Glycerol Afom Children 4.5 g Rectal Solution 6 Single Doses with Chamomile and Mallow

Glycerol Afom is a rectal solution based on Glycerol.

Therapeutic indications

Glycerol Afom is used in the short-term treatment of occasional constipation.

Dosage and Posology

The correct dose is the minimum sufficient to produce an easy evacuation. It is advisable to initially use the minimum doses provided:

• 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.

How to 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.

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, 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 cause cardiac and 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).

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 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 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.

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 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 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 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 a day, in order to facilitate the softening of the stool.

Expiry and Retention

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

Warning: do not use Glycerol Afom after the expiry date shown on the package

Composition

Each container of Afom Glycerol contains:

Active principle

Glycerol 4.5 g

Excipients

Chamomile fluid extract, Mallow fluid extract, Potato starch, Purified water