Prednisone Teva

Patient Information Leaflet

Prednisone Teva 5 mg Tablets

Generic Medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

1. What Prednisone Teva 5 mg tablets are and what they are used for
2. What you need to know before taking Prednisone Teva 5 mg tablets
3. How to take Prednisone Teva 5 mg tablets
4. Possible side effects
5. How to store Prednisone Teva 5 mg tablets
6. Contents of the pack and other information

1. What Prednisone Teva 5 mg Tablets are and what they are used for

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

• Acute and chronic rheumatic, muscular and joint diseases
• Bronchial asthma and pulmonary fibrosis
• Ulcerative colitis (inflammatory bowel disease)
• Hepatitis
• Addison's disease
• Adrenogenital syndrome
• Kidney and urinary tract diseases
• Allergic and inflammatory skin diseases
• Haemolytic anaemia
• Agranulocytosis (deficiency of white blood cells in the blood)
• Rheumatic purpura
• Acute leukaemia and other haematological disorders
• Certain inflammatory eye diseases (allergic conjunctivitis, keratitis, choroidoretinitis, iritis, iridocyclitis)

2. What you should know before taking Prednisone Teva 5 mg tablets

Do not take Prednisone Teva 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 you are due 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
Talk to your doctor or pharmacist before taking Prednisone Teva 5 mg tablets.

• If you have the following risk factors for osteoporosis: family history, aging, post-menopausal status, smoking, and lack of significant physical activity, as treatment with prednisone may cause loss of bone tissue
• During prolonged treatment with prednisone, your doctor may prescribe potassium supplements and suggest reducing your sodium intake
• In case of severe heart failure, careful medical monitoring is required
• 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 insufficiency (especially 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 considered especially in children with reduced immune defenses and in adults who have never had measles or chickenpox
• In children, prolonged treatment may cause damage to the pancreas
• The product contains a component that may cause positive results in anti-doping tests
• Prednisone may alter the results of skin allergy tests

Other medicines and Prednisone Teva 5 mg tablets
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), 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
• Prednisone may alter the effect of cyclophosphamide if taken simultaneously

Some medicines may increase the effects of Prednisone Teva, 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, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Prednisone Teva 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 your doctor. Your doctor will advise you whether to discontinue breastfeeding or stop treatment with prednisone.
Driving and using machines
It should be borne in mind that long-term treatments may reduce visual acuity, which could negatively affect your ability to drive safely in traffic.
Prednisone Teva 5 mg tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Use in athletes
Please note that the product contains a component that may cause positive results in anti-doping controls.

3. How to take Prednisone Teva 5 mg tablets

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Remember to take your dose.
The tablets should be taken whole with a sufficient amount of liquid. The total daily
dose should be divided into three or four administrations, taken during or after meals. In some cases, the prescribed
dose may be taken as a single daily dose, during or after breakfast. Sometimes, particularly in
children, and only if advised by the doctor, treatment should be taken on alternate days.
Your doctor will determine the dose best suited to your individual needs.
Prednisone Teva 5 mg tablets 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 of the duration of treatment with Prednisone Teva 5 mg tablets.
Do not stop treatment abruptly or before the scheduled end date; doing so could worsen your
condition. If you feel that the effect of Prednisone Teva 5 mg tablets 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 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 response is 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, the same approach applies, but the initial dose in severe cases ranges from 15 to 60 mg.
In the case of adjunctive treatment for organ transplantation, recommended daily doses may vary, depending on the organ involved, between 30 and 300 mg.

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

If you take more Prednisone Teva 5 mg tablets than you should
Acute intoxication with prednisone has not been reported. In case of overdose, the adverse reactions 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 Teva 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 normal.

If you stop taking Prednisone Teva 5 mg tablets
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

• In long-term treatments: abdominal and facial obesity ("moon face"), increased blood sugar levels, loss of bone tissue (osteoporosis), increased blood pressure, excessive hair growth, acne, menstrual suppression, sexual impotence in men, and growth delay.
• Glaucoma, cataract
• 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.

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.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 Teva 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 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 Teva 5 mg tablets contain

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

Description of the appearance of Prednisone Teva 5 mg tablets and package contents
White, cylindrical tablets with a break line on one side and the imprint “PD5” on the white side of the tablet. The break line is not intended to divide the tablet into two equal doses.
Prednisone Teva 5 mg tablets are packaged in PVC-PVDC/aluminum blisters.
Prednisone Teva 5 mg tablets are available in packages containing 10, 20 and 30 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l
Piazzale Luigi Cadorna, 4
20123 - 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 Teva 25 mg tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

1. What Prednisone Teva 25 mg tablets are and what they are used for
2. What you need to know before taking Prednisone Teva 25 mg tablets
3. How to take Prednisone Teva 25 mg tablets
4. Possible side effects
5. How to store Prednisone Teva 25 mg tablets
6. Contents of the pack and other information

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

Prednisone is a corticosteroid (glucocorticoid) derived from cortisone. It is involved in the regulation of many metabolic processes in the body.
Prednisone Teva 25 mg tablets is 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 diseases
• Hemolytic anemia
• Agranulocytosis (deficiency of white blood cells in the blood)
• Rheumatic purpura
• Acute leukemia and other hematological disorders
• Certain inflammatory eye diseases (allergic conjunctivitis, keratitis, choroiditis, iritis, iridocyclitis)
• As an adjunct in organ transplant therapy.

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

Do not take Prednisone Teva 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 Teva 25 mg tablets.

• If you have the following risk factors for osteoporosis: family predisposition, aging, post-menopause, smoking, and lack of significant physical activity, as treatment with prednisone may cause loss of bone tissue
• 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 is required
• Lower than recommended doses may be sufficient in case of poor thyroid function (hypothyroidism) or hepatic cirrhosis
• After a long period of treatment, if you need to stop or discontinue prednisone treatment, you may experience a relapse of the underlying disease, 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 considered especially in children with reduced immune defenses and in adults who have never had chickenpox or measles
• In children, prolonged treatment may induce pancreatic damage
• The product contains a component that may lead to positive results in anti-doping tests
• Prednisone may alter the results of skin allergy tests

Other medicines and Prednisone Teva 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 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), the risk of gastrointestinal bleeding may increase
• The effects of muscle relaxants may be enhanced if taken together with prednisone
• Prednisone must not be taken in combination with cyclosporine, as their activities mutually inhibit each other
• Prednisone may alter the effect of cyclophosphamide if taken simultaneously.

Some medicines may increase the effects of Prednisone Teva, 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 to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
You must not take Prednisone Teva 25 mg tablets during pregnancy unless prescribed by your doctor.
If symptoms of acute-onset diseases such as infectious diseases, digestive 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 stop breastfeeding or discontinue prednisone treatment.
Driving and using machines
You should be aware that long-term treatment may reduce visual acuity, which could negatively affect your ability to drive safely in traffic.
Prednisone Teva 25 mg tablets contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Use in athletes
Please note that the product contains a component that may lead to positive results in anti-doping tests.

3. How to take Prednisone Teva 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. Occasionally, particularly in
children, and only if advised by the doctor, treatment should be taken on alternate days.
Your doctor will determine the dose best suited to your individual needs.
Prednisone Teva 25 mg tablets 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 of the duration of treatment with Prednisone Teva 25 mg tablets.
Do not stop treatment suddenly or before the planned date; doing so could worsen your
condition. If you feel that the effect of Prednisone Teva 25 mg tablets is too strong or too
weak, discuss this with your doctor.
The recommended dose is:
Adults
The dose of treatment 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 response is achieved, the doctor will gradually reduce the prednisone dose until reaching the maintenance dose, which usually ranges between 5 and 10 mg per day.
In bronchial asthma, the same approach is followed, 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 of body weight/day.
If you take more Prednisone Teva 25 mg tablets than you should
Acute poisoning cases with prednisone are not known. In case of overdose, the adverse reactions described in this leaflet are expected to occur, but with greater intensity. Overdose may cause excitement, anxiety, depression, mental confusion, gastrointestinal bleeding, increased blood pressure and blood sugar levels, as well as fluid retention (edema).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately.
If you forget to take Prednisone Teva 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 Teva 25 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 levels, loss of bone tissue (osteoporosis), increased blood pressure, excessive hair growth, acne, menstrual irregularities, sexual impotence in men, and growth delay.
• Glaucoma, cataract
• 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: reduced white blood cell count or increased red blood cell count.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 Teva 25 mg tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prednisone Teva 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 Teva 25 mg tablets and pack contents
White, oval-shaped tablets.
Prednisone Teva 25 mg tablets are packaged in PVC-PVDC/aluminum blisters.
Prednisone Teva 25 mg tablets are available in packs containing 10 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l
Piazzale Luigi Cadorna, 4 - 20123 - Milan
Italy

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