Cortamethyl 16 mg. 20 tablets

1. What Cortamethyl is and what it is used for
Cortamethyl contains the active substance methylprednisolone, which belongs to a group of medicines 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 have a beneficial effect on the manifestations of various diseases and conditions due to inflammation and allergy.

Introducing additional amounts of corticosteroids such as Cortamethyl into your body can help if your body does not produce enough corticosteroids due to problems with the adrenal glands (e.g. adrenal insufficiency).

Corticosteroids can also help after operations (e.g. organ transplantation), injuries or other stressful conditions, such as inflammatory or allergic conditions affecting:

The brain (e.g. tuberculous meningitis);

Bowel (e.g. ulcerative colitis and Crohn's disease /inflammation of the large intestine associated with ulceration and severe and prolonged bloody diarrhea and cramps/);
Blood and blood vessels (e.g. leukemia);
Eyes (e.g. inflammation of the optic nerve and iritis or uveitis /inflammation of the front or back of the eye/);
Joints (e.g. rheumatoid arthritis or rheumatic fever);
Lungs (e.g. asthma and tuberculosis);
Muscles (e.g. dermatomyositis and polymyositis);
Skin (e.g. eczema).
Cortamethyl may be prescribed to treat other conditions than those listed above.

Talk to your doctor if you are not sure why this medicine has been prescribed for you, if you do not feel better or if you feel worse.

2. What you need to know before you use Cortamethyl
Do not take Cortamethyl:
if you are allergic to methylprednisolone or any of the other ingredients of this medicine (listed in section 6);
if you have severe fungal infections, e.g. affecting the lungs or oesophagus, or any other infections that are not treated with antibiotics or antiviral medicines.
if you have recently had or are due to have any vaccination.
Warnings and precautions
Your doctor will determine the appropriate dose to treat your condition and how long you should take the medicine. Follow his instructions carefully, do not change your prescribed dose without being specifically told to do so by your doctor.

Talk to your doctor or pharmacist before taking this medicine if you have any of the following conditions:

Chickenpox, measles or shingles. If you think you have been in contact with someone who has chickenpox, measles or shingles and you have not yet had these diseases or if you are not sure whether you have had them.
Parasitic infection (e.g. pinworms).
Severe depression or manic depression (bipolar disorder). This includes if you had depression before taking steroid medicines or if you have a family history of such illnesses.
Diabetes (or if there is a family history of diabetes).
Seizures.
Glaucoma (increased pressure in the eye) or if you have a family history of glaucoma or if you have cataracts.
Viral (e.g. herpes) or fungal eye infection.
You have recently had a heart attack.
Heart problems, including heart failure.
Hypertension (high blood pressure).
Hypothyroidism (underactive thyroid gland).
Pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back).
Peritonitis (inflammation of the thin lining (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 you have taken steroid medicines in the past.
Myasthenia gravis (a condition that causes tired and weak muscles).
Osteoporosis (brittle and brittle bones).
Pheochromocytoma (a rare tumour 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 too much cortisol hormone in your body).
Brain damage due to trauma.
Unusual stress.
It is especially important to know that:
Undesirable effects can be avoided or reduced if you take the lowest effective dose for the shortest possible time;
This medicine should not be stopped abruptly, as this may make your condition worse and your condition return;
The normal secretion of hormones by the adrenal gland is suppressed with prolonged treatment. To allow the adrenal gland to recover its function, the daily dose taken should be reduced gradually. Your doctor will give you specific instructions on how to do this.
You should know, and your loved ones should be informed, that mental disorders may develop during treatment with corticosteroids. Most often, it
The symptoms are observed several days to several weeks after the start of treatment. Most of them resolve completely either after reducing the dose or after stopping the treatment. However, this does not negate the need for specific treatment.
If you experience feelings of depression, anxiety, insomnia, lack of motivation, thoughts of self-harm, you should immediately share this with your loved ones and seek advice from a medical professional.

Corticosteroids can lead to growth retardation in children and adolescents, which is why treatment should be limited to the lowest possible dose and the shortest possible period of administration.

In elderly patients, some side effects (osteoporosis, diabetes, high blood pressure, tendency to infections) may be observed more often and they may have a more serious course, which is why they require increased monitoring by a doctor.

If you have an overactive thyroid gland (hyperthyroidism)
Contact your doctor immediately if you experience muscle weakness, muscle pain, cramps and stiffness while taking methylprednisolone. These may be symptoms of a condition called thyroid periodic paralysis, which can occur in patients with an overactive thyroid gland (hyperthyroidism) who are being treated with methylprednisolone. You may need additional treatment to relieve this condition.

If you are taking certain medicines on a long-term basis
If you are being treated for diabetes, high blood pressure or water retention (oedema), tell your doctor as he or she may need to adjust the dose of the medicines used to treat these conditions.

Before any surgery you are going to have, tell your doctor, dentist or anaesthetist that you are taking Cortamethyl.

If you need a test to be carried out by your doctor or in hospital, it is important to tell the doctor or nurse that you are taking Cortamethyl. This medicine may affect the results of some tests.

Other medicines and Cortamethyl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. These may be harmful or affect the way Cortamethyl or the other medicine works. Tell your doctor if you are taking any of the medicines listed below.

Acetazolamide - used to treat glaucoma and epilepsy.

Aminoglutethimide or cyclophosphamide - used to treat cancer.

Anticoagulants - used to thin the blood, such as acenocoumarol, phendineone 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 non-steroidal anti-inflammatory drugs (also called NSAIDs), such as ibuprofen, used to treat mild to moderate pain.
Barbiturates, carbamazepine, 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.
Ethinyl estradiol and norethisterone - contraceptives.
Antivirals (such as ritonavir, indinavir) and pharmacokinetic enhancers (such as cobicistat) used to treat AIDS.
Ketoconazole or itraconazole - used to treat fungal infections.
Pancuronium or vecuronium or other medicines called neuromuscular blockers, which are used in some surgical procedures.
Products that lower the amount of potassium in the blood - such as diuretics (sometimes called water tablets), amphotericin B, xanthones or beta2 agonists (e.g. medicines used to treat asthma).
Rifampicin and rifabutin - antibiotics used to treat tuberculosis (TB).
Tacrolimus - used after organ transplants to prevent organ rejection.
Vaccines - tell your doctor or nurse if you have recently had or are due to have any vaccinations. You should not be vaccinated with 'live' vaccines while you are using this medicine. Other vaccines may be less effective.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as it may slow down the growth of the baby.

There is a risk of having a low birth weight baby when corticosteroids are used during pregnancy. This risk can be minimised by taking
take the lowest effective dose of corticosteroids.

Cataracts have been observed in infants born to mothers who received long-term corticosteroid treatment during pregnancy.

If you are breast-feeding, consult 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 you are affected, do not drive or use machines.

Cortamethyl contains lactose monohydrate
The product contains lactose as an excipient. This makes it unsuitable for people with hereditary 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 Cortamethyl
Always take 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 possible dose.
The daily dose can be taken daily in one or more doses or as a single, but doubled dose, every other day.
It is recommended that the morning dose of the medicine be taken at around 8:00 a.m.

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

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

Do not take grapefruit or drink grapefruit juice while taking Cortamethyl.
If you have been prescribed Cortamethyl because your body does not produce enough of its own corticosteroids, your doctor may also recommend that you take a second type of steroid to help with your body's salt balance.

Side effects can be limited by using the lowest effective dose for the shortest possible period.

In most cases, treatment is started with a higher dose, which can be reduced or increased after some time depending on the effect achieved.

It is important to know that stopping the medicine should never be done abruptly.

When your doctor determines that your condition has improved, your dose will be reduced gradually. The dose will usually be reduced by no more than 2 mg every 7 to 10 days.

Children and adolescents
Corticosteroids can affect the growth of children, so your doctor will prescribe the lowest dose that will be effective for your child and for the shortest possible period of time. Your doctor may tell you to give your child this medicine as a single dose every other day.

Elderly patients
The daily dose, route and duration of administration will be adjusted to the fact that in adults side effects are more common and sometimes more serious.

If you take more Cortamethyl than you should
It is important not to take more tablets than you have been told to take. If you accidentally take too many tablets, seek medical help immediately.

If you forget to take Cortamethyl
If you forget to take a dose, take it as soon as possible after you remember. Do not take a double dose to make up for a forgotten one. Take the next dose at the usual time.
If you stop taking Cortamethyl
Do not stop treatment until your doctor tells you to, even if you feel better. Remember that stopping treatment should never be done abruptly, but by gradually reducing the daily dose.

You should not stop taking Cortamethyl suddenly, especially in the following cases:

if you have taken more than 6 mg of Cortamethyl per day for more than 3 weeks;

if you have taken high doses of Cortamethyl (more than 32 mg per day), even for only 3 weeks or less;

if you have already had a course of treatment with corticosteroid tablets or injections in the last year;

if you have already had problems with your adrenal glands (adrenocortical insufficiency) before starting treatment;

if you are taking repeated 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 lumps and weight loss.

If your symptoms return or get worse because the dose of Cortamethyl is 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, medicines such as Cortamethyl (steroids) should not be stopped suddenly. If you experience any of the following symptoms, seek medical attention immediately. Your doctor will decide whether you should continue taking this medicine:
Common side effects (affects less than 1 in 10 patients)
Worsening or bleeding of 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 may mask or change the signs and symptoms of some infections or reduce resistance to infections, so that they are difficult to diagnose early. Symptoms may include fever and feeling unwell. Symptoms of a previous tuberculosis infection may be coughing up blood or chest pain. You may also become more susceptible to developing serious infections.
Not known (frequency cannot be estimated from the available data)
Allergic reactions such as skin rash, swelling of the face or wheezing and difficulty breathing. This type of side effect is rare but can be serious.
Pancreatitis - abdominal pain spreading 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 inside the skull in children - symptoms include headache with vomiting, weakness 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 painful swollen, red and tender veins.
If you experience any of the following side effects or notice any other unusual effects not mentioned in this leaflet, tell your doctor immediately:
Cardiovascular system
Common
High blood pressure, symptoms of which are headache or general malaise.
Not known

Heart problems (heart failure), symptoms of which include swollen ankles, difficulty breathing and palpitations (a feeling of your heart beating) or irregular heartbeat, irregular or very fast or slow pulse.
Increased white blood cell count (leukocytosis).
Low blood pressure
Blood disorders
Not known

Increase in white blood cell count.
Water and salt content
Common

Swelling and high blood pressure caused by increased water and salt retention.
Cramps and spasms
Not known

Increased blood urea nitrogen levels.
Digestive system
Not known

Nausea or vomiting.
Ulcers, inflammation or sores in the gullet, which may cause discomfort when swallowing.
Inflammation of the thin lining around the intestines and stomach (peritonitis).
Stomach upset.
Stomach bloating.
Abdominal pain.
Diarrhoea.
Persistent hiccups, especially when taking high doses.
Eyes
Rare
Blurred vision.
Common
Cataracts.
Not known
Glaucoma (increased pressure in the eye, leading to eye pain and headache
Swelling of the optic nerve (papilloedema, presenting with 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 reduced vision (due to retinal and choroid disease).
Hepatobiliary disorders
Not known
Increased
liver enzymes.
Metabolic disorders
Common
Slowdown on normal growth in infants, children and adolescents, which may be permanent. Round or crescent-shaped face (Cushingoid facies).
Not known
Menstrual irregularities or complete absence of menstrual periods in women.
Increased body and facial hair in women (hirsutism).
Increased appetite and weight gain.
Increased levels of lipids in the blood (e.g. cholesterol and/or fat).
Development of diabetes or worsening of existing diabetes.
Long-term treatment may lead to lower levels of some hormones, which in turn may cause low blood pressure and dizziness. This effect may last for months.
The amount of some enzymes (alanine transaminase, aspartate transaminase and alkaline phosphatase), which help the body break down medicines and other substances in your body, may increase after treatment with corticosteroids. The change is usually small and the enzyme levels return to normal after the medicine has cleared naturally from your body. You will not notice any symptoms if this happens, but it will be detected if you have a blood test.
Accumulation of fatty tissue on different parts of the body, presenting with different symptoms, for example back pain or weakness (due to epidural lipomatosis).
Immune system
Not known
Increased susceptibility and severity of infections, masking their clinical manifestations, superimposition of additional infections.
Suppression of normal reactions to skin tests, such as those for tuberculosis.
Muscle and joint disorders
Common
Muscle weakness and atrophy (reduction in muscle mass). Not known
Thinning, thinning of the bones and tendency to spontaneous fractures (osteoporosis).
Bone breakdown due to poor blood circulation in the bones, causing pain in the thigh bone.
Joint pain.
Rupture of muscle tendons, causing pain and/or swelling.
Muscle pain, cramps or spasms.
Nervous system
Steroids, including methylprednisolone, can cause serious mental health problems
These are common in adults and children, and may affect about 5 in every 100 people taking medicines such as methylprednisolone.
Depression, including thoughts of harming yourself.
Anxiety, mood swings, sleep disturbances, restlessness, memory loss.
Not known
Irritability.
Seizures.
Dizziness, vertigo.
Headache.
5. How to store Cortamethyl
At a temperature below 25° C.
Expiration date after first opening the bank - 4 (four) months.
Store out of the reach of children.
Do not use Cortamethyl after the expiration date stated on the carton.
The expiration date corresponds to the last day of the month indicated.
Do not use Cortamethyl if you notice a change in the appearance of the tablet.

Do not throw away medicines via wastewater or household waste. 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 Cortamethyl contains
The active substance in one tablet is methylprednisolone (methylprednisolone) 16 mg.
The other ingredients (excipients) are lactose monohydrate/corn starch (85:15), anhydrous colloidal silicon dioxide, magnesium stearate.
What Cortamethyl looks like and contents of the pack
Round, flat tablets with a bevel and a score 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 jar, closed with a cap with a protective ring. One jar in a cardboard box.

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

 

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