Panaspar tablets p / o, No. 20

• To eliminate the deficiency of potassium and magnesium as part of combination therapy for various manifestations of coronary heart disease (including acute myocardial infarction);

• chronic heart failure;

• cardiac arrhythmias (including arrhythmias caused by an overdose of cardiac glycosides).

Before using it is necessary to consult a doctor.

Inside, without chewing and drinking plenty of water.

Panaspar should be taken after meals, because the acidic environment of the stomach reduces its effectiveness.

The recommended daily dose is 1 tablet 3 times a day.

The maximum daily dose is 1 tablet 3 times a day.

Active ingredients:

Potassium aspartate hemihydrate - 332.60 mg

in terms of potassium asparaginate - 316.00 mg

Magnesium aspartate tetrahydrate - 350.00 mg

in terms of magnesium asparaginate - 280.00 mg

Excipients:

Corn starch - 172.20 mg

Potato starch - 6.60 mg

Colloidal silicon dioxide - 4.00 mg

Talc - 20.00 mg

Magnesium stearate - 8.00 mg

Povidone - 6.60 mg

(medium molecular weight polyvinylpyrrolidone,

povidone K-30)

Core mass - 900.0 mg

Sheath:

Hypromellose (hydroxypropyl methylcellulose 6 cps) - 7.570 mg

Triacetin - 0.760 mg

Butyl methacrylate copolymer - 15,430 mg

Titanium dioxide - 3,850 mg

Talc - 4,520 mg

Stearic acid - 2,320 mg

Sodium lauryl sulfate - 1,550 mg

Film-coated tablet weight - 936.0 mg

• Hypersensitivity to any of the constituent components of the drug,

• acute and chronic renal failure,

• hyperkalemia,

• hypermagnesemia,

• Addison's disease

• atrioventricular block I-III degree,

• shock (including cardiogenic) (blood pressure less than 90 mm Hg),

• violation of amino acid metabolism,

• severe myasthenia gravis,

• hemolysis,

• acute metabolic acidosis,

• a state of dehydration,

• age up to 18 years (efficacy and safety have not been established).

Carefully

Pregnancy (especially in the first trimester of pregnancy) and the period of breastfeeding.

Trade name: Panaspar

International non-proprietary or group name: potassium asparaginate + magnesium asparaginate.

Dosage form: film-coated tablets.

Composition for one tablet

Active ingredients:

Potassium aspartate hemihydrate - 332.60 mg

in terms of potassium asparaginate - 316.00 mg

Magnesium aspartate tetrahydrate - 350.00 mg

in terms of magnesium asparaginate - 280.00 mg

Excipients:

Corn starch - 172.20 mg

Potato starch - 6.60 mg

Colloidal silicon dioxide - 4.00 mg

Talc - 20.00 mg

Magnesium stearate - 8.00 mg

Povidone - 6.60 mg

(medium molecular weight polyvinylpyrrolidone,

povidone K-30)

Core mass - 900.0 mg

Sheath:

Hypromellose (hydroxypropyl methylcellulose 6 cps) - 7.570 mg

Triacetin - 0.760 mg

Butyl methacrylate copolymer - 15,430 mg

Titanium dioxide - 3,850 mg

Talc - 4,520 mg

Stearic acid - 2,320 mg

Sodium lauryl sulfate - 1,550 mg

Film-coated tablet weight - 936.0 mg

Description

Film-coated tablets of white or almost white color, oval, biconvex. The cut is white or almost white.

Pharmacotherapeutic group: potassium and magnesium drug.

ATX code: ј12—’

Pharmacological properties

Pharmacodynamics

The most important intracellular cations of potassium (K +) and magnesium (Mg2 +) play a key role in the functioning of numerous enzymes, in the formation of bonds between macromolecules and intracellular structures, and in the mechanism of muscle contractility. The intra- and extracellular ratio of potassium, calcium, sodium and magnesium ions affects myocardial contractility. Endogenous asparaginate acts as a conductor of ions: it has a high affinity for cells, due to the slight dissociation of its salts, ions in the form of complex compounds penetrate into the cell. Magnesium asparaginate and potassium asparaginate improve myocardial metabolism. Lack of magnesium / potassium predisposes to the development of arterial hypertension, atherosclerosis of the coronary arteries, arrhythmias and metabolic changes in the myocardium.

Pharmacokinetics

Potassium and magnesium aspartates are intensively absorbed in the intestine, mainly in the small intestine. Excreted by the kidneys.

Indications for use

• To eliminate the deficiency of potassium and magnesium as part of combination therapy for various manifestations of coronary heart disease (including acute myocardial infarction);

• chronic heart failure;

• cardiac arrhythmias (including arrhythmias caused by an overdose of cardiac glycosides).

Contraindications

• Hypersensitivity to any of the constituent components of the drug,

• acute and chronic renal failure,

• hyperkalemia,

• hypermagnesemia,

• Addison's disease

• atrioventricular block I-III degree,

• shock (including cardiogenic) (blood pressure less than 90 mm Hg),

• violation of amino acid metabolism,

• severe myasthenia gravis,

• hemolysis,

• acute metabolic acidosis,

• a state of dehydration,

• age up to 18 years (efficacy and safety have not been established).

Carefully

Pregnancy (especially in the first trimester of pregnancy) and the period of breastfeeding.

Pregnancy and breastfeeding

Application is possible if the potential benefit to the mother outweighs the potential risk to the fetus.

Potassium asparaginate + magnesium asparaginate pass into breast milk. If it is necessary to take the drug during breastfeeding, breastfeeding should be discontinued.

Method of administration and dosage

Before using it is necessary to consult a doctor.

Inside, without chewing and drinking plenty of water.

Panaspar should be taken after meals, because the acidic environment of the stomach reduces its effectiveness.

The recommended daily dose is 1 tablet 3 times a day.

The maximum daily dose is 1 tablet 3 times a day.

Side effect

Possible nausea, vomiting, diarrhea, discomfort or burning sensation in the epigastric region (in patients with anacid gastritis or cholecystitis), atrioventricular block, paradoxical reaction (an increase in the number of extrasystoles), hyperkalemia (nausea, vomiting, diarrhea, paresthesia) (redness of the face) , feeling of thirst, lowering blood pressure, hyporeflexia, respiratory depression, convulsions).

If any of the listed adverse reactions become serious, or you notice the appearance of adverse reactions not listed in this leaflet, you should consult your doctor.

Overdose

The risk of symptoms of hyperkalemia and hypermagnesemia increases.

Symptoms of hyperkalemia: fatigue, myasthenia gravis, paresthesias, confusion, heart rhythm disturbances (bradycardia, atrioventricular block, arrhythmias, cardiac arrest).

Symptoms of hypermagnesemia: decreased neuromuscular excitability, nausea, vomiting, lethargy, decreased blood pressure.

With a sharp increase in the content of magnesium ions in the blood: suppression of deep tendon reflexes, respiratory paralysis, coma.

Treatment: symptomatic therapy - intravenous administration of calcium chloride at a dose of 100 mg / min, if necessary - hemodialysis.

Interaction with other medicinal products

Pharmacodynamic interaction

When used together with potassium-sparing diuretics (triamterene, spironolactone), beta-blockers, cyclosporine, heparin, angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, the risk of hyperkalemia up to the development of arrhythmia and asystole increases. The simultaneous use of potassium preparations with glucocorticosteroids eliminates the hypokalemia caused by the latter. Potassium reduces the unwanted effects of cardiac glycosides.

Panaspar drug enhances the negative dromo- and batmotropic effect of antiarrhythmic drugs. Magnesium reduces the effects of neomycin, polymyxin B, tetracycline, and streptomycin. Anesthetics increase the inhibitory effect of magnesium preparations on the central nervous system; with simultaneous use with atracuronium, decamethonium, succinyl chloride and suxamethonium, an increase in neuromuscular blockade is possible. Calcitriol increases the level of magnesium in the blood plasma, calcium preparations reduce the effects of magnesium preparations.

Pharmacokinetic interaction

Medicines with an astringent and enveloping effect reduce the absorption of potassium asparaginate + magnesium asparaginate in the gastrointestinal tract, therefore, it is necessary to observe a three-hour interval between taking Panaspar with the above medicinal products.

special instructions

Patients with diseases accompanied by hyperkalemia require special attention: regular monitoring of the potassium content in the blood plasma is necessary.

Influence on the ability to drive vehicles and mechanisms

No studies have been conducted. It is not expected to affect the ability to drive vehicles and work with mechanisms that require increased concentration of attention and speed of psychomotor reactions.

Release form

Film-coated tablets, 316 mg + 280 mg.

10 tablets in a blister strip made of PVC / PVDC and printed aluminum foil varnished.

2 or 5 blister packs with instructions for use are placed in a carton box.

Storage conditions

At a temperature not higher than 25 ? C.

Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date printed on the package.

Vacation conditions

Available without a prescription.

Marketing authorization holder / Legal entity in whose name the registration certificate was issued

OJSC 'Pharmstandard-Leksredstva'

305022, Russia, Kursk,

st. 2nd Aggregate, 1a / 18,

tel./fax: (4712) 34-03-13,

www.pharmstd.ru

Manufacturer / Organization accepting customer claims

OJSC 'Pharmstandard-Leksredstva'

305022, Russia, Kursk,

st. 2nd Aggregate, 1a / 18,

tel./fax: (4712) 34-03-13.

Representative

JSC 'Pharmstandard-Leksredstva'