MAGNESIE SAN PELLEGRINO 44,9 % Effervescent oral suspension powder aniseed Bottle/125g

Magnesium hydroxide ......................................................................................................... 44,90 g

For 100 g of effervescent powder for oral suspension.

One measuring spoon (4,5 g) contains 2 g of magnesium hydroxide and 222 mg of sodium.

Excipients: Sucrose, Ethanol, Sodium.

Symptomatic treatment of constipation.

Dosage

RESERVED FOR ADULTS.

One to 2 measuring spoons per day, diluted in a glass of water in the morning on an empty stomach or in the evening at bedtime.

This medicine is contraindicated in cases of:

• organic inflammatory colopathies (ulcerative colitis, Crohn's disease...).
• occlusive or subocclusive syndrome.
• abdominal painful syndromes of undetermined cause.
• Severe renal impairment (creatinine clearance < 30 ml/min).

Drug treatment of constipation is only an adjunct to hygienic-dietary treatment:

• enrichment of the diet with plant fibres and fluids (water);
• Advice on physical activity and rehabilitation of evacuation.

Prolonged use of a laxative is not recommended

In children, the prescription of laxatives must be exceptional: it must take into account the risk of interfering with the normal functioning of the defecation reflex.

This medicine contains 222 mg of sodium per measuring spoon. To be taken into account in patients on a strict low-sodium diet.

This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per measuring spoon.

Associations requiring precautions for use

A decrease in the digestive absorption of concomitantly administered medicines is observed.

Alkalinisation of the urine secondary to administration of magnesium hydroxide may alter the excretion of certain medicines; increased excretion of salicylates has thus been observed. As a precaution, this medicine should be taken at a distance from certain other medicines.

Space the intake of this medicine by more than 2 hours, if possible, from the following medicines:

• Acetylsalicylic acid
• Antisecretory agents, H2 antihistamines
• Antituberculosis agents (ethambutol, isoniazid)
• Beta-blockers (atenolol, metoprolol, propranolol)
• Bisphosphonates
• Calcium polystyrene sulfonate sodium (Kayexalate)
• Chloroquine
• Cyclines
• Digitalis,
• Iron salts
• Fexofenadine
• Fluorine
• Fluoroquinolones
• Glucocorticoids (except hydrocortisone in replacement therapy) - Described for prednisolone and dexamethasone. Decreased digestive absorption of glucocorticoids.
• Thyroid hormones
• Indomethacin
• Ketoconazole
• Lansoprazole
• Lincosamides
• Phenothiazine neuroleptics
• Penicillamine
• Phosphorus
• Sulpiride
• Ulipristal

Pregnancy

There are no reliable data on teratogenicity in animals.

In clinical practice, no particular malformative or foetotoxic effect has appeared to date.

However, follow-up of pregnancies exposed to this medicinal product is insufficient to exclude any risk.

As a result, use of this medicine should only be considered during pregnancy if necessary.

Breast-feeding

To be used with caution in pregnant or breast-feeding women, due to a lack of usable clinical data. It is recommended to limit the daily dose and, if possible, the duration of treatment.

Possibility of diarrhea and abdominal pain, particularly in subjects suffering from functional bowel disorder.

Hypermagnesemia. Observed after prolonged administration of magnesium hydroxide to patients with renal failure.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: www.signalement-sante.gouv.fr.

Related to magnesium hydroxide: Cases of severe hypermagnesaemia with circulatory collapse have been reported in the literature following overdose or prolonged use of magnesium hydroxide.

Oral magnesium overdose generally does not cause toxic reactions when kidney function is normal. Magnesium intoxication may, however, develop in cases of renal insufficiency.

The toxic effects depend on the blood magnesium level, and the signs are as follows:

• decreased blood pressure,
• nausea, vomiting,
• drowsiness, decreased reflexes, muscle fatigability, neuromuscular paralysis
• bradycardia, ECG abnormalities,
• hypoventilation
• in the most severe cases, respiratory paralysis, coma, renal failure or cardiac arrest may occur
• anuric syndrome.

Treatment: the effects of hypermagnesaemia may be antagonised by intravenous administration of calcium gluconate. In case of renal failure, haemodialysis or peritoneal dialysis is necessary.

Pharmacotherapeutic class: osmotic laxative, ATC code: A: alimentary tract and metabolism.

This medicine increases the hydration and volume of the colonic contents by an osmotic effect.

5 years

Store below 30°C and protect from moisture.

No special precautions.