GLICEROLO FIRST INF 12SUPP 900

GLICEROLO CARLO ERBA

active ingredients

GLICEROLO CARLO ERBA Early childhood 900 mg suppositories A supposed early childhood contains: active ingredient: Glicerol 900 mg. GLICEROLO CARLO ERBA Children 1375 mg supposedly A supposed child contains: active ingredient: Glycerol 1375 mg. GLICEROLO CARLO ERBA Adults 2250 mg suppositories An adult suppository contains: active ingredient: Glicerol 2250 mg. GLICEROLO CARLO ERBA Children 2,25 g rectal solution Each single-dose container contains: active ingredient: Glicerolo 2,25 g. GLICEROLO CARLO ERBA Adults 6,75 g rectal solution Each single-dose container contains: active ingredient: Glicerolo 6,75 g. For the full list of excipients, see paragraph 6.1.

Excellent

Supposes: sodium stearate; sodium carbonate. Straight solution: chamomile extract fluid; fluid extract mortar; wheat starch; purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

• hypersensitivity to the active ingredient or any excipient; • acute or unknown abdominal pain; • nausea or vomiting; • obstruction or intestinal stenosis; • rectal bleeding of unknown origin; • acute hemorrhoid crisis with pain and bleeding; • severe dehydration.

Population

The correct dose is sufficient to produce an easy evacuation. It is advisable to initially use the minimum doses provided. Population Supposes: Adults: 1 supposes adults in need, for a maximum of 1 or 2 administrations per day. Pediatric population Adolescents (12 – 18 years): 1 supposes adults in need, for a maximum of 1 or 2 administrations per day. Children between 2 and 11 years old: 1 supposes children in need, for a maximum of 1 or 2 administrations per day. Children between 1 month and 2 years: 1 supposes early childhood in need, for up to 1 or 2 administrations per day. Straight solution: Adults: 1 single-dose adult container for a maximum of 1 or 2 administrations per day. Pediatric population Adolescents (12 – 18 years): 1 single-dose adult container for a maximum of 1 or 2 administrations per day. Children aged 6 to 11 years: 1 or 2 single-dose containers children in need, for up to 1 or 2 administrations per day. Children between 2 and 6 years old: 1 single-dose children container for up to 1 or 2 administrations per day. Method of administration Supposes: Remove the suppository from its container and then, if necessary, moisten it to facilitate the rectal introduction. If the suppositories appeared soft dip the containers, before opening them, in cold water. Straight solution: To remove the safety cover of the single-dose container, place the index and thumb on the round needle placed above the bellows and, with the other hand, fold the cover until it causes the detachment of the body of the container. During the operation, never grasp the bellows, otherwise you would check out the medicine before use. It can be useful to lubricate the cannula with a drop of the solution itself, before introducing it into the rectum and press the bellows. Extract the cannula while holding the bellows. Each container must be used for only one administration; any remaining medicinal product must be eliminated. In children under twelve years the medicine can only be used after consulting the doctor. Laxatives must be used as frequently as possible and for no more than seven days (see paragraph 4.4). A fluid-rich diet promotes the effect of the medicine.

Conservation

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

Warnings

Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods requires the doctor’s prescription after adequate evaluation of the individual case. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. You should also consult your doctor before using the medicine. The abuse of laxatives can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In severe cases of abuse, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment of heart glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). In episodes of constipation, it is recommended first of all to correct food habits by integrating the daily diet with an adequate supply of fiber and water. When using laxatives it is appropriate to drink at least 6–8 glasses of water per day, or other liquids, so as to encourage the softening of feces.

Interactions

Specific interaction studies have not been carried out.

Effects

Undesirable effects observed during treatment in clinical trials and integrated with those collected during post-marketing experience are listed in the table below as per the Classification for Systems and Organs (using MedDRA terminology) and as follows: Very common ≥1/10; Common ≥1/100, Gastrointestinal diseases Notable Pain cramps of the abdomen*; abdominal colics, diarrhea****, anal irritation *usually isolated ** with loss of liquids and electrolytes Insulated cramping pains or abdominal colics and diarrhea are more frequent in severe constipation cases. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address "www.agenziafarmaco.gov.it/it/responsabili".

Overdosing

No overdose cases have been reported. In any case, excessive doses (abuse of laxatives – frequent or prolonged use or with excessive doses) can cause abdominal pain and persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. Liquid and electrolyte losses must be replaced. Electrolytic imbalances are characterized by the following symptoms: thirst, vomiting, weakening, edema, bone pain (osteomalacia) and hypoalbuminemia. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia).

No adequate and well-controlled studies have been carried out on the use of the medicinal product during pregnancy or breastfeeding. Although there are no obvious contraindications of the use of the medicinal product in pregnancy and during breastfeeding, it is recommended to take the medicine only if necessary and under medical supervision.

Source: Farmadati