Active substancePrednisolonePrednisolone
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  • Dosage form: & nbsppills
    Composition:

    1 the tablet contains:

    active substance: prednisolone 5 mg,

    Excipients: lactose monohydrate 62.0 mg, corn starch 43.5 mg, corn pregelatinized starch 6.5 mg, talc 2.5 mg, magnesium stearate 0.5 mg.

    Description:

    Tablets are white, round, flat on both sides, with bevelled edges, with a notch for division on one side and engraving "PD"Above and" 5.0 "below the incision for division.

    Pharmacotherapeutic group:glucocorticosteroid
    ATX: & nbsp

    H.02.A.B.06   Prednisolone

    Pharmacodynamics:

    Prednisolone Nycomed is a synthetic glucocorticosteroid drug, a dehydrated analog of hydrocortisone. Has anti-inflammatory, antiallergic, immunosuppressive action, increases the sensitivity of beta-adrenoreceptors to endogenous catecholamines.

    It interacts with cytoplasmic receptors of glucocorticosteroids (GCS) with the formation of a complex inducing the formation of proteins (including enzymes that regulate vital processes in cells.)

    Protein metabolism: reduces the number of globulins in the plasma, increases the synthesis of albumin in the liver and kidneys (with an increase in the albumin / globulin ratio in the blood plasma), reduces synthesis and enhances protein catabolism in muscle tissue.

    Lipid metabolism: increases the synthesis of higher fatty acids and triglycerides, redistributes fat (accumulation of fat occurs mainly in the area of ​​the shoulder girdle, face, abdomen), leads to the development of hypercholesterolemia.

    Carbohydrate metabolism: increases the absorption of carbohydrates from the gastrointestinal tract; increases the activity of glucose-6-phosphatase (increased intake of glucose from the liver into the blood); increases, phosphoenolpyruvate carboxylase activity and synthesis of aminotransferases (activation gluconeogenesis); promotes the development of hyperglycemia.

    Water-electrolyte exchange: retards sodium and water in the body, stimulates the excretion of potassium (mineralocorticoid activity), reduces the absorption of calcium from the gastrointestinal tract, reduces the mineralization of bone tissue.

    Anti-inflammatory effect is associated with the suppression of the release of eosinophils and mast cells by inflammatory mediators; inducing the formation of lipocortins and reducing the number of mast cells that produce hyaluronic acid; with a decrease in the permeability of capillaries; stabilization of cell membranes (especially lysosomal) and membranes of organelles. Acts on all phases of the inflammatory process: inhibits prostaglandin synthesis at the level of arachidonic acid (Lipokortin inhibits phospholipase A2 inhibits the release of arachidonic acid and endoperekisey inhibits biosynthesis of the leukotrienes contribute to inflammation, allergies, etc.), Synthesis of "proinflammatory cytokine" (interleukin1, tumor necrosis factor alpha, etc.); increases the resistance of the cell membrane to the action of various damaging factors.

    Immunodepressive effect is caused by involution of lymphoid tissue, suppression of lymphocyte proliferation (especially T-lymphocytes), suppression of B-lymphocyte migration and interaction of T and B lymphocytes, inhibition of release of cytokines (interleukin-1, 2, gamma-interferon) from lymphocytes and macrophages and a decrease the formation of antibodies.

    Antiallergic effect develops as a result of a decrease in the synthesis and secretion of mediators of allergy, inhibition of release from sensitized mast cells and basophils of histamine and other biologically active substances, a decrease in the number of circulating basophils, T- and B-lymphocytes, mast cells; suppression of the development of lymphoid and connective tissue, reducing the sensitivity of effector cells to mediators of allergy, inhibition of antibody formation, changes in the immune response of the body.

    In obstructive airway diseases, the effect is mainly due to the inhibition of inflammatory processes,prevention or reduction of the degree of edema of the mucous membranes, a decrease in the eosinophilic infiltration of the submucosal layer of the bronchial epithelium, and deposition in the bronchial mucosa circulating immune complexes, as well as inhibition of erosion and desquamation of the mucosa. Increases the sensitivity of beta-adrenergic receptors of bronchi of small and medium caliber to endogenous, catecholamines and exogenous sympathomimetics, reduces the viscosity of mucus due to the reduction of its production.

    Suppresses the synthesis and secretion of adrenocorticotropic hormone (ACTH) and again - the synthesis of endogenous GCS.

    It inhibits connective tissue reactions during the inflammatory process and reduces the possibility of scar tissue formation.

    Pharmacokinetics:

    When administered orally prednisolone well absorbed from the gastrointestinal tract. The maximum concentration in the blood is reached after 1-1.5 hours after oral administration. Up to 90% of prednisolone binds to plasma proteins: transcortin (globulin binding corticosteroids) and albumins. Prednisolone metabolized in the liver, partially in the kidneys and other tissues, mainly by conjugation with glucuronic and sulfuric acids.Metabolites are inactive.

    It is excreted with bile and urine by glomerular filtration and is reabsorbed by tubules by 80-90%. 20% of the dose is excreted by the kidneys unchanged. The half-life from the plasma after ingestion is 2-4 hours.
    Indications:

    - Systemic diseases of connective tissue (systemic lupus erythematosus, scleroderma, nodular periarteritis, dermatomyositis, rheumatoid arthritis).

    - Acute and chronic inflammatory diseases of the joints: gouty and psoriatic arthritis, osteoarthritis (including post-traumatic), polyarthritis (including senile), humeropathy periarthritis, ankylosing spondylitis (Bechterew's disease), juvenile arthritis, Still's syndrome in adults, bursitis, nonspecific tenosynovitis, synovitis and epicondylitis.

    - Rheumatic fever, acute rheumatic heart disease.

    - Bronchial asthma, asthmatic status.

    - Acute and chronic allergic diseases: allergic reactions to drugs and foods, serum sickness, hives, allergic rhinitis, angioedema, edema. - (angioedema), drug exanthema, hay fever.

    - Skin diseases: pemphigus, psoriasis, eczema, atopic dermatitis, contact dermatitis (affecting a large skin surfaces), drug reaction, seborrheic dermatitis, exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome), bullous dermatitis herpetiformis, malignant erythema multiforme (Stevens-Johnson syndrome ).

    - Cerebral edema (including on the background of a brain tumor or associated with surgery, radiation, therapy or head trauma) after pre-parenterally.

    - Allergic eye diseases: allergic corneal ulcers, allergic forms of conjunctivitis.

    - Inflammatory eye diseases: sympathetic ophthalmia, severe sluggish anterior and posterior uveitis, optic neuritis.

    - Renal diseases: primary or secondary adrenal insufficiency (including the state after removal of adrenal glands), congenital adrenal hyperplasia, kidney diseases of autoimmune origin (including acute glomerulonephritis), nephrotic syndrome.

    - Subacute thyroiditis.

    - Diseases of the blood: agranulocytosis, panmielopatiya, autoimmune hemolytic anemia,- acute lympho- and myeloblastic leukemia, lymphogranulomatosis, - thrombocytopenic purpura, secondary thrombocytopenia in adults, erythroblastopenia (erythrocyte anemia), congenital (erythroid) hypoplastic anemia.

    - Lung diseases: acute alveolitis, pulmonary fibrosis, sarcoidosis II-III st, tubercular meningitis, pulmonary tuberculosis, aspiration pneumonia (in combination with specific chemotherapy), berylliosis, Leffler's syndrome (not amenable to other therapy), lung cancer (in combination with cytostatics ).

    - Multiple sclerosis.

    - Diseases of the gastrointestinal tract (GIT): ulcerative colitis, Crohn's disease, local enteritis.

    - Hepatitis.

    - Prevention of rejection of graft rejection.

    - Hypercalcemia on the background of cancer, nausea and vomiting during cytostatic therapy.

    - Myeloma disease.

    Contraindications:

    - Hypersensitivity to prednisolone and other steroids or to any auxiliary substance (see section "Composition");

    - systemic fungal infections;

    - lactation;

    - galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

    In children during the growth period, SCS should be used only in absolute indications and under the strictest supervision of the attending physician.

    Carefully:

    With caution, the drug should be administered in the following conditions and conditions:

    - diseases of the gastrointestinal tract - peptic ulcer of the stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with perforation or abscessing, diverticulitis;

    - parasitic and infectious diseases of a viral, fungal or bacterial nature (current or recent, including recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chicken pox, measles; amebiasis, strongyloidiasis; systemic mycosis;

    - active or latent tuberculosis. The use in severe infectious diseases is permissible only against the background of specific antimicrobial therapy;

    - pre- and post-vaccination period (8 weeks before and 2 weeks after vaccination), lymphadenitis after BCG vaccination;

    - immunodeficiency states (including AIDS or HIV infection);

    - diseases of the cardiovascular system, incl. recently suffered myocardial infarction (in patients with acute and subacute myocardial infarction it is possible to spread a foci of necrosis,slowing the formation of scar tissue and, as a result, rupture of the heart muscle), severe chronic heart failure, arterial hypertension, hyperlipidemia, concomitant treatment with diuretics releasing potassium;

    - Endocrine diseases: diabetes mellitus (including a violation of carbohydrate tolerance), thyrotoxicosis, hypothyroidism, hyperparathyroidism, Itenko-Cushing's disease, obesity (III-IV century);

    - severe chronic renal and / or hepatic insufficiency, nephrourolythiasis;

    - hypoalbuminemia and conditions predisposing to its occurrence;

    - systemic osteoporosis, myasthenia gravis, acute psychosis, poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma, lymphatic tumors, latent epilepsy;

    - pregnancy.

    Pregnancy and lactation:

    During pregnancy (especially in the first trimester) is used only for life indications.

    With prolonged therapy during pregnancy, the possibility of impaired fetal growth is not ruled out. In the case of use in the III trimester of pregnancy, there is a risk of atrophy of the adrenal cortex in the fetus, which may require replacement therapy in the newborn.

    As glucocorticosteroids penetrate into breast milk, if breastfeeding is necessary during breastfeeding, breast-feeding should be discontinued.
    Dosing and Administration:

    The dose of the drug and the duration of treatment is determined by the doctor individually, depending on the indications and severity of the disease.

    At appointment it is necessary to consider a daily secretory rhythm of glucocorticosteroids: in the morning appoint a large (or all) part of the dose.

    Tablets should be taken during or immediately after meals, with a small amount of liquid.

    Substitution therapy - 20-30 mg / day; maintenance dose - 5-10 mg / day. In some diseases (nephrotic syndrome, some rheumatic diseases), higher doses are prescribed. If there is a history of psychosis, high doses are prescribed under the strict supervision of a doctor.

    Doses for children: the initial dose - 0,1-2 mg / kg / day for 4-6 receptions, maintenance dose - 0, 3-0.6 mg / kg / day.

    With prolonged use of the drug, the daily dose should be reduced gradually. Long-term therapy can not be stopped suddenly!
    Side effects:

    The frequency of development and the severity of unwanted adverse reactions (NDP) depends on the duration of the application,the magnitude of the dose used and the possibility of observing the circadian rhythm of prednisolone administration.

    Classification of CPD by frequency of development: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000); frequency is unknown (can not be estimated from available data).

    When applying Prednisolone may be noted:

    Disorders from the endocrine system

    Often: insufficiency of the adrenal cortex (beginning with inhibition of the hypothalamus and ending with a true atrophy of the adrenal cortex) with prolonged oral administration of prednisolone (see section "Special instructions"), withdrawal syndrome due to insufficiency of the adrenal cortex (headache, nausea, dizziness, anorexia, weakness, changes in emotional state, apathy and inadequate response to stressful situations (see section "Special instructions")), "steroidal" diabetes mellitus with low sensitivity to insulin, increased co The concentration of glucose in the blood in patients already suffering from diabetes. Retarded growth in children as a result of impaired growth hormone secretion and decreased sensitivity to growth hormone.

    Often: Itenko-Cushing syndrome (lunar face, obesity of the pituitary type, hirsutism, increased blood pressure, dysmenorrhea, muscle weakness, striae) with prolonged administration of oral doses higher than physiological (usually more than 50 mg per day). (see section "Special instructions"), hypokalemia due to the mineral corticoid effect, amenorrhea in women of childbearing age, increased cholesterol, triglycerides and lipoproteins when treated with high doses taken internally, decreased or increased appetite, weight gain.

    Infrequently: diabetes mellitus (<1%) when treated in small doses orally, increasing the concentration of cholesterol, triglycerides and lipoproteins in low-dose treatment.

    Rarely: changes in the function of the thyroid gland.

    Rarely: ketoacidosis and hyperosmolar coma, manifestation of latent hyperparathyroidism, acceleration of porphyria development, tumor lysis syndrome (see section "Special instructions").

    Frequency unknown: increased calcium excretion, hypocalcemia, negative nitrogen balance (increased protein breakdown).

    Disorders from the gastrointestinal tract

    Often: candidiasis of the oral mucosa, risk, perforation of the gastrointestinal tract in colitis, ileitis, diverticulitis.

    Infrequently: peptic ulcers in patients receiving treatment with acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding (0.5%).

    Rarely: Pancreatitis after long-term treatment with high doses.

    Frequency unknown: nausea, vomiting, flatulence, hiccough.

    Disorders from the cardiovascular system

    Often: increased blood pressure (due to delay in sodium, which leads to fluid retention), aggravation of chronic heart failure (as a result of sodium retention).

    Rarely: cardiomyopathy with an increased risk of reducing the cardiac output, arrhythmia due to hypokalemia, acute cardiovascular failure (see section "Special instructions").

    Frequency unknown: bradycardia (up to cardiac arrest). In patients with acute and subacute myocardial infarction - the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle.

    Disorders of the psyche

    Often: euphoria, depression, "steroid" psychosis.

    Infrequently: insomnia, mood swings, personality changes, manic syndrome (see "Special instructions") and hallucinations.

    Disturbances from the nervous system

    Rarely: violation of cognitive functions (eg, weakening of memory), epidural lipomatosis.

    Highly, rarely: manifestation of latent epilepsy, pseudotumor of the brain (benign intracranial hypertension with symptoms such as headache, blurred vision and visual impairment).

    Frequency unknown: delirium, disorientation, paranoia, increased intracranial pressure, nervousness or anxiety, dizziness, vertigo, convulsions.

    Disturbances on the part of the organ of sight

    Very often: increased intraocular pressure (up to 40% of patients treated with oral prednisolone), posterior subcapsular cataract in 30% with long-term oral treatment.

    Rarely: glaucoma (prolonged treatment with the drug orally).

    Very rarely: exophthalmos (after a very long treatment with the drug orally), chorioretinopathy.

    Frequency unknown: propensity to develop secondary bacterial, fungal or viral infections of the eyes, trophic changes in the cornea.

    Disturbances from musculoskeletal and connective tissue

    Often: osteoporosis with associated symptoms such as back pain, decreased mobility, acute pain, compression fractures of the vertebrae and decreased vertebrae height, fractures of long bones (25% with prolonged oral treatment (see section "Special instructions")); Myopathy (10%) when treated with high doses.

    Infrequently: avascular aseptic necrosis of bone tissue.

    Rarely: tendonopathy, especially the Achilles tendon and the tendon of the quadriceps muscle of the thigh (see section "Interaction").

    Frequency unknown: pathological fractures of bones, aseptic necrosis of the head of the humerus and femur, decrease in muscle mass (atrophy).

    Disturbances from the skin and subcutaneous tissues

    Often: fungal infections that affect the skin and mucous membranes, striae, acne, ecchymosis and petechia, dermatitis, facial erythema, atrophy, hirsutism, wound healing, increased sweating, telangiectasia and thinning of the skin.

    Rarely: epidermal necrolysis, Stevens-Johnson syndrome.

    Frequency unknown: hyper or hypopigmentation.

    Immune system disorders

    Often: immunosuppressive and anti-inflammatory effect, leading to masking or exacerbation of the existing disease (see section "Special instructions").

    Infrequently: allergic reactions (skin rash, itching, local allergic reactions).

    Frequency unknown: anaphylactic shock.

    Infectious and parasitic diseases

    Often: increased susceptibility to infection, exacerbation of existing infection, activation of latent infection and masking of infection symptoms due to immunosuppressive and anti-inflammatory effect of prednisolone (see section "Special instructions").

    Violations of the blood and lymphatic system

    Very often: a decrease in the number of eosinophils and lymphocytes.

    Often: increase in the number of leukocytes and platelets.

    Rarely: the risk of thrombosis due to increased blood coagulability.

    Disturbances from the respiratory system, chest and mediastinal organs

    Often: lung abscess in patients with lung cancer (12%).

    Often: increased risk of tuberculosis.

    Infrequently: myopathy, affecting the respiratory muscles.

    Violation of the kidneys and urinary tract

    Often: nocturnal polyuria.

    Infrequently: formation - urinary stones due to increased excretion of calcium and phosphate.

    Frequency unknown: leukocyturia.

    Laboratory and instrumental data

    Rarely: increased activity of "liver" transaminases and alkaline phosphatase.

    Overdose:It is possible to increase dose-dependent side effects. It is necessary to reduce the dose of Prednisolon Nycomed.
    Treatment is symptomatic.
    Interaction:

    The simultaneous use of prednisolone with:

    - inductors of microsomal liver enzymes (barbiturates, rifampicin, phenytoin, theophylline, ephedrine) leads to a decrease in its concentration;

    - Diuretics (especially "thiazide" and inhibitors of carbonic anhydrase) and amphotericin B can lead to increased excretion of potassium from the body and an increased risk of developing heart failure;

    - inhibitors of carbonic anhydrase and "loop" diuretics may increase the risk of osteoporosis;

    - Fluoroquinolones - increased risk of rupture of tendons; sodium-containing drugs - to the development of edema and increased blood pressure;

    - cardiac glycosides - increases the toxicity of cardiac glycosides (because of the resulting hypokalemia, the risk of arrhythmias increases);

    - indirect / anticoagulants - weakens (less intensifies) their effect (dose adjustment is required);

    - anticoagulants and thrombolytic - increases the risk of bleeding from ulcers in the gastrointestinal tract;

    - ethanol and non-steroidal anti-inflammatory drugs (NSAIDs) - the risk of erosive and ulcerative lesions in the gastrointestinal tract and bleeding increases (in combination with NSAIDs in the treatment of arthritis, a dose of glucocorticosteroids may be reduced due to the summation of the therapeutic effect);

    - indomethacin - increased risk of side effects of prednisolone (displacement of indomethacin prednisolone from bond with albumins);

    - paracetamol - the risk of hepatotoxicity increases (induction of microsomal liver enzymes and the formation of a toxic metabolite of paracetamol);

    - Acetylsalicylic acid - accelerates its elimination and reduces the concentration in the blood (with the withdrawal of prednisolone, the concentration of salicylates in the blood increases and the risk of side effects increases), increases the risk of gastrointestinal bleeding and ulceration;

    - insulin and oral hypoglycemic drugs, hypotensive drugs - their effectiveness decreases;

    - vitamin D - its effect on absorption of calcium ions decreases (Ca2+) in the intestine;

    - somatotropin - reduces the effectiveness of the latter, and with praziquantel - its concentration;

    - M-holinoblokatorami (including antihistamines and tricyclic antidepressants) and nitrates - promotes increased intraocular pressure;

    - neuromuscular blockers (for example, pancuronium bromide) - lowering the effectiveness of blocking neuromuscular transmission; increased risk of myopathy with prolonged simultaneous admission;

    - isoniazid and mexiletine - increases their metabolism (especially in "slow" acetylators), which leads to a decrease in their plasma concentrations;

    - quetiapine - a decrease in the concentration of quetiapine in the blood serum;

    - methotrexate, licorice preparations - increases the risk of side effects of prednisolone.

    Corticotropin enhances the action of prednisolone.

    Ergocalciferol and parathyroid hormone interfere with the development of osteopathy caused by prednisolone.

    Cyclosporine and ketoconazole, slowing the metabolism of prednisolone, can in some cases increase its toxicity.

    Simultaneous appointment of androgens and steroid anabolic drugs with prednisolone promotes the development of peripheral edema and hirsutism, the appearance of acne.

    Estrogens and oral estrogen-containing contraceptives reduce the metabolism of prednisolone in the liver, which increases the risk of side effects of glucocorticosteroids.

    Mitotane and other inhibitors of adrenal cortex function may necessitate an increase in the dose of prednisolone.

    With simultaneous use with live antiviral vaccines and against other types of immunizations, increases the risk of virus activation and the development of infections.

    Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with the Epstein-Barr virus.

    Antipsychotic drugs (antipsychotics) and azathioprine increase the risk of developing cataracts in the appointment of prednisolone.

    Simultaneous administration of antacids reduces the absorption of prednisolone.

    With simultaneous use with antithyroid drugs is reduced, and with thyroid hormones - increases the clearance of prednisolone.

    Special instructions:

    During treatment with Prednisolon Nycomed (especially prolonged), an ophthalmologist should be monitored, blood pressure control, water-electrolyte balance status, and peripheral blood and blood glucose levels monitored. Patients should be observed to identify suppression of the hypothalamic-pituitary-adrenal system (GGN) (insufficiency of the adrenal cortex), Itenko-Cushing syndrome, hyperglycemia and glucosuria.

    In order to reduce side effects, it is possible to prescribe antacids, and also to increase the intake of potassium in the body (diet, potassium preparations). Food should be rich in proteins, vitamins, with a restriction of fat, carbohydrates and table salt.

    The effect of the drug is enhanced in patients with hypothyroidism and liver cirrhosis.

    The drug may enhance existing emotional instability or psychotic disorders. When referring to a psychosis in an anamnesis, prednisolone Nycomed in high doses is prescribed under the strict supervision of a doctor.

    In stressful situations during maintenance treatment (for example, surgical operations, trauma or infectious diseases), a correction of the dose of the drug should be made in connection with an increase in the need for glucocorticosteroids.

    One should carefully monitor the patient within a year after the end of long-term therapy with Prednisolon Nycomed in connection with the possible development of a relative insufficiency of the adrenal cortex in stressful situations.

    In case of sudden cancellation, especially in case of prior application of high doses, it is possible to develop a withdrawal syndrome (anorexia, nausea, inhibition, generalized musculoskeletal pain, general weakness), as well as an exacerbation of the disease, in which Prednisolon Nycomed was appointed.

    During treatment with Prednisolone, Nycomed should not be vaccinated due to a decrease in her effectiveness (immune response).

    When prescribing Prednisolone Nycomed with intercurrent infections, septic conditions and tuberculosis, antimicrobial treatment should be concurrently administered.

    Prednisolone should be administered with caution in any known infectious disease or suspected of it (see section "Side effect"). Patients during treatment should avoid contact with patients with viral infections and immediately consult a doctor in case of contact with them.

    Children during long-term treatment with prednisolone Nycomed need careful monitoring of the dynamics of growth and development.

    Due to a weak mineralocorticoid effect for replacement therapy with adrenal insufficiency Prednisolone Nycomed is used in combination with mineralocorticoids.

    Prednisolone enhances gluconeogenesis. Approximately 20% of patients receiving treatment with high doses of glucocorticosteroids develop benign "steroid" diabetes mellitus with low sensitivity to insulin and a low renal threshold for glucose. The condition is reversible upon cancellation of therapy. Patients with diabetes should monitor blood glucose and, if necessary, correct therapy.

    Prolonged treatment with prednisolone affects the metabolism of calcium and phosphate and increases the risk of osteoporosis. The loss of bone tissue, induced by glucocorticosteroids, can prevent the appointment of calcium and vitamin D3. An x-ray control of the osteoarticular system (images of the spine, hands) is shown.

    Prednisolone Nycomed in patients with latent infectious diseases of the kidneys and urinary tract can cause leukocyturia,that can have diagnostic value.

    Prednisolone Nycomed increases the content of metabolites - 11 and 17-oxyketocorticosteroids.

    During the immunosuppressive therapy with glucocorticosteroids, vaccination with live viral or bacterial vaccines is counter-indicative. A reduced immune response may allow a live attenuated vaccine to cause an infectious disease.

    Effect on the ability to drive transp. cf. and fur:

    During treatment, patients are advised to use caution when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:Tablets, 5 mg.
    Packaging:

    For 10 tablets in a blister of PVC / PVDH film and aluminum lacquered foil;

    1, 3, 4 and 10 blisters with instructions for use in a cardboard bundle.

    Storage conditions:

    In the dark place at a temperature 18-25 FROM.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015850 / 02
    Date of registration:19.09.2011
    The owner of the registration certificate:Takeda Austria GmbHTakeda Austria GmbH Austria
    Manufacturer: & nbsp
    Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.
    Information update date: & nbsp28.08.2015
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