HEPAREMA LEVUL * SCIR 180G

HEPAREMA LEVUL * SCIR 180G

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage and method of use

Adults: a teaspoon in a little water, twice a day before meals. Children: one teaspoon a day, before the evening meal. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum doses provided. Take preferably in the evening. Laxatives should be used as infrequently as possible and for no more than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case. Swallow with an adequate amount of water (a large glass). A diet rich in liquids favors the effect of the medicine.

Contraindications

Hypersensitivity to the active substances or to any of the excipients. Mechanical obstruction of the biliary tract. Acute and chronic liver diseases. Gallstones. Hepatic insufficiency. Laxatives are contraindicated in people with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal obstruction or stricture, rectal bleeding of unknown origin, severe dehydration, inflammatory bowel conditions(Chron's disease – Ulcerative Colitis).Contraindicated during pregnancy and lactation (see p. 4.6). Contraindicated in pediatric age (see p. 4.4).

Side effects

Gastrointestinal disorders Occasionally: abdominal cramping pains, abdominal colic, more frequent in cases of severe constipation.Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

WarningsUse for short periods only. Keep out of the reach and sight of children. Do not use laxatives if abdominal pain, nausea and vomiting are present. The continued use of laxatives can cause addiction or damage of various kinds. If constipation is persistent, consult your doctor. 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 severe cases, the onset of dehydration or hypokalemia is possible, which can cause cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).Precautions for use. In children under the age of 12, the medicine can only be used after consulting your doctor. The treatment of chronic or recurrent constipation always requires the intervention of the doctor for the diagnosis, the prescription of drugs and the surveillance during the course of therapy. Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies on the use of the drug in pregnancy or breastfeeding. The use during pregnancy and during breastfeeding must be avoided because anthraquinones are partly excreted with breast milk giving it purgative properties.

Expiration and retention

This medicinal product does not require any special storage conditions.

Interactions with other drugs

Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative. Milk or antacids can change the effect of the medicine; allow an interval of at least one hour to elapse before taking the laxative. Caution should be exercised in case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids (see section 4.4).

Overdose

Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced. See also the information in the section "Special warnings and precautions for use" about the abuse of laxatives.

Active principles

100 ml of syrup contain: Active ingredients: Cascara sagrada fluid extract 11 g; Boldo fluid extract 5.6 g; Rhubarb fluid extract 2.5 g. Excipients: methyl – p – hydroxybenzoate, ethyl alcohol. For a full list of excipients, see section 6.1.

Excipients

Levulose, methyl – p – hydroxybenzoate, orange tincture, vanilla tincture, ethyl alcohol, purified water.