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ZETALAX*AD 18SUPP 2.25G

  • Zeta Farmaceutici S.p.A.
  • 028837019
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Indicated for use in pregnancy and lactation.


Emollient laxative.


Intestine wellness.


















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ZETALAX*AD 18SUPP 2.25G

Therapeutic indications

Short-term treatment of occasional and transient constipation.

Dosage and method of use

The correct dose is the minimum sufficient to produce an easy evacuation. It is advisable to initially use the minimum doses envisaged.Dosage Adults:1 adult suppository as needed, for a maximum of 1 or 2 administrations per day.Pediatric populationAdolescents (12-18 years): 1 adult suppository as needed, for a maximum of 1 or 2 administrations per day. Children aged between 2-11 years: 1 children's suppository as needed, for a maximum of 1 or 2 administrations per day. Children aged between 1 month and 2 years: 1 early childhood suppository as needed, for a maximum of 1 or 2 administrations per day. DO NOT EXCEED THE RECOMMENDED DOSES Laxatives should be used as infrequently as possible and for no more than seven days (see section 4.4). A diet rich in liquids favors the effect of the medicine.

Contraindications

-Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. -acute abdominal pain or pain of unknown origin; -nausea or vomiting; -intestinal obstruction or stenosis; -rectal bleeding of unknown origin; -acute hemorrhoidal crisis with pain and bleeding; -severe state of dehydration.

Side effects

Side effects observed during treatment in clinical studies and integrated with those collected during post-marketing experience are listed in the table below according to System Organ Class (using MedDRA terminology) and according to the following frequency: Very common ≥1 /10; Common ≥1/100,

Gastrointestinal disorders  
Not known Crampy abdominal pain*, abdominal colic, diarrhea**, anal irritation.

* usually isolated ** with loss of fluids and electrolytes Crampy abdominal pain, abdominal colic, diarrhea are more frequent in cases of severe constipation.Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Special 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 resulting in 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 ones (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.Precautions for useIf the suppositories appear softened, immerse the containers in cold water before opening them.

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.

Expiration and conservation

Store in the original packaging.

Interactions with other drugs

No interactions with other medications or of any other nature have been reported.

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 and 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).

Active principles

ZETALAX suppositories for adults Each suppository contains: active ingredient: glycerol 2,250 g. ZETALAX suppositories for children Each suppository contains: active ingredient: glycerol 1.375 g ZETALAX suppositories for infants Each suppository contains: active ingredient: glycerol 0.908 g.

Excipients

Sodium stearate and anhydrous sodium carbonate.

028837019

Data sheet

Packaging
to 18 suppositories
Product Type
HUMAN DRUG
ATC code
A06AX01
ATC description
Glycerol
Therapeutic Group
Laxatives, Emollients
Active principle
glycerol (DC.IT) (FU)
Class
C.
Pharmaceutical form
suppository
Type of Administration
rectal
Container
alveolus
Quantity
18 suppository
Quantity of the Active Ingredient
2250MG
Recipe required
OTC - self-medication medicine
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