Portolac 66.67 g / 100 ml - syrup against constipation 200 ml

Product Description

Syrup

Composition:

Portolac 200 g powder for oral solution Each jar contains 200 g of lactitol monohydrate. Portolac 5 g powder for oral solution Each sachet contains 5 g of lactitol monohydrate. Portolac 10 g powder for oral solution Each sachet contains 10 g of lactitol monohydrate. Portolac 66.67 g/100 ml syrup 100 ml of syrup contain 66.7 g of lactitol monohydrate. For the full list of excipients, see section 6.1.

Excipients

Powder for oral solution: none. Syrup: benzoic acid, sodium hydroxide, purified water.

Therapeutic indications

Portolac is indicated for the short-term treatment of occasional constipation.

Contraindications

Hypersensitivity to lactitol or to any of the excipients listed in section 6.1. Portolac exerts its effect in the colon and is therefore contraindicated in all cases where intestinal transit is not ensured (intestinal obstruction, etc.). As with all laxatives, Portolac should not be used in case of any symptom or suspicion of organic lesion of the digestive tract and in case of any abdominal pain of unknown origin or rectal bleeding. Fecal impaction must be treated otherwise before using laxatives. Breastfed children and children with autosomal recessive hereditary fructose intolerance. Portolac is contraindicated in galactosemia. Incomplete metabolism of lactitol can lead to the development of fructosemia and galactosemia and their sequelae. Pre-existing fluid and electrolyte imbalance.

Dosage

Adults Powder for oral solution: 10–15 g of Portolac per day, equal to 2–3 5 g measuring spoons of powder for oral solution, 2–3 5 g sachets or 1 10 g sachet, in a single administration, preferably in the evening before going to bed. Syrup: 15–30 ml of PORTOLAC syrup per day (corresponding to 1–2 measuring spoons filled to the 15 ml mark) in a single administration, preferably in the evening before going to bed. Paediatric population Children Powder for oral solution Portolac should be taken in a single administration, in the morning with breakfast: from 2 to 6 years, 5 g per day, equal to one 5 g measuring spoon of powder for oral solution or one 5 g sachet, over 6 years, 5–10 g per day, equal to 1–2 5 g measuring spoons of powder for oral solution, 1–2 5 g sachets or 1 10 g sachet. Syrup Portolac syrup should be taken as a single dose, in the morning with breakfast: from 2 to 6 years, 10 ml per day (equal to 1 measuring spoon filled to the 10 ml mark), over 6 years, 10–15 ml per day (equal to 1 measuring spoon filled to the 10 ml or 15 ml mark). Infants Powder for oral solution On average 1–2 g per day, equal to 1–2 1 g measuring spoons of powder for oral solution. Syrup On average 5 ml of syrup per day (equal to 1 measuring spoon filled to the 5 ml mark). In general, the optimal clinical response can be achieved with a dose of 10 ml per day. This can be achieved by adjusting the dosage by 5 g of powder for oral solution per day (more or less) in adults (equal to 1 measuring spoon of syrup filled to the 7.5 ml mark) and 1 g of powder for oral solution per day in children. Portolac in the form of powder for oral solution should be dissolved in water or other beverages (milk, tea, coffee, fruit juices) or added to other foods such as yogurt, cooked fruit, etc. The correct dose is the minimum sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum recommended doses. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated. 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 appropriate evaluation of the individual case. Ingest with an adequate quantity of water (a large glass). A diet rich in fluids promotes the effect of the medicine.

Warnings and precautions

— Avoid prolonged use of laxatives without interruption,— All cases of chronic constipation must first be treated with a high-fiber diet, sufficient fluid intake, or physical activity,— To avoid disturbances in electrolyte balance caused by diarrhea resulting from overdose, the physician should try to determine the optimal dosage at the beginning of treatment (see section 4.2 "Posology and method of administration") to achieve one bowel movement per day in patients with constipation. Elderly or debilitated patients on long-term treatment with Portolac should regularly monitor their serum electrolytes. As with all laxatives, any pre-existing fluid and electrolyte imbalance should be corrected before starting treatment. Following treatment with Portolac, hydrogen may accumulate in the intestine. Patients requiring electrocautery procedures should therefore perform thorough intestinal cleansing with a non-fermentable solution. – Patients complaining of nausea should be advised to take Portolac during meals. – Portolac is not recommended in cases of ileostomy or colostomy. In case of particularly stubborn constipation, a doctor should be consulted. Paediatric population Infants and children: Portolac should be used only if recommended by a doctor. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, galactosemia, or glucose-galactose malabsorption should not take this medicine. In the presence of intestinal meteorism, start treatment with the minimum indicated doses, then gradually increase them based on the effect obtained. Portolac has no cariogenic effect. Laxative abuse (frequent or prolonged use or excessive doses) can cause serious health problems. Cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium), and other essential nutrients. In more severe cases, dehydration or hypokalemia may occur, which can lead to cardiac or neuromuscular dysfunction, especially if treated with cardiac glycosides, diuretics, or corticosteroids. Laxative abuse, especially contact laxatives (stimulant laxatives), can cause dependence (and therefore the possible need to gradually increase the dosage), chronic constipation, and loss of normal intestinal function (intestinal atony). Treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications, and monitoring during therapy. Consult your doctor when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts more than two weeks or when laxative use fails to produce effects. It is also advisable for elderly or otherwise unhealthy subjects to consult their doctor before using the medicine.

Interactions

Since antacids and neomycin can neutralize the acidifying effect of lactitol on the stool, they should not be administered simultaneously with lactitol in cirrhotic patients with hepatic encephalopathy. However, neither substance alters the laxative effect in patients with constipation. Like all laxatives, Portolac may increase potassium loss caused by other drugs (e.g., thiazolidinediones, corticosteroids, carbenoxolone, amphotericin B). Potassium deficiency may increase the risk of toxic effects of cardioglycosides in patients receiving concomitant therapy. Lactitol has a negligible caloric value (2 kcal/g or 8.5 kJ/g) and has no effect on insulinemia or blood glucose levels and can therefore be administered to diabetic patients. In case of intestinal dysbiosis, it should be noted that broad-spectrum antibacterial agents and antacids, administered orally at the same time as lactitol, may reduce the product's effects on intestinal microflora. 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, wait at least 2 hours before taking the laxative.

Side effects

At the beginning of treatment, Portolac may cause abdominal discomfort, especially flatulence, and rarely abdominal pain or sometimes abdominal distension. These effects tend to decrease or disappear after a few days of regular intake of Portolac. Due to inter-individual variability, some patients may experience diarrhea at the recommended dosage. This may resolve with a dose reduction. The adverse reactions listed below have been observed in clinical studies and confirmed by spontaneous reports. The MedDRA system organ classification is used with the following frequencies: very common (