SOL 4FL MONO 5ML

LAURILAX 4,465 G / 0,45 G / 0.0645 G, RECENTAL FUTURE

active ingredients

Sorbitol, liquid (crystable): 4,4650 g Citrate Sodium: 0.4500 g Sodium lauril solphosate 70%: 0.0645 g For 5 ml excipient rectal solution with known effect: Sorbic acid (5mg/5mL) For the full list of excipients, see paragraph 6.1.

Excellent

Glycerol Sorbic Acid Purified Water

Therapeutic indications

Laurilax is indicated for the symptomatic treatment of occasional constipation in adults.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. Do not use in case of intestinal obstruction or abdominal pain to unknown etiology. Concurrent treatment with calcium cationic exchange resins or sulphonate polystyrene sodium (see paragraph 4.5).

Population

Population Adults: 1 tube with dispenser per day. A dose should be given from 5 to 20 minutes before the desired effect. Method of administration Straight Use Break the tip. Introduce the dispenser for all its length in the rectum and empty the entire tube content by applying pressure, then extract the syringe by continuing to exert pressure on the tube.

Conservation

No special precaution for conservation.

Warnings

If symptoms persist for more than a few days or worsen, consult a doctor and avoid prolonged use. Medical treatment of constipation is only an additional measure compared to a healthy lifestyle: • high intake of liquids and vegetable fibers; • recommendations of physical activity and intestinal training. Precautions for use It is recommended to avoid the use of this medicine in case of hemorrhoids, anal spiders or hemorrhagic rectifiers. Preserve extreme caution in case of use in patients suffering from inflammatory or ulcerative diseases of the cranial intestine or from acute gastrointestinal pathologies. Laurilax contains sorbic acid that can cause reactions on the localized skin (e.g. contact dermatitis).

Interactions

Interaction with calcium cationic exchange resins or sulphonate polystyrene sodium Individual cases of ileocolic perforation and necrosis of the colon or intestinal with oral administration and calcium rectal and sulphonated polystyrene sodium with sorbitol use in patients treated for hyperkaliemia. Patients taking sorbitol must avoid calcium and sodium polystyrene sulphonate. Concurrent drugs for rectal use must be avoided as they may be expelled from the gastrointestinal tract and not absorbed.

Effects

In the table below are included adverse reactions to the drug observed during the post-marketing experience with sorbitol, citrate sodium and sulphonate lauril sodium. The frequency of adverse reactions to the drug is provided using the following convention: • Very common (≥1/10) • Common (≥1/100, Classification for systems and organs Adverse events Frequency category Immune system disorders Notable Hypersensitivity reactions (e.g. hives) Gastrointestinal diseases Notable Abdominal pain^a, Anorectal fastidium, Liquid feces ^a includes (PTs): abdominal discomfort, abdominal pain and upper abdomen pain 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 the address http://www.aifa.gov.it/content/comesegnalare-una-sospetta-reazio ne-adverse.

Overdosing

From the analysis of post-marketing data and scientific literature on the use of these ingredients administered intrarectally, no symptom has emerged due to overdose.

Pregnancy

There is no adequate data and well-controlled studies on pregnant women. When used according to the recommendations the only expected systemic absorption of this medicine is limited, therefore there are no unexpected effects if used during pregnancy.

Food

It is not known whether sodium citrate, sodium lauril sulphonate and sorbitol are excreted in breast milk. When used according to the recommendations the only expected systemic absorption of this medicine is limited, therefore there are no unexpected effects if used during breastfeeding. As a result, the use of this medicine can be taken into account during pregnancy and nursing, only if necessary.

Fertility

Studies conducted on rats and rabbits (only sorbitol) showed no impact on fertility (see paragraph 5.3).

Source: Farmadati