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ZETALAX * AD 18SUPP 2.25G

  • ZETA FARMACEUTICI SpA
  • 028837019
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Quick action.


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 provided.Dosage Adults:1 adult suppository as needed, for a maximum of 1 or 2 doses per day.Pediatric populationAdolescents (12-18 years): 1 adult suppository as needed, for a maximum of 1 or 2 doses per day. Children aged 2-11 years: 1 suppository for children as needed, for a maximum of 1 or 2 doses per day. Children aged 1 month to 2 years: 1 suppository early childhood as needed, for a maximum of 1 or 2 doses per day. DO NOT EXCEED 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 section 6.1. - acute abdominal pain or of unknown origin; nausea or vomiting; intestinal obstruction or stricture; - rectal bleeding of unknown origin; acute hemorrhoidal crisis with pain and bleeding; - severe dehydration.

Side effects

Undesirable effects observed during treatment in clinical trials and integrated with those collected during post-marketing experience are listed in the table below according to the 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 pains *, abdominal colic, diarrhea **, anal irritation.

* usually isolated ** with loss of fluids and electrolytes Cramping pains in the abdomen, abdominal colic, diarrhea, are more frequent in cases of severe constipation.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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 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, mineral salts (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 dysfunctions, especially in the case of simultaneous treatment of 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 a day, in order to facilitate the softening of the stool.Precautions for useIf the suppositories appear softened, immerse the containers, before opening them, in cold water.

Pregnancy and breastfeeding

There have been no adequate and well-controlled studies on the use of the medicine in pregnancy or lactation. 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.

Expiration and retention

Store in the original packaging.

Interactions with other drugs

No interactions with other medicaments or other types have been reported.

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 and persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. Leaks of fluids and electrolytes must be replaced. Electrolyte imbalances are characterized by the following symptoms: thirst, vomiting, weakness, edema, bone pain (osteomalacia) and hypoalbuminemia. In severe cases, the onset of dehydration or hypokalemia 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).

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 suppository for infants Each suppository contains: active ingredient: glycerol 0.908 g.

Excipients

Sodium stearate and anhydrous sodium carbonate.

028837019
21 Items

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