GLICEROLO PH TR AD 18SUPP 2250

GLICEROLO PHARMA TRENTA SUPPLY

active ingredients

GLICEROLO PHARMA TRENTA – Children 1375 mg presumed A supposed children contains: active ingredient: Glycerol 1375 mg GLICEROLO PHARMA TRENTA – Adults 2250 mg presumed An adult suppository contains: active ingredient: Glicerol 2250 mg For the complete list of excipients, see paragraph 6.1.

Excellent

Sodium bicarbonate and Sodium stearate, both used to confer the physical properties required to the assumptions of Glicerolo.

Therapeutic indications

Short-term treatment of occasional constipation

Contraindications

– Hypersensitivity to the active ingredient or any of the excipients. – acute or unknown abdominal pain, – nausea or vomiting, – obstruction or intestinal stenosis, – rectal bleeding of unknown origin, – acute hemorrhoid crisis with pain and bleeding, – severe dehydration.

Population

The correct dose is sufficient to produce an easy evacuation. It is advisable to initially use the minimum doses provided. Adults and teenagers (12–18 years): 1 supposes adults in need, for a maximum of 1 or 2 administrations per day. Children aged 2–11 years: 1 supposes children in need, for a maximum of 1 or 2 administrations per day Children between 1 month and 2 years: 1 supposes early childhood in need, for up to 1 or 2 administrations per day. Instructions for use Remove the suppository from its container and then, if necessary, moisten it to facilitate the rectal introduction. If the suppositories appeared soft dip the containers, before opening them, in cold water. In children under twelve years the medicine can only be used after consulting the doctor. Take at least 2 hours before or after meals, as the medicine may interfere with the absorption of nutrients and vitamins. Laxatives must be used as frequently as possible and for no more than seven days (see paragraph 4.4). A fluid-rich diet promotes the effect of the medicine.

Conservation

Store at a temperature not exceeding 30°C. Store in the original packaging to protect the medicine from moisture and away from direct sources of heat.

Warnings

Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. You should also consult your doctor before using the medicine. Laxative abuse can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In severe cases of abuse, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment of heart glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). In episodes of constipation, it is recommended first of all to correct food habits by integrating the daily diet with an adequate supply of fiber and water. In episodes of constipation, it is recommended first of all to correct food habits by integrating the daily diet with an adequate supply of fiber and water. When using laxatives it is appropriate to drink at least 6–8 glasses of water per day, or other liquids, so as to encourage the softening of feces. Important information about some excipients: There is no important information about excipients used, dealing solely with substances (also used as additives for food) normally used to give the necessary physical characteristics (consistency, etc.) to the mass of suppositories in normal conditions of conservation and therapeutic use.

Interactions

Specific interaction studies have not been carried out. It is known that laxatives can reduce the time of stay in the intestine, and consequently also the absorption of other drugs taken at the same time by mouth. It is therefore recommended, after taking an oral medicine, to let go at least 2 hours before taking a laxative.

Effects

Below are the undesirable effects of glycerol organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Gastrointestinal diseases: insulated cramping pains or abdominal colic pains and diarrhea, with loss of liquids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation.

Overdosing

No overdose cases have been reported. In any case, excessive doses (abuse of laxatives – frequent or prolonged use or with excessive doses) can cause abdominal pain, persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. Liquid and electrolyte losses must be replaced. Electrolytic imbalances are characterized by the following symptoms: thirst, vomiting, weakening, edema, bone pain (osteomalacia) and hypoalbuminemia. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia).

No adequate and well-controlled studies have been carried out on the use of the medicinal product during pregnancy or breastfeeding. Although there are no obvious contraindications of the use of the medicinal product during pregnancy and during breastfeeding, it is recommended to take the medicinal product only if necessary and under medical supervision.

Source: Farmadati