Farmakopea glycerol 6,75g

Rectal Solution

Short-term treatment of occasional constipation.

Excipients :

No specific interaction studies have been performed.

Composition:

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

CONTRAINDICATIONS
- 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 haemorrhoidal crisis with pain and bleeding, - severe 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 adult single-dose container of 6.75 g as needed, for a maximum of 1 or 2 doses per day. Children aged 6-11 years: 1 single-dose container of 4.5 g children as needed, for a maximum of 1 or 2 doses per day. Children aged 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 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.

WARNINGS AND PRECAUTIONS
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, minerals (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 lead to 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, 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.

DESIRED EFFECTS
The following 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 Isolated cramping pains 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 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 in case of need and under medical supervision.