Lisamethyle 40 mg. 2 ml. 1 vial

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Lisamethyl belongs to a group of medicines called corticosteroids

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What Lisamethyl is and what it is used for

Lisamethyl belongs to a group of medicines called corticosteroids or steroids.

Lisamethyl is used to treat:

Hormonal diseases: for example, if the adrenal glands do not work properly for some reason, so that the body does not produce enough of its own hormones; with a certain type of circulatory insufficiency (shock in adrenal insufficiency or shock unresponsive to standard treatment, in which there may be insufficiency only of the cortex of the adrenal glands); in patients who are about to undergo surgery, have a severe trauma or other disease combined with impaired function of the adrenal glands; hypercalcemia (increased levels of calcium in the blood) associated with cancer; a certain type of inflammation of the thyroid gland (non-purulent thyroiditis); in congenital overgrowth of the adrenal glands.

Rheumatic diseases: rheumatoid arthritis (an autoimmune disease with inflammation affecting the joints and/or other parts of the body in adults or children); acute and subacute bursitis (inflammation of a periarticular bursa), acute nonspecific tendosynovitis (inflammation of the sheath of a muscle tendon), acute gouty arthritis (inflammation of a joint in gout), post-traumatic osteoarthritis (inflammation of a joint after trauma), synovitis in osteoarthritis (inflammation of the intra-articular mucosa), epicondylitis (inflammation of the end part of certain bones or of the tendons attached to them). It is also used as an additional therapy for ankylosing spondylitis (joints of the spine and pelvis become ossified and fused together), psoriatic arthritis (joint inflammation in psoriasis).

Collagenous (connective tissue diseases): inflammation of muscles (such as dermatomyositis or polymyositis); systemic lupus erythematosus (an autoimmune disease characterized by a rash accompanied by fever, arthritis, inflammation of blood vessels, kidney disorders and disorders affecting the brain); acute rheumatic carditis (affecting the heart muscle in rheumatism); other connective tissue diseases (such as polyarteritis nodosa or Goodpasture's syndrome).

Skin diseases: pemphitus vulgaris (appearance of blisters on the skin), other skin diseases (bullous dermatitis herpetiformis or seborrheic dermatitis, severe psoriasis, severe form of erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides).

Allergic conditions: asthma; severe forms of hay fever and other allergies accompanied by a runny nose; allergies to certain drugs (such as penicillin) and serum sickness (allergy to vaccines made from animal serum); skin allergy due to contact with certain substances (contact dermatitis), swelling of the larynx and others.

Eye diseases: iritis or iridocyclitis (inflammation of the front part of the eye); posterior uveitis (inflammation of the back of the eye); optic neuritis (inflammation of the optic nerve), inflammation of the anterior segment of the eye, allergic conjunctivitis or other allergic changes (ulcers on the corneal edge) and other eye diseases (herpes zoster ophthalmicus, chorioretinitis, keratitis).

Intestinal diseases: inflammation and ulceration of the colon (ulcerative colitis); inflammation of different parts of the intestine (regional enteritis).

Pulmonary inflammation: pulmonary sarcoidosis (inflammation of the tissues and lymph glands of the lungs); tuberculosis that has progressed rapidly or has spread to other parts of the lung (simultaneously with antituberculosis drugs); inflammation caused by the entry of stomach contents or vomit into the lungs when unconscious (aspiration pneumonia); moderate to severe pneumonia caused by Pneumocystis carinii in a patient with AIDS (as adjunctive therapy) and other lung diseases (berylliosis, Loeffler's syndrome and chronic obstructive pulmonary disease).

Blood disorders: idiopathic thrombocytopenic purpura in adults (increased tendency to subcutaneous hemorrhages and bleeding due to low number of blood cells involved in blood clotting), secondary thrombocytopenia in adults (low number of blood cells involved in blood clotting); autoimmune hemolytic anemia (when the immune system attacks its own red blood cells (erythrocytes)) and other anemias.

Malignant diseases: leukemia (excessive formation of white blood cells in the bone marrow); cancer of the lymphatic system, which usually affects the lymph nodes (glands) and the spleen (spleen); improving quality of life in patients with terminal cancer.

Edema conditions: to increase diuresis (urine output) in nephrotic syndrome (kidney disease).

Other conditions: multiple sclerosis; tuberculosis infection, causing inflammation of the meninges (the coverings of the brain), simultaneously with anti-tuberculosis drugs; brain edema caused by a tumor; early treatment of spinal cord injury; organ transplantation; prevention of nausea and vomiting in cancer treatment.

Your doctor could administer L

If you were previously treated with steroids, did it cause psychosis (a mental illness requiring outpatient or inpatient treatment)? If you have a disease accompanied by seizures.

If you have myasthenia gravis (when you feel weak in some or all muscles or get tired easily).

If you have ever had an eye infection caused by herpes simplex virus. Do you currently have an eye herpes infection (a long-standing eye ulcer or inflammation of the eye)?

If you have heart failure.

Do you have swelling around your ankles, difficulty breathing and palpitations?

If you have or are prone to a thromboembolic disorder (formation of a blood clot that travels in your blood vessels) or have high blood pressure.

If you have problems with your digestive tract, such as stomach or intestinal ulcers (can lead to stomach pain even if it doesn't bother you at the moment), diverticulitis (inflamed "pockets" on the inner wall, most often of the large intestine, causing left-sided abdominal pain , constipation or diarrhoea) or ulcerative colitis (swelling and ulcers in areas of the intestine).

Although steroids are very effective in treating the inflammation of ulcerative colitis, they can also increase the risk of bleeding or perforation (rupture) of the ulcerated bowel.

Have you recently had surgery on your stomach, appendix, gallbladder, pancreas, or small or large intestine?

If you have ever had myopathy (muscle problems with weakness or stiffness, especially in the lower limbs and buttocks) during steroid treatment.

If you have osteoporosis (brittle bones).

If you have kidney problems (leading to increased or decreased urine output).

If you have scleroderma (also known as systemic sclerosis - an autoimmune disease), as the risk of a serious complication called scleroderma renal crisis may be increased.

If you have hypoprothrombinemia (a disease associated with a reduced ability of the blood to clot).

If you have a brain injury.

There is evidence to suggest that this drug should not be used routinely to treat brain injuries.

If you have a pheochromocytoma (a type of tumor of the adrenal gland).

The occurrence of acute hepatitis (inflammation of the liver) is not excluded when this drug is administered by intravenous infusion. This adverse event may occur several weeks after initiation of treatment and is expected to resolve upon discontinuation.

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

If you need to have any tests, tell the doctor that you are taking Lisamethyl.

Children

The growth and development of infants and children undergoing long-term treatment with corticosteroids should be carefully monitored. There is a risk of growth suppression in children receiving long-term treatment with corticosteroids in a daily dose divided into several doses. The application of such a scheme should be limited to cases with the most severe indications.

Infants and children undergoing long-term treatment with corticosteroids are at particularly high risk of increased intracranial pressure.

High doses of corticosteroids can lead to pancreatitis (inflammation of the pancreas) in children.

Other drugs and Lisamethyl

You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking any of the medicines listed below:

some antibiotics (eg troleacdomycin, clarithromycin, erythromycin, isoniazid), antifungal medicines (eg itraconazole, ketoconazole), calcium antagonists (to treat high blood pressure or angina pectoris, eg diltiazem), some schukoviral medicines (including some medicines to treat HIV medicines, eg indinavir, ritonavir, cobicistat), antiemetics (medicines to treat nausea and vomiting, eg aprepitant, fosaprepitant) and birth control pills (eg ethinyl estradiol/norethindrone) can reduce the excretion of methylprednisolone from the body, by thus increase the effect of Lisamethyl - if you are taking such drugs, your doctor may need to adjust the dosage of Lisamethyl and ask to monitor you closely;

certain anticonvulsants (medicines to treat seizures, eg carbamazepine, phenobarbital, phenytoin) or anti-tuberculosis medicines (eg rifampicin) may increase the clearance of methylprednisolone from your body, thereby reducing the effect of Lisamethyl, so it is necessary increasing the dose of Lisamethyl to achieve the desired response;

anticoagulants (drugs that suppress blood coagulation): the simultaneous use of Lisamethyl can both strengthen and weaken their anticoagulant effect, which is why it is necessary for your doctor to carefully monitor your coagulation parameters;

neuromuscular blockers (medicines used to relax muscles in

3. How to use Lisamethyl

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will decide what dose you should receive. The dose depends on your disease and its severity. Your doctor will always try to use the lowest possible dose that gives a good result.

Your doctor may prescribe a higher dose for a few days to control your condition. If your condition is not controlled, he may change the treatment. Your doctor may check you frequently to make sure you are feeling better.

The starting dose chosen by your doctor will be continued until he considers that your condition has improved. If the doctor finds that your condition has improved, he will gradually reduce the dosage.

The medicinal product can be administered as a venous and intramuscular injection.

Use in children

Lisamethyl can be prescribed in children. A lower dose than for adults is usually prescribed, but this depends on the severity of the condition and response to treatment.

If you have used more than the required dose of Lisamethyl

Because this medicinal product is administered as an injection under medical supervision, the possibility of missing a dose or receiving a larger dose is unlikely. If you have any doubts, ask your doctor.

If you have stopped using Lisamethyl

Your doctor will decide when it is time to stop treatment.

Treatment with Lisamethyl should not be stopped abruptly, but with a gradual reduction of the dose, as determined by your doctor. This is because tapering the steroid dose too quickly can lead to acute adrenal insufficiency (the adrenal glands do not produce enough of their own corticosteroids), very low blood pressure (causing dizziness and fainting), and potentially fatal outcome. This is more likely to happen when repeated doses have been received.

If you feel that your symptoms are returning as you reduce the dose of Lisamethyl, tell your doctor as soon as possible. If you get an infection, have an accident, or need surgery, your dose may need to be temporarily increased. If you have stopped taking the medicine recently before an infection, accident or surgery, you may need to start taking it again for a short time.

When changing your dose, remind your doctor about any other medicines you are taking, especially medicines such as aspirin. Also remember that you must tell any doctor who examines you further that you have been given methylprednisolone.

If you have any further questions related to the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

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

You are more likely to experience side effects if you receive a large dose over a long period of time. Your doctor will prescribe the lowest possible dose that relieves your symptoms for the shortest possible time. This means that the risk of developing serious adverse drug reactions is small, while the chance of your condition improving is high.

If you are over the age of 65, side effects may be more serious. Your doctor will monitor your condition closely.

Tell your doctor immediately if you notice any of the following reactions or if you think you are at risk of infection (eg if you have been in contact with a person who has an infection),

With an unknown frequency (an estimate cannot be made from the available data) are:

reduced resistance and increased risk of infections, infection of the lining of the abdominal organs (peritonitis);

increase in the number of white blood cells (leukocytosis);

allergy (hypersensitivity) to the drug; acute severe allergic (anaphylactic) reaction with a sharp drop in blood pressure, urticarial rash, edema and difficulty breathing; a severe allergic (anaphylactoid) reaction that causes difficulty breathing or dizziness;

rounded or moon-like face (Cushingoid facies), decreased pituitary function (hypopituitarism), steroid withdrawal syndrome (withdrawal);

increased levels of acidity of fluids in the body (metabolic acidosis), accumulation of fatty tissue in certain parts of the body (lipomatosis), sodium retention, fluid retention, increase in the content of fluids and salts in the body (alkalosis), increase in the content of fat in the blood (dyslipidaemia), impaired glucose tolerance, increased need for insulin, increased appetite (which may lead to weight gain);

mental disorder (including depression, euphoria, emotional instability, drug dependence, suicidal ideation), psychotic disorder (including mania, delusions, hallucinations and schizophrenia), mood disorder, personality changes, confusion, anxiety, mood changes

5. How to store Lisamethyl

Keep out of the reach of children.

To be stored below 25°C.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day (of the specified month).

Do not use this medicine if you notice particles or discoloration.

6. Contents of the package and additional information

What Lisamethyl contains

This medicine contains 40 mg of methylprednisolone as the active ingredient (as methylprednisolone sodium succinate).

Solvent: water for injections

What Lisamethyl looks like and contents of the pack

Single-dose type III clear glass vial with rubber stopper and red breakaway cap.

Solvent

Type I glass ampoule.

Lisamethyl is available in packs of 1, 5, 10, 50 or 100 vials of methylprednisolone powder for solution for injection and 1, 5, 10, 50 or 100 ampoules of solvent, respectively, and a patient leaflet placed in a cardboard box.

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