ZETALAX AD 18SUPP 2,25G

ZETALAX GLICERINA SUPPLY

active ingredients

ZETALAX adult suppositories Each suppository contains: active ingredient: glycerol 2,250 g. ZETALAX children's suppositories Each suppository contains: active ingredient: glycerol 1,375 g ZETALAX suppositories Each suppository contains: active ingredient: glycerol 0,908 g.

Excellent

Sodium stearate and sodium carbonate anidro.

Therapeutic indications

Short-term treatment of occasional and transitory stipsis.

Contraindications

-Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. -acute or unknown abdominal pain; -nausea or vomiting; -obstruction or intestinal stenosis; -rectal bleeding of unknown origin; -hemorrhoid acrylic acute with pain and bleeding; -no dehydration.

Population

The correct dose is sufficient to produce an easy evacuation. It is advisable to initially use the minimum doses provided. Population 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 aged 2-11 years: 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. DOESN'T EVERYTHING 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.

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 stypsis 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 it is possible the occurrence of dehydration or hypopotassiemia, which can determine heart 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 stipsi episodes, 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 facilitate the softening of stools. Precautions for use If the suppositories appeared soft, dip the containers, before opening them, in cold water.

Interactions

Interactions with other medicines or other types have not been reported.

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 liquid loss and electrolytes Pain cramps of the abdomen, abdominal colics, diarrhea, are more frequent in cases of severe constipation. 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

No overdose cases have been reported. In any case, excessive doses (frequent or prolonged laxative abuse or 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 medicinal product only if necessary and under medical supervision.

Source: Farmadati