Prednisone Doc Generici

Package leaflet: Information for the user

PREDNISONE DOC Generici 5 mg tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone, involved in the regulation of many metabolic processes in the body.
PREDNISONE DOC Generici 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 disorders
• 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)

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

Do not take PREDNISONE DOC Generici

• 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 have chickenpox or herpes
• in case of systemic fungal infections
• if vaccination is required, do not take prednisone for the 8 weeks prior to vaccination and for the 2 weeks following vaccination
• in case of severe arterial hypertension
• if you suffer from glaucoma

Warnings and precautions
Talk to your doctor or pharmacist before taking PREDNISONE DOC Generici.

• If you have the following risk factors for osteoporosis: family predisposition, age, post-menopause, smoking, and lack of significant physical activity, as treatment with prednisone may cause bone loss.
• During prolonged treatment with prednisone, your doctor may prescribe potassium supplements and advise you to reduce sodium intake.
• In case of severe heart failure, careful medical monitoring should be performed.
• Lower than recommended doses may be sufficient in case of impaired thyroid function (hypothyroidism) or liver cirrhosis.
• If you have overactive thyroid (hyperthyroidism).
• After a long period of treatment, if you need to stop or discontinue prednisone therapy, you may experience a relapse of the underlying condition, acute adrenal insufficiency (particularly if you have an infection or after an accident), or corticosteroid withdrawal syndrome.
• Chickenpox or measles may be particularly severe in patients treated with glucocorticoids. This should be especially considered in children with weakened defenses and in adults who have had measles or chickenpox.
• In children, prolonged treatment may induce pancreatic damage.
• The product contains a component that may lead to a positive result in anti-doping control tests.
• Prednisone may alter the results of skin allergy tests.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If you have 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 blood pressure and reduced urine output. Your doctor may advise regular monitoring of blood pressure and urine.

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 overactive thyroid (hyperthyroidism) treated with prednisone. Additional treatment may be required to relieve this condition.

Other medicines and PREDNISONE DOC Generici
Inform your doctor if you are taking or have recently taken any other medicines, including those 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 medications for treating diabetes, the effect of these medications on blood sugar levels may be reduced.
• If you are taking coumarin derivatives (medicines to control blood clotting), administration of prednisone may reduce their anticoagulant effect.
• If you take prednisone together with digitalis agents, diuretics, or amphotericin B, potassium levels may be altered.
• If you take prednisone and non-steroidal anti-inflammatory drugs or antirheumatic agents (indomethacin, acetylsalicylic acid) simultaneously, the risk of gastrointestinal bleeding may increase.
• The effects of muscle-relaxing medicines may be enhanced when taken together with prednisone.
• Prednisone should not be taken in combination with cyclosporine, as their activities mutually inhibit each other.
• When taken together, prednisone may alter the effect of cyclophosphamide.
• Some medicines may increase the effects of prednisone, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take PREDNISONE DOC Generici during pregnancy unless prescribed by your doctor.
If symptoms of acute-onset diseases such as infections, gastrointestinal disorders, or psychiatric disturbances occur during treatment, consult your doctor.
The use of prednisone during breastfeeding is not recommended unless prescribed by your doctor. Your doctor will advise you whether to discontinue breastfeeding or stop treatment with prednisone.

Driving and using machines
Please note that long-term treatment may reduce visual acuity, which could negatively affect your ability to drive safely in traffic.

PREDNISONE DOC Generici contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

PREDNISONE DOC Generici contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e., it is essentially 'sodium-free'.

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

3. How to take PREDNISONE DOC Generici

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 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 as a single daily dose, during or after breakfast. Occasionally, especially in
children, and only if your doctor has instructed you to do so, treatment should be taken on alternate days.
Your doctor will determine the dose best suited to your needs.
PREDNISONE DOC Generici must not be stopped abruptly; instead, the dosage should be
gradually reduced.
In general, the maintenance dose should always be the lowest possible.
Your doctor will inform you about the duration of treatment with PREDNISONE DOC Generici.
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 DOC Generici is too strong or too weak,
discuss this with your doctor.
Recommended dose:
Adults
The treatment dose will depend on the type and severity of the disease and on the individual patient's response.
Typically, 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,
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 ranges from 15 to 60 mg.
For adjunctive treatment following 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.
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 than you should
There are no known cases of acute intoxication with prednisone. In the event of overdose,
the adverse effects described in this leaflet may 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 DOC Generici
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 DOC Generici
If you have any doubts about using 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 levels, bone loss (osteoporosis), increased blood pressure, excessive hair growth, acne, suppression of menstruation, sexual impotence in men, and growth retardation.
• Glaucoma, cataract, blurred vision.
• Excitability, irritability, and increased appetite.
• Muscle atrophy and muscle pain.
• Gastric and duodenal ulcers and gastrointestinal bleeding.
• Delayed wound healing, stretch marks.
• Infections may be masked, and the patient may become more susceptible to them.
• Blood disorders: reduction in white blood cells or increase in red blood cells.
• Slowing of the heart rate (frequency not known).
• 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 (frequency not known).
• Hiccups (frequency not known).

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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PREDNISONE DOC Generici

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 DOC Generici contains

• 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 DOC Generici and package contents
White, cylindrical, biconvex tablets with a score line on one side and "PD5" engraved
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/aluminum blisters.
PREDNISONE DOC Generici 5 mg tablets are available in packages containing 10, 20 and 30
tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici srl
Via Turati, 40
20121 – Milan
Italy
Manufacturer
SPECIAL PRODUCT’S LINE S.P.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy

Package leaflet: information for the user

PREDNISONE DOC Generici 25 mg tablets

Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PREDNISONE DOC Generici is and what it is used for
2. What you need to know before taking PREDNISONE DOC Generici
3. How to take PREDNISONE DOC Generici
4. Possible side effects
5. How to store PREDNISONE DOC Generici
6. Package contents and other information

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

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone, involved in the regulation of many metabolic processes in the body.
PREDNISONE DOC Generici 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 disorders
• hemolytic anemia
• agranulocytosis (deficiency of white blood cells)
• rheumatic purpura
• acute leukemia and other hematological disorders
• certain inflammatory eye diseases (allergic conjunctivitis, keratitis, choroidoretinitis, iritis, iridocyclitis)
• as an adjunct in organ transplant therapy

2. What you should know before taking PREDNISONE DOC Generici

Do not take PREDNISONE DOC Generici

• 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 have chickenpox or herpes
• in case of systemic fungal infections
• if vaccination is required, do not take prednisone for the 8 weeks prior to vaccination and for the 2 weeks following vaccination
• in case of severe arterial hypertension
• if you suffer from glaucoma

Warnings and precautions
Talk to your doctor or pharmacist before taking PREDNISONE DOC Generici.

• If you have the following risk factors for osteoporosis: family predisposition, age, post-menopause, smoking, and lack of significant physical activity, as treatment with prednisone may cause bone loss.
• During prolonged treatment with prednisone, your doctor may prescribe potassium supplements and advise you to reduce sodium intake.
• In case of severe heart failure, careful medical monitoring should be performed.
• In case of reduced thyroid function (hypothyroidism) or liver cirrhosis, lower doses than those recommended may be sufficient.
• If you have an overactive thyroid (hyperthyroidism).
• After a long period of treatment, if you need to stop or discontinue treatment with prednisone, you may experience a relapse of the underlying condition, acute adrenal insufficiency (especially if you have an infection or following an accident), or corticosteroid withdrawal syndrome.
• Chickenpox or measles could be particularly severe in patients treated with glucocorticoids. This should be considered especially in children with weakened defenses and in adults who have had measles or chickenpox.
• In children, prolonged treatment may induce damage to the pancreas.
• The product contains a component that may cause a positive result in anti-doping control tests.
• Prednisone may alter the results of skin allergy tests.
• Contact your doctor if blurred vision or other visual disturbances occur.
• If you have 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 blood pressure and reduced urine output. Your doctor may advise regular monitoring of blood pressure and urine.

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 overactive thyroid (hyperthyroidism) treated with prednisone. Additional
treatment may be required to relieve this condition.

Other medicines and PREDNISONE DOC Generici
Inform 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 together with medicines for treating diabetes, the effect of these medicines on blood sugar levels may be reduced.
• If you are taking coumarin derivatives (medicines to control blood clotting), administration of prednisone may reduce their anticoagulant effect.
• If you take prednisone together with digitalis agents, diuretics, or amphotericin B, potassium levels may be altered.
• If you take prednisone and non-steroidal anti-inflammatory drugs or anti-rheumatic agents (indomethacin, acetylsalicylic acid) simultaneously, the risk of gastrointestinal bleeding may increase.
• The effects of muscle-relaxing medicines may be increased if taken together with prednisone.
• Prednisone must not be taken together with cyclosporine, as their activities mutually inhibit each other.
• When taken simultaneously, prednisone may alter the effect of cyclophosphamide.
• Some medicines may increase the effects of prednisone, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think 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 DOC Generici during pregnancy unless prescribed by your doctor.
If symptoms of acute-onset diseases such as infectious diseases, gastrointestinal disorders, or psychiatric
alterations occur during treatment, consult your doctor.
The use of prednisone during breastfeeding is not recommended unless prescribed by your doctor. Your
doctor will advise you whether to discontinue breastfeeding or stop treatment with prednisone.

Driving and using machines
It should be noted that long-term treatment may reduce visual acuity, which could negatively affect your
ability to drive safely in traffic.

PREDNISONE DOC Generici contains lactose.
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this
medicine.

PREDNISONE DOC Generici contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e., it is essentially ‘sodium-free’.

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

3. How to take PREDNISONE DOC Generici

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, 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 your doctor has instructed you to do so, treatment should be taken on alternate days.
Your doctor will determine the dose best suited to your individual needs.
PREDNISONE DOC Generici 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 DOC Generici.
Do not stop treatment suddenly or before the scheduled time; this could worsen your
condition. If you feel that the effect of PREDNISONE DOC Generici 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 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 between 15 and 60 mg.
In the case of adjunctive treatment following 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 of body weight/day.
If you take more PREDNISONE DOC Generici than you should
Acute intoxication with prednisone has not been reported. In case of overdose, the adverse effects
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, contact your doctor or pharmacist immediately.
If you forget to take PREDNISONE DOC Generici
Do not take a double dose to make up for the missed dose. Wait for the next scheduled dose and continue treatment as normal.
If you stop taking PREDNISONE DOC Generici
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.

• In long-term treatments: abdominal and facial obesity (moon face), increased blood sugar, bone loss (osteoporosis), increased blood pressure, excessive hair growth, acne, suppression of menstruation, sexual impotence in men, and growth delay.
• Glaucoma, cataract, 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 become more susceptible to them.
• Blood abnormalities: decreased white blood cells or increased red blood cells.
• Slowing of the heartbeat (frequency not known).
• Scleroderma renal crisis in patients already affected by scleroderma (an autoimmune disease). Signs of scleroderma renal crisis include increased arterial pressure and reduced urine production (frequency not known).
• Hiccups (frequency not known).

Reporting of side effects
If you get any side effects, including ones 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PREDNISONE DOC Generici

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 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. Pack contents and other information

What PREDNISONE DOC Generici contains

• 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 DOC Generici 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 and 20 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici srl
Via Turati, 40
20121 – Milan
Italy

Manufacturer
SPECIAL PRODUCT’S LINE S.P.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy