MELAXOSE Oral paste in pot Pot PP/200g+measure

Oral paste (shiny, yellow to orange-yellow, opaque and compact, finely granular).
Pot of 150 g or of 200 g, with a measuring spoon graduated at 2,5 ml and at 5 ml.

For 100 g of oral paste :

Lactulose: 35,00 g

Solidified special paraffin oil,
Quantity corresponding to:

• Vaseline: 21,45 g
• Liquid paraffin (PRIMOL 352): 42,91 g

Excipient(s) with known effect : Aspartame (E951).

Symptomatic treatment of constipation in adults.

Dosage

Reserved for adults.

The recommended daily dose is 1 to 3 measuring spoons (teaspoon), in a single intake, preferably in the evening.

The dose must be adapted to the needs of each subject according to the clinical response.

Initial treatment: 2 to 3 measuring spoons (teaspoon) per day, preferably in the evening.

Maintenance treatment: 1 to 3 measuring spoons (teaspoon) per day, preferably in the evening.

If diarrhoea occurs, the dose should be reduced. If diarrhoea persists, treatment with MELAXOSE must be discontinued.

One measuring spoon (5 ml) of this medicine (teaspoon) = 1,75 g of lactulose, 2.15 g of liquid paraffin and 1.07 g of vaseline.

Method of administration

Oral use.

The medicine must not be taken lying down or just before going to bed (see section Warnings and precautions).

• Hypersensitivity to the active substances or to any of the excipients listed in section Composition.
• Chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), toxic megacolon, gastrointestinal obstruction or subobstructive syndromes, perforation or risk of digestive perforation, abdominal pain syndromes of undetermined cause.
• Due to the presence of aspartame, this medicine is contraindicated in cases of phenylketonuria.
• Do not use in people with swallowing difficulties because of the risk of bronchial inhalation and lipid pneumonia.

Prolonged use of this medicine without medical supervision is not recommended.

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

• Enrichment of the diet with vegetable fibres and drinks,
• Advice on physical activity and rehabilitation of evacuation.

This medicine may be prescribed to diabetics because it does not contain glucose.

Due to the presence of aspartame, use of this medicine should be avoided in patients at risk of phenylketonuria.

Prolonged use of paraffin oil is likely to reduce the absorption of fat-soluble vitamins (A, D, E, K).

Since lactulose-induced diarrhoea may lead to an electrolyte imbalance, it is recommended to use this medicine with caution in patients likely to develop electrolyte disorders (such as patients with renal or hepatic insufficiency, or patients receiving concomitant diuretic treatment).

Administration of paraffin oil to debilitated persons, in the lying position, with swallowing difficulties or with gastro-oesophageal reflux should be done with caution due to the risk of bronchial inhalation and lipoid pneumonia (see sections Dosage and administration and Adverse effects).

Paediatric population

In the absence of clinical results in the paediatric population, this medicine is not recommended in children.

Due to the paraffin contained in this medicine, prolonged use of it may decrease the absorption of fat-soluble vitamins (A, D, E, K).

No teratogenesis study with paraffin oil is available in animals. There are currently no relevant data, or sufficient data, to assess a possible malformative or foetotoxic effect of paraffin oil when administered during pregnancy.

Consequently, as a precaution, it is preferable not to use this medicine during pregnancy. The decreased absorption of fat-soluble vitamins (A, D, E, K) should be taken into account.

The frequency of undesirable effects is defined using the following convention: 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), frequency not known (cannot be estimated from the available data).

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: https://signalement.social-sante.gouv.fr.

Symptoms : diarrhoea.

Treatment : discontinuation of treatment or reduction of the dose. Significant fluid loss due to diarrhoea or vomiting may require correction of the electrolyte imbalance.

Pharmacotherapeutic class: OSMOTIC LAXATIVES (LACTULOSE, COMBINATIONS), ATC code: A06AD61.

Mechanism of action

This medicine is a laxative that acts through two different mechanisms:

• Lactulose increases the hydration and volume of the colonic contents through an osmotic effect.
• Liquid paraffin is a laxative with a mechanical action, which acts by lubricating the colonic contents and softening the faeces.

Its action becomes apparent within 6 to 8 hours following administration.

Lactulose, a synthetic disaccharide, passes through the upper parts of the digestive tract unchanged and without being absorbed. When it reaches the colon, it is transformed under the effect of the local saccharolytic flora into organic acids (lactic and acetic), which are eliminated in the stools.

Liquid paraffin is not absorbed.

After oral administration of MELAXOSE to rats for 28 days, at doses corresponding to ten times the maximum daily dose that can be administered to humans, no symptoms or abnormalities of the main organs were observed.

3 years.

After first opening: 4 weeks.

Store at a temperature not exceeding 30 °C.

Social Security reimbursement at 30%. Collect.

Pot of 200 g: Not reimbursed by Social Security.