Prednisone EG

Package leaflet: Information for the user

Prednisone EG 5 mg tablets, 25 mg tablets

prednisone
Read all of 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 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, contact your doctor or pharmacist.

Contents of this leaflet

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

1. What Prednisone EG is and what it is used for

Prednisone EG is a tablet medicine containing the active substance prednisone, a synthetic hormone belonging to the group of corticosteroids.
Corticosteroids are hormones produced by the adrenal glands that have anti-inflammatory activity. Anti-inflammatory medicines reduce pain, swelling, stiffness, redness, and heat in affected tissues.
Due to these properties, Prednisone EG is used:

• as an 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 specific cases of systemic lupus erythematosus (a chronic disease caused by an alteration of the immune system leading to inflammation and tissue damage), dermatomyositis (a chronic inflammatory muscle disease), inflammation affecting structures adjacent to the joints (e.g. bursae, tendons, connective tissue), cardiac inflammation of rheumatic origin;
• in cases of severe or debilitating allergies, such as bronchial asthma, contact dermatitis, atopic dermatitis, which do not respond or respond inadequately to other treatments;
• in the treatment of sarcoidosis (an inflammatory disease that can affect various organs, but primarily the lungs and lymph nodes);
• to treat certain blood disorders (e.g. certain forms of anaemia);
• as palliative therapy for certain malignant proliferations (cancers) of white blood cells (leukaemias) or of certain organs (e.g. lymph node tumours);
• in combination with other medicines, for the treatment of certain gastrointestinal tract disorders (e.g. ulcerative colitis).

2. What you need to know before taking Prednisone EG

Do not take Prednisone EG
➢ if you are allergic to prednisone or to any of the other ingredients of this medicine (listed in
section 6);
➢ if you suffer from:
o tuberculosis (TB), a bacterial infection that usually affects the lungs;
o stomach or intestinal ulcers;
o psychiatric disorders;
o viral infections (e.g. eye disease caused by herpes simplex);
o systemic fungal infections;
o severe bone weakening (severe osteoporosis);
➢ if your immune system is impaired;
➢ if you have high blood sugar (glucose) levels that you cannot control (unstable diabetes).

Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisone EG.
You must inform your doctor if you currently have or have previously had any of the following conditions, or if you have undergone any of the following treatments:

• intestinal diseases such as colitis and diverticula;
• intestinal surgery;
• sores in the stomach wall (active peptic ulcer);
• kidney diseases;
• high blood pressure;
• severe muscle weakness;
• bone weakening (mild or moderate osteoporosis);
• dental infections or abscesses;
• psychological or emotional disorders;
• blurred vision or other visual disturbances;
• excessively high blood sugar (glucose) levels (diabetes). Your doctor may need to increase your diabetes medication dose and closely monitor your blood glucose levels;
• scleroderma (also known as systemic sclerosis, an autoimmune disease), because daily doses equal to or greater than 15 mg may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased arterial pressure and reduced urine output. Your doctor may recommend regular monitoring of blood pressure and urine;
• if you have an overactive thyroid (hyperthyroidism). Contact your doctor immediately if, during treatment with prednisone, you develop muscle weakness, muscle pain, cramps, or stiffness. These may be symptoms of a condition called "thyrotoxic periodic paralysis", which may occur in patients with hyperthyroidism treated with prednisone. Additional treatment may be required to relieve this condition.

Other important information about Prednisone EG
Prednisone EG may affect your immune system. This may impair your ability to fight
infections. If your immune system is impaired:

• vaccinations may not be effective during treatment with Prednisone EG;
• there may be an increased risk of serious infections. Treatment with Prednisone EG may increase the likelihood of developing an infection. If an infection develops, it may be more difficult to detect during treatment with Prednisone EG.

Treatment with Prednisone EG may negatively affect calcium metabolism in your bones. For this reason, you should discuss 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.
A dose reduction of Prednisone EG may be necessary in case of:

• hypothyroidism (underactive thyroid gland);
• liver cirrhosis (liver disease caused by alcoholism or hepatitis);
• adrenal insufficiency. This occurs when the adrenal glands do not produce enough cortisol (a hormone), particularly likely during stressful situations, such as ongoing infections, after an accident, or if you are undergoing increased physical strain.

You may need to adjust the dose of Prednisone EG during stressful events, such as surgery or an ongoing infection.
If you take Prednisone EG for several months or longer, your doctor will perform periodic checks, such as eye examination, blood tests, and blood pressure monitoring.

Children
In early infancy, this medicine should be administered only when strictly necessary and under direct medical supervision. Children undergoing prolonged therapy must be closely monitored for growth and development.

For those engaged in sports: using the drug without therapeutic need constitutes doping and may lead to a positive anti-doping test.
YOUR DOCTOR WILL ADVISE YOU ON WHAT TO DO.

Other medicines and Prednisone EG
Inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may enhance the effects of Prednisone EG, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).
Treatment with Prednisone EG may reduce the effects of the following medicines:

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

The following medicines may reduce the effect of Prednisone EG:

• phenobarbital, primidone, carbamazepine, phenytoin, used to treat epilepsy;
• antibiotics such as rifampicin, used to treat infections;
• bronchodilators such as ephedrine, used to treat asthma.

The following medicines may increase the effect of Prednisone EG:

• diltiazem, used to treat heart conditions;
• antibiotics (Macrolides) such as erythromycin, troleandomycin, used to treat infections;
• estrogens, the main female sex hormones.

Other effects of Prednisone EG:

• increases the risk of gastrointestinal bleeding associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, diclofenac, and ibuprofen;
• may increase or decrease, depending on the individual, the blood-thinning effects of anticoagulant medicines; in particular, Prednisone EG increases the anticoagulant effect of warfarin.

If you are taking any of the above-mentioned medicines, your doctor may prescribe an alternative medicine or adjust the dose of Prednisone EG or the other medicine.
YOUR DOCTOR WILL ADVISE YOU ON WHAT TO DO.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
It is unlikely that Prednisone EG will impair your ability to drive or operate machinery. However, if you experience adverse effects such as visual disturbances or changes in mental status, you should avoid performing these activities.

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

3. How to take Prednisone EG

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
consult your doctor or pharmacist.
The dose of Prednisone EG prescribed by your 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 your doctor’s advice, gradually reduced to the maintenance dose depending on:

• the symptoms of the disease;
• your response to Prednisone EG.

Method of administration:
Prednisone EG is taken orally. Take the number of tablets prescribed by your doctor. Your doctor will discuss with you the required duration of treatment.
If you take more Prednisone EG than you should:
you are likely to experience an increase in adverse effects on electrolyte balance (salts), which may lead to an increased risk of heart rhythm abnormalities, and on the metabolism of certain minerals such as calcium, which may increase the risk of fractures.
CONTACT A DOCTOR IF YOU ARE CONCERNED OR IF YOU NOTICE AN INCREASE IN ADVERSE EFFECTS
If you forget to take Prednisone EG
CONTACT YOUR DOCTOR TO FIND OUT WHAT TO DO
If you stop taking Prednisone EG
Do not stop taking Prednisone EG suddenly. If you stop treatment with Prednisone EG:

• the symptoms of your condition may return;
• you may develop corticosteroid withdrawal syndrome (a serious condition caused by the body’s failure to produce cortisol).

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 dosage and duration of treatment.
Very common: more than 1 in 10 people taking Prednisone EG
Common: less than 1 in 10 but more than 1 in 100 people taking Prednisone EG
Uncommon: less than 1 in 100 but more than 1 in 1,000 people taking Prednisone EG
Rare: less than 1 in 1,000 but more than 1 in 10,000 people taking Prednisone EG
Very rare: less than 1 in 10,000 people taking Prednisone EG

Very common side effects of Prednisone EG:
Mouth ulcers (aphthae).
Burning sensation and stomach pain.
Nausea, vomiting, diarrhoea.
Abdominal swelling with cramps and pain.
General malaise, weakness, fever.
Urticaria, itching, wheals.
Skin redness, acne, skin striae.
Headache, dizziness.
Throat irritation, cough.
Infections from various causes, reduced ability to fight them. Infections may be more severe or symptoms may be masked.

Common side effects of Prednisone EG:
Increase or decrease in the number of blood cells.
Elevated liver enzyme (transaminases), bilirubin, digestive enzyme (amylase, lipase), blood glucose, and blood clotting monitoring test (INR) values.
Abscesses.
Heart disease and disturbances in heart rhythm.
Indigestion, inflammation of the stomach and intestine, oesophageal burning.
Swelling of mucous membranes and face. Eye burning. Contact dermatitis.
Fluid accumulation (oedema).
Muscle deterioration and weakness, bone deterioration leading to increased risk of bone fractures (osteopenia and osteoporosis).
Drowsiness, dizziness, transient paralysis of limbs, particularly the hand.
Restlessness, irritability, confusion, difficulty sleeping.
Bronchopneumonia, pneumonia.
Capillary fragility, bruising.

Uncommon side effects of Prednisone EG:
Failure to produce blood cells.
Disorders in the secretion of sex hormones, which may cause irregular menstruation in women or impotence in men.
Diabetes.
Increased hair growth.
Clouding of the lens (cataract) and increased eye pressure (glaucoma), with or without eye pain. Double vision, decreased vision.
Dryness, inflammation of the mouth, tingling of the tongue.
Constipation.
Gastric and duodenal ulcers, intestinal bleeding, blood in stools.
High fever, septicaemia.
Gallbladder problems.
Injury and/or rupture of the Achilles tendon.
Disturbances in the balance of sugars, fats, and salts in the body, which may lead to increased appetite and body weight.
Loss of appetite.
Growth retardation in children.
Development or worsening of epileptic seizures.
Delayed wound healing and dry skin.
Fainting due to low blood pressure.
Tremors.
Depression (feeling of sadness), anxiety, irritability, feelings of unjustified happiness, increased impulsivity, loss of touch with reality (psychosis), memory disturbance, panic attack.
Fluid retention.
Increased urine volume, blood in urine.
Breathing difficulties.
Increased blood pressure.
Phenomena of cell death.
Thickening or inflammation of blood vessel lining and blood clots.
Herpes.
Slowed heart rate.

Rare side effects of Prednisone EG:
Hormonal imbalance causing Cushing's syndrome (typical symptoms: round face, often called "moon face", weight gain in the upper part of the body).
Blindness in one eye, swelling around the eye area.
Bleeding from the mouth, oesophageal ulcers.
Tooth loss, fragile teeth.
Diverticulitis. Intestinal obstruction.
Severe and rapid swelling (oedema) of the skin, mucous membranes, and submucosal tissues.
Severe and simultaneous dysfunction of multiple organs (multi-organ failure).
Reversible changes in cerebral perfusion (reversible posterior leukoencephalopathy).
Severe liver problems.
Virus-associated tumours (Kaposi's sarcoma).
Reactivation of viral diseases.
Hallucinations, attempted suicide.
Widespread pain due to inflammation of peripheral sensory nerves.
Severe kidney disorders.

Very rare side effects of Prednisone EG:
Overactivity of the thyroid gland (hyperthyroidism) which may cause periodic episodes of paralysis.

Side effects with unknown frequency of Prednisone EG:
Inflammation of the pancreas (acute pancreatitis).
Scleroderma renal crisis in patients already affected by scleroderma (an autoimmune disease). Signs of scleroderma renal crisis include increased blood pressure and reduced urine output.
Blurred vision.
Hiccups.

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 http://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 Prednisone EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Prednisone EG contains
The active substance is prednisone.
One tablet of Prednisone EG 5 mg contains 5 mg of prednisone.
The excipients are: stearic acid; maize starch; microcrystalline cellulose; lactose.
One tablet of Prednisone EG 25 mg contains 25 mg of prednisone.
The excipients are: magnesium stearate; maize starch; microcrystalline cellulose; lactose.

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

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

Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Manufacturer
DOPPEL FARMACEUTICI S.r.l. - Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)
MIPHARM S.p.A. - Via B. Quaranta n. 12 - 20141 Milan (MI)
SPECIAL PRODUCT’S LINE S.p.A. - Via Fratta Rotonda Vado Largo n.1 - 03012 Anagni (FR)

REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
February 2026