Magnesia S.Pellegrino 45% effervescent powder lemon flavour 100g

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Short-term treatment of occasional constipation. Antacid.

ACTIVE INGREDIENTS

100 g of powder contains: 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 section 6.1.

EXCIPIENTS

Magnesia S. Pellegrino 90% powder for oral suspension: without flavouring: sucrose. lemon flavour: sucrose, natural lemon flavour. Magnesia S. Pellegrino 45% effervescent powder: without flavouring: sodium bicarbonate, tartaric acid, sucrose. anise flavour: sodium bicarbonate, tartaric acid, sucrose, anethole. fruit flavour: sodium bicarbonate, tartaric acid, sucrose, natural fruit flavour. lemon flavour: sodium bicarbonate, tartaric acid, sucrose, natural lemon flavour. mandarin flavour: sodium bicarbonate, tartaric acid, sucrose, natural mandarin flavour.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients, listed in paragraph 6.1. Laxatives are contraindicated in subjects with acute abdominal pain or pain of unknown origin, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration. Children under 6 years of age. Severe renal insufficiency (creatinine clearance less than 30 mL/min)

DOSAGE

Dosage Adults: as an antacid 1 teaspoon; as a laxative 1 teaspoon; as a purgative 1 tbsp. Children: between 6 and 12 years: half the doses. Magnesia S. Pellegrino is contraindicated in children under 6 years of age (see section 4.3). Dilute the powder in half a glass of water and ingest. The correct dose is the minimum sufficient to produce an easy evacuation of loose stools. It is advisable to initially use the minimum doses provided. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Take preferably in the evening. Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. Swallow together with an adequate quantity of water (a large glass). A diet rich in liquids favors the effect of the medicine.

CONSERVATION

Magnesia S. Pellegrino 90% powder for oral suspension:without aroma: Store below 25°C. lemon flavour: This medicine does not require any special storage conditions. Magnesia S. Pellegrino 45% effervescent powder:

unflavored: This medicinal product does not require any special storage conditions.

anise flavour: This medicine does not require any special storage conditions.

fruit flavour: This medicine does not require any special storage conditions.

lemon flavour: Store below 25°C.

mandarin flavour: Store below 25°C.

WARNINGS

Warnings The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In more severe cases, the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunction, especially in case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact ones (stimulant laxatives), can cause dependence (need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). The treatment of chronic or recurrent constipation always requires the formulation of a diagnosis, the prescription of drugs and monitoring during the course of therapy. When the need for the laxative derives from a sudden change in previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of the laxative fails to produce effects, a clinical reassessment is necessary. Administer with caution in the elderly and in subjects with impaired renal function. In young children, the use of magnesium hydroxide can lead to hypermagnesemia, particularly if they have kidney damage or dehydration. Magnesia S. Pellegrino contains sucrose Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. Magnesia S. Pellegrino 45% effervescent powder contains sodium salts. This medicine contains: • approximately 386 mg of sodium per 1 teaspoon (approximately 7 g of product) equivalent to 19.3% of the maximum daily intake recommended by WHO which corresponds to 2 g of sodium for an adult. • approximately 552 mg of sodium per 1 teaspoon (approximately 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 of sodium for an adult. • approximately 1.1 g of sodium per 1 tablespoon (approximately 20 g of product) equivalent to 55% of the maximum daily intake recommended by the WHO which corresponds to 2 g of sodium for an adult. To be taken into consideration in people with reduced renal function or who follow a low-sodium diet (low sodium diet).

INTERACTIONS

Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid taking laxatives and other medicines at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative. Magnesium hydroxide, like all antacids, should not be taken at the same time as antibiotics of the tetracycline class as it reduces their absorption. Milk or antacids can change the effect of the medicine; leave an interval of at least one hour before taking the laxative. The alkalinization of the urine following the administration of magnesium hydroxide can modify the excretion of some drugs; therefore, increased excretion of salicylates was observed. Association to avoid: - tetracyclines: formation of insoluble complexes with reduction in the absorption and activity of these antibiotics. Association not recommended: - quinidine: increase in quinidine plasma levels and risk of overdose due to decreased excretion. Associations requiring precautions for use: - indomethacin, phosphorus, dexamethasone, digitalis, iron salts, nitrofurantoin, lincomycin: decreased absorption in the digestive system.

SIDE EFFECTS

Undesirable effects are reported below with the following frequencies: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), not known (the frequency cannot be estimated from the available data). Gastrointestinal disorders Not known: Abdominal pain, diarrhea, isolated cramping pain or abdominal colic, more frequent in cases of severe constipation. Metabolism and nutrition disorders Very rare: Hypermagnesemia. Observed after prolonged administration of magnesium hydroxide to patients with renal impairment. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa

OVERDOSE

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

PREGNANCY AND BREASTFEEDING

Pregnancy Magnesia S. Pellegrino must be used only if necessary after evaluating the expected benefit for the mother in relation to the possible risk for the fetus. Breastfeeding Magnesium is considered compatible with breastfeeding.

EFFECTS ON DRIVING ABILITY

Magnesia S. Pellegrino does not alter the ability to drive and use machinery.