PORTOLAC EPS "10 G POWDER FOR ORAL SOLUTION" 20 SACHETS"

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


What is it and what is it for?
Portolac EPS contains the active substance lactitol monohydrate, which belongs to a group of medicines called antidotes, which work 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 alterations in brain function due to insufficient liver function (portosystemic encephalopathy), which causes the accumulation of certain toxic substances.
• in the prevention and treatment of pre-coma and hepatic coma, caused by the most severe forms of portosystemic encephalopathy.
• in the treatment of 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 a bowel injury
• if you have any stomach pain that you don't know the cause of
• if you have rectal bleeding
• if you suffer from hydro-electrolytic imbalance (alteration of the concentrations of liquids and salts present in the body)
• if you suffer from galactose intolerance (a type of sugar).

Do not give Portolac EPS to breastfed children and children with intolerance to fructose (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 electrocautery procedures (a medical procedure used to remove pieces of tissue) in your intestine
• if you experience nausea or flatulence (gas in the stomach)
• if you have had an ileostomy or colostomy (surgical techniques that allow an opening in the belly to allow faeces to be eliminated externally)
• if your doctor has diagnosed you with an intolerance to some 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 check your blood salt levels.

It is important to treat any fluid and electrolyte imbalance (alteration of the concentrations of fluids and salts present in the body) before starting treatment with a laxative.

To avoid the onset of diarrhea, the physician 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 may cause abdominal discomfort, especially with gas, and rarely abdominal pain or sometimes abdominal bloating. These effects tend to decrease or disappear after a few days of regular use of Portolac EPS.
The doctor may decide to reduce the dosage in case of diarrhea.

The following side effects may occur according to the following frequency:

Rare (may affect up to 1 in 1,000 people)
• vomit
• diarrhea
• stomach pain
• bloating of the belly
• gas production from the intestine

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to 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.