Glycerol Microenemas Carlo Erba 6 containers 6.75g

GLYCEROL * AD 6CONT 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 Suppositories:Adults: 1 adult suppository as needed, for a maximum of 1 or 2 doses per day.Pediatric population Teenagers (12 - 18 years): 1 adult suppository as needed, for a maximum of 1 or 2 doses per day.Children aged 2 - 11 years: 1 suppository for children as needed, for a maximum of 1 or 2 doses per day.Children aged 1 month to 2 years: 1 suppository early childhood as needed, for a maximum of 1 or 2 doses per day.Rectal solution:Adults: 1 single-dose container for adults as needed, for a maximum of 1 or 2 administrations per day.Pediatric population Teenagers (12 - 18 years): 1 single-dose container for adults as needed, for a maximum of 1 or 2 administrations per day.Children aged 6 - 11 years: 1 or 2 single-dose containers for children as needed, for a maximum of 1 or 2 administrations per day.Children aged between 2 - 6 years: 1 single-dose container for children as needed for a maximum of 1 or 2 administrations per day.Method of administration Suppositories: Remove the suppository from its container and then, if necessary, moisten it to facilitate its rectal introduction. If the suppositories appear soft, immerse the containers, before opening them, in cold water.Rectal solution: To remove the safety cannula cover from the single-dose container, place your index finger and thumb on the round ring located above the bellows and, with the other hand, bend the cannula cover until it detaches from the body of the container. 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. In children under the age of twelve, the medicine can only be used after consulting your 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 favors the effect of the medicine.

Contraindications

• hypersensitivity to the active substance or to any of the excipients; • acute abdominal pain or pain of unknown origin; • nausea or vomiting; • intestinal obstruction or stricture; • rectal bleeding of unknown origin; • acute haemorrhoidal crisis with pain and bleeding; • severe state of dehydration.

Side effects

Undesirable effects observed during treatment in clinical studies and integrated with those collected during post-marketing experience are listed in the table below according to the System Organ Class (using MedDRA terminology) and according to the following frequency: Very common ≥1 / 10; Common ≥1 / 100,

* usually isolated ** with loss of fluids and electrolytes Isolated cramping pains or abdominal colic and diarrhea are more frequent in cases of severe constipation.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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. 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 the doctor for the diagnosis, the prescription of drugs and the surveillance 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. 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 dysfunction, especially in the case of simultaneous treatment with 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 first of all recommended 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

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.

Expiry 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 (laxative abuse - frequent or prolonged use or with excessive doses) can cause abdominal pain and persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. Leaking 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 hypokalaemia is possible, which can lead to cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment with 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).

Active principles

GLYCEROL CARLO ERBA Early childhood 900 mg suppositoriesAn early childhood suppository contains: active ingredient: Glycerol 900 mg.GLYCEROL CARLO ERBA Children 1375 mg suppositoriesOne suppository for children contains: active ingredient: Glycerol 1375 mg.GLYCEROL CARLO ERBA Adults 2250 mg suppositoriesOne adult suppository contains: active ingredient: Glycerol 2250 mg.GLYCEROL CARLO ERBA Children 2.25 g rectal solutionEach single-dose container contains: active ingredient: Glycerol 2.25 g.GLYCEROL CARLO ERBA Adults 6.75 g rectal solutionEach single-dose container contains: active ingredient: Glycerol 6.75 g. For the full list of excipients, see section 6.1.

Excipients

Suppositories: sodium stearate; sodium carbonate.Rectal solution: chamomile fluid extract; mallow fluid extract; wheat starch; purified water.