Prednisone Mylan Pharma

Package leaflet: Information for the user

Prednisone Mylan Pharma 5 mg tablets

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

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

Contents of this leaflet:

1. What Prednisone Mylan Pharma 5 mg tablets are and what they are 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. Possible side effects
5. How to store Prednisone Mylan Pharma 5 mg tablets
6. Contents of the pack and other information

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

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone. It plays a role in regulating many metabolic processes in 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
• haemolytic anaemia
• agranulocytosis (deficiency of white blood cells)
• rheumatic purpura
• acute leukaemia and other haematological disorders
• certain inflammatory eye diseases (allergic conjunctivitis, keratitis, choriorétinitis, iritis, iridocyclitis)

2. What you should 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 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

Contact your doctor if you experience blurred vision or other visual disturbances.
Warnings and precautions
Talk to 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-menopausal status, 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.
• If you have severe heart failure, careful medical monitoring is required.
• If you have an overactive thyroid (hyperthyroidism)
• In case of underactive thyroid (hypothyroidism) or hepatic cirrhosis, lower doses than those 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 cortex insufficiency (especially 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 considered especially in children with reduced 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 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 recommend regular monitoring of blood pressure and urine.

Contact your doctor immediately if, during treatment with prednisone, you develop muscle weakness,
muscle pain, cramps, and stiffness. These may be symptoms of a condition called “thyrotoxic periodic
paralysis,” which may occur in patients with an overactive thyroid (hyperthyroidism) treated with
prednisone. Additional treatment may be necessary to relieve this condition.
Other medicines and Prednisone Mylan Pharma 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 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 efficacy of prednisone.
• If prednisone is taken simultaneously 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 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 must not be taken in combination 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 some
medicines for the treatment of HIV: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Prednisone Mylan Pharma 5 mg tablets during pregnancy unless prescribed by your doctor.
If symptoms of acute-onset diseases such as infectious diseases, gastrointestinal disorders, or psychiatric disturbances occur during treatment, consult your doctor.
The use of prednisone is not recommended during breastfeeding unless prescribed by a doctor. Your doctor will advise you whether to discontinue breastfeeding or stop treatment with prednisone.
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.
Use in athletes
Please note that the product contains a component that may lead to a positive anti-doping test.
Prednisone Mylan Pharma 5 mg tablets contain lactose and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her 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 exactly as instructed 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, particularly 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 Mylan Pharma 5 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 Mylan Pharma 5 mg tablets.
Do not stop treatment suddenly or before the scheduled time; this could worsen your condition. If you feel that the effect of Prednisone Mylan Pharma 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 on 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, 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 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, 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 Mylan Pharma 5 mg tablets than you should
Acute intoxication due to 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 Mylan Pharma 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 Mylan Pharma 5 mg tablets
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, menstrual suppression, 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: reduced white blood cells or increased red blood cells.

Frequency not known (cannot be estimated from available data):

• Hiccups;
• 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);
• Slow heart rate.

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 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 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. Package contents and other information

What Prednisone Mylan Pharma 5 mg tablets contain

• The active substance is prednisone. Each tablet contains 5 mg of prednisone.
• The other components (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 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 two equal doses.
Prednisone Mylan Pharma 5 mg tablets are packaged in PVC-PVDC/aluminum blisters.
Prednisone Mylan Pharma 5 mg tablets are available in packs containing 10, 20 and 30 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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

Package leaflet: information for the user

Prednisone Mylan Pharma 25 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Prednisone Mylan Pharma 25 mg tablets are and what they are 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
4. Possible side effects
5. How to store Prednisone Mylan Pharma 25 mg tablets
6. Contents of the pack and other information

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

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

• acute and chronic musculoskeletal and joint rheumatic 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 conditions
• 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 adjunct in organ transplant therapy

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 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 you are due to be vaccinated, 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 Mylan Pharma 25 mg tablets.

• If you have the following risk factors for osteoporosis: family history, 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 suggest reducing sodium intake.
• If you have severe heart failure, careful medical monitoring is required.
• If you have an overactive thyroid (hyperthyroidism)
• In case of reduced thyroid function (hypothyroidism) or hepatic cirrhosis, lower doses than those 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 disease, acute adrenal cortex insufficiency (particularly if you have an infection or after an accident), or cortisone withdrawal syndrome.
• Chickenpox or measles could be particularly severe in patients treated with glucocorticoids. This should be taken into consideration especially in children with weakened defences 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 lead to 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 you to undergo regular checks of blood pressure and urine.

Contact your doctor immediately if, during treatment with prednisone, you experience muscle weakness,
muscle pain, cramps and 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.
Other medicines and Prednisone Mylan Pharma 25 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 without a prescription.

• Rifampicin, phenytoin, carbamazepine and barbiturates may reduce the effect of prednisone. Erythromycin and ketoconazole may increase it.
• Contraceptives containing oestrogens may increase the effect of prednisone.
• Antacids (aluminium, magnesium) may reduce absorption and therefore may reduce the effectiveness of prednisone.
• If prednisone is taken at the same time as 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 antirheumatic 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 in combination 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 some medicines for the treatment of HIV: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take Prednisone Mylan Pharma 25 mg tablets during pregnancy unless prescribed by your doctor.
If symptoms of acute-onset diseases such as infectious diseases, gastrointestinal disorders or psychiatric disturbances occur during treatment, consult your doctor.
The use of prednisone is not recommended during breastfeeding unless prescribed by a doctor. Your doctor will advise you whether to stop breastfeeding or discontinue treatment with prednisone.
Driving and using machines
It should be borne in mind that long-term treatment may reduce visual acuity, which could negatively affect your ability to drive safely in traffic.
Use in athletes
Please note that the product contains a component that may lead to a positive result in anti-doping tests.
Prednisone Mylan Pharma 25 mg tablets contain lactose and sodium.
If you have been diagnosed with an intolerance to certain sugars, contact your doctor 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 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, 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 needs.
Prednisone Mylan Pharma 25 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 Mylan Pharma 25 mg tablets.
Do not stop treatment suddenly or before the scheduled date; this could worsen your condition. If you
feel that the effect of Prednisone Mylan Pharma 25 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 on 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, 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, proceed similarly, but the initial dose in severe cases ranges from 15 to 60 mg.
In adjuvant 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 body weight/day.

If you take more Prednisone Mylan Pharma 25 mg tablets than you should
Acute intoxication cases with prednisone are not known. 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 Mylan Pharma 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 Mylan Pharma 25 mg tablets
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, menstrual suppression, sexual impotence in men, and growth retardation.
• Glaucoma, cataract, blurred vision.
• Excitability, irritability, and increased appetite.
• Muscle atrophy and muscle 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: reduction in white blood cells or increase in red blood cells.

Frequency not known (cannot be estimated from available data):

• Hiccups;
• Scleroderma renal crisis in patients already affected by scleroderma (an autoimmune disease). Signs of scleroderma renal crisis include increased arterial pressure and reduced urine output (frequency not known);
• Slow heart rate.

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 following website: 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 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 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 Mylan Pharma 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 Mylan Pharma 25 mg tablets and pack contents
White, biconvex, cylindrical tablets with a groove on one side. The groove is not intended to divide the tablet into two equal doses. Prednisone Mylan Pharma 25 mg tablets are packaged in PVC-PVDC/aluminum blisters.
Prednisone Mylan Pharma 25 mg tablets are available in packs containing 10 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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