CHLORUMAGENE Powder oral suspension Bag/100g

Magnesium hydroxide................................................................................................................100 g

For a box of 100 g

Symptomatic treatment of constipation.

Dosage

Adults

1 measuring spoonful in the evening at bedtime or in the morning on an empty stomach.

Method of administration

To be taken diluted in a glass of water.

Duration of treatment

Treatment should be of short duration (maximum 8 to 10 days).

• Severe renal impairment
• Inflammatory bowel diseases (ulcerative colitis, Crohn's disease...)
• Obstructive or subobstructive syndrome
• Abdominal pain syndromes of undetermined cause
• Children under 12 years of age (unless medically prescribed).

Warning

Prolonged use (more than 8 days) should be discouraged.

In case of diarrhoea or abdominal pain, administration of the product should be suspended.

Drug treatment of constipation is only an adjunct to dietary and lifestyle measures:

• Enrichment of the diet with plant fibres and fluids
• Advice on physical activity and rehabilitation of evacuation.

Paediatric population

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

In young children, the use of magnesium hydroxide may cause a hypermagnesaemia, particularly if they have renal impairment or dehydration.

Combinations not recommended

Risk of hypokalaemia and therefore drug interactions when a stimulant laxative is combined with:

• antiarrhythmics causing torsades de pointes: bepridil, class Ia antiarrhythmic (quinidine type), sotalol, amiodarone.
• lidoflazine, vincamine (non-antiarrhythmic drugs causing torsades de pointes).

Risk of torsades de pointes (hypokalaemia is a predisposing factor, as are bradycardia and a pre-existing long QT interval); use a non-stimulant laxative.

Associations requiring precautions for use

• digitalis glycosides : (hypokalaemia enhances the toxic effects of digitalis glycosides).
• other hypokalaemic agents: amphotericin B (intravenous route), corticosteroids (glucocorticoids, mineralocorticoids : systemic route), tetracosactide, hypokalaemic diuretics (alone or in combination). Increased risk of hypokalaemia (additive effect).

Monitor serum potassium and correct if necessary. Use a non-stimulant laxative.

Alkalinisation of the urine secondary to administration of magnesium hydroxide may alter the excretion of certain drugs; increased excretion of salicylates has thus been observed.

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.

The undesirable effects below are classified by frequency and by system organ class. Frequency is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).

Metabolism and nutrition disorders:

Very rare : Hypermagnesaemia. Observed after prolonged administration of magnesium hydroxide to patients with renal insufficiency.

Gastrointestinal disorders:

Frequency not known : Abdominal pain.

In some cases, intake of the product may be followed by diarrhoea, particularly in subjects suffering from irritable colon.

Prolonged intake may cause colonic irritation, at most resulting in laxative colitis (with electrolyte disturbances, in particular hypokalaemia).

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 reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr.

• Symptoms: diarrhoea.
• Management: discontinue treatment; correct any fluid and electrolyte disturbances in case of very significant fluid loss.

Saline stimulant laxative :

It exerts an osmotic effect, the intensity of which places it close to the stimulant class.

It modifies intestinal fluid and electrolyte exchanges and stimulates colonic motility.

Onset of action: 6 to 8 hours.

In the presence of gastric juice, nascent magnesium chloride is formed.

3 years

No special precautions for storage.

No special requirements.