PORTOLAC EPS*OS POWD 20SACHETS10G

Portolac EPS 10 g powder for oral solution
Portolac EPS 200 g powder for oral solution
Lactitol monohydrate

What it is and what it is used for
Portolac EPS contains the active ingredient lactitol monohydrate, which belongs to a group of medicines called antidotes, which act by preventing the production and absorption in the intestine of certain toxic substances, including ammonia.

Portolac EPS is indicated:
• in the prevention and treatment, both in the acute and stable phase, of brain function disorders due to insufficient liver function (porto-systemic encephalopathy), which causes the accumulation of certain toxic substances.
• in the prevention and treatment of hepatic pre-coma and coma, caused by the most severe forms of porto-systemic encephalopathy.
• in the treatment of a severe liver disease (liver cirrhosis).

What you need to know before taking the medicine
Do not take Portolac EPS
• if you are allergic to lactitol monohydrate or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from reduced intestinal transit (e.g., intestinal blockage, etc.)
• if you have or think you have an intestinal lesion
• if you have any abdominal pain of unknown cause
• if you have rectal bleeding
• if you suffer from hydro-electrolytic imbalance (alteration of the concentrations of fluids and salts present in the body)
• if you suffer from galactose intolerance (a type of sugar).

Do not give Portolac EPS to breastfed infants and children with fructose intolerance (a type of sugar).

Warnings and precautions
Talk to your doctor or pharmacist before taking Portolac EPS.

Consult your doctor:
• if you need to undergo electrocauterization procedures (a medical procedure used to remove tissue) in the intestine
• if you experience nausea or flatulence (gas in the abdomen)
• if you have had an ileostomy or colostomy (surgical techniques that create an opening in the abdomen to eliminate faeces externally)
• if your doctor has diagnosed you with an intolerance to certain sugars
• if you are elderly and/or debilitated and need to take Portolac EPS for a long time, as your doctor may want to regularly monitor your blood salt levels.

It is important to correct any hydro-electrolytic imbalance (alteration of the concentrations of fluids and salts present in the body) before starting treatment with a laxative.

To avoid the occurrence of diarrhea, the doctor should try to determine the optimal dosage at the beginning of treatment to achieve two bowel movements per day in patients with cirrhosis.

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.

Children
In children and infants, use Portolac EPS only if recommended by your doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the beginning of treatment, Portolac EPS can cause abdominal discomfort, especially with the emission of gas from the intestine, and rarely abdominal pain or sometimes abdominal swelling. These effects tend to decrease or disappear after a few days of regular Portolac EPS intake.
The doctor may decide to reduce the dosage in case of diarrhea.

The following side effects may occur with the following frequency:

Rare (may affect up to 1 in 1,000 people)
• vomiting
• diarrhea
• abdominal pain
• abdominal swelling
• gas production from the intestine

Very rare (may affect up to 1 in 10,000 people)
• nausea
• abnormal stomach and intestinal sounds
• anal itching

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.