Prednisone Zentiva: detailed information

Package leaflet: Information for the user

Prednisone Zentiva 5 mg tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Prednisone Zentiva 5 mg tablets are and what they are used for
What you need to know before taking Prednisone Zentiva 5 mg tablets
How to take Prednisone Zentiva 5 mg tablets
Possible side effects
How to store Prednisone Zentiva 5 mg tablets
Contents of the pack and other information

1. What Prednisone Zentiva 5 mg tablets are and what they are used for

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone. It is involved in the regulation of many metabolic processes in the body.
Prednisone Zentiva 5 mg tablets are used in the treatment of:

Acute and chronic rheumatic, muscular and joint diseases
Bronchial asthma and pulmonary fibrosis
Ulcerative colitis (inflammatory bowel disease)
Hepatitis
Addison's disease
Adrenogenital syndrome
Kidney and urinary tract diseases
Allergic and inflammatory skin diseases
Hemolytic anemia
Agranulocytosis (deficiency of white blood cells)
Rheumatic purpura
Acute leukemia and other hematological disorders
Certain inflammatory eye diseases (allergic conjunctivitis, keratitis, chorioretinitis, iritis, iridocyclitis).

2. What you need to know before taking Prednisone Zentiva 5 mg tablets

Do not take Prednisone Zentiva 5 mg tablets:

if you are allergic to prednisone, to other glucocorticoids, or to any of the other ingredients of this medicine (listed in section 6)
if you have stomach ulcer, gastritis, or esophagitis (digestive disorders)
if you have viral infections (such as ocular herpes simplex, chickenpox), before or after vaccination.

Your doctor may have recommended taking Prednisone Zentiva even if you have
one of the following conditions; in such cases, regular monitoring is necessary:

in case of osteomalacia or osteoporosis (bone disorders)
if you have diabetes mellitus
if you have uncontrolled psychotic disorders (psychiatric disorders)
in cases of active tuberculosis (currently untreated)
if you have an infection caused by bacteria, fungi, or amoebae, or if you suffer from systemic mycosis (fungal infection spread throughout the body)
if you have lymphomas (a type of lymphatic system tumor) that appeared after a tuberculosis vaccination
if you have psychiatric diseases. It is recommended to consult your doctor before using this medicine
if you have very high blood pressure
in case of cardiopathy with pulmonary edema and uremia (a syndrome characterized by excess nitrogenous substances in the blood)
if you have myasthenia gravis (muscle weakness)
in case of renal insufficiency.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisone Zentiva 5 mg tablets.
Since treatment with Prednisone Zentiva may lower the body's defenses, it may
increase the risk of developing new infections or reactivating existing ones (e.g., tuberculosis or hepatitis B). In case of severe infections or tuberculosis, Prednisone Zentiva must be used only in combination with specific anti-infective treatment.
Inform your doctor if you have any type of infection, or if you have been vaccinated or plan to be vaccinated. If, during treatment, symptoms of acute-onset diseases such as infectious diseases, gastrointestinal disorders, or mental disturbances occur, contact your doctor.
You should avoid contact with people who have chickenpox or measles. If during treatment with Prednisone Zentiva you come into contact with people affected by chickenpox or measles, you must contact your doctor immediately, even if you do not show any symptoms.
This medicine should be used with caution in patients suffering from gastric ulcer, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), gastro-entero-anastomosis (after surgery), or mental disorders.
If you have osteoporosis, your doctor may recommend increasing your intake of calcium and vitamin D.
Talk to your doctor or pharmacist before taking Prednisone Zentiva:

if you have an overactive thyroid (hyperthyroidism). Contact your doctor immediately if, during prednisone treatment, you experience 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 needed to relieve this condition.

Inform your doctor if you have any heart disease and require high doses of
prednisone.
If you are diabetic or suffer from heart failure, very high blood pressure, or glaucoma, your doctor will monitor you regularly.
The risk of tendon inflammation and tendon rupture is increased when prednisone is administered concomitantly with fluorochinolones (e.g., ciprofloxacin).
Your doctor may increase your dose during periods of excessive physical stress (such as infections, surgical procedures, trauma, etc.).
In case of prolonged treatment, your doctor will perform regular check-ups to prevent eye complications, blood tests, growth monitoring (in children and adolescents), and will monitor the function of your hypothalamic-pituitary-adrenal axis.
Contact your doctor if blurred vision or other visual disturbances occur.
During prolonged prednisone treatment, your doctor may prescribe potassium supplements and suggest reducing sodium (salt) intake.
Contact your doctor before taking Prednisone Zentiva if you have scleroderma (also known as systemic sclerosis, an autoimmune disease), as daily doses equal to or greater than 15 mg may increase the risk of a serious kidney complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and reduced urine output. Your doctor may advise you to regularly monitor your blood pressure and urine.
Prednisone Zentiva should be used in children only when strictly necessary, and treatment should be limited in duration and administered on an alternate-day basis.
In elderly patients, the doctor will perform regular monitoring. Elderly individuals should avoid prolonged treatment with this medicine.
Prednisone Zentiva may alter the results of skin allergy tests (allergy patches, tuberculin skin tests, etc.).
Use in athletes
Please note that this medicine contains prednisone, a substance that may lead to a positive analytical result in anti-doping controls.
Treatment must not be stopped abruptly but tapered gradually. Do not stop taking this medicine without first consulting your doctor (see section 3).
Other medicines and Prednisone Zentiva 5 mg tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This also applies to medicines obtained without a prescription. Some medicines may increase the effects of Prednisone Zentiva, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Prednisone Zentiva may interact with the following medicines:

non-steroidal anti-inflammatory drugs (e.g.: indometacin, acetylsalicylic acid)
medicines for treating diabetes
enzyme inducers:
o carbamazepine, phenytoin, phenobarbital, or primidone (medicines used to treat epilepsy)
o rifampicin, rifabutin (antibiotics)
enzyme inhibitors such as ketoconazole (used for fungal infections)
ephedrine
oral anticoagulants (such as Sintrom)
estrogens (medicines used for hormonal imbalances), oral contraceptives
atropine
cardiac glycosides (medicines used for heart conditions)
potassium-depleting diuretics (medicines used to eliminate fluids) and laxatives
praziquantel (an antiparasitic drug)
some medicines used to treat high blood pressure
some medicines for treating malaria
immunosuppressants (medicines used to prevent transplant rejection)
non-depolarizing neuromuscular blockers (medicines mainly used in intensive care and operating rooms)
growth hormone
protirelin (a medicine used to stimulate the thyroid gland)
fluorochinolones: may increase the risk of tendon rupture
antacids
salicylates (aspirin-like medicines).

Interference with laboratory tests: skin reactions in allergy tests may
be suppressed.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Prednisone Zentiva 5 mg tablets during pregnancy unless prescribed by your doctor. Inform your doctor as soon as possible if you become pregnant during treatment.
Breastfeeding
Prednisone passes into breast milk; therefore, it is recommended to discontinue breastfeeding during treatment, especially during prolonged treatment or with high doses.
Driving and using machines
Please be aware that long-term treatments may reduce visual acuity, which could negatively affect your ability to drive safely in traffic.
Prednisone Zentiva 5 mg tablets contain sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.
Prednisone Zentiva 5 mg tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Prednisone Zentiva

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Remember to take your dose.
The tablets should be taken whole with an adequate amount of liquid. The total daily dose should be divided into three or four administrations, during or after meals. In some cases, the prescribed dose may be taken as a single daily dose, during or after breakfast. Sometimes, especially in children and only if advised by the doctor, treatment should be taken on alternate days.
Your doctor will determine the dose best suited to your needs.
Prednisone Zentiva 5 mg tablets must not be stopped abruptly; the dosage should instead be gradually reduced.
In general, the maintenance dose should always be the lowest possible.
Your doctor will inform you of the duration of treatment with Prednisone Zentiva 5 mg tablets.
Do not stop treatment suddenly or before the scheduled time; doing so could worsen your condition. If you feel that the effect of Prednisone Zentiva 5 mg tablets is too strong or too weak, discuss it with your doctor.

Recommended dose:
Adults
The treatment dose will depend on the type and severity of the disease and the individual patient's response. Usually, the initial dose is 20–90 mg (milligrams) per day, as prescribed by the doctor. These initial doses will be administered until a satisfactory response is observed. Once achieved, your doctor will gradually reduce the prednisone dose to reach the maintenance dose, which usually ranges between 5 and 10 mg per day.
In bronchial asthma, proceed similarly, but the initial dose in severe cases is between 15 and 60 mg.
For adjunctive treatment in organ transplantation, recommended daily doses may vary depending on the organ involved, between 30 and 300 mg.

Children
In general, prednisone treatment in children may be administered on alternate days or intermittently. The recommended initial doses are 1–3 mg of prednisone per kilogram of body weight per day. The maintenance dose is 0.25 mg of prednisone/kg body weight/day.

If you take more Prednisone Zentiva 5 mg tablets than you should
There are no known cases of acute intoxication with prednisone. In case of overdose, the adverse reactions described in this leaflet are expected to occur, but with greater intensity. Overdose may cause excitement, anxiety, depression, mental confusion, gastrointestinal bleeding, increased blood pressure and blood sugar levels, as well as fluid retention (edema).
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately.

If you forget to take Prednisone Zentiva 5 mg tablets
Do not take a double dose to make up for the missed dose. Wait for the next scheduled dose and continue treatment as usual.

If you stop taking Prednisone Zentiva 5 mg tablets
Do not stop treatment with this medicine without consulting your doctor.
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 everybody gets them.
The side effects observed are listed below according to their frequency:
Very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people);
uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people);
very rare (may affect up to 1 in 10,000 people); not known (frequency cannot be estimated from the available data).

In most cases, side effects occur especially when the medicine is used at high doses or for prolonged periods, and are detailed below:

Disorders of the blood and lymphatic system: leucocytosis (increased white blood cells in the blood), lymphopenia (decreased lymphocytes in the blood), eosinopenia (decreased eosinophils in the blood), polycythaemia (increased red blood cells in the blood).

Endocrine disorders: signs of overactivity of the adrenal glands (Cushing's syndrome, a disease caused by increased production of a hormone called cortisol); and adrenal insufficiency during prolonged treatment (a condition characterised by weakness, constant fatigue, loss of appetite and weight loss).

Eye disorders: glaucoma and cataract. Blurred vision.

Gastrointestinal disorders: gastric ulcers, intestinal bleeding, and pancreatitis (inflammation of the pancreas).

General disorders and administration site conditions: delayed wound healing.

Immune system disorders: severe allergic reactions, including arrhythmias, bronchospasm, decreased or increased blood pressure, cardiovascular failure, heart attack.

Infections and infestations: existing infections may worsen, and new infections that are difficult to diagnose may occur.

Metabolism and nutrition disorders: fluid retention (oedema), potassium deficiency (which may lead to changes in heart rhythm), weight gain, increased blood sugar, diabetes mellitus, increased blood cholesterol and triglyceride levels, increased appetite, growth retardation in children.

Cardiac disorders (frequency not known): decreased heart rate.

Musculoskeletal and connective tissue disorders: muscle diseases, muscle weakness, tendon disorders, tendinitis, tendon ruptures, loss of calcium from bones, osteoporosis, growth retardation in children.

Nervous system disorders: increased intracranial pressure (especially in children), increased seizures in epileptic patients or onset of epileptic seizures.

Psychiatric disorders: psychosis, mania, depression, hallucinations, emotional lability, irritability, increased impulses, euphoria, anxiety, sleep disorders, suicidal thoughts.

Reproductive system and breast disorders: irregular or absent menstruation, hirsutism (excessive hair growth).

Skin and subcutaneous tissue disorders: acne and other skin problems (allergy, bruising, skin striae), oedema, changes in skin pigmentation, perioral dermatitis.

Vascular disorders: increased blood pressure, increased risk of atherosclerosis (narrowing and hardening of arteries) and thrombosis (blood clot formation), vasculitis, and capillary fragility.

Renal and urinary disorders: renal crisis caused by scleroderma in patients who already suffer from scleroderma (an autoimmune disease). Signs of a scleroderma-related renal crisis include increased blood pressure and reduced urine output.

Rapid dose reduction after long-term treatment may cause muscle and joint pain.

If you think any of the adverse reactions you are experiencing are severe, or if you experience any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you get any side effects, 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
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 Zentiva 5 mg tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the pack after
EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Prednisone Zentiva 5 mg tablets contain

The active substance is prednisone. Each tablet contains 5 mg of prednisone.
The other components (excipients) are: monohydrate lactose, sodium starch glycolate (type A), magnesium stearate, anhydrous colloidal silica, and talc.

Description of the appearance of Prednisone Zentiva 5 mg tablets and pack contents
White, cylindrical, biconvex tablets with a score line on one side and "PD5" printed on the other side. The score line is not intended to divide the tablet into equal doses.
Prednisone Zentiva 5 mg tablets are packaged in PVC-PVDC/aluminum blisters.
Prednisone Zentiva 5 mg tablets are available in packs containing 10, 20, and 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 – Milan
Italy

Exclusive Distributor for Sales:
Zentiva Italia Srl
Milan
(logo)

Manufacturer
CYNDEA PHARMA S.L
Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31 42110 Ólvega (Soria), Spain
Special Product's Line S.P.A.,
via Fratta Rotonda Vado Largo, 1
03012 - Anagni (FR), Italy

Patient Information Leaflet: Information for the User

Prednisone Zentiva 25 mg tablets

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, consult 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, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Prednisone Zentiva 25 mg tablets are and what they are used for
What you need to know before taking Prednisone Zentiva 25 mg tablets
How to take Prednisone Zentiva 25 mg tablets
Possible side effects
How to store Prednisone Zentiva 25 mg tablets
Package contents and other information

1. What Prednisone Zentiva 25 mg tablets are and what they are used for

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone. It plays a role in regulating many metabolic processes in the body.
Prednisone Zentiva 25 mg tablets are used in the treatment of:

acute and chronic rheumatic, muscular and joint diseases
bronchial asthma and pulmonary fibrosis
ulcerative colitis (inflammatory bowel disease)
hepatitis
Addison's disease
adrenogenital syndrome
kidney and urinary tract diseases
allergic and inflammatory skin diseases
haemolytic anaemia
agranulocytosis (deficiency of white blood cells)
rheumatic purpura
acute leukaemia and other haematological disorders
certain inflammatory eye diseases (allergic conjunctivitis, keratitis, choroidoretinitis, iritis, iridocyclitis)
as an adjunctive therapy in organ transplantation.

2. What you need to know before taking Prednisone Zentiva 25 mg tablets

Do not take Prednisone Zentiva 25 mg tablets:

if you are allergic to prednisone, other glucocorticoids, or any of the other ingredients of this medicine (listed in section 6)
if you have stomach ulcer, gastritis, or esophagitis (gastrointestinal disorders)
if you have viral infections (such as ocular herpes simplex, chickenpox), before or after vaccination.

Your doctor might have recommended taking Prednisone Zentiva even if you have
one of the following conditions; in such cases, regular monitoring is necessary:

in case of osteomalacia and osteoporosis (bone disorders)
if you have diabetes mellitus
if you have uncontrolled psychosis (psychotic disorders) not managed with treatment
in cases of active tuberculosis (currently untreated)
if you have a bacterial, fungal, or amoebic infection, or suffer from systemic mycosis (a fungal infection widespread throughout the body)
if you have lymphomas (a type of lymphatic system tumor) that appeared after a tuberculosis vaccination
if you suffer from psychiatric diseases. It is recommended to consult your doctor before using this medicine
if you have very high blood pressure
in case of asystole (heart disease) with pulmonary edema and uremia (a syndrome characterized by excess nitrogenous substances in the blood)
if you suffer from myasthenia gravis (muscle weakness)
in case of renal insufficiency.

Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisone Zentiva 25 mg tablets:
Since treatment with Prednisone Zentiva may lower your body's defenses,
increasing the risk of developing new infections or reactivating existing ones
(e.g., tuberculosis or hepatitis B). In case of severe infections or tuberculosis, Prednisone Zentiva
should only be used together with specific treatment for the infection.
Inform your doctor if you have any type of infection and if you have been vaccinated or plan
to be vaccinated. If, during treatment, symptoms of acute-onset diseases such as infectious
diseases, gastrointestinal disorders, or mental disturbances occur, contact your doctor.
You should avoid contact with people affected by chickenpox or measles. If, during treatment
with Prednisone Zentiva, you come into contact with people affected by chickenpox or
measles, you must contact your doctor immediately, even if you do not have any symptoms.
This medicine should be used with caution in people suffering from gastric
ulcer, ulcerative colitis (intestinal disease), diverticulitis (intestinal disease), or gastro-
entero-anastomosis (after surgery), or mental disorders.
If you suffer from osteoporosis, your doctor may advise you to increase your intake of calcium
and vitamin D.
Talk to your doctor or pharmacist before taking Prednisone Zentiva:

if you have an overactive thyroid (hyperthyroidism). Contact your doctor immediately if, during prednisone use, you experience muscle weakness, muscle pain, cramps, or stiffness. These may be symptoms of a condition called "thyrotoxic periodic paralysis," which may occur in patients with overactive thyroid (hyperthyroidism) treated with prednisone. Additional treatment may be needed to relieve this condition.

Inform your doctor if you have any heart disease and require high doses of
prednisone.
If you are diabetic or suffer from heart failure, very high blood pressure, or glaucoma,
your doctor will monitor you regularly.
The risk of tendon inflammation and tendon rupture is increased when administered concomitantly with fluorochinolones (e.g., ciprofloxacin).
Your doctor may increase your dose during periods of excessive physical stress (such as
infections, surgical procedures, trauma, etc.).
In case of prolonged treatment, your doctor will perform regular checks to prevent
eye complications, blood tests, growth monitoring (in children and adolescents), and will monitor the function of your hypothalamic-pituitary-adrenal axis.
Contact your doctor if blurred vision or other visual disturbances occur.
During prolonged prednisone treatment, your doctor may prescribe potassium supplements and suggest reducing sodium (salt) intake.
Contact your doctor before taking Prednisone Zentiva if you suffer from scleroderma (also
known as systemic sclerosis, an autoimmune disease), as daily doses equal to or exceeding 15 mg may increase the risk of a serious kidney complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and reduced urine output. Your doctor may recommend regular monitoring of blood pressure and urine.
Prednisone Zentiva should be used in children only when strictly necessary, and treatment should be time-limited and administered on an alternate-day basis.
In elderly patients, the doctor will monitor the patient regularly. Elderly people should avoid prolonged treatment with this medicine.
Prednisone Zentiva may alter the results of skin allergy tests (allergy patches, tuberculin skin tests, etc.).
Use in athletes
Please note that this medicine contains prednisone, a substance that may lead to a positive analytical result in anti-doping tests.
Treatment must not be stopped abruptly but should be tapered gradually. Do not stop taking this medicine without first consulting your doctor (see section 3).
Other medicines and Prednisone Zentiva 25 mg tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This includes medicines obtained without a prescription. Some medicines may enhance the effects of Prednisone Zentiva, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Prednisone Zentiva may interact with the following medicines:

non-steroidal anti-inflammatory drugs (e.g.: indometacin, acetylsalicylic acid)
medicines for treating diabetes
enzyme inducers: carbamazepine, phenytoin, phenobarbital, or primidone (medicines used to treat epilepsy), or rifampicin, rifabutin (antibiotics)
enzyme inhibitors such as ketoconazole (used for fungal infections)
ephedrine
oral anticoagulants (such as Sintrom)
estrogens (medicines used for hormonal imbalances), oral contraceptives
atropine
cardioactive glycosides (medicines used for heart diseases)
potassium-depleting diuretics (medicines used to eliminate fluids) and laxatives
praziquantel (an antiparasitic drug)
some medicines used to treat high blood pressure
some medicines for treating malaria
immunosuppressants (medicines used to prevent transplant rejection)
non-depolarizing neuromuscular blocking agents (medicines mainly used in intensive care and operating rooms)
growth hormone
protirelin (a medicine used to stimulate the thyroid)
fluorochinolones: may increase the risk of tendon rupture
antacids
salicylates (aspirin-like medicines).

Interference with laboratory tests: skin reactions to allergy tests may
be suppressed.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this
medicine.
You must not take Prednisone Zentiva 25 mg tablets during pregnancy unless prescribed by your doctor. Inform your doctor as soon as possible if you become pregnant during treatment.
Breastfeeding
Prednisone passes into breast milk; therefore, breastfeeding is not recommended
during treatment, especially during prolonged treatment or with high doses.
Driving and using machines
It should be considered that long-term treatments may reduce visual acuity, which could negatively affect your ability to drive safely in traffic.
Prednisone Zentiva 25 mg tablets contain sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.,
essentially 'sodium-free'.
Prednisone Zentiva 25 mg tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Prednisone Zentiva 25 mg tablets

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Remember to take your dose.
The tablets should be taken whole with a sufficient amount of liquid. The total daily dose should be divided into three or four administrations, taken during or after meals. In some cases, the prescribed dose may be taken as a single daily dose during or after breakfast.
Sometimes, especially in children and only if advised by the doctor, treatment should be taken on alternate days.
Your doctor will decide the dose best suited to your needs.
Prednisone Zentiva 25 mg tablets must not be stopped abruptly; the dosage should instead be gradually reduced.
In general, the maintenance dose should always be as low as possible.
Your doctor will inform you of the duration of treatment with Prednisone Zentiva 25 mg tablets.
Do not stop treatment abruptly or before the scheduled end date; doing so could worsen your condition. If you feel that the effect of Prednisone Zentiva 25 mg tablets is too strong or too weak, speak to your doctor.

Recommended dose
Adults
The treatment dose will depend on the type and severity of the disease and the individual patient's response. Usually, the initial dose is 20–90 mg (milligrams) per day, as prescribed by the doctor. These initial doses will be administered until a satisfactory response is observed. Once this occurs, the doctor will gradually reduce the prednisone dose until reaching the maintenance dose, which usually ranges between 5 and 10 mg per day.
In bronchial asthma, follow the same approach, but the initial dose in severe cases ranges from 15 to 60 mg.
In adjuvant treatment following organ transplantation, the recommended daily doses may vary, depending on the organ involved, between 30 and 300 mg.

Children
In general, treatment with prednisone in children may be administered on alternate days or intermittently. The recommended initial doses are 1–3 mg of prednisone per kilogram of body weight per day. The maintenance dose is 0.25 mg of prednisone/kg body weight/day.

If you take more Prednisone Zentiva 25 mg tablets than you should
Acute poisoning with prednisone is not known to have occurred. In case of overdose, the adverse reactions described in this leaflet are expected to occur but with greater intensity. Overdose may cause excitement, anxiety, depression, mental confusion, gastrointestinal bleeding, increased blood pressure and blood sugar levels, as well as fluid retention (edema).
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately.

If you forget to take Prednisone Zentiva 25 mg tablets
Do not take a double dose to make up for the forgotten dose. Wait for the next scheduled dose and continue treatment as usual.

If you stop taking Prednisone Zentiva 25 mg tablets
Do not stop treatment with this medicine without consulting your doctor.
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 everyone will experience them.
Side effects are grouped according to their frequency as follows:
very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); not known (frequency cannot be estimated from the available data).
In most cases, side effects occur especially when the drug is used at high doses and during prolonged treatment, and are detailed below:
Blood and lymphatic system disorders: leucocytosis (increased white blood cells in the blood), lymphopenia (decreased lymphocytes in the blood), eosinopenia (decreased eosinophils in the blood), polycythemia (increased red blood cells in the blood)
Endocrine disorders: signs of overactivity of the adrenal glands (Cushing's syndrome, a disease caused by increased production of a hormone called cortisol); and adrenal insufficiency during prolonged treatment (a condition characterized by weakness, constant fatigue, and loss of appetite and weight).
Eye disorders: glaucoma and cataracts. Blurred vision.
Gastrointestinal disorders: gastric ulcers, gastrointestinal bleeding, and pancreatitis (inflammation of the pancreas).
General disorders and administration site conditions: delayed wound healing.
Immune system disorders: severe allergic reactions, including arrhythmias, bronchospasm, decrease or increase in blood pressure, cardiovascular failure, heart attack.
Infections and infestations: existing infections may worsen and new infections, difficult to diagnose, may occur.
Metabolism and nutrition disorders: fluid retention (edema), potassium deficiency (which may lead to changes in heart rhythm), weight gain, increased blood sugar, diabetes mellitus, increased blood cholesterol and triglyceride levels, increased appetite, growth retardation in children.
Cardiac disorders (frequency not known): decreased heart rate.
Musculoskeletal and connective tissue disorders: muscle disorders, muscle weakness, tendon disorders, tendinitis, tendon ruptures, loss of calcium from bones, osteoporosis, growth retardation in children.
Nervous system disorders: increased intracranial pressure (especially in children), increased seizures in epileptic patients or onset of epileptic seizures.
Psychiatric disorders: psychosis, mania, depression, hallucinations, emotional lability, irritability, increased impulses, euphoria, anxiety, sleep disorders, suicidal thoughts.
Reproductive system and breast disorders: irregular menstruation or absence of menstruation, hirsutism (excessive hair growth).
Skin and subcutaneous tissue disorders: acne and other skin disorders (allergy, bruising, stretch marks), edema, changes in skin pigmentation, perioral dermatitis.
Vascular disorders: increased blood pressure, increased risk of atherosclerosis (narrowing and hardening of arteries) and thrombosis (formation of blood clots), vasculitis, and capillary fragility.
Renal and urinary disorders: renal crisis caused by scleroderma in patients who already suffer from scleroderma (an autoimmune disease). Signs of a renal crisis caused by scleroderma include increased blood pressure and reduced urine output.
Rapid reduction of the dose after long-term treatment may cause muscle and joint pain.
If you think any of the adverse reactions you are experiencing are severe, or if you experience any adverse reaction not mentioned in this leaflet, please inform your doctor or pharmacist.
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 the website
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 Zentiva 25 mg tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
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 Prednisone Zentiva 25 mg tablets contain

The active substance is prednisone. Each tablet contains 25 mg of prednisone.
The other components (excipients) are: monohydrate lactose, sodium starch glycolate (type A), magnesium stearate, anhydrous colloidal silica and talc.

Description of the appearance of Prednisone Zentiva 25 mg tablets and pack contents
White, cylindrical, biconvex tablets with a score line on one side.
Prednisone Zentiva 25 mg tablets are packaged in PVC-PVDC/aluminium blisters.
Prednisone Zentiva 25 mg tablets are available in packs containing 10 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29 20149 – Milan - Italy
Exclusive Sales Licensee:
Zentiva Italia Srl
Milan
(logo)
Manufacturer
CYNDEA PHARMA S.L
Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31 42110 Ólvega
(Soria) Spain
Special Product's Line S.P.A.,
via Fratta Rotonda Vado Largo, 1
03012 - Anagni (FR), Italy