|Medication:||Generic Prednisone||Generic Prednisone|
|Dosage:||40 mg, 20 mg, 10 mg, 5 mg||5ml|
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Name of the medicinal product
Prednisolone 20 mg, tablet secable Prednisone
Please read this leaflet carefully before taking Prednisone as it contains important information for you.
* Keep this leaflet. You might need to read it again.
- · If you have any other questions, ask your doctor or pharmacist.
- · Prelone has been prescribed to you personally. Do not give it to other people. It could be harmful to them, even if the signs of their illness are identical to yours.
- · If you experience any side effects, tell your doctor or pharmacist. This also applies to any adverse reactions that are not mentioned in this leaflet. See section 4.
What does this leaflet contain?
- 1. What is Prednisolone 20 mg, breakable tablet and what is it used for?
- 2. What information should I know before taking Prednisolone 20 mg, breakable tablet?
- 3. How to take Prednisolone 20 mg, breakable tablet?
- 4. What are the possible side effects?
- 5. How to store Prednisolone 20 mg, breakable tablet?
- 6. Contents of the package and other information.
1. WHAT IS Prednisolone 20 mg, Breakable tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Glucocorticoids - systemic use, ATC code: H02AB07 (H: Systemic non-sexual hormones).Therapeutic indications
Prelone is a corticosteroid (also called steroidal anti-inflammatory drug).
Prelone is reserved for adults and children over 6 years of age and over 20 kg.
Orapred Syrup is used in many diseases, where it is used for its anti-inflammatory effect. Its action is useful in the treatment of many inflammatory or allergic conditions.
In high doses, Prelone decreases immune reactions and is therefore also used to prevent or treat organ transplant rejection.
2. WHAT IS THE INFORMATION TO KNOW BEFORE TAKING Prednisolone 20 mg, breakable tablet?
Do not take Prednisolone 20 mg, breakable tablet :
- ·if you are allergic to prednisone or to any of the other ingredients contained in Prednisone, mentioned in section 6 ;
- *if you have an infection ;
- ·if you are currently suffering from a viral disease (viral hepatitis, chickenpox) or which may recur (herpes, shingles) ;
- ·if you have mental problems and are not being treated for them ;
- *if you need to be vaccinated with a live vaccine (for example against measles, chickenpox, yellow fever ...) ;
- ·in children under 6 years of age because they may swallow the tablet askew and choke.
Warnings and precautions
Talk to your doctor or pharmacist before taking Prednisolone.
This medication should be taken under strict medical supervision.
Before treatment, tell your doctor :
- ·if you have recently been vaccinated ;
- ·if you have a digestive ulcer, a disease of the large intestine, or if you have recently had surgery for a bowel problem ;
- ·if you have diabetes (too high a blood sugar level), or high blood pressure ;
- ·if you have an infection (especially if you have had tuberculosis) ;
- ·if your kidneys or liver are not working properly ;
- ·if you suffer from osteoporosis (bone disease with bone fragility) and myasthenia gravis (muscle disease with muscle fatigue) ;
- ·if you have stayed in the tropics, subtropics or the south of Europe, due to the risk of parasitic disease ;
- ·if you have an adrenal gland disease called Cushing's Syndrome ;
- · if you have kidney problems or a high level of uric acid in your blood before starting treatment with Prednisolone. You should inform your doctor if you have symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, loss of vision or visual disturbances, shortness of breath, seizures, irregular heartbeat or kidney failure (decreased urine output or darkening of the urine) in case you suffer from a hematological malignancy (see section 4 "What are the possible side effects").
Talk to your doctor before taking Prednisolone if you suffer from :
- *scleroderma (also known as systemic sclerosis, an autoimmune disorder), as daily doses of 15 mg or more can increase the risk of developing a serious complication called scleroderma kidney crisis. The signs of a scleroderma kidney attack are, among other things, an increase in blood pressure and a decrease in urine production. Your doctor may advise you to have your blood pressure and urine checked regularly.
During and after treatment :
- *Tell your doctor immediately if you feel pain in the tendons (recognizable by pain during movements). Indeed, Prelone can promote the appearance of tendon involvement or even exceptionally a tendon rupture.
- · Prelone can also lead to the occurrence of seizures related to the presence of pheochromocytoma (tumor of the adrenal glands) and which can endanger your life.
- *Avoid contact with people with chickenpox or measles, these diseases can be particularly serious in patients treated with Prednisolone.
- *Tell the doctor that you are taking or that you have taken Prednisone (for one year after stopping treatment) if you need to have surgery or if you are in a stressful situation (fever, illness).
- ·Your doctor may advise you to follow a diet, in particular low in salt, sugar and high in protein.
- ·If the treatment is prolonged, your doctor will also prescribe a calcium and vitamin D intake.
- · In case of prolonged treatment, the discontinuation of Prednisolone should be done gradually in order to avoid certain adverse effects.
- *Contact your doctor in case of blurred vision or other visual disturbances.
Children and adolescents
Other medicines and Prednisolone 20 mg, breakable tablet
Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking any other medication.
You should never take Prednisolone if you need to be vaccinated with a live attenuated vaccine.
Unless your doctor advises otherwise, you should not take Prednisolone at the same time as medicines containing aspirin (acetylsalicylic acid) in doses greater than or equal to 1 gram per dose and / or 3 grams per day, potent inhibitors of CYP3A, mifamurtide.
Tell your doctor if you are taking any of the following medicines :
- *Hypokalemic drugs (drugs used to lower the level of potassium in the blood) ;
- *Oral anticoagulants (drugs used to thin the blood and prevent the formation of blood clots in the circulatory system) ;
- *Enzyme-inducing anticonvulsants (drugs that can stimulate the activity of liver enzymes that are involved in metabolism, i.e. the breakdown of other drug substances) ;
- *Cobimetinib ;
- *Digoxin (medicines used to increase the strength of the contraction of the heart muscle or to regulate the heart rhythm) ;
- ·Isoniazid (anti-tuberculosis drugs) ;
- *Fluoroquinolones (medicines used to treat bacterial infections) ;
- *Aspirin (acetylsalicylic acid· in doses greater than or equal to 500 milligrams per dose and/or less than 3 grams per day ;
- ·Non-steroidal anti-inflammatory drugs (medicines used to treat pain or fever) ;
- ·Heparins ;
- *Gastrointestinal topicals, antacids and adsorbents.
Some medicines can increase the effects of Prednisolone and your doctor may want to monitor you carefully if you are taking these medicines (including some medicines to treat HIV infection: ritonavir, cobicistat).
The pharmaceutical form of Prelone is not suitable for children under 6 years of age. However, in premature infants treated with other drugs of the same class, a cardiac ultrasound should be performed to monitor the structure and function of the heart muscle. Prednisolone 20 mg, tablet that can be split with food and drinks
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Prednisone.
Use Prednisolone during the first trimester of pregnancy only after discussing with your doctor the potential benefits and risks for you and your unborn child, the different treatment options. Indeed, Prednisolone can increase the risk that a child will be born with a cleft lip and/or a cleft palate (openings or slits in the upper lip and/or the palate of the mouth).
If you are planning to become pregnant or are pregnant during treatment, talk to your doctor about using Prednisolone.
Orapred Syrup passes into breast milk. Therefore, breastfeeding is not recommended during treatment.
Driving vehicles and using machines
Prednisolone 20 mg, breakable tablet contains
3. HOW TO TAKE Prednisolone 20 mg, breakable tablet?
Always take Prednisone exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Prelone is reserved for adults and children over 6 years of age and over 20 kg. In children under 6 years of age and weighing less than 20 kg, there are more suitable forms.
The dose to be used is determined by your doctor, depending on your weight and the disease being treated. It is strictly individual.
The dosage of Prednisolone 20 mg is suitable if you are starting a treatment or if you need to take this treatment for a short time requiring medium or high doses.
If you need to take this treatment for an extended period of time and in doses of less than 20 mg per day, there are more appropriate dosages.
Method of administration
Prelone is used orally.
Swallow the tablets with a little water, preferably with a meal, in one dose in the morning.
Duration of treatment
It is determined by your doctor.
It is very important to follow the treatment regularly and not to modify it, nor to stop it abruptly without the advice of your doctor.
In case of prolonged treatment, follow your doctor's recommendations for decreasing doses.
If you have taken more Prednisolone 20 mg, breakable tablet than you should have
Consult your doctor or pharmacist immediately.
If you have taken more Prednisolone than you should, more serious side effects may occur, especially with regard to the endocrine system (hormone production system), metabolism and electrolyte balance.
If you forget to take Prednisolone 20 mg, breakable tablet
To be effective, Orapred Syrup must be used regularly. However, if you forget to take a dose, continue treatment as normal.
If you stop taking Prednisolone 20 mg, breakable tablet
After prolonged use of Prednisolone, if your treatment should be stopped, follow the advice of your doctor. Your doctor may ask you to gradually reduce the amount of medication you are taking until you stop taking it completely.
Abrupt cessation of treatment can lead to :
- corticosteroid withdrawal syndrome (see section 4),
- acute adrenocortical insufficiency (low cortisol level) or,
- there could be a recurrence (return) or a worsening of the underlying disease being treated.
If you have any further questions about the use of Prednisone, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE UNDESIRABLE EFFECTS?
Like all medicines, Prednisone can cause side effects, but not everybody gets them.
Prelone, essential for your health, is most often well tolerated when following the recommendations and in particular the diet low in salt, sugar and high in protein (see also the paragraph "Warnings and Precautions").
Nevertheless, it can lead, depending on the dose and the duration of the treatment, to more or less bothersome effects.
- Serious allergic reactions that may include heart rhythm disturbances, difficulty breathing, hypotension or hypertension, sudden and rapid drop in blood pressure, cardiac arrest, skin rashes, decreased ability of the body to defend itself against infections (which may lead to the recurrence of an existing infection or increase the risk of serious complications after vaccination) ;
- increase in the number of white blood cells in the blood ;
- loss of self-regulation of the hormone production system by the brain ;
- *a change in some of the results of your analyzes (salt, sugar, potassium) that may require a diet or additional treatment ;
- * disorder of the acid-base balance of the blood ;
- *an appearance of bruises or small red spots on the skin ;
- *a rise in blood pressure, water and salt retention that can lead to heart failure ;
- * inability of the heart to pump blood from the rest of the body (congestive heart failure) ;
- *mood disorders (excitement, euphoria), sleep disorders (frequent) ;
- * serious disorder of the mental state that can manifest itself in a loss of contact with reality, disorganization of thinking, discourses and delusions (psychosis) ;
- ·a set of disorders called Cushing's syndrome recognizable by weight gain, swelling and redness of the face, excessive hair development ;
- * decreased glucose tolerance, diabetes ;
- *bone fragility (osteoporosis, fractures) ;
- *painful damage to the bones in the hip joint (osteonecrosis).
- *insufficient production of hormones by the gland located above the kidneys (adrenal gland) ;
- *a growth retardation in the child ;
- *menstrual disorders ;
- * inability to have or maintain an erection (impotence) and decreased libido in men ;
- *muscle weakness, tendon rupture especially if Prednisolone is combined with certain antibiotics (fluoroquinolones) ;
- *digestive disorders: digestive ulcer, bleeding and digestive perforations, inflammation of the pancreas especially in children ;
- *weakening of the skin, delayed healing, acne ;
- *disorientation in time and space (confusion), convulsion, depressive state at the end of treatment ;
- *vision disorders that can lead to loss of sight: blurred vision, certain forms of glaucoma (increased pressure of the fluid in the eye) and cataracts (clouding of the lens), chorioretinopathies (retinal disease), complications in patients with a corneal infection by the herpes simplex virus ;
- *endocrine disorders (hormonal disorders): occurrence of crises related to the presence of pheochromocytoma (tumor of the adrenal glands) and which can endanger your life.
- *scleroderma renal crisis in patients already suffering from scleroderma (an autoimmune disorder). The signs of a scleroderma kidney attack are, among other things, an increase in blood pressure and a decrease in urine production.
- *heart disorders: increased heart muscle volume in premature infants ;
- ·increased pressure in the brain ;
- ·increased risk of fat accumulation in the blood vessels, which can form blood clots and clog the blood vessels. Frequency unknown (frequency cannot be estimated based on available data) :
- * cases of tumor lysis syndrome have been reported in patients suffering from a hematological malignancy. Tumor lysis syndrome can be revealed by your doctor based on changes in blood tests such as an increase in uric acid, potassium or phosphorus levels and a decrease in calcium levels, and can lead to symptoms such as muscle cramps, muscle weakness, confusion, loss of vision or visual disturbances, shortness of breath, seizures, irregular heartbeat or kidney failure (decrease in the amount of urine or darkening of urine). If you experience such symptoms, you must inform your doctor immediately (see section 2 "Warnings and Precautions") ;
- *slow heartbeat ;
- ·the following side effects have been observed after abrupt discontinuation of Prednisolone following prolonged use, although not everyone suffers from them (steroid withdrawal syndrome): symptoms such as fever, loss of appetite, nausea, fatigue, restlessness, joint pain, peeling of the skin, low blood pressure and weight loss.
Declaration of side effects
If you experience any side effects, tell your doctor or pharmacist. This also applies to any adverse reactions that are not mentioned in this leaflet.
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE Prednisolone 20 mg, breakable tablet?
Keep Prednisone out of the sight and reach of children.
Do not use Prednisone after the expiration date indicated on the package. The expiration date refers to the last day of this month.
Prelone does not require special storage precautions.
Do not throw any medicine down the drain or with household waste. Ask your pharmacist to dispose of medicines that you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Prednisolone 20 mg, breakable tablet contains
·The active substance is : Prednisone 20 mg
For a breakable tablet.
·The other components are : Microcrystalline cellulose, pregelatinized starch, magnesium stearate, povidone K90.
What is Prednisolone 20 mg, breakable tablet and contents of the pack
Prelone is available in the form of a breakable tablet. Box of 20, 28, 30 or 100.
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About America’s Essential Hospitals
America’s Essential Hospitals is the leading association and champion for hospitals dedicated to equitable, high-quality care for all, including those who face social and financial barriers to care. Since 1981, America’s Essential Hospitals has advanced policies and programs that promote health, health care access, and equity.