Laurilax® Rectal Solution 12 Micro-enemas of 5ml

Laurilax® Rectal Solution

Laurilax belongs to a group of medicines called laxatives. It softens the stool and causes the evacuation reflex (defecation).

Laurilax is used to treat occasional constipation. This medicine is intended for use in adults only.

Active principles

Sorbitol, liquid (crystallizable) 4.4650 g Sodium citrate 0.4500 g Sodium lauryl sulfoacetate 70% 0.0645 g For 5 ml of rectal solution For a full list of excipients, see section 6.1.

Excipients

Glycerol Sorbic acid Purified water

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Do not use in case of intestinal obstruction or abdominal pain of unknown etiology. Concomitant treatment with cation exchange resins of calcium or sodium polystyrene sulfonate (see section 4.5).

Dosage

Posology Adults: 1 tube with dispenser per day. A dose should be administered 5 to 20 minutes before the desired effect. Method of administration Rectal use Break off the tip. Insert the dispenser into the rectum and empty the entire contents of the tube by applying pressure, then withdraw the syringe while continuing to apply pressure on the tube.

storage

No particular precautions for storage.

Warnings

Warnings If symptoms persist for more than a few days, consult a doctor and avoid prolonged use. Medical treatment of constipation is only an additional measure to a healthy lifestyle: • high intake of fluids and vegetable fibers • recommendations for physical activity and bowel training. Combinations not recommended This medicinal product must not be used in combination with cation exchange resins of calcium or sodium polystyrene sulphonate (oral and rectal): risk of colonic necrosis, life-threatening. Precautions for use: It is recommended to avoid the use of this medicine in case of exacerbations of haemorrhoids, anal fissures or hemorrhagic colitis. Extreme caution should be exercised in case of use in patients suffering from inflammatory or ulcerative diseases of the large intestine or from acute gastrointestinal diseases.

Effects

The table below includes adverse drug reactions observed during post-marketing experience with sorbitol, sodium citrate and sodium lauryl sulfoacetate. The frequency of adverse drug reactions is provided using the following convention: • 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) • Not known (cannot be estimated from the available data)

CLASSIFICATION BY SYSTEMS AND ORGANS Frequency category Adverse events

IMMUNE SYSTEM DISORDERS Not known Hypersensitivity reactions (e.g. urticaria)

GASTROINTESTINAL DISORDERS Not known Abdominal pain, Anorectal discomfort, Liquid stools

Overdose

From the analysis of post-marketing data and from the scientific literature on the use of these ingredients administered intrarectally, no symptoms of overdose emerged.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with frequency not known: • Abdominal pain • Anorectal discomfort • Liquid stools • Hypersensitivity reactions (hives)

Pregnancy

There are no adequate data and well-controlled studies in pregnant women. When used as recommended, the expected systemic absorption of this medicinal product is limited, therefore no unexpected effects are expected when used in pregnancy. Breastfeeding It is not known whether sodium citrate, sodium lauryl sulfoacetate and sorbitol are excreted in human milk. When used as recommended the expected systemic absorption of this medicinal product is limited, therefore no unexpected effects are expected when used during breastfeeding. Consequently, the use of this medicine can only be considered during pregnancy and breastfeeding if necessary. Fertility Studies in rats and rabbits (sorbitol only) did not show any impact on fertility (see section 5.3).

Format

Pack with 12 micro-enemas of 5ml.