Description
Short-term treatment of occasional constipation.
Active Ingredients
GLYCEROL Sella children 1375 mg suppositories One children's suppository contains: active ingredient : glycerol 1375 mg GLYCEROL Sella adults 2250 mg suppositories One adult suppository contains: active ingredient : glycerol 2250 mg For the full list of excipients, see section 6.1.
Excipients
sodium stearate, sodium bicarbonate
Dosage
The correct dose is the minimum sufficient to produce easy evacuation. It is advisable to initially use the minimum doses provided. Adults and adolescents (12–18 years) : 1 adult suppository as needed, for a maximum of 1 or 2 administrations per day. Children aged 2–11 years : 1 child suppository as needed, for a maximum of 1 or 2 administrations per day Instructions for use Remove the suppository from its container and then, if necessary, moisten it to facilitate rectal introduction. If the suppositories appear softened, immerse the containers in cold water before opening them. In children under twelve years of age the medicine can only be used after consulting a doctor. Laxatives should be used as infrequently as possible and for no more than seven days (see section 4.4). A diet rich in liquids promotes the effect of the medicine.
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 the intervention of a doctor 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. Abuse of laxatives can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients. In the most serious cases of abuse, dehydration or hypokalemia may occur, which can cause cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, 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 functions (intestinal atony). In episodes of constipation, it is recommended first of all to correct eating habits by integrating 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 per day, in order to promote the softening of the stool.
Conservation
Store in the original package to protect from moisture and away from direct sources of heat.
Contraindications
– 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 haemorrhoidal crisis with pain and bleeding, – severe state of dehydration.
Side effects
The following are the adverse reactions 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 irritation at the rectal level.
Overdose
No cases of overdose have been reported. However, excessive doses (abuse of laxatives - frequent or prolonged use or with 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 serious cases, dehydration or hypokalemia may occur, which may cause cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with cardiac glycosides, diuretics or corticosteroids. Abuse of laxatives, 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 functions (intestinal atony).
Pregnancy
There are no adequate and well-controlled studies 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.
