Characteristics
Each single-dose container contains 6.75g of Glycerol as the active ingredient.
Dose and dosage
The correct dose is the minimum sufficient to produce easy evacuation. It is advisable to initially use the minimum recommended doses. Adults and adolescents (12–18 years): 1 single-dose adult container of 6.75g as needed, for a maximum of 1 or 2 administrations per day. Children aged 2–6 years: 1 single-dose container for infants containing 2.25 g as needed, for a maximum of 1 or 2 administrations per day. Instructions for use: After removing the cap, lubricate the cannula with a drop of the solution before inserting it into the rectum and pressing the bellows. Remove the cannula while keeping the bellows pressed. Each container must be used for a single administration; any residual medicine must be discarded. In children under twelve years of age, the medicine may be used only after consulting a doctor. Laxatives should be used as infrequently as possible and for no longer than seven days (see section 4.4). A diet rich in liquids promotes the effect of the medicine.
Contraindications/Side effects
– Hypersensitivity to the active substance or to any of the excipients. – acute or unknown abdominal pain, – nausea or vomiting, – intestinal obstruction or stenosis, – rectal bleeding of unknown origin, – acute hemorrhoidal crisis with pain and bleeding, – severe dehydration.
Storage
Keep in a closed container away from light.
Warnings
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. The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of drugs, and monitoring during therapy. It is also advisable for elderly or unhealthy subjects to consult their doctor before using the medicine. Laxative abuse can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium), and other essential nutrients. In more severe cases of abuse, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially when treated concomitantly with cardiac glycosides, diuretics, or corticosteroids. Laxative abuse, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation, and loss of normal intestinal function (intestinal atony). In cases of constipation, it is recommended first of all to correct eating habits by supplementing the daily diet with an adequate intake of fiber and water. When using laxatives, it is advisable to drink at least 6–8 glasses of water or other liquids a day to help soften the stool.
Interactions
No specific interaction studies have been performed.
Undesirable effects
The following are the undesirable effects of glycerol organized according to the MedDRA system organ classification. There are insufficient data to establish the frequency of the individual effects listed. Gastrointestinal disorders Isolated cramping pain or abdominal colic and diarrhea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation.
Overdose
No cases of overdose have been reported. In any case, excessive doses (laxative abuse – frequent or prolonged use or in excessive doses) can cause abdominal pain, persistent diarrhea with consequent loss of water, mineral salts (especially potassium), and other essential nutrients. Fluid and electrolyte losses must be replaced. Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia), and hypoalbuminemia. In more severe cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics, or corticosteroids. Laxative abuse, especially contact laxatives (stimulant laxatives), can cause serious complications. cause dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation, and loss of normal intestinal function (intestinal atony).
Pregnancy and breastfeeding
No adequate and well-controlled studies have been conducted on the use of the medicine during pregnancy or breastfeeding. Although there are no obvious contraindications to the use of the medicine during pregnancy and breastfeeding, it is recommended to take the medicine only when necessary and under medical supervision.
Format
Pack with 6 single-dose containers.
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