S.PELL POLV 100G 90%

MAGNESIA S.PELLEGRINO DUST

active ingredients

100 g of powder contain: Magnesia S. Pellegrino 90% powder for oral suspension Active ingredient: magnesium hydroxide 90 g Excipient with known effects: sucrose. Magnesia S. Pellegrino 45% effervescent powder Active ingredient: magnesium hydroxide 45 g Excipient with known effects: sucrose and sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Magnesia S. Pellegrino powder 90% for oral suspension:no aroma: sucrose. lemon taste: sucrose, natural lemon aroma. Magnesia S. Pellegrino 45% effervescent powder: without aroma: sodium bicarbonate, tartaric acid, sucrose. anise taste: sodium bicarbonate, tartaric acid, sucrose, anetolo. fruit taste: sodium bicarbonate, tartaric acid, sucrose, natural fruit aroma. lemon taste: sodium bicarbonate, tartaric acid, sucrose, natural lemon aroma. mandarin taste: sodium bicarbonate, tartaric acid, sucrose, natural aroma to mandarin.

Therapeutic indications

Short-term treatment of occasional constipation. Anti-acid.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. Laxatives are contraindicated in subjects with acute or unknown abdominal pain, nausea or vomiting, obstruction or intestinal stenosis, rectal bleeding of unknown origin, severe state of dehydration. Children under the age of 6. Severe kidney failure (cancer of creatine less than 30 mL/min)

Population

Population Adults: as an acid 1 teaspoon coffee; as a laxative 1 tablespoon of tea; as a purgante 1 tablespoon. Children: between 6 and 12 years: half of the doses. Magnesia S. Pellegrino is contraindicated in children under the age of 6 (see paragraph 4.3). Dilute the powder in half a glass of water and ingest. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Preferably in the evening. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case. Eating together with an adequate amount of water (a plentiful glass). A fluid-rich diet promotes the effect of the medicine.

Conservation

Magnesia S. Pellegrino powder 90% for oral suspension:without aroma: Store at a temperature below 25°C. Lemon taste: This medicine does not require any special condition of conservation. Magnesia S. Pellegrino 45% effervescent powder:

without aroma:	This medicine does not require any special condition of conservation.
anise taste:	This medicine does not require any special condition of conservation.
fruit taste:	This medicine does not require any special condition of conservation.
lemon taste:	Store at a temperature below 25°C.
mandarin taste:	Store at a temperature below 25°C.

Warnings

Warnings Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). Treatment of chronic or recurring constipation always requires the formulation of a diagnosis, prescription of drugs and surveillance during therapy. When the need for laxative comes from a sudden change of previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of laxative fails to produce effects a clinical revaluation is necessary. Carefully administer in the elderly and in subjects with altered renal funizone. In small children the use of hydroxide magnesium can lead to hypermagnesemia, especially if they have kidney damage or dehydration. Magnesia S. Pellegrino contains sucrose Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption or insufficiency of isomaltase sucrasis should not take this medicine. Magnesia S. Pellegrino 45%polvere effervescent contains sodium salts. This medicine contains: • about 386 mg sodium for 1 teaspoon coffee (about 7 g of product) equivalent to 19.3% of the maximum daily consumption recommended by the WHO which corresponds to 2 g sodium for an adult. • about 552 mg of sodioper 1 teaspoon (about 10 g of product) of substance taken equivalent to 27.6% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. • approximately 1.1 g of sodium for 1 tablespoon (about 20 g of product) equivalent to 55% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. To be taken into account in people with reduced kidney function or following a low sodium diet (hypode diet).

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid taking laxatives and other drugs at the same time: after taking a medicine let spend a range of at least 2 hours before taking laxative. Magnesium hydroxide, like all antacids, should not be taken simultaneously with tetracycline class antibiotics as it reduces absorption. Milk or antacids may change the effect of the medicinal product; let spend a range of at least an hour before taking the laxative. Alcalinization of urine after administration of hydroxide magnesium may change the excretion of certain drugs; therefore, a greater excretion of salicylates has been observed. Association to avoid: - tetracycline: formation of insoluble complexes with reduction of absorption and activity of such antibiotics. Not recommended: - chinidine: increased plasma rates of chinidine and risk of overdose due to decreased excretion. Associations requiring precautions of use: - indometacin, phosphorus, dexamethasone, digital, iron salts, nitrofurantoin, lincomycin: decrease in absorption at the digestive system level.

Effects

The side effects are shown below with the following frequencies: very common (≥ 1/10), common (≥ 1/100, Gastrointestinal diseases Notable: Abdominal pain, diarrhea, isolated crampiform pain or abdominal colic pain, more frequent in cases of severe constipation. Disorders of metabolism and nutrition Very rare: Hypermagnesemia. Observed after prolonged administration of hydroxide magnesium to patients with kidney damage. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

Excessive doses can cause abdominal pain and diarrhea; the consequent losses of liquids and electrolytes must be replaced. Treatment of magnesium overdose: rehydration, forced diuresis. In case of kidney failure, hemodialysis or peritoneal dialysis is necessary.

Pregnancy Magnesia S. Pellegrino must be used only in case of need after evaluating the expected benefit for the mother in relation to the possible risk for the fetus. Magnesium is considered compatible with breast milk.

Source: Farmadati