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Methylprednisolone Cortico 16 mg. 20 tablets

Product Code: Methylprednisolone Cortico 16 mg. 20 tablets
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What Methylprednisolone Cortico is and what it is used for
Methylprednisolone Cortico contains the active substance methylprednisolone, which belongs to the group of drugs called corticosteroids. Corticosteroids are produced naturally in your body and are important for many body functions. They have a pronounced anti-inflammatory and anti-allergic effect. They favorably affect the manifestations of various diseases and conditions due to inflammation and allergy.

Giving your body extra corticosteroids such as Methylprednisolone Cortico can help if your body doesn't make enough corticosteroids because of problems with your adrenal glands (eg adrenal insufficiency).

Corticosteroids can also help after surgery (for example, an organ transplant), injuries, or other stressful conditions, such as inflammatory or allergic conditions affecting:
Brain (eg, tuberculous meningitis);
Bowel (e.g. ulcerative colitis and Crohn's disease / ulcerative colitis with severe and prolonged bloody diarrhea and cramping
Blood and blood vessels (eg leukemia);
Eyes (eg inflammation of the optic nerve and iritis or uveitis /inflammation of the front or back of the eye/);
Joints (eg rheumatoid arthritis or rheumatic fever);
Lungs (eg asthma and tuberculosis);
Muscles (eg dermatomyositis and polymyositis);
The skin (eg eczema).
Methylprednisolone Cortico may be prescribed to treat conditions other than those listed above.
Talk to your doctor if you are not sure why you have been prescribed this medicine, if you do not feel better or if you feel worse.

2. What you need to know before using
Methylprednisolone Cortico

Do not take Methylprednisolone Cortico:
if you are allergic to methylprednisolone or to any of the other ingredients of this medicine (listed in section 6);
if you have severe fungal infections, e.g. affecting the lung or esophagus, or any other infections that are not treated with an antibiotic or antiviral medicine.
if you have recently received or are expected to receive any vaccination.
Warnings and precautions
Your doctor will determine the appropriate dose to treat your condition and how long you should take the medicine. Strictly follow its instructions, do not change your prescribed dose without it being specifically prescribed by a doctor.

Talk to your doctor or pharmacist before taking this medicine if you have any of the following conditions:
Chickenpox, measles and herpes zoster. If you think you have been in contact with someone with chicken pox, measles or herpes zoster and you have not yet had such diseases, or if you are not sure if you have.
Parasite infestation (eg pinworms).
Major depression or manic depression (bipolar disorder). This includes having depression before taking steroid medication or having a family history of such conditions.
Diabetes (or if there is a family history of diabetes).
Seizures.
Glaucoma (increased intraocular pressure) or if you have a family history of glaucoma or if you have cataracts.
Viral (eg herpes) or fungal eye infection.
You recently had a heart attack.
Heart problems, incl. heart failure,
Hypertension (high blood pressure).
Hypothyroidism (reduced thyroid gland function).
Pancreatitis (inflammation of the pancreas that causes severe pain in the abdomen and back).
Peritonitis (inflammation of the thin membrane /peritoneum/ around the intestines and stomach.
Kidney or liver disease.
Kaposi's sarcoma (a type of skin cancer).
Muscle problems (pain or weakness) that have occurred while taking steroid medicines in the past.
Myasthenia gravis (a condition that causes tired and weak muscles).
Osteoporosis (brittle and brittle bones).
Pheochromocytoma (a rare tumor of the adrenal gland).
Skin abscess.
Stomach ulcer or other serious stomach or intestinal problems.
Thrombophlebitis - vein problems due to thrombosis (clots in the veins) leading to phlebitis (red, swollen and tender veins).
Tuberculosis or if you have had tuberculosis in the past.
Cushing's disease (a condition caused by excess cortisol hormone in your body).
Brain damage due to trauma.
Unusual stress.
It is especially important to know that:
unwanted effects can be avoided or reduced if you take the lowest dose that has a therapeutic effect for the shortest possible time;
taking this drug should not be stopped abruptly, because this can lead to worsening of the condition and recurrence of the disease;
the normal release of hormones from the adrenal gland is suppressed with longer treatment. To allow the adrenal gland to recover its function, the daily dose should be reduced gradually. Your doctor will give you specific instructions on how to do this.
It is necessary for you to know, and for your loved ones to be informed, that during treatment with
Other medicines and Methylprednisolone Cortico
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription. This may be harmful or affect the way Methylprednisolone Cortico or the other medicine works. Report if you are taking any of the medicines listed below:

Acetazolamide - used to treat glaucoma and epilepsy.
Aminoglutethimide or cyclophosphamide - used to treat
Anticoagulants - used to thin the blood, such as acenocoumarol, fendineone and warfarin.
Anticholinesterases - used to treat myasthenia gravis (a muscle condition), such as distigmine and neostigmine.
Antibacterials (such as isoniazid, erythromycin, clarithromycin, and troleandomycin).
Antidiabetic products - medicines used to treat high blood sugar.
Aprepitant or fosaprepitant - used to prevent nausea and vomiting.
Aspirin and nonsteroidal anti-inflammatory drugs (also called NSAIDs), such as ibuprofen, used to treat mild to moderate pain.
Barbiturates, carbamezepine, phenytoin and primidone - used to treat epilepsy.
Carbenoxolone and cimetidine - used for heartburn and indigestion.
Cyclosporine - used to treat conditions such as severe rheumatoid arthritis, severe psoriasis or after an organ or bone marrow transplant.
Digoxin - used for heart failure and/or irregular heartbeat.
Diltiazem or mibefradil - used for heart problems or high blood pressure.
Ethinylestradiol and norethisterone - contraceptives. Antivirals (such as ritonavir, indinavir) and pharmacokinetic enhancers (such as cobicinstat) used to treat AIDS.
Ketoconazole or itraconazole - used to treat fungal infections.
Pancuronium or vecuronium or other medicines called neuromuscular blocking agents, which are used in some surgical procedures.
Products that lower the level of potassium in the blood - such as diuretics (sometimes called water tablets), amphotericin B, keantones or beta2 agonists (eg medicines used to treat asthma),
Rifampicin and rifabutin - antibiotics used to treat tuberculosis (TB) Tacrolimus - used after an organ transplant to prevent rejection of the organ.
Vaccines - tell your doctor or nurse if you have recently had or are expected to have any vaccinations. You should not be vaccinated with "live" vaccines while using this medicine. Other vaccines may be less effective.
Pregnancy, lactation and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before using this medicine as it may slow the baby's growth.

There is a risk of having a low birth weight baby with the use of corticosteroids during pregnancy. This risk can be minimized by taking the lowest effective dose of corticosteroids.

Cataract development has been observed in infants born to mothers treated long-term with corticosteroids during pregnancy.

If you are breast-feeding, ask your doctor or pharmacist, as small amounts of corticosteroid medicines may pass into breast milk.

Driving and using machines
Adverse reactions such as dizziness, vertigo, visual disturbances and fatigue are possible after treatment with corticosteroids. If affected, do not drive or operate machinery.

Methylprednisolone Cortico contains lactose monohydrate

Lactose is included in the composition of the product as an auxiliary substance. This makes it unsuitable for people with congenital intolerance to some sugars (lactase deficiency, galactosemia or glucose/galactose malabsorption syndrome).

If your doctor has told you that you have such an intolerance, you should not take this product.

3. How to take Methylprednisolone Cortico
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults
The normal daily dose is between 4 mg and 360 mg per day, depending on your condition, the type of disease, its severity and course. Your doctor will prescribe the lowest dose possible.

The daily dose can be taken daily in one or several doses or as a single but doubled dose every other day.

It is recommended to take the medicine in the morning around 8:00 a.m.

The daily dose, method and frequency of administration, duration of treatment will be determined by your doctor, according to the type of disease, its severity and course.

The tablets are taken whole or divided with a sufficient amount of water. The tablet can be divided into equal doses.

Do not eat grapefruit or drink grapefruit juice while taking Methylprednisolone Cortico.

If you have been prescribed Methylprednisolone Cortico because your body is not producing enough
You should not suddenly stop taking Methylprednisolone Cortico, especially in the following cases:

if you have taken more than 6 mg of Methylprednisolone Cortico daily for more than 3 weeks;
if you have been taking high doses of Methylprednisolone Cortico (more than 32 mg daily), even for just 3 weeks or less;
if you have already had a course of treatment with corticosteroid tablets or injections in the last year;
if you already had problems with the adrenal glands (adrenocortical insufficiency) before starting treatment;
if you take repeat doses in the evening.
It is necessary to stop treatment gradually to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pain, runny nose, red and watery eyes, loss of appetite, nausea, vomiting, headache, feeling tired, itchy skin nodules, and weight loss.

If your symptoms return or worsen because the dose of Methylprednisolone Cortico has been reduced, tell your doctor immediately.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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

In certain conditions, drugs such as Methylprednisolone Cortico (steroids) should not be stopped abruptly. If you experience any of the following symptoms, seek immediate medical attention. Your doctor will decide whether you should continue taking this medicine:

Common side effects (affects less than 1 in 10 patients)
Worsening or bleeding ulcers, symptoms of which are stomach pain (especially if it seems to spread to the back), black or bloody stools and/or vomiting blood.

Infections. This medicine can mask or change the signs and symptoms of some infections or reduce resistance to infections so that they are difficult to diagnose at an early stage. Symptoms may include fever and malaise. Symptoms of a previous TB infection may include coughing up blood or chest pain. You may also become more susceptible to developing severe infections.

Not known (frequency cannot be estimated from the available data)
Allergic reactions, such as skin rash, facial swelling or wheezing and difficulty breathing. This type of side effect is rare but can be serious.

Pancreatitis - pain in the abdomen that spreads to the back, accompanied by vomiting, shock and loss of consciousness.

Pulmonary embolism (blood clots in the lungs) - symptoms include sudden sharp chest pain, shortness of breath and coughing up blood.

Increased pressure in the skull in children - the symptoms are headache with vomiting, fatigue and drowsiness. This side effect usually occurs after stopping treatment.

Thrombophlebitis (blood clots or thrombosis in the veins of the legs), symptoms of which include painfully swollen, red and tender veins.

If you get any of the following side effects or notice any other unusual effects not mentioned in this leaflet, tell your doctor straight away:

Cardiovascular system
Frequent
High blood pressure, the symptoms of which are headache or feeling unwell. With an unknown frequency

Problems with how the heart works (heart failure), symptoms of which are swollen ankles, difficulty breathing and palpitations (feeling of a heartbeat) or irregular heartbeat, irregular or very fast or slow pulse.

Increased number of white blood cells (leukocytosis).

Low blood pressure

Blood disorders

With an unknown frequency
Increase in the number of white blood cells.

Water and salt content

Frequent
Edema and high blood pressure caused by increased water and salt retention.

Cramps and spasms

With an unknown frequency
Increased levels of blood urea.

Digestive system

With an unknown frequency
Nausea or vomiting.
Ulcers, inflammation or canker sores of the esophagus, which can cause discomfort when swallowing.
Inflammation of the thin lining around the intestines and stomach (peritonitis).
Stomach upset.
Stomach swelling.
Stomach ache.
Diarrhea.
Persistent hiccups, especially when high doses are taken.
Eyes
Rare
Blurred vision.
Frequent
Cataract.

With an unknown frequency
Glaucoma (increased intraocular pressure leading to eye pain and headaches)
Edema of the optic nerve (papilloedema, manifested by visual impairment).
Thinning of the clear front part of the eye (cornea) or the white part of the eye (sclera).
Worsening of viral or fungal eye infections.
Protrusion of the eyeballs (exophthalmos).
Blurred or impaired vision (due to disease of the retina and choroid).
Biliary-hepatic disorders
With an unknown frequency
Elevation of liver enzymes.
Disorders of metabolism
Frequent
Slowing down of normal growth in infants, children and adolescents, which may be permanent.

Round or moon-shaped face (Cushingoid face
5. How to store Methylprednisolone Cortico
At a temperature below 25°C.

Validity period after the first opening of the bank - 4 (four) months. Keep out of the reach of children.

Do not use Methylprednisolone Cortico after the expiry date stated on the carton. The expiration date corresponds to the last day of the specified month.

Do not use Methylprednisolone Cortico if you notice a change in the appearance of the tablet.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Methylprednisolone Cortico contains

The active substance in one tablet is methylprednisolone 16 mg

The other ingredients (excipients) are lactose monohydrate/maize starch (85:15), colloidal anhydrous silica, magnesium stearate

What Methylprednisolone Cortico looks like and contents of the pack

Round, flat tablets with a facet and a dividing line on one side, diameter 13 mm.

10 (ten) tablets in a blister of transparent, orange PVC/PVDC/A1 foil. Two blisters in a box.

40 (forty) tablets in a white, opaque plastic bank, closed with a cap with a protective ring, One bank in a cardboard box.

100 (one hundred) tablets in a white, opaque plastic bank, closed with a cap with a protective ring. One bank in a cardboard box.

 

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