Surrenol

Italy
Brand name Surrenol
Form tablets
Active substance / Dosage
DEFLAZACORT
Prescription type Prescription only
ATC code
H02AB13
Registration number 037432
Manufacturer EPIFARMA S.R.L

Table of Contents

Package leaflet: Information for the patient

SURRENOL 6 mg tablets, 30 mg tablets

Deflazacort
Generic 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 others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SURRENOL is and what it is used for

SURRENOL 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 related to general health.
SURRENOL is used to treat inflammation and to reduce the immune system’s response (the system that protects the body from viruses, bacteria, etc.) in certain diseases.

SURRENOL is indicated for the treatment of:

  • disorders due to insufficient activity of the adrenal glands (primary and secondary adrenocortical insufficiency) (alone or in combination with other medicines called mineralocorticoids);
  • rheumatic diseases (psoriatic arthropathy, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis, post-traumatic osteoarthritis, acute and subacute bursitis, acute non-specific tenosynovitis, epicondylitis);
  • systemic connective tissue diseases (tissue connecting other tissues within the body) [systemic lupus erythematosus (SLE), acute rheumatic carditis (rheumatic heart disease), systemic dermatomyositis (polymyositis)];
  • skin diseases [pemphigus, bullous herpetiform dermatitis, 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, fulminant or disseminated pulmonary tuberculosis (in association with appropriate chemotherapy), aspiration pneumonia];
  • eye diseases due to severe acute and chronic inflammatory or allergic processes (allergic marginal 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 those with malignant progression (secondary thrombocytopenia in adults, autoimmune hemolytic anemia, erythroblastopenia, congenital hypoplastic anemia, Hodgkin’s disease, non-Hodgkin lymphomas, chronic lymphocytic leukemia, acute leukemia in children, etc.);
  • conditions characterized by fluid accumulation (idiopathic nephrotic syndrome of unconfirmed or secondary origin due to Systemic Lupus Erythematosus);
  • gastrointestinal diseases (ulcerative colitis, regional enteritis).

2. What you need to know before taking SURRENOL

Do not take SURRENOL

  • 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 (mycotic systemic infections);
  • if you suffer from mental illness (psychosis);
  • if you have been administered a vaccine containing live attenuated virus.

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

  • if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking SURRENOL or other deflazacort-containing medicines. Serious skin reactions, including toxic epidermal necrolysis, have been reported in association with SURRENOL treatment. Discontinue use of SURRENOL and consult a doctor immediately if you notice any of the symptoms described in section 4.
  • if you have or have had particular stress: your doctor will adjust the dose according to the type of stress. Even if you have stopped treatment several months ago, your doctor will decide whether to continue it, restart it, or prescribe appropriate hormone therapy. The dose must always be gradually reduced to minimize impairment of adrenal gland function;
  • if you have low thyroid function (hypothyroidism);
  • if you have liver disease (hepatic cirrhosis);
  • if you have tuberculosis: you may use SURRENOL in cases of fulminant or generalized disease, and only in combination with appropriate anti-tuberculosis treatment. Your doctor will closely monitor you;
  • if you have a form of intestinal inflammation with risk of bowel perforation (non-specific ulcerative colitis);
  • if you have pus collections (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 bones (osteoporosis);
  • if you suffer from a disease causing severe muscle weakness (myasthenia gravis);
  • if you have an infection: corticosteroids may mask certain signs of infection and additional infections may occur during treatment. In such cases, your doctor will evaluate whether to administer an antibiotic;
  • if you need to be vaccinated: vaccination should not be performed during corticosteroid treatment;
  • if you have or have had emotional instability or a tendency to develop mental illness, as these may worsen during treatment. Manifestations 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 receiving SURRENOL treatment should take special care to avoid exposure to measles and should consult a doctor immediately if exposure occurs.
Prolonged use of SURRENOL, as with other glucocorticoids, may cause clouding of the eye's natural lens, known as posterior subcapsular cataract, and increased intraocular pressure (glaucoma), possibly damaging the optic nerves, and may increase the risk of fungal or viral eye infections.
Contact your doctor if blurred vision or other visual disturbances occur.
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 early infancy, this product should be used only when strictly necessary and under direct medical supervision.
The 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 SURRENOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Although no known interactions or incompatibilities exist with other medicines and SURRENOL, 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 clot formation (coumarin anticoagulants, e.g. warfarin). Consult your doctor, as specific monitoring is required (prothrombin time or INR);
  • ephedrine, a medicine used as a bronchodilator;
  • 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 preparations containing female hormones.

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

  • acetylsalicylic acid (an anti-inflammatory medicine, used at 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 SURRENOL;
  • 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;
  • medicines used to relax muscles (non-depolarizing muscle relaxants). Concurrent use of these medicines with SURRENOL 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 SURRENOL 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.

SURRENOL 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.

SURRENOL 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 SURRENOL

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

If you forget to take SURRENOL
Do not take a double dose to make up for the missed tablet.

If you stop taking SURRENOL
Do not stop treatment abruptly. Your doctor will instruct you on how to gradually reduce the dose.
If you have any questions 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 everyone will experience them.
Discontinue use of SURRENOL 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 rashes 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) caused by changes in blood electrolyte levels (electrolyte imbalance);

During treatment with corticosteroids such as SURRENOL, especially with intensive and prolonged therapy, the following side effects may occur with unknown frequency:

  • weight gain, increased appetite, disturbances in carbohydrate metabolism (reduced glucose tolerance), latent diabetes mellitus, need for increased hypoglycemic medication in diabetic patients;
  • increased risk of infections without typical symptoms, lung infection caused by a bacterium (latent tuberculosis), fungal infections (candidiasis);
  • bone problems (osteoporosis), bone fragility, muscle problems (myopathies), vertebral and long bone fractures, death of bone tissue due to interruption of 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, thinning and fragility of the skin, 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 infections);
  • stomach and intestinal disorders (peptic, gastric or duodenal ulcer), digestive difficulties (dyspepsia), bleeding (hemorrhage), 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 nitrogen content in the body due to reduced muscle mass from excessive metabolism); electrolyte imbalance including hypokalemia (reduced potassium in blood) and hypernatremia (increased sodium in blood);
  • disruption of the connection between the brain and adrenal gland (interference with hypothalamic-pituitary-adrenal axis function), particularly during periods of stress, hormonal disturbances (endocrine dysfunction), changes in physical appearance ("moon face");
  • increased number of white blood cells in the blood (leukocytosis);
  • allergic reactions (hypersensitivity), including anaphylaxis (a specific pathological reaction in a previously sensitized organism upon re-exposure to the same substance);
  • formation of blood clots in veins (thromboembolism) in patients predisposed to thrombosis, increased intracranial pressure (benign intracranial hypertension);
  • hiccups.

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

  • growth disturbances.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 SURRENOL

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 SURRENOL 6 mg tablets contain

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

What SURRENOL 30 mg tablets contain

  • The active substance is deflazacort: each 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 SURRENOL and the contents of the pack
Packs of 6 mg and 30 mg containing 10 tablets in PVC/PVDC/AL blisters.
Marketing Authorization Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 - Episcopia (Potenza)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 - Cortemaggiore (Piacenza)