Expiration date: 11/2025

The composition and form of issue: 

Tablets with sustained release, film-coated. 1 tablet contains active substance: 

metoprolol succinate 23,75 mg or 47,5 mg or 95 mg

(equal to 19.5, 39 and 78 mg metoprolol 25, 50 and 100 mg of metoprolol tartrate, respectively) 

other ingredients: ethyl cellulose polymer of hyprolose paraffin, macrogol, silicon dioxide, sodium fumarate titanium dioxide 

in blister packs of aluminium/PVC 14 PCs. in cardboard pack 1 blister (tab. 25 mg) or in plastic bottle with screw cap with tamper-evident 30 PCs cartons 1 a bottle (tab. at 50 and 100 mg).

Description pharmaceutical form:

Betaloc ZOK 25 mg: oval biconvex tablets are white or almost white, film-coated with the notch on both sides and engraved A/&beta on the same side.

Betaloc ZOK 50 mg: round biconvex tablets white or almost white, coated with a notch on one side and engraving A/mo on the other side.

Betaloc ZOK 100 mg: round biconvex tablets white or almost white, coated with a notch on one side and engraving A/ms on the other side.

Indications:

• hypertension
  
• angina
  
• stable symptomatic chronic heart failure with systolic dysfunction of the left ventricle (as a secondary therapy to basic treatment of chronic heart failure)
  
• reducing mortality and frequency of reinfarction after the acute phase of myocardial infarction
  
• cardiac arrhythmias, including supraventricular tachycardia, a reduction in the frequency of ventricular contraction during atrial fibrillation and ventricular extrasystoles
  
• functional cardiac abnormalities, accompanied by palpitations
  
• prevention of migraine attacks.
  

Contraindications:

• known hypersensitivity to metoprolol and its components or to other &beta-blockers
  
• AV blockade II and III level, heart failure decompensation, patients receiving prolonged or intermittent inotropic therapy means acting beta-adrenergic receptors, clinically significant sinus bradycardia, sick sinus syndrome node, cardiogenic shock, severe peripheral circulatory disorders, hypotension
  
• patients with acute myocardial infarction with heart rate less than 45 beats per minute, a PQ interval of more than 0,24 or sad less than 100 mm Hg.St.
  
• severe peripheral vascular disease with the threat of gangrene
  
• in/in the introduction blockers "slow" calcium channels such as verapamil
  
• the age of 18 years (efficacy and safety not established).
  

Caution: AV blockade of I degree, Prinzmetal's angina, asthma, COPD, diabetes, severe renal insufficiency, severe hepatic insufficiency, metabolic acidosis, joint appointment with cardiac glycosides.

Application of pregnancy and breast-feeding:

Like most drugs Betaloc ZOK should not be administered during pregnancy and breastfeeding, except in those cases where the expected benefit to the mother outweighs the potential risk to the fetus and/or child. Like other antihypertensive agents, &beta-blockers can cause side effects, e.g., bradycardia in fetus, infants or children, breastfeeding.

Number of metoprolol released in the breast milk, and beta-adrenoblokirtee the action of the child who is breast-feeding (while taking metoprolol mother in therapeutic doses), are insignificant.

Side effects:

Betaloc ZOK is well tolerated by patients, side effects are mostly mild and reversible.

To assess the frequency of cases has applied the following criteria: very common (>10%), often (1-9,9%), uncommon (0,1–0,9%), rare (0,01–0,09%) and very rare (<0,01%).

From the CCC: often — aetiology, orthostatic hypotension (very rarely accompanied by fainting), cold extremities, and rarely other disorders of heart conduction, arrhythmia, very rarely — gangrene in patients with previous severely impaired peripheral blood circulation.

CNS: very often fatigue often dizziness, headache, rarely — increased nervous irritability, anxiety, impotence/sexual dysfunction infrequently, paresthesia, convulsions, depression, weakened attention, drowsiness or insomnia, nightmares very rare: amnesia/memory impairment, depression, hallucinations.

From the digestive tract: often — nausea, pain in the abdomen, diarrhea, constipation infrequently — vomiting rare — dry mouth.

Hepatic: rarely — infringements of function of a liver very rarely — hepatitis.

With the skin: rarely — rash (urticaria), increased sweating, rarely hair loss is very rarely photosensitivity, exacerbation of psoriasis.

From the side of respiratory system: often — shortness of breath during physical effort rarely, bronchospasm rare — rhinitis.

From the sensory organs: rare — visual disturbances, dry and/or irritated eyes, conjunctivitis very rarely tinnitus, breach of taste sensations.

From the skeletal-muscular system: very rarely — artralgia.

From the metabolic: rare — increase in body weight.

From the side of blood system: rarely — thrombocytopenia.

Method of application and dose:

Betaloc ZOK designed for daily use, 1 times a day, it is recommended to take the drug in the morning. Tablet Betaloc ZOK should be swallowed with liquid. Tablets (or tablet split in half) you should not chew or crush. Eating does not affect the bioavailability of the drug.

The selection of doses necessary to avoid the development of bradycardia.

Hypertension. 50-100 mg 1 time per day. If necessary, the dose can be increased to 100 mg/day or add other antihypertensive agents, preferably a diuretic and calcium antagonist digidropiridinovmi series.

Angina. 100-200 mg Betaloc ZOK 1 time per day. If necessary, therapy can be added to other antianginal drug.

Stable symptomatic chronic heart failure with systolic dysfunction of the left ventricle. Patients should be in the stage of stable chronic heart failure without exacerbation episodes during the last 6 weeks and no change in the basic therapy during the past 2 weeks.

Therapy heart failure beta-blockers can sometimes lead to temporary impairment of the symptomatic picture. In some cases, continued therapy or dose reduction, in some cases, you may need the drug.

Stable chronic heart failure II functional class. The recommended initial dose of the drug Betaloc ZOK in the first 2 weeks — on 25 mg 1 times per day. After 2 weeks of therapy, the dose may be increased to 50 mg 1 time a day, and could continue to double every 2 weeks.

Maintenance dose for long term treatment — 200 mg of drug Betaloc ZOK 1 time per day.

Stable chronic heart failure III–IV functional class. The recommended starting dose in the first 2 weeks — 12.5 mg Betaloc ZOK (half tablet of 25 mg) 1 times a day. The dose is adjusted individually. In the period of increasing the dose the patient should be monitored, since some patients have symptoms of heart failure may worsen.

After 1-2 weeks the dose may be increased to 25 mg Betaloc ZOK 1 time per day. Then, after 2 weeks, the dose may be increased to 50 mg 1 time a day. Patients who tolerate the drug, doubling the dose every 2 weeks until the maximum dose is 200 mg Betaloc ZOK 1 time per day.

In the event of hypotension and/or bradycardia may need to decrease concomitant therapy or dose reduction of the drug Betaloc ZOK. Hypotension at the beginning of therapy does not necessarily indicate that this dose Betaloc ZOK not to be tolerated in the future long-term care. However, the dose should not be increased as long as the condition is not stabiliziruemost. May require monitoring of kidney function.

Heart rhythm abnormalities. 100-200 mg of drug Betaloc ZOK 1 time per day.

Maintenance treatment after myocardial infarction. 200 mg of the drug Betaloc ZOK 1 time per day.

Functional cardiac abnormalities, accompanied by tachycardia. 100 mg of drug Betaloc ZOK 1 time per day. If necessary, the dose can be increased to 200 mg/day.

Prevention of migraine attacks. 100-200 mg of drug Betaloc ZOK 1 time per day.

The impairment of renal function. There is no need to adjust the dose in patients with impaired renal function.

The liver dysfunction. Usually due to low degree of Association with plasma proteins, dose adjustment of metoprolol is required. However, in severe liver dysfunction (in patients with severe liver cirrhosis or portocaval anastomosis) may require dose reduction.

Old age. No need to adjust the dose in elderly patients.

Children. The experience of the drug Betaloc ZOK in children is limited.

Overdose:

Toxicity

Metoprolol at a dose of 7.5 g in an adult caused intoxication with fatal outcome. 5-year-old child who took 100 mg metoprolol, after gastric lavage were observed for signs of intoxication. Receiving 450 mg metoprolol teenager 12 years has led to moderate intoxication. Reception 1.4 and 2.5 g of metoprolol adults caused moderate and severe intoxication, respectively. Receiving 7.5 g adults has led to extremely severe intoxication.

Symptoms: in overdose metoprolol most serious are the symptoms of SSS, but sometimes, especially in children and adolescents, may prevail symptoms of the Central nervous system and the suppression of pulmonary function, aetiology, AV blockade of I–III extent, asystole, marked reduction in blood pressure, weak peripheral perfusion, cardiac failure, cardiogenic shock, depression of lung function, apnea, as well as, increased fatigue, impaired consciousness, loss of consciousness, tremor, convulsions, sweating, paresthesia, bronchospasm, nausea, vomiting, possible spasm esofagului, hypoglycemia (especially in children) or hyperglycemia, hyperkalemia effects on the kidneys transient myasthenic syndrome concomitant ingestion of alcohol, antihypertensive drugs, quinidine or barbiturates may worsen the patient's condition. The first signs of overdose may be observed 20 minutes to 2 hours after administration of the drug.

Treatment: use activated charcoal, if necessary gastric lavage.

IMPORTANT! Atropine (0.25–0.5 mg in/in adults, 10-20 micrograms/kg for children) should be appointed to gastric lavage (because of the risk of stimulation of the vagus nerve). If necessary, maintain airway (intubation), and adequate ventilation. To fill the BCC and infusion of glucose. Monitoring of ECG. Atropine 1-2 mg in/in, if necessary, repeat the introduction (especially in the case of vagal symptoms). In the case of suppression (depression) of the myocardium is shown infusion introduction dobutamine or dopamine. You can also use glucagon 50-150 µg/kg/every 1 min. In some cases, it may be effectively adding to the therapy of adrenaline. When arrhythmias and extensive ventricular (QRS) complex infusion administered solutions of sodium (chloride or bicarbonate). Is possible to install an artificial pacemaker. In case of cardiac arrest due to an overdose may need resuscitation for several hours. For the relief of bronchospasm may be used terbutaline (injectable or via inhalation). Is symptomatic treatment.

Special instructions:

Patients receiving &beta-blockers should not be administered in/in blockers "slow" calcium channels such as verapamil.

Patients suffering from obstructive pulmonary disease, it is not recommended to assign &beta-blockers. In case of poor tolerability of other antihypertensive drugs or their ineffectiveness, you can assign metoprolol because it is a selective drug. You must assign the minimum effective dose, if necessary, you can assign &beta2-agonists.

Not recommended for non-selective &beta-blockers for patients with angina prinzmetals. This group of patients &beta-selective blockers should be prescribed with caution.

When using a &beta1-blockers risk their effect on carbohydrate metabolism or masking of symptoms of hypoglycemia is significantly less than when using non-selective &beta-blockers.

In patients with chronic heart failure decompensation is necessary to achieve the compensation stage, both before and during drug treatment.

Very rarely in patients with impaired AV conduction can occur deterioration (possible outcome — AV blockade). If during treatment developed bradycardia, the dose must be reduced or gradually stop the drug.

Metoprolol can worsen the symptoms of peripheral circulatory disorders mainly due to decline in AD.

Caution should be exercised when prescribing the drug to patients suffering from severe renal failure, with metabolic acidosis, a joint appointment with cardiac glycosides.

In patients receiving &beta-adrenoblokatora, anaphylactic shock occurs in a more severe form. The use of epinephrine in therapeutic doses does not always produce the desired clinical effect in patients receiving metoprolol. Patients suffering from pheochromocytoma, in parallel with the drug Betaloc ZOK assign &alpha-blocker.

In the case of surgical intervention should inform the anesthetist that the patient takes Betaloc ZOK. Patients who have surgery, discontinue treatment &beta-adrenoblokatorami is not recommended.

The clinical trial data on efficacy and safety in patients with severe stable symptomatic heart failure (class IV NYHA classification) is limited. The treatment of such patients should be performed by doctors with special knowledge and experience.

Patients with symptomatic heart failure in conjunction with acute myocardial infarction and unstable angina were excluded from the studies on the basis of which was defined the indications. The efficacy and safety of the drug for this group of patients is not described. Use in unstable heart failure decompensation contraindicated.

Avoid abrupt discontinuation of the drug. If necessary, discontinuation of the drug, the abolition should be gradual. In most patients the drug can be cancelled up to 14 days. Dose of the drug reduced gradually in stages until the ultimate dose of 25 mg 1 time per day.

Effects on ability to drive and work with technical devices. When driving and performing potentially hazardous activities, require high concentration and psychomotor speed reactions, should be aware that when using the drug Betaloc ZOK may experience dizziness and fatigue.

Review:

Before using the drug you must read the instructions for use.