Guttalax 7.5mg/ml oral drops 15ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Short-term treatment of occasional constipation.

ACTIVE INGREDIENTS

1 ml (15 drops) of solution contains: Active ingredient: sodium picosulphate 7.5 mg. Excipient with known effects: 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.

CONTRAINDICATIONS AND SIDE EFFECTS

Guttalax is contraindicated in patients with: • Hypersensitivity to the active substance and to any excipients, listed in paragraph 6.1; • Paralytic ileus or intestinal or biliary tract 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 one of the excipients (see section 4.4). • Nausea or vomiting; • Acute inflammation of the gastrointestinal tract; • Rectal bleeding of unknown origin; • Gallstones; • Liver failure; • Pregnancy and breastfeeding (see section 4.6). Do not administer to children under 3 years of age (see section 4.4).

DOSAGE

The following dosages are recommended: Adults In 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 used. Pediatric population In children (over 3 years): 2-3 drops in water per day. Do not exceed the recommended doses. It is advisable to initially use the minimum doses provided. The correct dose is the minimum sufficient to produce an easy evacuation of loose 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 induce evacuation the following morning. Swallow together 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 longer than seven days. Use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.

CONSERVATION

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

WARNINGS

Warnings Like all laxatives, Guttalax should not be taken continuously every day or for long periods of time without investigating the cause of 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 data available on these cases suggest that the events could be related to syncope from defecation (or syncope attributable to the effort of evacuation), 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 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). Precautions for use In children aged between 3 and 12 years the medicine can only be used after consulting the doctor. 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. Consult your doctor when the need for the laxative derives from a sudden change in previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable for elderly people or those in poor health to 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 disease, should not be given this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) in 20 drops, the maximum recommended daily dose for an adult, i.e. it is essentially “sodium-free”.

INTERACTIONS

Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other medicines 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 one hour before taking the laxative. Continued use of Guttalax may increase patients' response to oral anticoagulants and change glucose tolerance. The 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 increased sensitivity to cardiac glycosides. Concomitant administration of antibiotics may reduce the laxative effect of Guttalax.

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, < 1/10 Uncommon ≥ 1/1,000, < 1/100 Rare ≥ 1/10,000, < 1/1,000 Very rare < 1/10,000 Not known frequency cannot be defined on the basis of available data. 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 picosulphate appear to be attributable to a vasovagal response (resulting, for example, from abdominal pain or the evacuation of feces). Gastrointestinal disorders. Very common: diarrhea; Common: abdominal cramps, abdominal pain and abdominal discomfort; Uncommon: vomiting, nausea. Occasionally: isolated cramping pain or abdominal colic, more frequent in cases of severe constipation. Pathologies of the skin and subcutaneous tissue. Not known*: skin reactions such as angioedema, rash on taking the medicine, rash, itching. *These adverse reactions were observed in post-marketing experience. At 95% probability, the frequency category is not greater than uncommon, but could be lower. A precise estimate of the frequency is not possible since these adverse reactions did not occur in 1020 patients in clinical trials. Reporting of side effects If you get any side effects, including any not listed in this leaflet, contact your doctor or pharmacist. Undesirable effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

OVERDOSE

Signs and symptoms Following the intake of high doses of the drug, the following may occur: watery stools (diarrhoea), abdominal cramps and a significant loss of fluids, potassium and other electrolytes. Cases of colonic mucosal ischemia have been reported with doses of Guttalax considerably higher than the recommended dosage for the treatment of occasional constipation. Guttalax, like other laxatives, in case of overdose causes chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism and kidney stones. In association with chronic laxative abuse, renal tubular injury, metabolic alkalosis and muscle weakness secondary to hypokalemia have also been described. Also see what is reported in the paragraph “Special warnings and precautions for use” regarding the abuse of laxatives. Treatment If action is taken within a short time of ingesting Guttalax, absorption can be reduced or avoided by inducing vomiting or gastric lavage. Fluid and electrolyte losses must be replaced. This is especially important in the elderly and young people. The administration of spasmolytics may be useful.

PREGNANCY AND BREASTFEEDING

Fertility No studies have been conducted to evaluate the effects on human fertility. Non-clinical studies have revealed no effects on fertility (see section 5.3). Pregnancy There are no adequate and well-controlled studies on the use of the medicine during pregnancy. Long experience has shown no evidence of unwanted or harmful effects during pregnancy. Although toxic effects have never been reported during pregnancy, the medicine must be used only if necessary, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus. Breastfeeding Clinical data demonstrate that neither the active fraction of sodium picosulphate, bis-(p-hydroxyphenyl)-pyridyl-2-methane (BHPM), nor the conjugated form (its glucuronic derivatives), are excreted in measurable quantities in breast milk. However, the medicine must be used only if necessary, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the infant.

EFFECTS ON DRIVING ABILITY

Since no specific studies have been carried out, there are no known inhibitory effects of Guttalax that would compromise the ability to drive and use machinery. However, patients should be informed that due to vasovagal response (e.g., abdominal spasm), dizziness and/or syncope may occur. If patients experience abdominal spasm they should avoid potentially dangerous activities such as driving or using machinery.