Guttalax drops 15ml 75mg 020949020

GUTTALAX * OS GTT 15ML 7.5MG / ML

Therapeutic indications

Short-term treatment of occasional constipation.

Dosage and method of use

The following dosages are recommended:AdultsIn adults it is recommended to start with 7-8 drops in water per day and to decrease if the effect is excessive or to increase if the laxative effect is not achieved. In cases of stubborn constipation, up to 15-20 drops in water can be reached.Pediatric populationIn children (over 3 years old): 2-3 drops in water per day. Do not exceed the recommended dose. It is advisable to initially use the minimum doses provided. The correct dose is the minimum sufficient to produce an easy evacuation of soft stools. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. Guttalax should preferably be taken in the evening to evacuate the next morning. Swallow with an adequate amount of water. A diet rich in liquids favors the effect of the medicine. 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.

Contraindications

Guttalax is contraindicated in patients with: • Hypersensitivity to the active substance and to any of the excipients, listed in section 6.1; • Paralytic ileus or intestinal or biliary obstruction or stenosis; • Acute severe painful and / or febrile abdominal conditions (such as appendicitis) associated with nausea and vomiting; • Severe state of dehydration; • Rare hereditary conditions of incompatibility with any of the excipients (see section 4.4). • Nausea or vomiting; • Acute inflammation of the gastrointestinal tract; • Rectal bleeding of unknown origin; • Gallstone disease; • Hepatic insufficiency; • Pregnancy and lactation (see section 4.6). Do not administer to children under 3 years of age (see section 4.4).

Side effects

Like all medicines, Guttalax can cause side effects, although not everybody gets them. Adverse reactions are listed below by system organ class and frequency according to the following categories: Very common ≥ 1/10 Common ≥ 1/100, Immune system disorders. Not known *: hypersensitivity.Nervous system disorders. Uncommon: dizziness; Not known *: syncope. The phenomena of dizziness and syncope that occur after taking sodium picosulfate appear to be attributable to a vasovagal response (resulting, for example, from abdominal pain or stool evacuation).Gastrointestinal disorders. Very common: diarrhea; Common: abdominal cramps, abdominal pain and abdominal discomfort; Uncommon: vomiting, nausea. Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.Skin and subcutaneous tissue disorders. Not known *: skin reactions such as angioedema, rash on taking the medicine, rash, pruritus.* These adverse reactions have been observed in post-marketing experience. 95% likely, the frequency category is not greater than uncommon, but it may be lower. A precise frequency estimate is not possible as these adverse reactions did not occur in 1020 patients in clinical trials.Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

Special warnings

WarningsLike all laxatives, Guttalax should not be taken continuously every day or for long periods of time without investigating the cause of the constipation. Prolonged and excessive use can lead to diarrhea, electrolyte imbalance and hypokalemia. Cases of dizziness and / or syncope have been reported in patients taking Guttalax. The available data on these cases suggest that the events could be related to defecation syncope (or syncope attributable to evacuative effort), or to a vasovagal response to abdominal pain related to constipation, and not necessarily to the intake of sodium picosulfate itself. The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. 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).Precautions for useIn children between 3 and 12 years of age, the medicine can only be used after consulting your doctor. 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. Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that elderly people or those in poor health conditions consult their doctor before using the medicine. This medicinal product contains 450 mg of sorbitol in 1 ml (15 drops), equivalent to 600 mg of sorbitol in the maximum recommended daily dose of 1.33 ml (20 drops) in the treatment of an adult patient. Sorbitol is a source of fructose. Patients with hereditary fructose intolerance (HFI), a rare genetic disorder, should not be given this medicine. This medicine contains less than 1 mmol sodium (23 mg) in 20 drops, the maximum recommended daily dose for an adult, ie essentially 'sodium-free'.

Pregnancy and breastfeeding

FertilityNo studies have been conducted to evaluate the effects on human fertility. Non-clinical studies revealed no effect on fertility (see section 5.3).PregnancyThere are no adequate and well-controlled studies on the use of the drug in pregnancy. Long experience has shown no evidence of unwanted or harmful effects during pregnancy. Although no toxic effects have ever been reported during pregnancy, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus.Feeding timeClinical data show that neither the active fraction of sodium picosulfate, bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM), nor the conjugated form (its glucuronic derivatives), are excreted, in detectable quantities in breast milk. However, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the infant.

Expiration and retention

Keep the bottle in the outer carton to protect the medicine from light. Validity after first opening: 12 months.

Interactions with other drugs

Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking the laxative. Milk or antacids can change the effect of the medicine; leave an interval of at least an hour before taking the laxative. Continued use of Guttalax may increase patient response to oral anticoagulants and change glucose tolerance. Concomitant use of diuretics or adrenocorticosteroids and excessive doses of Guttalax may lead to an increased risk of electrolyte imbalance. This imbalance, in turn, can lead to an increase in sensitivity to cardiac glycosides. Concomitant administration of antibiotics may reduce the laxative effect of Guttalax.

Overdose

Signs and symptomsFollowing high doses of the drug, watery stools (diarrhea), abdominal cramps and significant loss of fluids, potassium and other electrolytes may occur. Cases of colonic mucosal ischaemia have been reported with doses of Guttalax considerably higher than the recommended dosage for the treatment of occasional constipation. Guttalax, like other laxatives, causes chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism and stones when overdosed. kidney. In association with chronic laxative abuse, renal tubular injury, metabolic alkalosis and muscle weakness secondary to hypokalemia have also been described. See also the information in the section “Special warnings and precautions for use” regarding the abuse of laxatives.TreatmentIf action is taken within a short time after ingestion of Guttalax, absorption can be reduced or avoided by induction of vomiting or gastric lavage. Leaks of fluids and electrolytes must be replaced. This is particularly important in the elderly and young people. The administration of spasmolytics may be useful.

Active principles

1 ml (15 drops) of solution contains: Active ingredient: sodium picosulfate 7.5 mg. Excipient with known effect: Sorbitol (E420) 450 mg (see section 4.4). For the full list of excipients, see section 6.1.

Excipients

Sodium benzoate, liquid sorbitol (E420), sodium citrate, citric acid monohydrate, purified water.