Magnesium Diasporal 300 granules for preparation of oral solution, 5g No. 20

Established magnesium deficiency, isolated or associated with other deficiency conditions, accompanied by symptoms such as:

• increased irritability

• minor sleep disturbances

• gastrointestinal cramps

• increased fatigue

• pain and muscle spasms

• tingling sensation in the muscles.

If after a month of treatment there is no decrease in these symptoms, continued treatment is impractical.

Inside.

Adults 1 sachet daily. Dissolve contents of 1 packet in? glasses of fruit juice, tea or water.

On average, the duration of treatment is 1 month. Treatment should be discontinued after blood magnesium levels return to normal.

One package (5.0 g) contains:

Active substance:

Magnesium citrate 1830.0 mg

(equivalent to magnesium content of 295.7 mg)

Excipients:

sucrose 2341.2 mg, citric acid 660.0 mg, sodium bicarbonate 145.0 mg, orange flavor 22.3 mg, riboflavin (E101) 1.5 mg.

• Increased individual sensitivity to drug components

• severe renal failure (creatinine clearance less than 30 ml / min)

• atrioventricular block

• myasthenia gravis

• hypermagnesemia

• children's age (there are no data on the safety of using the drug Magnesium DiasporalЃ 300 in children).

Due to the presence of sucrose in the preparation, Magnesium DiasporalЃ 300 is contraindicated in case of fructose intolerance, glucose or galactose malabsorption syndrome, or in case of sucrase - isomaltase deficiency.

Carefully:

Moderate renal failure (risk of developing hypermagnesemia).

Trade name of the drug

Magnesium DiasporalЃ 300

International non-proprietary name

Magnesium citrate

Dosage form

granules for preparation of oral solution

Composition

One package (5.0 g) contains:

Active substance:

Magnesium citrate 1830.0 mg

(equivalent to magnesium content of 295.7 mg)

Excipients:

sucrose 2341.2 mg, citric acid 660.0 mg, sodium bicarbonate 145.0 mg, orange flavor 22.3 mg, riboflavin (E101) 1.5 mg.

Description

Mixture of irregularly shaped granules and yellow powder.

Pharmacotherapeutic group

Magnesium drug

ATX code

A12CC

Pharmacodynamics:

Magnesium is a vital element involved in most metabolic reactions and activates enzymes including choline and cholinesterase as a cofactor and is involved in many enzymatic processes. It participates in the processes of energy supply to muscles and is a membrane protector; it stabilizes the phospholipids of the cell membrane. Magnesium is a 'physiological' blocker of 'slow' calcium channels and is able to displace it from binding sites. Regulates metabolic processes, interneuronal transmission and muscle excitability prevents intake

calcium ions across the presynaptic membrane reduces the amount of acetylcholine in the peripheral nervous system and central nervous system (CNS).

Pharmacokinetics:

Absorption of magnesium occurs in a dose-dependent manner, mainly in the small intestine. The amount of absorption depends on the concentration of magnesium in the blood serum. The unabsorbed portion may have a laxative effect. With malabsorption syndrome and eating foods rich in fat, the absorption of magnesium is reduced. Magnesium is excreted by the kidneys. Serum contains about 1% of absorbed magnesium (08 - 10 mmol / l). Of these, about 45% of magnesium binds to albumin. Ionized magnesium has physiological activity. About half of all magnesium is localized inside cells, the other part is in the bones. The amount of whey magnesium is subject to daily fluctuations. Since there is an equilibrium between the concentration of magnesium in the blood serum and its content in the bones, it is impossible to judge magnesium deficiency from the serum concentration of magnesium.Magnesium deficiency may be indicated by impaired neuromuscular excitability.

Indications:

Established magnesium deficiency, isolated or associated with other deficiency conditions, accompanied by symptoms such as:

• increased irritability

• minor sleep disturbances

• gastrointestinal cramps

• increased fatigue

• pain and muscle spasms

• tingling sensation in the muscles.

If after a month of treatment there is no decrease in these symptoms, continued treatment is impractical.

Contraindications:

• Increased individual sensitivity to drug components

• severe renal failure (creatinine clearance less than 30 ml / min)

• atrioventricular block

• myasthenia gravis

• hypermagnesemia

• children's age (there are no data on the safety of using the drug Magnesium DiasporalЃ 300 in children).

Due to the presence of sucrose in the preparation, Magnesium DiasporalЃ 300 is contraindicated in case of fructose intolerance, glucose or galactose malabsorption syndrome, or in case of sucrase - isomaltase deficiency.

Carefully:

Moderate renal failure (risk of developing hypermagnesemia).

Pregnancy and lactation:

Pregnancy

Clinical experience with the use of magnesium citrate in a sufficient number of pregnant women did not reveal any adverse effect on the occurrence of fetal malformations or fetotoxic effects.

The drug Magnesium DiasporalЃ300 can be used during pregnancy only if necessary on the recommendation of a doctor if the intended benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Taking into account that magnesium penetrates into breast milk, if it is necessary to take the drug, it is recommended to stop feeding.

Method of administration and dosage:

Inside.

Adults 1 sachet daily. Dissolve contents of 1 packet in? glasses of fruit juice, tea or water.

On average, the duration of treatment is 1 month. Treatment should be discontinued after blood magnesium levels return to normal.

Side effects:

The frequency of occurrence of adverse reactions is determined as follows: very often (> 1/10) often (> 1/100 and <1/10) infrequently (> 1/1000 and <1/100) rarely (> 1/10000 and < 1/1 000) very rarely (<1/10 000 including individual cases) the frequency is unknown (based on the available data, it is not possible to estimate the frequency of occurrence).

From the gastrointestinal tract:

Uncommon : Loose stools before diarrhea at the beginning of treatment (usually disappears with continued treatment without specific treatment).

From the nervous system:

Very rare: weakness (occurs with prolonged use of the drug). If such an undesirable reaction occurs, the administration of the drug Magnesium DiasporalЃ 300 must be discontinued. After improvement of the condition, drug therapy can be resumed at a reduced dosage.

Frequency unknown: allergic reactions including skin reactions abdominal pain nausea flatulence.

If any of the side effects indicated in the instructions are aggravated or you notice any other side effects not indicated in the instructions, inform your doctor.

Overdose:

With normal kidney function, oral magnesium intake does not cause toxic reactions. Symptoms can occur only in the setting of severe renal failure Overdose symptoms, the severity of which depends on the concentration of magnesium in the blood plasma: lowering blood pressure nausea vomiting; depression of the central nervous system; decreased reflexes; changes in the electrocardiogram; respiratory depression coma cardiac arrest and respiratory paralysis; anuric syndrome.

Treatment: Intravenous calcium and intramuscular or subcutaneous injection of 1 - 2 ampoules (05 - 1 mg / ml) of neostigmine methyl sulfate; intravenous or oral administration of 09% sodium chloride; in case of renal failure, hemodialysis or peritoneal dialysis.

Interaction:

If it is necessary to use other drugs at the same time, you should consult with your doctor about the possibility of their simultaneous administration with Magnesium DiasporalЃ300.

Magnesium salts can enhance the effects of muscle relaxants.

Aminoglycoside antibiotics diuretics (thiazides furosemide) drugs inhibiting the secretion of gastric juice (omeprazole pantoprazole) cisplatin and cyclosporin A foscarnet cetuximab and erlotinib pentamidine rapamycin and amphotericin accelerate magnesium excretion and can cause magnesium deficiency in the body. Ions of magnesium iron fluorides and tetracycline mutually affect the absorption of each other, therefore, it is necessary to observe a 2-3 hour interval between taking Magnesium DiasporalЃ 300 and preparations containing the above substances.

Magnesium weakens the effect of indirect anticoagulants. The simultaneous use of preparations containing phosphates or calcium salts can significantly reduce the absorption of magnesium in the gastrointestinal tract.

Special instructions:

Use the drug according to the method of administration and in the doses indicated in the instructions for use. If necessary, please consult your doctor before using the medicinal product.

Contains sucrose (sugar). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose deficiency should not take Magnesium Diasporal Ѓ 300.

One packet of Magnesium DiasporalЃ 300 contains 175 mmol (40 mg) sodium, which should be taken into account by patients on a low salt diet.

If calcium and magnesium are deficient at the same time, the magnesium deficiency should be replenished before taking calcium supplements or dietary supplements containing calcium.

Impact on the ability to drive vehicles. Wed and fur .:

The drug does not affect the ability to control machines and mechanisms.

Release form / dosage:

Granules for preparation of oral solution.

Packaging:

50 g in a bag made of combined material (paper, foil, aluminum polyethylene film). 2 packages connected by a heat-sealable seam. 2 packages each, connected by a heat-sealable seam with the printed instruction text individually, or 20 or 50 packages each with instructions for use in a cardboard box.

Storage conditions:

At a temperature of 15 to 25 ? C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date indicated on the package.

Vacation conditions

Without recipe

Manufacturer

Protina Pharmaceutische GmbH, Adalperostrasse 37 und 90, 85737 Ismaning, Germany, Germany

Marketing Authorization Holder / Organization Receiving Consumer Claims:

Protina Pharmaceutische GmbH