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

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Short-term treatment of occasional constipation.

ACTIVE INGREDIENTS

GLYCEROL AFOM early childhood 2.25 g rectal solution - 6 single-dose containers with chamomile and mallow. Each single-dose container contains: active ingredients: Glycerol 2.25 g. GLYCEROL AFOM children 4.5 g rectal solution - 6 single-dose containers with chamomile and mallow. Each single-dose container contains: active ingredients: Glycerol 4.5 g. GLYCEROL AFOM adults 6.75 g rectal solution - 6 single-dose containers with chamomile and mallow. Each single-dose container contains: active ingredients: Glycerol 6.75 g. For the complete list of excipients see section 6.1.

EXCIPIENTS

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

CONTRAINDICATIONS AND SIDE EFFECTS

- 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.

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 adult container of 6.75 g as needed, for a maximum of 1 or 2 administrations per day. Children aged 6-11 years: 1 single-dose container of 4.5 g for children as needed, for a maximum of 1 or 2 administrations per day. Children aged 2-6 years: 1 single-dose infant container of 2.75 g as needed, for a maximum of 1 or 2 administrations per day. Instructions for use: Remove the cap of 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. Extract the cannula while holding down the bellows. Each container must be used for a single administration only; any residual medicine must be discarded. In children under twelve years of age the medicine can only be used after consulting a doctor. Laxatives should be used as infrequently as possible and for no longer than seven days (see section 4.4). A diet rich in liquids favors the effect of the medicine.

CONSERVATION

Store in the original packaging to protect the medicine from humidity and away from direct sources of heat.

WARNINGS

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.

OVERDOSE

No cases of overdose have been reported. In any case, excessive doses (abuse of laxatives - 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. Fluid and electrolyte losses must be replaced. Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia) and hypoalbuminemia. In more severe cases, 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).

PREGNANCY AND BREASTFEEDING

No adequate and well-controlled studies have been carried out 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 if necessary and under medical supervision.

EFFECTS ON DRIVING ABILITY

The medicine does not alter the ability to drive or use machines. However, it is possible that side effects may occur during treatment, therefore it is good to know the reaction to the drug before driving vehicles or using machinery.