Descrizione Clinica
GUTTALAX 7,5 MG/ML ORAL GOCCE DEVELOPMENT
active ingredients
1 ml (15 drops) of solution contains: Active ingredient: picosophate sodium 7.5 mg. Excipient with known effects: Sorbitol (E420) 450 mg (see paragraph 4.4). For the full list of excipients, see paragraph 6.1.Excellent
Benzoate sodium, liquid sorbitol (E420), citrate sodium, monohydrate citric acid, purified water.Therapeutic indications
Short-term treatment of occasional constipation.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 tract obstruction or stenosis;• Severe acute painful and/or febrile abdominal conditions (such as appendicitis) associated with nausea and vomiting;• Severe 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;• Hepatic insufficiency;• Pregnancy and breast-feeding (see section 4.6).Do not administer to children under 3 years of age (see section 4.4).Population
The following dosages are recommended: Adults In adults, it is recommended to start with 7-8 drops in water per day and decrease if the effect is excessive or increase if the laxative effect is not achieved.In cases of obstinate constipation, you can get up to 15-20 drops in water. Paediatric 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 sufficient to produce an easy evacuation of soft feces. When necessary, the dose may be increased, but never exceed the maximum indicated. Guttalax should be taken preferably in the evening to provoke evacuation in the following morning. Eating together with an adequate amount of water. A fluid-rich diet promotes the effect of the medicine. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods of time requires the doctor’s prescription after adequate evaluation of the individual case.Conservation
Keep the bottle in the outside packaging to protect the medicine from light. Valid after the 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. Extended and excessive use can lead to diarrhea, electrolytic imbalance and hypopotassium. Cases of dizziness and/or syncopathesis were reported in patients who hired Guttalax. The data available on these cases suggest that events may be related to defecation syncops (or syncope attributable to evacuative effort), or a vasovagal response to abdominal pain related to constipation, and not necessarily to the taking of picosophite sodium itself. Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. 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). Precautions for use In children aged 3 to 12 years, the medicine can only be used after consulting the doctor. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. You should also consult your doctor before using the medicine. This medicine contains 450 mg of sorbitol in 1 ml (15 drops), equivalent to 600 mg of sorbitol in the recommended daily maximum dose of 1,33 ml (20 drops) in the treatment of an adult patient. Sorbitol is a source of fructose. Patients suffering from hereditary intolerance to fructose (HFI), a rare genetic pathology, should not be given this medicine. This medicine contains less than 1 mmol of sodium (23 mg) in 20 drops, recommended maximum daily dose for an adult, i.e. it is essentially “without sodium”.Interactions
Laxatives can reduce the residence time in the intestine, and therefore the absorption, of other drugs administered orally at the same time.Therefore, avoid taking 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 modify the effect of the medicine;leave an interval of at least one hour before taking the laxative.Continued use of Guttalax may increase the response of patients to oral anticoagulants and alter glucose tolerance.Concomitant intake of diuretics or adrenocorticosteroids and excessive doses of Guttalax may lead to an increased risk of electrolyte imbalance.This imbalance, in turn, may lead to increased sensitivity to cardiac glycosides.Concomitant administration of antibiotics may reduce the laxative effect of Guttalax.Effects
Like all medicines, Guttalax can cause unwanted effects though not all people manifest them. Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common ≥ 1/10 Common ≥ 1/100, Immune disorders. Not known*: hypersensitivity. Diseases of the nervous system. Not common: dizziness; Not known*: syncope. The phenomena of capogiri and syncope that occur after the intake of picosophate sodium seem attributable to a vasovagal response (following, for example, abdominal pain or evacuation of the feces). Gastrointestinal diseases. Very common: diarrhea; Common: abdominal cramps, abdominal pain and abdominal discomfort; Not common: vomiting, nausea. Occasionally: isolated crampiform pain or abdominal colic pain, more frequent in cases of severe constipation. Pathologies of skin and subcutaneous tissue. Not known*: skin reactions such as angioedema, eruption for drug intake, rash, itching. *These adverse reactions were observed in the post-marketing experience. At 95% probability, the frequency category is not greater than uncommon, but could be lower. A precise frequency estimate is not possible since these adverse reactions did not occur in 1020 patients in clinical trial. . Reporting of side effects If any unwanted effect occurs, including those not listed in this sheet, please contact your doctor or pharmacist. The side effects can also be reported directly via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting of the side effects helps to provide more information on the safety of this medicine.Overdosing
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 ischemia of the colonic mucosa have been reported with doses of Guttalax considerably higher than the dosage recommended 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 abuse of laxatives, the following have also been described: renal tubular damage, metabolic alkalosis and muscle weakness secondary to hypokalemia.See also the section “Special warnings and precautions for use” regarding the abuse of laxatives. Treatment If Guttalax ingestion takes place within a short time, absorption can be reduced or avoided by induction of vomiting or gastric lavender. Liquid and electrolyte losses must be replaced. This is particularly important in the elderly and young people. Spasmolytic administration may be useful.Fertility
No studies have been conducted to evaluate the effects on human fertility.Non-clinical studies have not revealed any 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-term experience has not shown any evidence of undesirable or harmful effects during pregnancy.Although no toxic effects have ever been reported during pregnancy, the medicine should be used only when 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 show that neither the active fraction of picosophate sodium, bis-(p-hydroxyphenyl)-piridil-2-methane (BHPM), nor the conjugated form (her glucuronic derivatives), are excreted, in determinable quantities in breast milk. However, the medicine should only be used if necessary, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the infant.Source: Farmadati
