Sofar Glycerol 2.25g Early Childhood Rectal Solution 6 Single-Dose Containers With Chamomile and Mallow

Therapeutic indications

Short-term treatment of occasional constipation.

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 as needed, for a maximum of 1 or 2 doses per day. Children aged 6–11 years : 1–2 single-dose containers for children / infants as needed, for a maximum of 1 or 2 doses per day. Children aged 2-6 years : 1 single-dose container children / infants as needed, for a maximum of 1 or 2 doses per day. Instructions for use Remove the cannula cover by folding it at the base (as shown in the figure). Place your index finger and thumb on the round ring located above the bellows and, with the other hand, bend the cannula cover until it detaches from the body of the container. During the operation, never grasp the bellows, otherwise the medicine will come out before use. 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 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 the most serious cases, the onset of dehydration or hypokalaemia is possible, which can cause cardiac or 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 stenosis - rectal bleeding of unknown origin - acute haemorrhoidal crisis with pain and bleeding - severe dehydration.

Side 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.

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, minerals (especially potassium) and other essential nutritional factors. In the most severe cases of abuse, dehydration or hypokalaemia may develop, which can lead to cardiac or neuromuscular dysfunction, 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). 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.

Expiry and Retention

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

Active principles

GLYCEROL Sofar Infancy / Children 2.25 g rectal solution Each single-dose container contains: active ingredient: Glycerol 2.25 g GLYCEROL Sofar 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.

Excipients

Rectal solution, 6 single-dose containers: Wheat starch, purified water. Rectal solution, 6 single-dose containers with chamomile and mallow: Wheat starch, chamomile fluid extract, mallow fluid extract, purified water.