GLICEROLO ZETTE 6CONT 2,25G CAM

GLICEROLO ZET

active ingredients

GLICEROLO Zeta Early Childhood 2,25 g Rectal Solution Each single-dose container contains: active ingredient: glycerol 2.25 g. GLICEROLO Zeta children 4.5 g rectal solution Each single-dose container contains: active ingredient: glycerol 4.5 g. GLICEROLO Zeta adults 6,75 g rectal solution Each single-dose container contains: active ingredient: glycerol 6,75 g. For the full list of excipients, see paragraph 6.1.

Excellent

Chamomile extract fluid, malva extract fluid, pregelatinized starch, purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

– Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; – 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 adult single-dose container of 6.75 g per day, for up to 1 or 2 administrations per day. Children aged 6 to 11 years: 1 single-dose children 4,5 g in need, for up to 1 or 2 administrations per day Children aged 2 to 6 years: 1 single-dose container before childhood from 2.25 g to need, for up to 1 or 2 administrations per day. Instructions for use Remove the cap. During the operation, never grasp the bellows, otherwise you would check out the medicine before use. It can be useful to lubricate the cannula with a drop of the solution itself, before introducing it into the rectum and press the bellows. Extract the cannula while holding the bellows. Each container must be used for only one administration; any remaining medicinal product must be eliminated. In children under twelve years the medicine can only be used after consulting the doctor. 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 in the original packaging to protect the medicine from light.

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. The abuse of laxatives 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. When using laxatives it is appropriate to drink at least 6 – 8 glasses of water, or other liquids, so as to encourage the softening of feces.

Interactions

Specific interaction studies have not been carried out.

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 and diarrhea, with loss of liquids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation. Reporting of unwanted effects 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 www.agenziafarmaco.gov.it/it/responsabili.

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 in pregnancy and during breastfeeding, it is recommended to take the medicine only if necessary and under medical supervision.

Source: Farmadati