PORTOLAC EPS OS POLV 20BUST10G

PORTOLAC EPS

active ingredients

Portolac EPS 10 g powder for oral solution Each bag contains 10 g monohydrate lattitol. Portolac EPS 200 g oral powder Each jar contains 200 g monohydrate lattitol. Portolac EPS 66,67 g/100 ml syrup 100 ml syrup contain 66,67 g monohydrate lattitol. For the full list of excipients, see paragraph 6.1.

Excellent

Powder for oral solution: no one. Syrup: benzoic acid; hydroxide sodium; purified water.

Therapeutic indications

Portolac EPS is indicated in the prevention and treatment of the harbour encephalopathy – subclinical, acute, chronic: precoma prophylaxis and liver coma. Hepatic cirrhosis.

Contraindications

Hypersensitivity to lactyl or any of the excipients listed in paragraph 6.1. Portolac EPS produces its effect in the colon and is therefore contraindicated in all cases where intestinal transit is not insured (intestinal occlusion etc.). Portolac EPS should not be used in case of symptoms or suspicion of organic injury of the digestive tract and in case of any abdominal pain of unknown origin or rectal bleeding. Breasted children and children with autosomal hereditary intolerance to fructose. Galattosemia. The incomplete metabolism of lactyl can lead to the development of fructemia and galactosemia and their sequels. Pre-existing hydro-electronic imbalance.

Population

The dose of the Portolac EPS must be adapted to the phase and severity of the disease. In the prevention and stabilisation of pathology, a dosage of 0.3 g/kg body weight per day is sufficient: – 20 g of Portolac EPS powder for oral solution (equivalent to 2 sachets of 10 g or 4 scoops of 5 g powder); – 30 ml of Portolac EPS syrup (corresponding to 2 scoopers filled up to the 15 ml notch); to be taken in one evening administration. In the treatment of uncompensated and acute phases of pathology, a dosage of 0.4–0,8 g/kg body weight per day is recommended: – 30–60 g of Portolac EPS powder per oral solution (equivalent to 3–6 sachets of 10 g or 6–12 scoops of 5 g powder); – 45–90 ml of Portolac EPS syrup (corresponding to 3–6 scoops filled up to the 15 ml notch); divided into 3 administrations, at the main meals. Any dosing adjustments are 5 g of powder for oral solution or 1 measurin of syrup filled up to the cap 7.5 ml per day (in more or less), except for special requirements in case of acute liver coma. Portolac EPS powder for oral solution should be dissolved in water or in other drinks.

Conservation

Portolac EPS 10 g powder for oral solution: keep in the original packaging to protect the medicine from moisture. Portolac EPS 200 g powder for oral solution: do not store at temperature above 25° C. Store in the original packaging to protect the medicine from moisture. Portolac EPS syrup: this medicine does not require any special condition of conservation.

Warnings

To avoid alteration of the electrolytic balance caused by an overdose diarrhea, the doctor must try to determine the optimal dosage at the beginning of the treatment (see paragraph 4.2 "Posology and method of administration") to obtain two evacuations per day in cirrhotic patients. Senior or debilitated patients in long-term treatment with Portolac EPS must regularly monitor their serum electrolytes. Before starting treatment, a pre-existing hydro-electronic imbalance must be corrected. Following the treatment with Portolac EPS, hydrogen can be accumulated in the intestine. Patients who need to undergo electro-cauterization procedures must therefore perform intestinal cleansing with non-fermented solution. Patients who complain about nausea should suggest taking Portolac EPS during meals. Portolac EPS is not recommended in case of ileostomy or colostomy. Pediatric population Infants and children: Portolac EPS should only be used if recommended by a doctor. Patients with rare hereditary problems of fructose intolerance, galactose, galactose, or glucose–galactose mal absorption should not take this medicine. In the presence of intestinal meteorism begin treatment with the minimum doses indicated, then gradually increasing them according to the clinical response. Portolac EPS has no caryogenous power.

Interactions

Because antacids and neomycin can neutralize the acidifying effect of lattitol on feces, they should not be administered simultaneously to lattitol in cirrhotic patients with hepatic encephalopathy. Portolac EPS can increase potassium loss caused by other medicines (such as tiazo– diuretics, corticosteroids, carbenossolone, amfotericin B). Potassium deficiency can increase the risk of toxic effects of cardioglycosides in patients with concomitant therapy. Lactitol has a negligible caloric value (2 kcal/g or 8.5 kJ/g) and has no effects on insulinemia or blood glucose levels and can therefore be administered to diabetic patients.

Effects

At the beginning of the treatment, Portolac EPS can 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 EPS. Due to inter-individual variability, some patients, at the recommended dosage, may manifest diarrhea. This can be solved by reducing the dosage. The following adverse reactions were observed in clinical trials and confirmed by spontaneous reports. The MedDRA classification for systems/organs is used with the following frequencies. : very common (≥ 1/10), common (≥ 1/100 a COMPUTER Adverse reactions Gastrointestinal diseases   Rare Abdominal pain, abdominal distension, diarrhea, flatulence, vomiting Very rare Nausea, abnormal gastrointestinal sounds, anal itching. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

Synonyms Excessive doses can cause abdominal pain and diarrhea. Diarrhea is a sign of overdose that can also lead to an alteration of the serum electrolytes. Treatment Diarrhea can be stopped by decreasing the dosage or interrupting the treatment. The resulting losses of liquids and electrolytes must be adequately replaced.

Data relating to the use of Portolac EPS in pregnant women do not exist or are in limited number. Animal studies show no direct or indirect harmful effects of reproductive toxicity (see paragraph 5.3). As with all medicines, it is recommended to use Portolac EPS in the first trimester of pregnancy, only in case of absolute necessity. There is insufficient information on the excretion of lactol in breast milk. It is not believed that lactyl can cause effects on infants/ infants, since systemic exposure to lactol of nursing women is negligible.

Source: Farmadati