Glycerol Pharmakopoeia Early Childhood 6 Microenemas 2.25g C

NAME
FARMAKOPEA GLYCEROL

PHARMACOTHERAPEUTIC CATEGORY
Constipation medications.

ACTIVE PRINCIPLES
Glycerol.

EXCIPIENTS
Each single-dose container contains: chamomile fluid extract, mallow fluid extract, pregelatinised starch, purified water.

INDICATIONS
Short-term treatment of occasional constipation.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the excipients; acute abdominal pain or of unknown origin; nausea or vomiting; intestinal obstruction or stricture; rectal bleeding of unknown origin; acute hemorrhoidal crisis with pain and bleeding; severe state of dehydration.

DOSAGE
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 container of 6.75 g adults as needed, for a maximum of 1 or 2 doses per day Children aged 6-11 years: 1 single-dose container children from 4, 5 g as needed, for a maximum of 1 or 2 doses per day. Children aged between 2-6 years: 1 single-dose container for infants of 2.25 g as needed, for a maximum of 1 or 2 doses per day. Instructions for use: remove the cap from the single-dose container; 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 a medical consultation. Laxatives should be used as infrequently as possible and for no more than seven days. A diet rich in liquids favors the effect of the medicine.

STORAGE
Store in the original package to protect the medicine from humidity and away from direct heat sources.

WARNINGS
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a medical prescription after adequate evaluation of the individual case. The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during the course of therapy. It is also advisable that elderly people or those in poor health conditions 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 it is possible the onset of dehydration or hypokalaemia, which can cause cardiac or neuromuscular dysfunctions, especially in the case of simultaneous treatment of cardiac glucosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, 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 favor the softening of the stool.

INTERACTIONS
No specific interaction studies have been performed.

SIDE EFFECTS
Below are the side effects of glycerol organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed. Gastrointestinal disorders: cramping pains in isolation or abdominal colic and diarrhea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation.

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.