PREDNISONE 5 mg Коированная Таблетка

Содержание инструкции

1. Prednisone Pharmacare 5 mg tablets
   1. What is Prednisone Pharmacare 5 mg tablets and what it is used for
   2. What you need to know before taking Prednisone Pharmacare 5 mg tablets
   3. How to take Prednisone Pharmacare 5 mg tablets
2. 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 Pharmacare 5 mg tablets
   3. Contents of the pack and other information
3. Prednisone Pharmacare 25 mg tablets
   1. What is Prednisone Pharmacare 25 mg tablets and what is it used for
   2. What you need to know before taking Prednisone Pharmacare 25 mg tablets
   3. How to take Prednisone Pharmacare 25 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 Pharmacare 25 mg tablets
   3. Contents of the pack and other information

Prednisone Pharmacare 5 mg tablets

Equivalent 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 could beharmful.
• If you get any side effects, even those not listed inthis leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• Rheumatic muscular and joint diseases, acute and chronic
• 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 Pharmacare 5 mg tablets

Do not takePrednisone Pharmacare 5 mg tablets:

• if you are allergic to prednisone or to any of the other ingredients of this medicine (listed in section 6)
• 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 medicines 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 Pharmacare 5 mg
tablets:

• if you have the following risk factors for osteoporosis: family history, aging, post-menopause, smoking and insignificant physical activity, as treatment with prednisone may induce bone loss
• in prolonged treatment with prednisone, your doctor may prescribe potassium supplements and suggest a reduction in sodium intake
• in case of severe heart failure, careful medical monitoring is required
• in case of poor thyroid function (hypothyroidism) or liver cirrhosis, lower doses than recommended may be sufficient
• after a long period of treatment, if you need to stop or 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 adults who have suffered from measles or chickenpox
• in children, prolonged treatment may induce damage to the pancreas. Prednisone may alter the results of skin allergy tests.
• in children, prolonged treatment may induce damage to the pancreas
• the medicine contains a component that may induce a positive result in doping control analyses.
• prednisone may alter the results of skin allergy tests.
• 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.

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

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

• Rifampicin, phenytoin, carbamazepine and barbiturates may reduce the effect of prednisone. Erythromycin and ketoconazole may increase it.
• Contraceptives containing estrogens may increase the effect of prednisone
• Antacids (aluminum, magnesium) may reduce absorption and therefore may reduce the effectiveness of prednisone
• If prednisone is taken simultaneously with medicines to treat diabetes, the effect of the latter on blood sugar levels may be lower
• 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 rheumatic agents (indometacin, acetylsalicylic acid) you may increase the risk of gastrointestinal bleeding
• The effects of medicines that relax muscles may be increased if taken in association with prednisone
• Prednisone should not be taken in association with cyclosporine as their activity is mutually inhibited
• If taken simultaneously, prednisone may alter the effect of cyclophosphamide

Some medicines may increase the effects of Prednisone Pharmacare 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

Pregnancy

If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
You should not take Prednisone Pharmacare 5 mg tablets during pregnancy unless
prescribed by your doctor.
If symptoms of acute onset diseases, such as
infectious diseases, digestive diseases or psychiatric alterations, occur during treatment, consult your doctor.

Breastfeeding
Taking prednisone is not recommended during breastfeeding unless prescribed by your doctor. Your doctor will tell you whether to stop breastfeeding or discontinue
treatment with prednisone.

Driving and operating machinery
It should be taken into consideration that long-term treatments may reduce visual
acuity, which may have adverse effects on the ability to drive safely in
traffic.

Use in athletes
Note that the medicine contains a component that may induce a positive result in
doping control analyses.
Prednisone Pharmacare contains sodium. This medicine contains less than 1 mmol (23
mg) of sodium per dose, i.e. essentially “sodium-free”.
Prednisone Pharmacare 5 mg tablets contains lactose. If your doctor has diagnosed
you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Prednisone Pharmacare 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 recommended by the doctor, the treatment
must be taken on alternate days.
The doctor will decide the dose that will be most suitable for your needs.
Prednisone Pharmacare 5 mg tablets must not be stopped abruptly; the dosage
must, in fact, be reduced gradually.
In general, the maintenance dose should always be the lowest possible.
The doctor will tell you the duration of treatment with Prednisone Pharmacare 5 mg tablets.
Do not interrupt treatment abruptly or before the scheduled date; this could
worsen your condition. If you feel that the effect of Prednisone Pharmacare 5 mg
tablets is too strong or too weak, talk to your doctor.
The recommended dose is:

Adults
The dose for 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 the maintenance dose is reached, which usually varies between 5 and 10
mg per day.
In bronchial asthma, proceed in the same way but the initial dose in severe cases is between 15
and 60 mg.
In the case of adjuvant treatments for organ transplantation, the recommended daily doses
may vary, depending on the organ involved, between 30 and 300 mg.

Children
In general, treatment with prednisone in children can be administered on alternate
days or intermittently. The recommended initial doses are 1-3 mg of

prednisone per kilogram of body weight per day. The maintenance dose is 0.25 mg of

prednisone/kg of body weight/day.

If you take more Prednisone Pharmacare 5 mg tablets than you should
No cases of acute intoxication with prednisone are known. In case of overdose, you may
experience increased intensity. Overdosage can induce excitement, anxiety, depression, confusion
mental, 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 Pharmacare 5 mg tablets
Do not take a double dose to make up for the missed dose. Wait for the next
dose and follow the treatment as normal.

If you stop taking Prednisone Pharmacare 5 mg tablets
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• In long-term treatments, abdominal and facial obesity (moon face), increased blood sugar, bone loss (osteoporosis), increased blood pressure, hair growth, acne, suppression of menstruation, sexual impotence in men and delayed growth
• Glaucoma, 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 be more vulnerable to them
• Blood changes: reductions in white blood cells or increases in red blood cells.
• With unknown frequency: 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
• With unknown frequency: hiccups.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.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 Pharmacare 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 package after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist
how to eliminate the medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Prednisone Pharmacare 5 mg tablets contains

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

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Pharmacare S.r.l.
Via Marghera, 29

• 20149 – Milan Italy

Manufacturer
CYNDEA PHARMA S.L
Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31 42110 Ólvega
(Soria) Spain
Special Product's Line S.P.A., 7
via Fratta Rotonda Vado Largo, 1

• 03012 - Anagni (FR), Italy

Prednisone Pharmacare 25 mg tablets

Equivalent medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others,even if their symptoms are the same as yours, as it could beharmful.
• If you get any side effects, even those not listed inthis leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Prednisone Pharmacare 25 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 Pharmacare 25 mg tablets is used in the treatment of:

• rheumatic muscular and joint diseases, acute and chronic
• 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 Pharmacare 25 mg tablets

Do not take Prednisone Pharmacare 25 mg tablets:

• if you are allergic to prednisone or to any of the other ingredients of this medicine (listed in section 6)
• 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 medicines 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 Pharmacare 25 mg
tablets:

• if you have the following risk factors for osteoporosis: family history, aging, 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 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 insufficiency (especially if you have an infection or after an accident), or cortisone withdrawal syndrome
• chickenpox or measles may be particularly severe in patients treated with glucocorticoids. This must be taken into consideration in particular in children with reduced defenses and in adults who have suffered from measles or chickenpox
• in children, prolonged treatment may induce pancreatic damage
• prednisone may alter the results of skin allergy tests.
• the medicine contains a component that may induce a positive result in anti-doping tests.
• prednisone may alter the results of skin allergy tests.
• 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.

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

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

• Rifampicin, phenytoin, carbamazepine and barbiturates can reduce the effect of prednisone. Erythromycin and ketoconazole can 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 lower
• If you take coumarin derivatives (medicines to control blood coagulation), the administration of prednisone may reduce their anticoagulant effect
• If you take prednisone and digitalis agents, diuretics or amphotericin B at the same time, potassium levels may be altered
• If you take prednisone and non-steroidal anti-inflammatory drugs or rheumatic agents (indometacin, acetylsalicylic acid) may increase the risk of gastrointestinal bleeding.
• The effects of medicines that relax muscles may be increased if taken in combination with prednisone.
• Prednisone should not be taken in combination 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 Pharmacare and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
You should not take Prednisone Pharmacare 25 mg tablets during pregnancy unless
prescribed by your doctor.
If symptoms of acute-onset diseases, such as
infectious diseases, digestive diseases or psychiatric alterations, occur during treatment, consult your doctor.

Breastfeeding
Taking prednisone is not recommended during breastfeeding unless prescribed by your doctor. Your doctor will tell you whether to stop breastfeeding or discontinue
treatment with prednisone.

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

Use in athletes
Please note that the medicine contains a component that may induce a positive result in
anti-doping control tests.
Prednisone Pharmacare contains sodium. This medicine contains less than 1 mmol (23
mg) of sodium per dose, i.e. essentially sodium-free.
Prednisone Pharmacare 25 mg tablets contains lactose. If your doctor has diagnosed
you with intolerance to some sugars, contact him before taking this medicine.

3. How to take Prednisone Pharmacare 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 recommended by the doctor, the treatment
must be taken on alternate days.
The doctor will decide the dose that will be most suitable for your needs.
Prednisone Pharmacare 25 mg tablets must not be stopped abruptly; the dosage
must, in fact, be reduced gradually.
In general, the maintenance dose must always be the lowest possible.
The doctor will tell you the duration of treatment with Prednisone Pharmacare 25 mg tablets.
Do not interrupt treatment abruptly or before the scheduled date; this could
worsen your condition. If it seems to you that the effect of Prednisone Pharmacare 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 the maintenance dose is reached, 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 Pharmacare 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 Pharmacare 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 Pharmacare 25 mg tablets
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• In long-term treatments, abdominal and facial obesity (moon face), increased blood sugar, bone loss (osteoporosis), increased blood pressure, hair growth, acne, suppression of menstruation, sexual impotence in men and delayed growth
• Glaucoma, 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 be more vulnerable to them
• Blood changes: reductions in white blood cells or increases in red blood cells
• With unknown frequency: 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
• With unknown frequency: hiccups.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 Pharmacare 25 mg tablets

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is 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 Pharmacare 25 mg tablets contains

• 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 Pharmacare 25 mg tablets and contents of the pack
Cylindrical, biconvex tablets, with a groove on one side, white.
Prednisone Pharmacare 25 mg tablets are packaged in PVC-PVDC/aluminum blisters.
Prednisone Pharmacare 25 mg tablets are available in packs containing 10 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Pharmacare S.r.l.
Via Marghera, 29 20149 – Milan Italy

Manufacturer
CYNDEA PHARMA S.L
Polígono Industrial Emiliano Revilla Sanz, Avenida de Ágreda, 31 42110 Ólvega
(Soria) Spain
Special Product's Line S.P.A., 7
via Fratta Rotonda Vado Largo, 1

• 03012 - Anagni (FR), Italy