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1. Prednisone Mylan Pharma 25 mg tablets
   1. What is Prednisone Mylan Pharma 25 mg tablets and what it is used for
   2. What you need to know before taking Prednisone Mylan Pharma 25 mg tablets
   3. How to take Prednisone Mylan Pharma 25 mg tablets
2. prednisone per kilogram of body weight per day. The maintenance dose is 0.25mg of
   1. Possible side effects
   2. How to store Prednisone Mylan Pharma 25 mg tablets
   3. Contents of the pack and other information
3. Prednisone Mylan Pharma 5 mg tablets
   1. What is Prednisone Mylan Pharma 5 mg tablets and what is it used for
   2. What you need to know before taking Prednisone Mylan Pharma 5 mg tablets
   3. How to take Prednisone Mylan Pharma 5 mg tablets
4. prednisone per kilogram of body weight per day. The maintenance dose is 0.25 mg of
   1. Possible side effects
   2. How to store Prednisone Mylan Pharma 5 mg tablets
   3. Contents of the pack and other information

Prednisone Mylan Pharma 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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Prednisone Mylan Pharma 25 mg tablets and what it is used for

Prednisone 25 mg is a corticosteroid (glucocorticoid) derived from cortisone. It participates
in the regulation of many metabolic processes of the body.
Prednisone Mylan Pharma 25 mg tablets is used in the treatment of:

• rheumatic muscular and joint acute and chronic 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 Mylan Pharma 25 mg tablets

Do not take Prednisone Mylan Pharma 25 mg tablets

• if you are allergic or hypersensitive to prednisone or to any of the other ingredients 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 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 Mylan Pharma 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 can 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 experience a relapse of the underlying condition, acute adrenal 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 can cause damage to the pancreas
• The product contains a component that can 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.
• If you have scleroderma (also known as systemic sclerosis, an autoimmune disease) as daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. Your doctor may advise you to undergo regular blood pressure and urine checks.

Other medicines and Prednisone Mylan Pharma 25 mg tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes medicines without a prescription
medical.

• Rifampicin, phenytoin, carbamazepine and barbiturates can reduce the effect of prednisone. Erythromycin and ketoconazole can increase it.
• Contraceptives containing estrogen can increase the effect of prednisone.
• Antacids (aluminum, magnesium) can reduce absorption and therefore can 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 can 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 you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
You should not take Prednisone Mylan Pharma 25 mg tablets during pregnancy unless
it has been prescribed by your doctor.
If symptoms of acute-onset diseases, such as
infectious diseases, gastrointestinal diseases or psychiatric alterations, occur during treatment, consult
your doctor.
Taking prednisone is not recommended during breastfeeding unless it is
prescribed by your doctor. Your doctor will advise you whether to discontinue breastfeeding or
stop treatment with prednisone.

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

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

Prednisone Mylan Pharma 25 mg tablets contains lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is equivalent
to essentially “sodium-free”.

3. How to take Prednisone Mylan Pharma 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 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, especially 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 is most suitable for your needs.
Prednisone Mylan Pharma 25 mg tablets must not be stopped abruptly; the
dosage must, in fact, be reduced gradually.
In general, the maintenance dose should always be as low as possible.
The doctor will tell you the duration of treatment with Prednisone Mylan Pharma 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 Mylan Pharma 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'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 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 0.25mg of

prednisone/kg of body weight/day.

If you take more Prednisone Mylan Pharma 25 mg tablets than you should
Cases of acute intoxication with prednisone are not known. In case of overdose, you may
experience increased intensity. Overdosage can 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 Mylan Pharma 25 mg tablets
Do not take a double dose to make up for a missed dose. Wait for the next
dose and continue treatment as normal.

If you stop taking Prednisone Mylan Pharma 25 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, cataract, blurred vision.
• Excitability, irritability and increased appetite.
• Muscle atrophy and tenderness.
• Hiccups (frequency not known).
• 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 alterations: reductions in white blood cells or increases in red blood cells.
• Sclerodermic renal crisis in patients already affected by scleroderma (an autoimmune disease). Signs of sclerodermic renal crisis include increased blood pressure and reduced urine production (frequency not known).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 Mylan Pharma 25 mg tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular 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 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 Mylan Pharma 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, anhydrous colloidal silica and talc.

Description of the appearance of Prednisone Mylan Pharma 25 mg tablets and pack content
Cylindrical, white tablets.
Prednisone Mylan Pharma 25 mg tablets are packaged in PVC-PVDC/aluminium blisters.
Prednisone Mylan Pharma 25 mg tablets are available in packs containing 10
tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer
CYNDEA PHARMA S.L
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 36
42110 Ólvega
(Soria) Spain

Prednisone Mylan Pharma 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 they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Prednisone Mylan Pharma 5 mg tablets and what is it used for

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone. It participates in the
regulation of many metabolic processes of the body.
Prednisone Mylan Pharma 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 Mylan Pharma 5 mg tablets

Do not take Prednisone Mylan Pharma 5 mg tablets

• if you are allergic or hypersensitive to prednisone or to any of the other ingredients 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 before vaccination and for the 2 weeks after vaccination
• in case of severe arterial hypertension
• if you suffer from glaucoma

Contact your doctor if you experience blurred vision or other visual disturbances.

Warnings and precautions
Consult your doctor or pharmacist before taking Prednisone Mylan Pharma 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 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 experience a relapse of the underlying condition, acute adrenal 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 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) as daily doses of 15 mg or more may increase the risk of a serious complication called scleroderma renal crisis. Signs of scleroderma renal crisis include increased blood pressure and decreased urine production. Your doctor may advise you to undergo regular blood pressure and urine checks.

Other medicines and Prednisone Mylan Pharma 5 mg tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. This includes medicines without a prescription
medical.

• 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 clotting), 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 antirheumatic agents (indometacin, acetylsalicylic acid) 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 you may be pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
You should not take Prednisone Mylan Pharma 5 mg tablets during pregnancy unless
prescribed by your doctor.
If you experience symptoms of acute onset diseases during treatment, such as
infectious diseases, gastrointestinal diseases or psychiatric alterations, consult your
doctor.
Taking prednisone is not recommended during breastfeeding unless prescribed by your
doctor. Your doctor will advise you whether to discontinue breastfeeding or
stop 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.

Use in athletes
Note that the product contains a component that may result in positive doping tests.

Prednisone Mylan Pharma 5 mg tablets contains lactose and sodium.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e.
essentially “sodium-free”.

3. How to take Prednisone Mylan Pharma 5 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 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, especially 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 Mylan Pharma 5 mg tablets should not be stopped abruptly; the
dosage must in fact be reduced gradually.
In general, the maintenance dose should always be as low as possible.
The doctor will tell you the duration of treatment with Prednisone Mylan Pharma 5 mg tablets.
Do not stop treatment abruptly or before the scheduled date; this could
worsen your condition. If you think that the effect of Prednisone Mylan Pharma 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 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 Mylan Pharma 5 mg tablets than you should
Cases of acute intoxication with prednisone are not known. In case of overdose, you may experience
increased intensity. Overdosage can 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 Mylan Pharma 5 mg tablets
Do not take a double dose to make up for a missed dose. Wait for the next
dose and continue treatment as normal.

If you stop taking Prednisone Mylan Pharma 5 mg tablets
If you have any doubts about the use of this medicine, contact 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, growth of body hair, acne, suppression of menstruation, sexual impotence in men and delayed growth.
• Glaucoma, cataract, blurred vision.
• Excitability, irritability and increased appetite.
• Muscle atrophy and tenderness.
• Hiccups (frequency not known).
• 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.
• Sclerodermic renal crisis in patients already affected by scleroderma (an autoimmune disease). Signs of sclerodermic renal crisis include increased blood pressure and decreased urine production (frequency not known).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://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 Mylan Pharma 5 mg tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions
Do not use this medicine after the expiry date which is reported on the packaging after
EXP. 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 eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Prednisone Mylan Pharma 5 mg tablets contain

• 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 Mylan Pharma 5 mg tablets and contents of the pack
White, cylindrical, biconvex tablets with a groove on one side and stamped PD5
on the other side. The groove is not intended to divide the tablet into two equal doses.
Prednisone Mylan Pharma 5 mg tablets are packaged in PVC-PVDC/aluminium blisters.
Prednisone Mylan Pharma 5 mg tablets are available in packs containing 10,
20 and 30 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer
CYNDEA PHARMA S.L
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 36
42110 Ólvega
(Soria) Spain