Guttalax Drops 15 Ml

WARNINGS
The product 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 the drug. 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 the most severe cases the onset of dehydration or hypokalaemia is possible, which can cause cardiac or neuromuscular dysfunction, 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, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony). In children aged between 3 and 12 years, the medicine can be used only after medical consultation. The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of drugs and 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. 1 ml (15 drops) of solution contains 0.45 g of sorbitol, equivalent to 0.6 g of sorbitol for taking the maximum recommended daily dose, in the treatment of adults. Patients with rare hereditary conditions of fructose intolerance should not take this medicine.
PHARMACOTHERAPEUTIC CATEGORY
Constipation medications.
STORAGE
No special storage precautions. Validity after first opening: 12 months.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance and to any excipients; paralytic ileus or intestinal or biliary obstruction or stricture; 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; nausea or vomiting; acute inflammation of the gastrointestinal tract; rectal bleeding of unknown origin; gallstones; liver failure; pregnancy and breastfeeding; do not administer to children younger 'less than 3 years.
NAME
GUTTALAX 7.5 MG / ML ORAL DROPS, SOLUTION
EXCIPIENTS
Sodium benzoate, liquid sorbitol, sodium citrate, citric acid monohydrate, purified water.
SIDE EFFECTS
Like all medicines, the medicine 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. Disorders of the immune system. Not known: hypersensitivity '. Nervous system disorders. Uncommon: dizziness; not known: syncope. The phenomena of dizziness and syncope that occur after the intake of 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. At 95% probability, the frequency category is not greater than uncommon, but it may be lower. A precise estimate of the frequency is not possible since these adverse reactions did not occur in 1020 patients in clinical trials. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
PREGNANCY AND BREASTFEEDING
No studies have been conducted to evaluate the effects on human fertility. Non-clinical studies did not reveal any effect on fertility. There 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 toxic effects have never been reported during pregnancy, the drug should only be used in case of need ', after evaluating the expected benefit to the mother in relation to the possible risk to the fetus. Clinical 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 quantities that can be determined in milk. maternal. However, the medicine should be used only in case of need ', after evaluating the expected benefit to the mother in relation to the possible risk to the infant.
INDICATIONS
Short-term treatment of occasional constipation.
INTERACTIONS
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 the drug may increase patient response to oral anticoagulants and change glucose tolerance. Concomitant intake of diuretics or adrenocorticosteroids and excessive doses of the drug can 'lead to an increased risk of electrolyte imbalance. This imbalance, in turn, can lead to an increase in sensitivity to cardioactive glycosides. The concomitant administration of antibiotics can reduce the laxative effect of the product.
DOSAGE
The following dosages are recommended. 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 it can reach up to 15-20 drops in water. >> Pediatric population. In 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 never exceed the maximum indicated. The medicine should preferably be taken in the evening to provoke evacuation the next morning. Ingest together with an adequate quantity 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.
ACTIVE PRINCIPLES
Sodium picosulfate.