bisoprolol | Niperten tablets 5 mg, 30 pcs.

Release form

Film-coated tablets.



packaging 30 pcs

Pharmacological action

Niperten has a hypotensive, antianginal, antiarrhythmic effect.

Indications

arterial hypertension

CHD: prevention of angina attacks

CHF.

Contraindications

hypersensitivity to Niperten components and other β-blockers

shock (including cardiogenic)

collapse

pulmonary edema

acute heart failure, CHF in the stage of decompensation

AV block II – III degree

sinoatrial blockade

sinus syndrome weak syndrome

severe bradycardia

angina pectorismetal

cardiomegaly (without signs of heart failure) cardiomyopathy with less than 100 mm arterial hypertension )

severe bronchial asthma and chronic obstructive pulmonary disease (COPD) with a history of

simultaneous administration of MAO inhibitors (except MAO-B)

late stages of peripheral circulatory disorders srd lkp Raynaud's disease

pheochromocytoma (without the simultaneous use of -adrenoblockers)

metabolic acidosis

age under 18 years (efficacy and safety have not been established).

Precautions: liver failure, chronic renal failure, myasthenia gravis, thyrotoxicosis, diabetes mellitus, AV block I degree, depression (including a history), psoriasis, allergic reactions (history), old age.

Use during pregnancy and lactation

Use during pregnancy and lactation is possible when the expected benefits of therapy for the mother outweigh the risk of side effects in the fetus or infant.

It should be borne in mind that the drug is capable of causing intrauterine retardation of the fetus, hypoglycemia, bradycardia.

There is no data on the allocation of bisoprolol with breast milk. Therefore, if necessary, use the drug during lactation, breastfeeding should be discontinued.

Composition

1 tablet contains bisoprolol fumarate (2: 1) 5 mg

excipients: MCC carboxymethyl starch sodium povidone silicon dioxide colloidal anhydrous magnesium stearate

shell: hypromellose macrogol titanium dioxide talc.

Dosage and administration

Niperten is taken orally, on an empty stomach in the morning, without chewing, once. It is recommended to take 5 mg once. If necessary, increase the dose to 10 mg once a day. The maximum daily dose is 20 mg.

Side effects of

From the central nervous system and peripheral nervous system: increased fatigue, weakness, dizziness, headache, sleep disorders, depression, anxiety, confusion or short-term loss of memory, hallucinations, asthenia, myasthenia gravis, paresthesia in the extremities (in patients with intermittent claudication and Raynaud's syndrome), tremors, convulsions (including including calf muscles).

From the side of the organ of vision: visual impairment, decreased secretion of lacrimal fluid, dryness and soreness of the eyes, conjunctivitis.

From the cardiovascular system: sinus bradycardia, palpitations, impaired myocardial conduction, AV block (up to the development of complete transverse blockade and cardiac arrest), arrhythmias, weakening myocardial contractility, development (aggravation) of heart failure (swelling of the ankles, feet shortness of breath), decreased blood pressure, orthostatic hypotension, the manifestation of angiospasm (increased impairment of peripheral circulation, cooling of the lower extremities, Raynaud's syndrome), chest pain.

From the digestive system: dry oral mucosa, nausea, vomiting, abdominal pain, constipation or diarrhea, impaired liver function (dark urine, yellowness of the sclera or skin, cholestasis), taste changes.

From the respiratory system: nasal congestion, difficulty breathing when prescribed in high doses (loss of selectivity) and / or in predisposed patients - laryngo- and bronchospasm.

From the endocrine system: hyperglycemia (in patients with non-insulin-dependent diabetes), hypoglycemia (in patients receiving insulin), hypothyroid state.

Allergic reactions: pruritus, rash, urticaria.

From the skin: increased sweating, flushing of the skin, exanthema, psoriasis-like skin reactions, exacerbation of symptoms of psoriasis, alopecia.

Laboratory parameters: thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia, changes in liver enzyme activity (increased ALT, ACT, bilirubin, triglycerides.

Effect on the fetus: intrauterine growth retardation, hypoglycemia, s bradycardia. , arthralgia, decreased libido, decreased potency, withdrawal syndrome (increased angina attacks, increased blood pressure)

Drug Interaction

Allergens used for immunotherapy or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving bisoprolol.

Iodine-containing X-ray contrast agents for IV administration increase the risk of anaphylactic reactions.

Phenytoin with / in administration, inhalation anesthesia agents (hydrocarbon derivatives) increase the severity of the cardiodepressive action of bisoprolol and the likelihood of a decrease in BP.

Niperten alters the effectiveness of insulin and hypoglycemic agents for ingestion, masking the symptoms of developing hypoglycemia (tachycardia, increased blood pressure).

Bisoprolol decreases the clearance of lidocaine and xanthines (except for theophylline) and increases their plasma concentrations, especially in patients with initially increased theophylline clearance under the influence of smoking.

Hypotensive effect is weakened by NSAIDs (delay of sodium ions and blockade of synthesis of prostaglandin by kidneys), GKS and estrogens (delay of sodium ions).

Cardiac glycosides, methyldopa, reserpine and guanfacin, slow calcium channel blockers (verapamil, diltiazem), amiodarone, and other antiarrhythmic agents increase the risk of developing or worsening bradycardia, AV blockade, cardiac arrest, and heart failure.

Nifedipine can significantly reduce blood pressure.

Diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive agents can lead to an excessive decrease in blood pressure.

Extends the action of non-depolarizing muscle relaxants and increases the anticoagulant effect of coumarins.

Tri- and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and sleeping pills increase CNS depression.

Concomitant use with MAO inhibitors is not recommended due to the significant increase in antihypertensive activity, The interval between treatment with MAO inhibitors and bisoprolol should be at least 14 days.

Non-hydrogenated ergot alkaloids increase the risk of peripheral circulation disorders.

Ergotamine increases the risk of peripheral circulation disorders, sulfasalazine increases the plasma bisoprolol concentration of rifampicin.

Overdose

Symptoms: arrhythmia, ventricular extrasystole, pronounced bradycardia, AV blockade, severe BP, chronic heart failure, cyanosis of finger nails or palms, difficulty breathing, bronchospasm.

Treatment: gastric lavage and adsorption. Symptomatic therapy: with the development of AV blockade - the introduction of 1-2 mg of atropine, epinephrine or temporary staging of the pacemaker for ventricular extrasystole - lidocaine (class IA drugs are not used) in reducing blood pressure - the patient should be in Trendelenburg if there is no evidence of pulmonary edema - in / in the introduction of plasma replacement solutions, with inefficiency, inefficiency, for maintenance of chronotropic and inotropic action and elimination of the expressed decrease in blood pressure) at heart failure - cardiac glycosides, diuretics, glucagon at convulsions - in / in diazepam at b rohospasm - beta2-adrenostimulants inhalation.

Storage conditions

In the dark place at a temperature of no higher than 25 РC.

Expiration

2 years.

Active ingredient

bisoprolol

dosage form

dosage form PMA



KRKA d.d. Novo mesto AO, Slovenia