Expiration date: 10/2025

The composition and form of issue:

Tablets, film-coated, prolonged action. 1 table contains:

felodipine 5 mg

metoprolol succinate (50 mg metoprolol tartrate) 47,5 mg

Excipients: ethyl cellulose hydroxypropyl methylcellulose hydroxypropyl cellulose lactose anhydrous polyoxyl 40 hydrogenated castor oil microcrystalline wax polyethylene glycol, the propyl gallate silicon dioxide sodium aluminum silicate sodium stearyl fumarate titanium dioxide (E171), iron oxides (E172) 

in plastic bottles to 30 PCs. in cardboard pack 1 bottle.

Description pharmaceutical form:

Pills apricot color, film-coated, round, 10 mm in diameter, biconvex, engraved A/FG on the same side. Pills are composed of microcapsules of metoprolol succinate, individually coated with a special membrane, providing uniform release of metoprolol, the microcapsules are placed together with felodipine in the gel matrix.

Pharmacological action:

Blocks beta1-adrenergic receptors in the myocardium (metoprolol), and inhibits the entrance of calcium ions into cells smooth muscles receptacles (felodipine).

Pharmacokinetics:

Completely absorbed from the gastrointestinal tract. The systemic bioavailability of felodipine — 15%, metoprolol — 50%. The plasma protein binding have felodipine is 99%. T1/2 of felodipine — h 25, metoprolol 3-5 hours the Active ingredients are metabolized in the liver. 70% of felodipine is excreted as metabolites in the urine, the rest — with feces. Less than 5% metoprolol is excreted unchanged by the kidneys.

Description pharmacological action:

Metoprolol reduces the stimulatory effect of catecholamines on the myocardium, cardiac output and blood pressure.

The felodipine relaxes smooth muscle of the vascular wall, reduces round and potentiates (each) metoprolol-induced hypotension.

Clinical pharmacology:

The hypotensive effect is stable for 24 hours

Indications:

Hypertension, symptomatic arterial hypertension.

Contraindications:

Hypersensitivity, acute myocardial infarction, unstable angina, expressed sinusova aetiology, AV blockade II-III degree, syndrome weakness sinusnogo unit severe peripheral circulatory disorders, decompensated heart failure, cardiogenic shock, pregnancy.

Application of pregnancy and breast-feeding:

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects:

• From the nervous system and sensory organs: more 1% — headache, weakness
  
• 0,1–0,9% — dizziness, paresthesia, depression, weakening of concentration, drowsiness or insomnia
  
• 0,01–0,09% — nervousness, anxiety, blurred vision, dry or irritated eyes, conjunctivitis
  
• less than 0.01% — amnesia, confusion, hallucinations, tinnitus, breach of taste sensations.
  
• From the cardiovascular system and blood (hematopoiesis, hemostasis): 1-9,9% — redness of the face, bradycardia, palpitation, postural disorders, cold extremities, peripheral edema
  
• 0,1–0,9% — tachycardia, AV blockade of I degree, the pain in the heart area
  
• 0,01–0,09% — syncope
  
• less than 0,01% — gangrene in patients with severe peripheral circulatory disorders, thrombocytopenia.
  
• From the respiratory system: more 1% — shortness of breath during physical effort
  
• 0,1–0,9% — rhinitis.
  
• On the part of the digestive tract: more than 1% — nausea, abdominal pain, diarrhea or constipation
  
• 0,1–0,9% — vomiting, loss of body weight
  
• 0,01–0,09% — dry mouth, changes in liver function tests
  
• less than 0.01% — hyperplasia of the mucosa, increase in the concentration of liver enzymes.
  
• From the urogenital system: 0,1–0,9% — impotence, sexual dysfunction.
  
• From the musculoskeletal: less than 0.01% — myalgia, arthralgia.
  
• With the skin: 0,1–0,9% — rash (in the form of urticaria psoriasiform), dystrophic skin lesions
  
• 0,01–0,09% — hair loss
  
• less than 0,01% — photosensitivity.
  
• Allergic reactions: less than 0.01% — angioneurotic edema.
  

Drug interactions:

Calcium channel blockers of the type verapamil potentiate the negative Ino - and chronotropic effect. Do negative foreign and dromotropony action of antiarrhythmic drugs (analogs of quinidine, amiodarone), cardiodepressivne — inhaled anesthetics. Increase the concentration of metoprolol in plasma cimetidine, hydralazine, alcohol, lower — rifampicin. Indomethacin and other inhibitors prostaglandinsynthase weaken hypotensive effect.

Method of application and dose:

Inside, in the morning, without chewing, drinking water. Initial dose 1 table. 1 time a day, if necessary, the dose is doubled.

No need to adjust the treatment regimen in patients with impaired renal function. Usually no need to adjust the treatment regimen in patients with hepatic impairment, including patients with cirrhosis of the liver. If you have symptoms of serious disturbances of liver function (e.g. in patients with a history of operations with bypass) should consider the possibility of reducing the dose of the drug.

In patients of advanced age are usually sufficient 1 table. 1 time a day, if necessary — 2 times a day.

Overdose:

Symptoms: hypotension, sinus bradycardia, AV blockade, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, nausea, vomiting, cyanosis. The first signs can appear within 20 min — 2 h after administration.

Treatment: induction of vomiting, gastric lavage, symptomatic therapy: in the case of severe hypotension, bradycardia or threats of heart failure — beta1-agonist (in/in intervals of 2-5 minutes or by infusion) or dopamine (in/in) or atropine sulfate the purpose of the blockade of the vagus nerve dobutamine, norepinephrine, glucagon (1-10 mg). If necessary the use of a pacemaker. For the relief of bronchospasm in/in the introduction of beta2-agonist.

Precautions:

Nor should appoint patients with suspected acute myocardial infarction with heart rate less than 45 beats/min, PQ interval of more than 0,24 or sad less than 100 mm Hg.St. Close medical monitoring is necessary while the use of ganglioblokatorami, . beta-adrenoblokatorami, MAO inhibitors. While the use of clonidine and the need to cancel the last treatment with Logimax should be discontinued several days before clonidine undo. Before surgery should notify the anesthesiologist about the drug. Cancel gradually over 1.5–2 weeks.