GLYCEROL FG * AD 6ENEMA 6,75G

GLYCEROL FG * AD 6ENEMA 6,75G

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.Dosage. Adults and adolescents (12-18 years):1 single-dose container of GLYCEROL FG 6.75 g as needed, for a maximum of 1 or 2 doses per day.Children aged 2-11 years:1 single-dose container of GLYCEROL FG 2.25 g as needed, for a maximum of 1 or 2 doses per day. Laxatives should be used as infrequently as possible and for no more than seven days (see section 4.4). A diet rich in liquids favors the effect of the medicine. In children under the age of twelve, the medicine can only be used under strict medical supervision.Method of administration:Remove the cap. During the operation, never grasp the bellows, otherwise the medicine will come out 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. Remove the cannula while pressing the bellows. Each container should be used for one administration only; any remaining medicine must be discarded.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, - acute abdominal pain or of unknown origin, - nausea or vomiting, - intestinal obstruction or stricture, - rectal bleeding of unknown origin, - acute haemorrhoidal crisis with pain and bleeding, - severe dehydration.

Side effects

The following are the undesirable effects of glycerol organized according to the MedDRA system organ class with the following frequency: Very common ≥1 / 10; Common: ≥ 1/100,

Cramping pains are usually isolated. Cramping pains, abdominal colic and diarrhea are more common in cases of severe constipation.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio 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 more than seven days (see section 4.2). 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 careful medical evaluation for diagnosis, prescription of drugs and surveillance during the course of therapy. In the elderly or in poor health conditions, the medicine must be used with caution and under medical supervision. The abuse of laxatives can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In the most severe cases of abuse, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment of cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (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 advisable 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 a day, in order to facilitate the softening of the stool.

Pregnancy and breastfeeding

There have been no adequate and well-controlled studies on the use of the medicine in pregnancy or lactation. Although there are no obvious contraindications to the use of the medicine during pregnancy and breastfeeding, it is recommended to take the medicine only in case of need and under medical supervision.Fertility:Non-clinical toxicity studies revealed no effects of glycerol on reproductive parameters (see section 5.3).

Expiration and retention

Store in the original package in order to protect from moisture and away from direct heat sources.

Interactions with other drugs

No specific interaction studies have been performed.

Overdose

No cases of overdose have been reported. In any case, excessive doses can cause abdominal pain, persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. Leaks of fluids and electrolytes must be replaced. Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia) and hypoalbuminemia. In severe cases, the onset of dehydration or hypokalemia is possible, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.

Active principles

GLYCEROL FG Children 2.25 g rectal solution. Each single-dose container contains:Active principle: Glycerol 2.25 g GLYCEROL FG Adults 6.75 g rectal solution. Each single-dose container contains:Active principle: Glycerol 6.75 g For a full list of excipients see section 6.1.

Excipients

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