MACROLAX RETT SOLUZ FL 120ML

MACROLAX 36 G + 0.24 G RECOVERNMENT

active ingredients

120 ml contain: – liquid sorbitol not crystallized 36 g; – sodium docusate 0.24 g. Excipient with known effects: methyl parahydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Parahydroxybenzoate, purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to active ingredients or any excipient listed in 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. Generally contraindicated during pregnancy and nursing (see paragraph 4.6). Generally contraindicated in pediatric age (see paragraph 4.4).

Population

Population All the contents of the bottle for an enema. The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. Do not exceed the recommended doses. Preferably in the evening. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods of time requires the doctor’s prescription after adequate evaluation of the individual case. A fluid-rich diet promotes the effect of the medicine.

Conservation

This medicine does not require any special condition of conservation.

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 (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). Precautions for use Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. You should also consult your doctor before using the medicine. Pediatric population In children under 12 years, the medicine can only be used after consulting the doctor. Macrolax contains methyl parahydroxybenzoate : may cause allergic reactions (also delayed).

Interactions

This product should not be used along with other medicines and mineral or laxative oil that contain it. 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.

Effects

Occasionally: isolated crampiform pain or abdominal colic pain, more frequent in cases of severe constipation. 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: www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Excessive doses can cause abdominal pain and diarrhea; the consequent losses of liquids and electrolytes must be replaced. See also in paragraph 4.4 about the abuse of laxatives.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicinal product must be used only in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or for the infant.

Source: Farmadati