Glycerol Afom Adults 6.75g Rectal Solution 6 Single-Dose Containers with Chamomile and Mallow

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Short-term treatment of occasional constipation.

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 stenosis, - rectal bleeding of unknown origin, - acute haemorrhoidal crisis with pain and bleeding, - severe state of dehydration.

WARNINGS AND PRECAUTIONS FOR USE

Laxatives should be used as infrequently as possible and for no longer 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 a doctor for diagnosis, prescription of drugs and monitoring 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. Abuse of laxatives can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In more serious cases of abuse, the onset of dehydration or hypokalemia is possible, which can cause cardiac or neuromuscular dysfunction, especially in case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). In episodes of constipation, it is recommended 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 to help soften 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 organic classification. There is insufficient data to establish the frequency of the individual effects listed. Gastrointestinal disorders: Isolated crampy pain or abdominal colic and diarrhea, with loss of fluids and electrolytes, more frequent in cases of severe constipation, as well as rectal irritation.