PREDNISONE 5 mg Tabletka Powlekana

Treść ulotki

1. PREDNISONE DOC Generici 5 mg tablets
   1. What is PREDNISONE DOC Generici 5 mg tablets and what is it used for
   2. What you need to know before taking PREDNISONE DOC Generici 5 mg tablets
   3. How to take PREDNISONE DOC Generici 5 mg tablets
   4. Possible side effects
   5. How to store PREDNISONE DOC Generici 5 mg tablets
   6. Contents of the pack and other information
2. PREDNISONE DOC Generici 25 mg tablets
   1. What is PREDNISONE DOC Generici 25 mg tablets and what is it used for
   2. What you need to know before taking PREDNISONE DOC Generici 25 mg tablets
   3. How to take PREDNISONE DOC Generici 25 mg tablets
   4. Possible side effects
   5. How to store PREDNISONE DOC Generici 25 mg tablets
   6. Contents of the pack and other information

PREDNISONE DOC Generici 5 mg tablets

Generic medicine

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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is PREDNISONE DOC Generici 5 mg tablets and what is it used for

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone, involved in the regulation
of many metabolic processes of the body.
PREDNISONE DOC Generici 5 mg tablets is 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 fever
• acute leukemia and other hematological diseases
• some inflammatory diseases of the eyes (allergic conjunctivitis, keratitis, chorioretinitis, iritis, iridocyclitis)

2. What you need to know before taking PREDNISONE DOC Generici 5 mg tablets

Do not take PREDNISONE DOC Generici 5 mg tablets

• if you are allergic or hypersensitive to prednisone or to any of the other ingredients of this medicine
• in case of malacia and osteoporosis
• if you have diabetes mellitus
• if you suffer from psychosis
• in case of peptic ulcer
• in cases of active tuberculosis (unless chemotherapeutic drugs are used simultaneously)
• in acute bacterial infections
• if you suffer from chickenpox or herpes
• in case of systemic fungal infections
• if you are to be vaccinated, do not take prednisone for the 8 weeks before vaccination and for the 2 weeks after vaccination
• in case of severe arterial hypertension
• if you suffer from glaucoma

Warnings and precautions
Consult your doctor or pharmacist before taking PREDNISONE DOC Generici 5 mg tablets.

• If you have the following risk factors for osteoporosis: family history, age, post-menopause, smoking and insignificant physical activity, as treatment with prednisone may induce bone loss.
• In prolonged treatment with prednisone, your doctor may prescribe potassium supplements and suggest a reduction in sodium intake.
• In case of severe heart failure, careful medical monitoring is required.
• In case of poor thyroid function (hypothyroidism) or liver cirrhosis, lower doses than recommended may be sufficient.
• After a long period of treatment, if you need to stop or interrupt treatment with prednisone, you may experience a relapse of the underlying condition, acute adrenal cortex insufficiency (especially if you have an infection or after an accident), or cortisone withdrawal syndrome.
• Chickenpox or measles may be particularly severe in patients treated with glucocorticoids. This must be taken into consideration in particular in children with reduced defenses and in adults who have suffered from measles or chickenpox.
• In children, prolonged treatment may cause damage to the pancreas
• The product contains a component that may induce a positive result in anti-doping tests.
• Prednisone may alter the results of skin allergy tests.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and PREDNISONE DOC Generici 5 mg tablets
Tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.

• Rifampicin, phenytoin, carbamazepine and barbiturates may reduce the effect of prednisone
• Erythromycin and ketoconazole may increase it.
• Contraceptives containing estrogens may increase the effect of prednisone.
• Antacids (aluminum, magnesium) may reduce absorption and therefore may reduce the effectiveness of prednisone.
• If prednisone is taken simultaneously with medicines to treat diabetes, the effect of the latter on blood sugar levels may be reduced.
• If you take coumarin derivatives (medicines to control blood coagulation), the administration of prednisone may reduce their anticoagulant effect.
• If you take prednisone and digitalis agents, diuretics or amphotericin B at the same time, potassium levels may be altered.
• If you take prednisone and non-steroidal anti-inflammatory drugs or rheumatic agents (indometacin, acetylsalicylic acid) you may increase the risk of gastrointestinal bleeding.
• The effects of medicines that relax muscles may be increased if taken in association with prednisone.
• Prednisone should not be taken in association with cyclosporine as their activity is mutually inhibited.
• If taken simultaneously, prednisone may alter the effect of cyclophosphamide.
• Some medicines may increase the effects of prednisone 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).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
You should not take PREDNISONE DOC Generici 5 mg tablets during pregnancy unless
prescribed by your doctor.
If symptoms of acute-onset diseases, such as infectious diseases, digestive system diseases or psychiatric alterations, occur during treatment, consult your doctor.
Taking prednisone is not recommended during breastfeeding unless prescribed
by your doctor. Your doctor will advise you whether to stop breastfeeding or interrupt treatment
with prednisone.

Driving and operating machinery
It should be considered that long-term treatments may reduce visual acuity,
which may negatively affect the ability to drive safely in traffic.

PREDNISONE DOC Generici 5 mg tablets contains lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

Use in athletes
Please note that the product contains a component that may result in a positive doping test.

3. How to take PREDNISONE DOC Generici 5 mg tablets

Take this medicine following strictly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Remember to take the dose.
The tablets must be swallowed whole with a sufficient 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 in a single daily dose, during or after breakfast. Sometimes, in particular in children, and only if your doctor has told you to do so, the treatment must be taken on alternate days.
The doctor will decide the dose that is most suitable for your needs.
PREDNISONE DOC Generici 5 mg tablets must not be stopped abruptly; the dosage must, in fact, be reduced gradually.
In general, the maintenance dose must always be the lowest possible.
The doctor will tell you the duration of treatment with PREDNISONE DOC Generici 5 mg tablets.
Do not interrupt the treatment abruptly or before the scheduled date; this could worsen your condition. If you feel that the effect of PREDNISONE DOC Generici 5 mg tablets is too strong or too weak, talk to your doctor.

The recommended dose is:
Adults
The dose of treatment 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.
When this is present, the doctor will gradually reduce the dose of prednisone until reaching the maintenance dose, which usually varies between 5 and 10 mg per day.
In bronchial asthma, proceed in the same way, but the initial dose in severe cases is between 15 and 60 mg.
In the case of adjuvant treatments for 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 can 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 of body weight/day.

If you take more PREDNISONE DOC Generici 5 mg tablets than you should
No cases of acute intoxication with prednisone are known. In case of overdose, it is expected that an overdose may induce 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 DOC Generici 5 mg tablets
Do not take a double dose to make up for the missed dose. Wait for the next dose and follow the treatment normally.

If you stop taking PREDNISONE DOC Generici 5 mg tablets
If you have any doubts 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.

• In long-term treatments, abdominal and facial obesity (moon face), increased blood sugar, bone loss (osteoporosis), increased blood pressure, hair growth, acne, suppression of menstruation, sexual impotence in men and delayed growth.
• Glaucoma, cataracts, blurred vision.
• Excitability, irritability and increased appetite.
• Muscle atrophy and tenderness.
• Gastric and duodenal ulcers and gastrointestinal bleeding.
• Delayed wound healing, stretch marks.
• Infections may be masked and the patient may be more vulnerable to them.
• Blood changes: reductions in white blood cells or increases in red blood cells.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store PREDNISONE DOC Generici 5 mg tablets

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The
expiry date refers to the last day of that month.
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 PREDNISONE DOC Generici 5 mg tablets contains

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

Description of the appearance of PREDNISONE DOC Generici 5 mg tablets and contents of the pack
White, cylindrical, biconvex tablets, with a score line on one side and PD5 imprinted
on the other side. The score line does not divide the tablet into equal doses.
PREDNISONE DOC Generici 5 mg tablets are packaged in PVC-PVDC/aluminium blisters.
PREDNISONE DOC Generici 5 mg tablets are available in packs containing 10, 20 and
30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici srl
Via Turati, 40

• 20121 – Milan Italy

Manufacturer
CYNDEA PHARMA S.L
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
42110 Ólvega (Soria)
Spain

PREDNISONE DOC Generici 25 mg tablets

Generic medicine

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 only for you. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What PREDNISONE DOC Generici 25 mg tablets is and what it is used for
• 2. What you need to know before you take PREDNISONE DOC Generici 25 mg tablets
• 3. How to take PREDNISONE DOC Generici 25 mg tablets
• 4. Possible side effects
• 5. How to store PREDNISONE DOC Generici 25 mg tablets
• 6. Contents of the pack and other information

1. What is PREDNISONE DOC Generici 25 mg tablets and what is it used for

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone, involved in the regulation
of many metabolic processes of the body.
PREDNISONE DOC Generici 25 mg tablets is 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 fever
• acute leukemia and other hematological diseases
• some inflammatory diseases of the eyes (allergic conjunctivitis, keratitis, chorioretinitis, iritis, iridocyclitis)
• as an adjunct to therapy for organ transplantation

2. What you need to know before taking PREDNISONE DOC Generici 25 mg tablets

Do not take PREDNISONE DOC Generici 25 mg tablets

• if you are allergic or hypersensitive to prednisone or to any of the other components of this medicine
• in case of osteomalacia and osteoporosis
• if you have diabetes mellitus
• if you suffer from psychosis
• in case of peptic ulcer
• in cases of active tuberculosis (unless chemotherapeutic drugs are used simultaneously)
• in acute bacterial infections
• if you suffer from chickenpox or herpes
• in case of systemic fungal infections
• if you are to be vaccinated, do not take prednisone for the 8 weeks preceding vaccination and for the 2 weeks following vaccination
• in case of severe arterial hypertension
• if you suffer from glaucoma

Warnings and precautions
Consult your doctor or pharmacist before taking PREDNISONE DOC Generici 25 mg
tablets.

• If you have the following risk factors for osteoporosis: family history, age, post-menopause, smoking and insignificant physical activity, as treatment with prednisone may induce bone loss.
• In prolonged treatment with prednisone, your doctor may prescribe you potassium supplements and suggest a reduction in sodium intake.
• In case of severe heart failure, careful medical monitoring is required.
• In case of poor thyroid function (hypothyroidism) or liver cirrhosis, lower doses than recommended may be sufficient.
• After a long period of treatment, if you need to stop or discontinue treatment with prednisone, you may have a relapse of the underlying condition, acute adrenal cortex insufficiency (especially if you have an infection or after an accident), or cortisone withdrawal syndrome.
• Chickenpox or measles may be particularly severe in patients treated with glucocorticoids. This should be taken into consideration especially in children with reduced defenses and in adults who have suffered from measles or chickenpox.
• In children, prolonged treatment may cause damage to the pancreas
• The product contains a component that may induce a positive result in anti-doping tests.
• Prednisone may alter the results of skin allergy tests.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and PREDNISONE DOC Generici 25 mg tablets
Tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.

• Rifampicin, phenytoin, carbamazepine and barbiturates may reduce the effect of prednisone
• Erythromycin and ketoconazole may increase it.
• Contraceptives containing estrogens may increase the effect of prednisone.
• Antacids (aluminum, magnesium) may reduce absorption and therefore may reduce the effectiveness of prednisone.
• If prednisone is taken simultaneously with drugs to treat diabetes, the effect of the latter on blood sugar levels may be lower.
• If you take coumarin derivatives (medicines to control blood coagulation), the administration of prednisone may reduce their anticoagulant effect.
• If you take prednisone and digitalis agents, diuretics or amphotericin B at the same time, potassium levels may be altered.
• If you take prednisone and non-steroidal anti-inflammatory drugs or rheumatic agents (indometacin, acetylsalicylic acid) you may increase the risk of gastrointestinal bleeding.
• The effects of medicines that relax muscles may be increased if taken in association with prednisone.
• Prednisone should not be taken in association with cyclosporine as their activity is mutually inhibited.
• If taken simultaneously, prednisone may alter the effect of cyclophosphamide.
• Some medicines may increase the effects of prednisone 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).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
You should not take PREDNISONE DOC Generici 25 mg tablets during pregnancy unless
prescribed by your doctor.
If symptoms of acute onset diseases, such as infectious diseases, digestive system diseases or psychiatric alterations, occur during treatment, consult your doctor.
Taking prednisone is not recommended during breastfeeding unless prescribed
by your doctor. Your doctor will advise you whether to stop breastfeeding or discontinue treatment
with prednisone.

Driving and operating machinery
It should be considered that long-term treatments may reduce visual acuity,
which may negatively affect the ability to drive safely in traffic.

PREDNISONE DOC Generici 25 mg tablets contains lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

Use in athletes
Note that the product contains a component that may determine positivity to doping tests.

3. How to take PREDNISONE DOC Generici 25 mg tablets

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Remember to take the dose.
The tablets must be taken whole with a sufficient 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 in a single daily dose, during or after breakfast. Sometimes, particularly in children, and only if your doctor has told you to, the treatment must be taken on alternate days.
The doctor will decide the dose that will be most suitable for your needs.
PREDNISONE DOC Generici 25 mg tablets must not be stopped abruptly; the dosage must, in fact, be reduced gradually.
In general, the maintenance dose must always be the lowest possible.
The doctor will tell you the duration of treatment with PREDNISONE DOC Generici 25 mg tablets.
Do not interrupt treatment abruptly or before the scheduled date; this could worsen your condition. If you think that the effect of PREDNISONE DOC Generici 25 mg tablets is too strong or too weak, talk to your doctor.

The recommended dose is:
Adults
The treatment dose will depend on the type and severity of the disease and the individual patient 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.
When this is present, the doctor will gradually reduce the dose of prednisone until reaching the maintenance dose, which usually ranges from 5 to 10 mg per day.
In bronchial asthma, proceed in the same way, but the initial dose in severe cases is between 15 and 60 mg.
In the case of adjuvant treatments for 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 can 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 of body weight/day.

If you take more PREDNISONE DOC Generici 25 mg tablets than you should
No cases of acute poisoning with prednisone are known. In case of overdose, it is expected that overdose may induce 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 DOC Generici 25 mg tablets
Do not take a double dose to make up for a missed dose. Wait for the next dose and follow the treatment normally.

If you stop taking PREDNISONE DOC Generici 25 mg tablets
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.

• In long-term treatments, abdominal and facial obesity (moon face), increased blood sugar, bone loss (osteoporosis), increased blood pressure, hair growth, acne, suppression of menstruation, sexual impotence in men and delayed growth.
• Glaucoma, cataracts, blurred vision.
• Excitability, irritability and increased appetite.
• Muscle atrophy and tenderness.
• Gastric and duodenal ulcers and gastrointestinal bleeding.
• Delayed wound healing, stretch marks.
• Infections may be masked and the patient may be more vulnerable to them.
• Blood changes: reductions in white blood cells or increases in red blood cells.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store PREDNISONE DOC Generici 25 mg tablets

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is reported on the package after SCAD. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 PREDNISONE DOC Generici 25 mg tablets contain

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici srl
Via Turati, 40

• 20121 – Milan Italy

Manufacturer
CYNDEA PHARMA S.L
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31
42110 Ólvega (Soria)
Spain