Micro-enemas glycerol Zeta 6 cont 6.75g minsan 031329030

GLYCEROL ZETA*6CONT 6.75G CAM

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage and method of use

The correct dose is the minimum sufficient to produce an easy evacuation. It is advisable to initially use the minimum doses provided.Adults and adolescents (12 – 18 years): 1 single-dose adult container of 6.75 g as needed, for a maximum of 1 or 2 administrations per day.Children aged 6 – 11 years: 1 single-dose container of 4.5 g for children as needed, for a maximum of 1 or 2 administrations per dayChildren aged 2 – 6 years: 1 single-dose infant container of 2.25 g as needed, for a maximum of 1 or 2 administrations per day.Instructions for UseRemove the cap. During the operation, never grasp the bellows, otherwise the medicine would leak before use. It may be useful to lubricate the cannula with a drop of the solution itself, before introducing it into the rectum and pressing the bellows. Extract the cannula while holding down the bellows. Each container must be used for a single administration only; any residual medicine must be discarded. 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 longer than seven days (see section 4.4). A diet rich in liquids favors the effect of the medicine.

Contraindications

– Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1; – acute abdominal pain or pain of unknown origin; – nausea or vomiting; – intestinal obstruction or stenosis; – rectal bleeding of unknown origin; – acute hemorrhoidal crisis with pain and bleeding; – severe state of dehydration.

Side effects

Below are the side effects of glycerol organized according to the MedDRA system organic classification. There is insufficient data to establish the frequency of the individual effects listed.Gastrointestinal disordersIsolated crampy pain or abdominal colic and diarrhea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation.Reporting of side effectsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Laxatives should be used as infrequently as possible and for no longer 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 the course of therapy. It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine. Abuse of laxatives can cause persistent diarrhea resulting in loss of water, mineral salts (especially potassium) and other essential nutritional factors. In more serious cases of abuse, the onset of dehydration or hypokalemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, possible need to progressively 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 to help soften the stool.

Pregnancy and breastfeeding

No adequate and well-controlled studies have been carried out 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 if necessary and under medical supervision.

Expiration and conservation

Store in the original package in order to protect the medicine from light.

Interactions with other drugs

No specific interaction studies have been performed.

Overdose

No cases of overdose 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 with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. 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, the onset of dehydration or hypokalemia is possible which can cause cardiac or neuromuscular dysfunction, especially in case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).

Active principles

GLYCEROL Zeta early childhood 2.25 g rectal solution Each single-dose container contains:active principle: glycerol 2.25 g. GLYCEROL Zeta children 4.5 g rectal solution Each single-dose container contains:active principle: glycerol 4.5 g. GLYCEROL Zeta adults 6.75 g rectal solution Each single-dose container contains:active principle: glycerol 6.75 g. For the full list of excipients, see section 6.1.

Excipients

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