DELTACORTENE 5 mg Tablet

Зміст інструкції

1. DELTACORTENE 5 mg tablets, 25 mg tablets
   1. What is DELTACORTENE and what is it used for
   2. WHAT YOU NEED TO KNOW BEFORE TAKING DELTACORTENE
   3. How to take DELTACORTENE
   4. POSSIBLE SIDE EFFECTS
   5. How to store DELTACORTENE
   6. Contents of the pack and other information

DELTACORTENE 5 mg tablets, 25 mg tablets

prednisone

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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet

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

1. What is DELTACORTENE and what is it used for

DELTACORTENE is a medicine in tablet form, containing the active ingredient prednisone, a synthetic hormone
that belongs to the group of corticosteroids.
Corticosteroids are hormones produced by the adrenal glands that possess anti-inflammatory activity. Anti-inflammatory
drugs reduce pain, swelling, stiffness, redness and heat in the affected tissues.
Due to these properties DELTACORTENE is used:

• in addition to other medicines, in the treatment of rheumatic diseases (e.g. rheumatoid arthritis, Still's disease, ankylosing spondylitis, acute gouty arthritis)
• as therapy for severe and/or widespread inflammation, for example in particular cases of systemic lupus erythematosus (chronic disease due to an alteration of the immune system that causes inflammation and tissue damage), dermatomyositis (chronic inflammatory disease of the muscles), inflammation affecting structures adjacent to the joints (for example bursae, tendons, connective tissue), rheumatic heart inflammation
• in case of severe or debilitating allergies, such as bronchial asthma, contact dermatitis, atopic dermatitis, which do not respond or respond insufficiently to other therapies
• in the treatment of sarcoidosis (inflammatory disease that can affect various organs, but mainly lungs and lymph nodes)
• to treat some blood diseases (e.g. some forms of anemia)
• as palliative therapy for some malignant (tumour) proliferations of white blood cells (leukemias) or of some organs (e.g. lymphomas)
• in addition to other medicines, for the treatment of some pathologies of the gastrointestinal tract (e.g. ulcerative colitis).

2. WHAT YOU NEED TO KNOW BEFORE TAKING DELTACORTENE

Do not take DELTACORTENE

• if you are allergic to prednisone or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from: tuberculosis (TB), a bacterial infection that usually affects the lungs; ulcers of the stomach or intestine; mental disorders; viral infections (e.g. herpes simplex eye disease); widespread fungal infections; severe weakening of the bones (severe osteoporosis);
• if your immune system is altered
• if you have a high level of sugar (glucose) in your blood and cannot keep it under control (unstable diabetes)

Warnings and precautions
Talk to your doctor or pharmacist before taking DELTACORTENE.
You must inform your doctor if you have (currently) or have had (in the past) any of the following conditions, or if you have been
subjected to any of the following treatments:

• intestinal diseases such as colitis and diverticula;
• surgery on the intestine;
• wounds in the stomach wall (active peptic ulcer);
• kidney disease;
• high blood pressure;
• severe muscle weakness;
• weakening of the bones (mild or moderate osteoporosis);
• dental infections or abscesses;
• psychological or emotional disorders;
• blurred vision or other visual disturbances;
• too high a level of sugar (glucose) in the blood (diabetes). Your doctor may increase the dose of diabetes medications and closely monitor blood glucose levels;
• scleroderma (also known as systemic sclerosis, an autoimmune disease) as daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. Your doctor may advise you to undergo regular blood pressure and urine checks.

Other important information about DELTACORTENE
DELTACORTENE can have an effect on the immune system. This compromises its ability to
fight infections. If your immune system is altered:

• vaccinations may not be effective during treatment with DELTACORTENE;
• there may be a greater risk of serious infections. Treatment with DELTACORTENE may increase the likelihood of developing an infection. If you are developing an infection, it may be more difficult to detect during treatment with DELTACORTENE.

Treatment with DELTACORTENE can have a negative effect on the way calcium is metabolized in
your bones. For this reason, you should clarify with your doctor the risk of osteoporosis (loss of
bone mass and fractures), especially if there are family members with a history of bone fractures, if
you do not exercise regularly, if you are a woman in or post-menopause, or if you are elderly.
It may be necessary to reduce the dose of DELTACORTENE in case of:

• hypothyroidism (thyroid gland not sufficiently active)
• liver cirrhosis (liver disease caused by alcoholism or hepatitis)
• adrenal insufficiency. This occurs when the adrenal gland does not produce enough cortisol (a hormone), particularly likely in stressful situations, such as with ongoing infections, after an accident, or if you are subjected to greater physical exertion.

It may be necessary to adjust the dose of DELTACORTENE in case of stressful events, such as surgery
or an ongoing infection.
If you take DELTACORTENE for several months and beyond, your doctor will perform periodic checks, such as: eye
examination, blood tests, blood pressure check.

Children
In early infancy, the medicine should be administered only when absolutely necessary, under the direct supervision
of the doctor. Children undergoing prolonged therapy should be closely monitored for growth and
development.

For athletes: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.
YOUR DOCTOR WILL ADVISE YOU WHAT TO DO.

Other medicines and DELTACORTENE
Tell your doctor if you are taking or have recently taken any other medicines, including over-the-counter
medicines.
Some medicines can increase the effects of DELTACORTENE 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).
Treatment with DELTACORTENE may reduce the effects of the following medicines:

• medicines for diabetes, e.g. oral antidiabetics such as sulfonylureas;
• medicines containing salicylate.

The following medicines may reduce the effect of DELTACORTENE:

• phenobarbital, primidone, carbamazepine, phenytoin, used for the treatment of epilepsy;
• antibiotics such as rifampicin, used for the treatment of infections;
• bronchodilators such as ephedrine, used for the treatment of asthma.

The following medicines may increase the effect of DELTACORTENE:

• diltiazem, used for the treatment of heart disease;
• antibiotics (Macrolides) such as erythromycin, troleandomycin, used for the treatment of infections;
• estrogens, the main female sex hormones.

Other effects of DELTACORTENE:

• increases the risk of gastrointestinal bleeding associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, diclofenac and ibuprofen,
• increases or decreases, depending on the subject, the blood-thinning effects of anticoagulant drugs; in particular, DELTACORTENE increases the anticoagulant effect of warfarin

If you are taking any of the above medicines, your doctor may prescribe you another medicine or
adjust the dose of DELTACORTENE or the other medicine.
YOUR DOCTOR WILL ADVISE YOU WHAT TO DO.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast milk,
ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
It is unlikely that DELTACORTENE will impair your ability to drive vehicles or operate machinery. However, if you
experience side effects such as visual disturbances or changes in mental state, it is best to avoid
engaging in these activities.

DELTACORTENE contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
DELTACORTENE.

3. How to take DELTACORTENE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The dose of DELTACORTENE prescribed by the doctor depends on the severity of the disease. Usually the maintenance dose should not exceed 10-15 mg of prednisone per day.
The initial dose may be higher and, on the advice of the doctor, subsequently reduced gradually to the
maintenance dose based on:

• the symptoms of the disease;
• the response to DELTACORTENE

Method of administration:
DELTACORTENE is taken orally. Take the number of tablets prescribed by the doctor. The doctor
will discuss with you the duration necessary for the treatment.

If you take more DELTACORTENE than you should:
an increase in undesirable effects on electrolyte balance (salts) is likely, which may lead to an
increased risk of heart rhythm abnormalities, and on the metabolism of some minerals such as calcium, which may
lead to an increased risk of fractures.
CONTACT A DOCTOR IF YOU ARE CONCERNED OR IF YOU NOTICE AN INCREASE IN UNDESIRABLE
EFFECTS

If you forget to take DELTACORTENE
CONTACT YOUR DOCTOR TO FIND OUT HOW TO BEHAVE

If you stop taking DELTACORTENE
Do not suddenly stop taking DELTACORTENE. If you stop treatment with DELTACORTENE:

• the symptoms of the disease you suffer from may reappear
• you may experience cortisone withdrawal syndrome (a serious illness caused by the failure to produce cortisol by the body).

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 everybody gets them.
The frequency and severity of the side effects listed below depend on the dose and duration of
treatment.
Very common: more than 1 in 10 people taking DELTACORTENE
Common: less than 1 in 10 but more than 1 in 100 people taking DELTACORTENE
Uncommon: less than 1 in 100 but more than 1 in 1000 people taking DELTACORTENE
Rare: less than 1 in 1000 but more than 1 in 10,000 people taking DELTACORTENE
Very rare: less than 1 in 10,000 people taking DELTACORTENE

Very common side effects of DELTACORTENE:
Mouth ulcers (Aphthous ulcers).
Burning sensation and stomach pain.
Nausea, Vomiting, Diarrhea.
Abdominal bloating with cramps and pain.
General malaise, weakness, fever.
Hives, Itching, Welts.
Skin redness, Acne, stretch marks.
Headache, Dizziness.
Sore throat, Cough.
Infections of various causes, reduced ability to fight them. Infections may be more severe or the
symptoms may be masked.

Common side effects of DELTACORTENE:
Increase or decrease in the number of blood cells.
Increase in the values of liver enzymes (Transaminases), bilirubin, digestive enzymes (Amylase, Lipase),
blood glucose, values of the test for monitoring blood fluidity (INR).
Abscesses.
Heart disease and heart rhythm disorders.
Difficulty digesting, Inflammation of the stomach and intestines, Burning in the esophagus.
Swelling of the mucous membranes and face. Burning eyes. Contact dermatitis.
Fluid retention (edema).
Deterioration and weakness of the muscles, deterioration of the bones leading to an increased risk of
bone fractures (osteopenia and osteoporosis).
Drowsiness, dizziness, transient paralysis of the limbs and especially the hand.
Agitation, Irritability, Confusion, Difficulty sleeping.
Bronchopneumonia, Pneumonia.
Capillary fragility, Bruising.

Uncommon side effects of DELTACORTENE:
Failure to produce blood cells.
Disorders of the secretion of sex hormones, which can cause irregular periods in women or
impotence in men.
Diabetes.
Increased hair growth.
Opacity of the lens (cataract) and increased pressure in the eye (glaucoma) with or without eye pain.
Double vision, decreased vision.
Dryness, inflammation of the mouth, tingling of the tongue.
Constipation.
Gastric and duodenal ulcer, bleeding from the intestine, blood in the stool.
High fever, septicemia.
Problems with the gallbladder.
Injury and/or rupture of the Achilles tendon.
Disorders of the balance of sugars, fats and salts in the body, which can cause increased
appetite and body weight.
Loss of appetite.
Delayed growth in children.
Development or worsening of epileptic seizures.
Delayed wound healing and dry skin.
Fainting due to decreased blood pressure.
Tremors.
Depression (feeling sad), anxiety, irritability, feelings of happiness unjustified by reality,
increased impulsivity, loss of contact with reality (psychosis), memory impairment, panic attack
Fluid retention.
Increased amount of urine, blood in the urine.
Difficulty breathing.
Increased blood pressure.
Cell death phenomena
Thickening or inflammation of the lining of blood vessels and blood clots.
Herpes
Slowing of the heartbeat

Rare side effects of DELTACORTENE:
Hormonal imbalance causing Cushing's syndrome (typical symptoms: round face, often called "moon
face", weight gain in the upper body)
Blindness in one eye, swelling around the eye.
Blood from the mouth, ulcers in the esophagus.
Tooth loss, fragile teeth.
Hiccups
Diverticulitis. Intestinal obstruction.
Severe and rapid swelling (edema) of the skin, mucous membranes and submucosal tissues.
Severe and simultaneous impairment of multiple organ function (multiple organ failure).
Reversible cerebral perfusion alterations (reversible posterior leukoencephalopathy).
Severe liver problems.
Virally correlated tumors (Kaposi's sarcoma).
Reactivation of viral diseases.
Hallucinations, attempted suicide.
Widespread pain due to inflammation of the peripheral sensory nerves.
Severe kidney problems

Very rare side effects of DELTACORTENE:
Hyperactivity of the thyroid gland (hyperthyroidism) which can cause periodic paralysis.

Side effects with unknown frequency of DELTACORTENE:
Inflammation of the pancreas (acute pancreatitis).
Renal scleroderma crisis in patients already affected by scleroderma (an autoimmune disease). Signs of renal
scleroderma crisis include increased blood pressure and decreased urine production.
Blurred vision.

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
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". Reporting side effects can help provide more
information on the safety of this medicine.

5. How to store DELTACORTENE

• 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 pack. The expiry date refers to the last day of the month
• Do not store at a temperature above 25°C
• 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. Contents of the pack and other information

What DELTACORTENE contains
The active ingredient is prednisone.
One DELTACORTENE 5 mg tablet contains 5 mg of prednisone.
The excipients are: stearic acid; corn starch; microcrystalline cellulose; lactose
One DELTACORTENE 25 mg tablet contains 25 mg of prednisone.
The excipients are: magnesium stearate; corn starch; microcrystalline cellulose; lactose.

What DELTACORTENE looks like and contents of the pack
DELTACORTENE is available in:

• pack of 10 or 20 tablets of 5 mg.
• pack of 10 tablets of 25 mg.

MARKETING AUTHORISATION HOLDER
BRUNO FARMACEUTICI S.p.A. - Via delle Ande, 15 - 00144 ROMA

MANUFACTURER

• DOPPEL FARMACEUTICI S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
• MIPHARM S.p.A. - Via B. Quaranta n. 12 - 20141 Milano (MI)
• Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo n.1 - 03012 Anagni (FR)