Prednisolone Cortico 5mg 30 tablets

Pack

30

Prednisolone Cortico 5 mg tablets Prednisolone / Prednisolone Read the entire package 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 further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. The package leaflet contains: 1. What Prednisolone Cortico is and what it is used for 2. What you need to know before you take Prednisolone Cortico 3. How to take Prednisolone Cortico 4. Possible side effects 5. How to store Prednisolone Cortico 6. Contents of the pack and other information 1. What Prednisolone Cortico is and what it is used for The active substance in this product is Prednisolone. It belongs to a group of medicines called corticosteroids. They are analogues of hormones called glucocorticosteroids and are secreted by the adrenal cortex. Prednisolone has a strong anti-inflammatory and anti-allergic effect, which positively affects a number of diseases and conditions caused by inflammation and allergies. Prednisolone Cortico is used to treat rheumatic diseases (e.g., rheumatoid arthritis, juvenile arthritis, etc.), connective tissue diseases (lupus, including systemic lupus erythematosus, dermatomyositis), allergic diseases, including drug-induced allergies, bronchial asthma, skin and eye diseases, some blood system diseases, ulcerative colitis and Crohn's disease (inflammation of the large intestine associated with ulcer formation, characterized by severe and persistent bloody diarrhea and spasms), and others. It is also used in patients where the adrenal glands produce insufficient amounts of hormones (glucocorticosteroids) for various reasons, requiring them to be taken as medication. 2. What you need to know before you take Prednisolone Cortico Do not take Prednisolone Cortico - If you are allergic (hypersensitive) to prednisolone or any of the other ingredients of this product; - If you have severe infections affecting the whole body; - If you currently have a herpes infection affecting your eyes. Warnings and precautions Talk to your doctor or pharmacist before taking Prednisolone Cortico. Pay special attention when taking Prednisolone Cortico Side effects associated with the use of prednisolone can be avoided or reduced by taking the lowest effective dose that achieves the therapeutic effect in the shortest possible time. Your doctor will determine the appropriate dosage and duration of treatment for you. Follow your doctor's instructions strictly, do not change the dosage prescribed by your doctor without consulting them. It is important to know that: - You should not stop taking this medicine suddenly, as this may lead to worsening of your condition and/or recurrence of the disease; - Normal secretion of hormones from the adrenal gland is suppressed by long-term treatment. In order for the adrenal gland to restore its function and meet the body's usual needs, the daily dose is gradually reduced. Your doctor will give you specific instructions on how to do this, taking into account the duration of treatment and the dose received. Corticosteroids can mask some signs of infection, and new infections caused by fungi, viruses, or bacteria may develop during treatment with them. Chickenpox (varicella) can be very severe and cause serious complications in immunocompromised individuals, including those taking corticosteroids for a long period (these products suppress immunity). Therefore, it is important to avoid contact with patients with chickenpox or herpes zoster; it is recommended to administer immunoglobulin to protect the body. It is important to note that if you contract chickenpox while taking this product, treatment with this product should not be stopped, and in some cases, the dose may need to be increased. For the same reasons, you should also avoid contact with people who have measles (morbilli). Live vaccines should be avoided. If necessary, consult a specialist. If corticosteroid treatment is necessary in patients with latent tuberculosis or a positive tuberculin test, strict medical supervision is required to prevent reactivation of the disease. When taking digoxin, increased control and periodic medical supervision are necessary, as corticosteroids disrupt water-salt balance and cause potassium loss. Special caution is required when treating with this product if you have: - Osteoporosis (decreased bone density and increased risk of fractures); - High blood pressure, heart failure (heart disease causing fatigue, shortness of breath, swelling of the ankles), recent myocardial infarction; - Diabetes mellitus; - Glaucoma (increased intraocular pressure); - Liver (including cirrhosis), kidney, stomach and intestinal diseases (especially stomach ulcers); - Epilepsy; - Myasthenia gravis. Inform your doctor before starting treatment if you have a history of tuberculosis, mental illness, frequent vein inflammation, 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 renal crisis in scleroderma include increased blood pressure and decreased urine output. Your doctor will regularly monitor your blood pressure and perform urine analysis. It is important to know and also inform your loved ones that mental disorders may occur during corticosteroid treatment. This most often manifests within a few days to a few weeks after starting treatment. Most of these disappear completely after dose reduction or discontinuation of treatment. However, this is a necessary reason to stop treatment. If you experience thoughts of depression, anxiety, insomnia, lack of motivation, self-harm, you should immediately share this with your loved ones and consult your doctor. Corticosteroids can cause growth retardation in children and adolescents, so treatment should be limited to the minimum possible dose and shortest duration. In elderly patients, some side effects (osteoporosis, diabetes, high blood pressure, susceptibility to infections) may occur more frequently and may have a more serious course, requiring close medical monitoring. Prednisolone Cortico and other medicines Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Seizures have been reported with the simultaneous administration of prednisolone and cyclosporine. Rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, primidone, and aminoglutethimide may increase the breakdown of corticosteroids in the liver and reduce their therapeutic effect. Cimetidine, erythromycin, ketoconazole, itraconazole, diltiazem, and mibefradil may reduce the rate of corticosteroid breakdown in the liver and thus increase their blood concentration. Corticosteroids may reduce the effect of the following medicines: - Medicines for diabetes, including insulin; - Medicines for high blood pressure - Diuretics (medicines for swelling, which increase urine output); Corticosteroids may increase the effect of the following medicines: - Coumarin anticoagulants (medicines used to reduce blood clotting), requiring intensive monitoring of prothrombin time and other laboratory parameters; - Medicines containing salicylates (in some cases, intoxication may develop). Taking Prednisolone Cortico with food and drinks Grapefruit (juice and fruit) should not be consumed during treatment with this product, as it increases the breakdown of the product by the liver and can lead to a decrease in its concentration in the blood. Pregnancy and breastfeeding Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy Prednisolone crosses the placental barrier. It is known that all products of the corticosteroid group can cause congenital defects in animals – closure of the hard palate, growth retardation, negative impact on brain growth and development. There is insufficient evidence that corticosteroids cause similar effects in humans, but their use during pregnancy is only possible after the doctor has determined that the benefit to the mother outweighs the potential risk to the fetus and newborn. Breastfeeding Corticosteroids are excreted in small amounts in breast milk. During breastfeeding, corticosteroids should not be used unless the doctor assesses that the benefit to the mother outweighs the potential risk to the child. Ability to drive and use machines There is no evidence of side effects affecting the ability to drive and use machines. 3. How to take Prednisolone Cortico Always take Prednisolone Cortico exactly as your doctor has told you. If you are unsure about anything, ask your doctor or pharmacist. Adults The recommended daily starting dose is usually 5 to 60 mg (1-30 tablets), depending on the type of disease. The daily dose is usually taken in several divided doses, and in so-called pulse therapy, the daily dose is doubled and taken once in the morning, usually at 8:00 AM, every other day. During long-term treatment, the daily dose may be temporarily increased before stress, any infection, or impending surgery, as well as during exacerbations of the disease. The daily dose, method of administration, and frequency, and duration of treatment will be determined by your doctor based on the type, severity, and course of the disease. Side effects can be limited by using the lowest effective dose for the shortest possible time. In most cases, treatment starts with a higher dose, which can be reduced or increased after 3-7 days depending on the therapeutic effect achieved. After determining the lowest effective dose, treatment continues for various periods depending on the type and course of the disease. As soon as the desired therapeutic effect is achieved, the daily dose should be gradually reduced for acute diseases (asthma, acute eye inflammation, etc.) until complete cessation of treatment, or for chronic diseases, until the lowest effective maintenance dose is reached (rheumatoid arthritis, lupus, etc.). For reference, the generally recommended daily doses commonly used to start treatment for some more common conditions are given below. Allergic and skin diseases - starting daily dose 5-15 mg (1-3 tablets). Systemic connective tissue diseases, so-called collagenoses - starting daily dose 20-30 mg (4-6 tablets). Rheumatoid arthritis - usual starting daily dose is 10-15 mg per day (2-3 tablets). Blood diseases and lymphoma - starting daily dose is 15-60 mg (3-12 tablets). Children In children, the dose is determined by the doctor's decision, who can adjust it according to the effect achieved. If possible, the daily dose should be administered once every other day, and treatment should be carried out with the lowest dose for the shortest time. Elderly patients When determining the daily dose, method of administration, and duration, it should be taken into account that side effects of the drug in adults are more frequent and serious. The tablet can be divided into two equal doses. If you take more Prednisolone Cortico than you should No specific symptoms are observed in acute overdose of prednisolone. In case of chronic overdose, so-called "cushingoid symptoms" are observed – accumulation of fatty tissue in the face, abdomen, and hips, appearance of stretch marks, redness of the cheeks, etc. If you forget to take Prednisolone Cortico If you miss a dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose. Take the next dose at the usual time. If you want to stop taking Prednisolone Cortico Do not stop using the product even if you feel better, until your doctor tells you to. Remember that stopping treatment always involves gradually reducing the daily dose received. If you suddenly stop taking the product, a so-called withdrawal syndrome may develop (see section on side effects). If you have any questions about the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. The following side effects may occur: Gastrointestinal disorders Heartburn, nausea, bloating, stomach and esophageal ulcers, thrush on the tongue and esophagus, acute pancreatitis, stomach bleeding. Laboratory abnormalities Increase in liver enzymes and alkaline phosphatase. Immune system disorders Increased susceptibility to infections and their more severe course, reactivation of latent ("sleeping") tuberculosis. Musculoskeletal disorders Osteoporosis, spontaneous fractures of the spine and long bones, muscle weakness, muscle damage, tendon rupture. Water-electrolyte balance disorders Sodium and water retention, potassium loss, changes in acid-base balance. Skin and subcutaneous tissue disorders Reduced, delayed wound healing, thinning of the skin, tendency to injury, formation of stretch marks, dilation of blood vessels, acne, petechial hemorrhages. Endocrine gland and metabolism disorders Suppression of adrenal gland function, growth arrest in newborns, children and adolescents, menstrual irregularities up to complete absence of the monthly cycle, worsening of diabetes mellitus or its manifestation, increased blood sugar levels and the need for higher doses of diabetes medications; infrequent – accumulation of fatty tissue in the face and redness of the cheeks (so-called Cushingoid face), hair loss, weight gain, increased appetite. Nervous system disorders and mental disorders Irritability, euphoria, depression, mood swings, thoughts of self-harm, hallucinations, behavioral disorders, excitability, restlessness, sleep disturbances, seizures, confusion and memory loss. The incidence of severe reactions in adults reaches 5-6%. Reports of increased intracranial pressure in children after discontinuation of prednisone have been documented. Eye disorders Increased intraocular pressure, glaucoma, thinning of the cornea and sclera, exacerbation of viral or fungal eye infections, swelling of the eyeball with possible damage to the optic nerve, permanent irreversible exophthalmos. Cardiovascular disorders Congestive heart failure (a heart condition that can cause fatigue, shortness of breath, swelling of the ankles, etc.), increased blood pressure, bradycardia. Kidney and urinary tract disorders Renal crisis in patients with scleroderma (autoimmune disease) who already have scleroderma. Signs of renal crisis in scleroderma include increased blood pressure and decreased urine output. General disorders Leukocytosis, hypersensitivity reactions, including anaphylaxis, thrombosis, weakness, persistent hiccups with high-dose treatment. Withdrawal symptoms Upon sudden discontinuation of treatment (withdrawal syndrome), rapid dose reduction during long-term treatment can lead to acute adrenal insufficiency, significant drop in blood pressure, and death. Fever, joint and muscle pain, runny nose, conjunctivitis, painful, itchy skin nodules, and weight loss can also occur with "withdrawal syndrome." Reporting of suspected side effects If you notice any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Prednisolone Cortico Store at a temperature not exceeding 25°C. Keep out of reach of children. Do not use Prednisolone Cortico after the expiry date indicated on the cardboard box. The expiry date refers to the last day of that month. Tablets should not be taken if you notice any external changes. Medicines should not be disposed of in drains or household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Prednisolone Cortico contains Active substance per tablet: Prednisolone 5 mg. Excipients: Lactose monohydrate, corn starch, magnesium stearate. Appearance of Prednisolone Cortico and contents of the pack Prednisolone Cortico tablets are white, round, flat tablets, 7 mm in diameter, with a dividing score on one side. 10 (ten) or 20 (twenty) tablets are packed in a PVC/AL foil blister. 10 (ten) or 20 (twenty) tablets are packed in a PVC/PVdC/AL foil blister. 1 (one) blister with 20 tablets is placed in a cardboard box. 3 (three) blisters with 10 tablets are placed in a cardboard box. See also: Prednisolone - Prednisolone 5mg 28 tablets