. The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 DEFLAN contains
DEFLAN 6 mg tablets
One tablet contains:

Active ingredient: deflazacort 6 mg.

Other ingredients: lactose, magnesium stearate, corn starch, microcrystalline cellulose.
DEFLAN 30 mg tablets
One tablet contains:

Active ingredient: deflazacort 30 mg.

Other ingredients: lactose, magnesium stearate, corn starch, microcrystalline cellulose.
DEFLAN 22.75 mg/ml oral drops, suspension
1 ml of suspension contains:

Active ingredient: deflazacort 22.75 mg.

Other ingredients: aluminium and magnesium silicate, sodium carboxymethylcellulose, benzyl alcohol, sorbitol 70% solution, polysorbate 80, acetic acid, purified water.

Description of the appearance of DEFLAN and package contents
DEFLAN 6 mg tablets
Circular, uncoated, white tablets, with a cross on one side and the number 6 on the other.
Pack of 10 tablets of 6 mg in blisters.
DEFLAN 30 mg tablets
Circular, uncoated, white tablets, with a cross on one side and the number 30 on the other.
Pack of 10 tablets of 30 mg in blisters.
DEFLAN 22.75 mg/ml oral drops, suspension
Suspension of white or almost white colour, slightly viscous and homogeneous after shaking.

• Bottle of 8 ml of suspension with dropper.
• Bottle of 13 ml of suspension with dropper.

Marketing Authorisation Holder
LABORATORI GUIDOTTI S.p.A. – Via Livornese 897 – PISA – La Vettola.

Distributor for sale:
F.I.R.M.A. S.p.A., Via di Scandicci, 37 – Florence

Manufacturer
Laboratorios Menarini S.A. – C/. Alfonso XII, 587 – Badalona – Barcelona (Spain).