Deflazacort Pharmeg: detailed information

Package leaflet: Information for the patient

DEFLAZACORT PHARMEG 6 mg tablets, 30 mg tablets

Equivalent Medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

DEFLAZACORT PHARMEG contains the active substance deflazacort, which belongs to a group of
medicines called corticosteroids (or glucocorticoids). Corticosteroids are naturally produced in our
body and help regulate important processes involved in general health.
DEFLAZACORT PHARMEG is used to treat inflammation and to reduce the immune system response (the system that defends the body against viruses, bacteria, etc.) in certain diseases.
DEFLAZACORT PHARMEG is indicated for the treatment of:

disorders due to insufficient activity of the adrenal glands (primary and secondary adrenal insufficiency) (alone or in combination with other medicines called mineralocorticoids);
rheumatic diseases (psoriatic arthropathy, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthropathy, post-traumatic osteoarthritis, acute and subacute bursitis, acute non-specific tenosynovitis, epicondylitis);
systemic diseases of connective tissue (tissue connecting other tissues within the body) [systemic lupus erythematosus (SLE), acute rheumatic carditis (rheumatic heart disease), systemic dermatomyositis (polymyositis)];
skin diseases [pemphigus, bullous dermatitis herpetiformis, severe polymorphic erythema (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides (cutaneous lymphoma), severe psoriasis, severe seborrheic dermatitis];
allergies (seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity);
respiratory diseases [symptomatic sarcoidosis, berylliosis, fulminating or disseminated pulmonary tuberculosis (in association with appropriate chemotherapy), aspiration pneumonia];
eye diseases due to severe acute and chronic inflammatory or allergic processes (marginal allergic corneal 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, including malignant forms (secondary thrombocytopenia in adults, autoimmune hemolytic anemia, erythroblastopenia, congenital hypoplastic anemia, Hodgkin’s disease, non-Hodgkin lymphomas, chronic lymphocytic leukemia, acute leukemia in childhood, etc.);
conditions characterized by fluid accumulation (idiopathic nephrotic syndrome of unconfirmed or secondary origin due to Systemic Lupus Erythematosus);
diseases of the stomach and intestine (ulcerative colitis, regional enteritis).

2. What you need to know before taking DEFLAZACORT PHARMEG

Do not take DEFLAZACORT PHARMEG

if you are allergic to deflazacort or to any of the other ingredients of this medicine (listed in section 6);
if you have tuberculosis;
if you have peptic ulcer;
if you have an eye infection caused by the Herpes simplex virus;
if you have systemic fungal infections (systemic mycoses);
if you suffer from mental illness (psychosis);
if you have recently received a live attenuated viral vaccine.

Warnings and precautions
Talk to your doctor or pharmacist before taking DEFLAZACORT PHARMEG.
Patients undergoing treatment for more than 3 weeks should carry the prescription for DEFLAZACORT PHARMEG treatment with them and show it to any healthcare professional involved in their care.
Do not stop taking DEFLAZACORT PHARMEG suddenly unless advised by your doctor.
Be especially careful with DEFLAZACORT PHARMEG and inform your doctor:

if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after taking DEFLAZACORT PHARMEG or other deflazacort-containing medicines. Serious skin reactions, including toxic epidermal necrolysis, have been reported in association with DEFLAZACORT PHARMEG treatment. Stop using DEFLAZACORT PHARMEG and consult a doctor immediately if you notice any of the symptoms described in section 4.
if you have had or currently have significant stress: your doctor will adjust the dose according to the type of stress. Even if you stopped treatment several months ago, your doctor will decide whether to continue, restart the medicine, or prescribe appropriate hormonal therapy. The dose should always be reduced gradually to minimize impairment of adrenal gland function;
if you have underactive thyroid (hypothyroidism);
if you have liver disease (hepatic cirrhosis);
if you have tuberculosis: you may use DEFLAZACORT PHARMEG in cases of fulminant or generalized disease, provided it is administered together with appropriate anti-tuberculosis treatment. Your doctor will monitor you closely;
if you have a form of intestinal inflammation with risk of intestinal perforation (non-specific ulcerative colitis);
if you have pus-filled abscesses or infections causing pus formation;
if you have a disease caused by inflammation of part of the intestine (diverticulitis);
if you have recently undergone intestinal surgery (intestinal anastomoses);
if you have kidney disease (renal failure);
if you have high blood pressure;
if you have diabetes;
if you have reduced mineral content in your bones (osteoporosis);
if you suffer from a disease causing severe muscle weakness (myasthenia gravis);
if you have an infection: corticosteroids may mask signs of infection, and additional infections may occur during their use. In such cases, your doctor will assess whether to administer an antibiotic;
if you need to be vaccinated: you must not be vaccinated during corticosteroid treatment;
if you have or have had emotional instability or a tendency to develop mental illness, as these may worsen during treatment. Symptoms such as euphoria, difficulty sleeping (insomnia), mood or personality changes, severe depression, or symptoms of actual psychiatric disorders may also occur;
if you come into contact with people affected by chickenpox or shingles, especially if you have not previously had chickenpox.

Patients being treated with DEFLAZACORT PHARMEG should take special care to avoid exposure to measles and should consult a doctor immediately if exposure occurs.
Prolonged use of DEFLAZACORT PHARMEG, as with other glucocorticoids, may cause clouding of the eye's natural lens known as posterior subcapsular cataract, increased intraocular pressure (glaucoma) with possible damage to the optic nerves, and may increase the risk of fungal or viral eye infections.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are being treated concomitantly with other medicines such as diuretics and beta2 agonists, your doctor may prescribe blood tests to monitor certain parameters (potassium and blood pH).
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
In very early infancy, this product should only be used when strictly necessary and under direct medical supervision.
Your doctor will carefully monitor the growth and development of children undergoing prolonged treatment.
Consult your doctor immediately if your child comes into contact with someone affected by chickenpox or shingles and has not previously had chickenpox.
Other medicines and DEFLAZACORT PHARMEG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Although no interactions or incompatibilities with other medicines are known for DEFLAZACORT PHARMEG, your doctor may decide to increase the dose during concomitant treatment with:

anticonvulsant medicines (phenobarbital, diphenylhydantoin, carbamazepine, phenytoin, primidone);
certain antibiotics used to treat bacterial infections (rifampicin, rifabutin);
medicines used to prevent blood clotting (coumarin anticoagulants, e.g., warfarin). Consult your doctor, as specific monitoring (prothrombin time or INR) is required;
ephedrine, a bronchodilator medicine;
aminoglutethimide, a medicine used to reduce steroid hormone production.

Your doctor may decide to reduce the dose during concomitant treatment with:

antibiotics used to treat bacterial infections (erythromycin, troleandomycin);
ketoconazole, used for fungal infections;
medicines containing female hormones (estrogens) or estrogen-containing preparations.

Some medicines may enhance the effects of DEFLAZACORT PHARMEG, and your doctor may decide to monitor you closely if you are taking these (including certain HIV medicines: ritonavir, cobicistat).
Your doctor will prescribe this medicine cautiously during concomitant treatment with:

acetylsalicylic acid (an anti-inflammatory medicine, used in low doses to prevent blood clots). Consult your doctor if you have blood clotting disorders (hypoprothrombinemia);
medicines used to reduce stomach acidity (antacids), as they may reduce the intestinal absorption of DEFLAZACORT PHARMEG;
quetiapine, a medicine used for mental disorders;
medicines used to treat infections (anti-infectives);
medicines used to treat diabetes (oral agents and insulin);
medicines used to control blood pressure or heart conditions (antihypertensives, loop diuretics, thiazide diuretics), medicines used to treat 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;
muscle relaxants (non-depolarizing neuromuscular blockers). Using these medicines together with DEFLAZACORT PHARMEG may cause prolonged muscle relaxation and muscle problems (acute myopathy).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, take DEFLAZACORT PHARMEG only when strictly necessary and under direct medical supervision, as it may cause harm to the fetus or newborn.
Do not take this medicine during pregnancy or while breastfeeding unless carefully evaluated by your doctor.
Driving and using machines
Currently, no effects of glucocorticoids on the ability to drive or operate machinery are known.
DEFLAZACORT PHARMEG 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 him/her before taking this medicine.
DEFLAZACORT PHARMEG 30 mg tablets contain lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take DEFLAZACORT PHARMEG

Take this medicine exactly as directed 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, by oral administration.

The tablets cannot be divided. Therefore, if the required dose cannot be achieved with the available dosage strengths, another medicine must be used.

The recommended initial dose in adults ranges from 6 mg to 90 mg per day, depending on the severity and progression of the disease being treated. Your doctor will evaluate whether to maintain or adjust the initial dose to achieve an adequate therapeutic response based on the disease and individual response. The maintenance dose should always be the lowest dose capable of controlling symptoms.

Dose reduction must always be carried out gradually.

Use in children

In early infancy, this product should be used only when strictly necessary and under direct medical supervision. Children undergoing prolonged corticosteroid treatment must be closely monitored with regard to growth and development.

If you take more DEFLAZACORT PHARMEG than you should

In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take DEFLAZACORT PHARMEG

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

If you stop taking DEFLAZACORT PHARMEG

Do not stop treatment abruptly. Your doctor will advise you on how to gradually reduce the dose.

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 will experience them.
Discontinue use of DEFLAZACORT PHARMEG and consult a doctor immediately if you notice any of the following symptoms:

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

The following side effects may occur:
Rare side effects (may affect up to 1 in 1,000 people):

blurred vision;
heart problems (hypertension and congestive heart failure), induced by changes in blood electrolyte levels (electrolyte imbalance);

During treatment with corticosteroids, such as DEFLAZACORT PHARMEG, especially with intensive and prolonged therapy, some of the following side effects may occur with frequency not known:

weight gain, increased appetite, disturbances in carbohydrate metabolism (reduced glucose tolerance), latent diabetes mellitus, need for increased antidiabetic medication in diabetic patients;
increased susceptibility to infections without symptoms, lung infection caused by bacteria (latent tuberculosis), fungal infections (candidiasis);
bone problems (osteoporosis), bone fragility, muscle problems (myopathies), vertebral and long bone fractures, bone tissue death due to interrupted blood supply (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;
various psychiatric disorders such as irritability, feelings of worry or fear (anxiety), suicidal thoughts, obsessive ideas and behaviors (mania), depression, hallucinations, worsening of schizophrenia, feelings of well-being (euphoria), sleep disturbances (insomnia), mood or personality changes, severe depression, memory (amnesia) and attention disorders (cognitive disturbances), including confusion;
delayed wound healing, skin thinning and fragility, increased hair growth in areas not normally hairy (hirsutism), appearance of "pimples" (acne), stretch marks (striae), bruising (ecchymoses), dilation of small superficial blood vessels (telangiectasia), swelling in various parts of the body due to fluid retention (edema);
eye disorders: posterior subcapsular cataract (progressive loss of lens transparency), increased intraocular pressure, inflammation of the inner eye membrane (chorioretinopathy), thinning of the white part of the eye (sclera) or of the membrane covering the eye (cornea), worsening of viral or fungal eye diseases (viral or fungal ophthalmic diseases);
stomach and intestinal disorders (gastric or duodenal peptic ulcer), digestive difficulties (dyspepsia), bleeding (haemorrhage), nausea, perforation of peptic ulcer, acute pancreatitis (especially in children), candidiasis (fungal infection);
irregular menstrual cycle;
heart problems (heart failure: inability of the heart to supply adequate blood flow to meet the body's needs);
negative nitrogen balance (decreased body nitrogen due to reduced muscle mass from excessive metabolism); electrolyte imbalance including hypokalaemia (reduced potassium in the blood) and hypernatraemia (increased sodium in the blood);
disruption of the connection between the brain and adrenal gland (interference with hypothalamic-pituitary-adrenal axis function), particularly during periods of stress, hormonal disorders (endocrine dysfunction), changes in facial appearance ("moon face");
increased number of white blood cells in the blood (leucocytosis);
allergic reactions (hypersensitivity), including anaphylaxis (a specific pathological reaction in an organism already sensitized to a substance upon re-exposure to that substance);
formation of blood clots in veins (thromboembolism) in patients with a tendency to thrombosis, increased intracranial pressure (benign intracranial hypertension);
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 DEFLAZACORT PHARMEG

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 DEFLAZACORT PHARMEG 6 mg tablets contain

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

What DEFLAZACORT PHARMEG 30 mg tablets contain

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

Description of the appearance of DEFLAZACORT PHARMEG and contents of the pack
6 mg and 30 mg packs containing 10 tablets in PVC/PVDC/AL blisters.
Marketing Authorization Holder
Pharmeg S.r.l. - Via dei Giardini, 34 - 85033 - Episcopia (Potenza)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 - Cortemaggiore (Piacenza)