Portolac EPS
Italy
Table of Contents
Package leaflet: Information for the patient
Portolac EPS 10 g powder for oral solution, 200 g powder for oral solution
Lactitol monohydrate
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Portolac EPS is and what it is used for
- What you need to know before taking Portolac EPS
- How to take Portolac EPS
- Possible side effects
- How to store Portolac EPS
- Contents of the pack and other information
1. What Portolac EPS is and what it is used for
Portolac EPS contains the active substance lactitol monohydrate, which belongs to a group of medicines called antidotes. These act by preventing the production and intestinal absorption of certain toxic substances, including ammonia.
Portolac EPS is indicated:
- for the prevention and treatment, both in the acute and stable phases, of alterations in brain function caused by inadequate liver function (portosystemic encephalopathy), which leads to the accumulation of certain toxic substances.
- for the prevention and treatment of precoma and hepatic coma caused by severe forms of portosystemic encephalopathy.
- for the treatment of a serious liver disease (hepatic cirrhosis).
2. What you need to know before taking Portolac EPS
Do not take Portolac EPS
- if you are allergic to lactitol monohydrate or to any of the other ingredients of this medicine (listed in section 6)
- if you suffer from reduced intestinal transit (for example, intestinal obstruction, etc.)
- if you have or think you may have intestinal damage
- if you have any abdominal pain of unknown origin
- if you experience rectal bleeding
- if you suffer from a hydro-electrolytic imbalance (alteration in the concentrations of fluids and salts in the body)
- if you suffer from galactose intolerance (a type of sugar).
Do not give Portolac EPS to breastfed infants or 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 are scheduled to undergo electrocauterization procedures (a medical procedure used to remove tissue) in the intestine
- if you develop nausea or bloating (gas in the stomach)
- if you have undergone ileostomy or colostomy (surgical techniques that create an opening in the abdominal wall allowing feces to be expelled externally)
- if your doctor has diagnosed you with intolerance to certain sugars
- if you are elderly and/or debilitated and need to take Portolac EPS for a prolonged period, as your doctor may wish to regularly monitor your blood electrolyte levels.
It is important to correct any existing hydro-electrolytic imbalance (alteration in the concentrations of fluids and salts in the body) before starting treatment with a laxative.
To avoid the onset of diarrhea, the doctor should aim to determine the optimal dosage at the beginning of treatment to achieve two bowel movements per day in patients with cirrhosis.
Lactitol has negligible caloric value (2 kcal/g or 8.5 kJ/g) and does not affect insulin levels or blood glucose levels, and may therefore be administered to diabetic patients.
Children
Use Portolac EPS in children and infants only if recommended by a doctor.
Other medicines and Portolac EPS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking:
- neomycin (a medicine used to treat infections) and antacids (medicines used to treat stomach acidity). If you are being treated for cirrhosis, avoid taking these medicines together with Portolac EPS;
- cardiac glycosides (medicines used to treat heart conditions), as they may increase the toxic effects of these medicines;
- medicines that, when taken together with Portolac EPS, increase potassium loss, for example:
- thiazide diuretics (medicines that increase urine production);
- corticosteroids (anti-inflammatory agents);
- carbenoxolone (a medicine used to treat ulcers);
- amphotericin B (a medicine used to treat fungal infections).
Portolac EPS with food and drinks
If you experience nausea, take Portolac EPS during meals.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During the first three months of pregnancy, take Portolac EPS only if clearly needed and under medical supervision.
Breastfeeding
If you are breastfeeding, consult your doctor before taking Portolac EPS.
Effects on ability to drive and use machines
Portolac EPS does not affect the ability to drive vehicles or operate machinery.
3. How to take Portolac EPS
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
Your doctor will prescribe the appropriate dose of Portolac EPS depending on the stage and severity of the disease.
For prevention and stable phases of the disease
- The recommended dose is 0.3 g/kg body weight per day, corresponding to approximately 20 g of Portolac EPS oral solution powder (equivalent to 2 sachets of 10 g or 4 full measuring spoons of 5 g powder), taken as a single evening dose.
For treatment of decompensated and acute phases of the disease
- The recommended dose is 0.4–0.8 g/kg body weight per day, corresponding to 30–60 g of Portolac EPS oral solution powder (equivalent to 3–6 sachets of 10 g or 6–12 full measuring spoons of 5 g powder), divided into three daily doses taken with main meals.
Depending on individual needs, your doctor may increase or decrease the above doses by prescribing an additional or reduced amount of 5 g of oral solution powder per day.
The duration of treatment should be determined by your doctor based on your response and clinical condition.
Instructions for use
Use the provided measuring spoon filled to the rim.
Clean the measuring spoon thoroughly after each use before storing it back in the package.
Portolac EPS powder for oral solution should be dissolved in water or other beverages.
Use in children and adolescents
Use Portolac EPS in children and infants only if recommended by a doctor.
If you take more Portolac EPS than you should
In case of accidental ingestion/overdose of Portolac EPS, contact your doctor immediately or go to the nearest hospital.
If you accidentally take too much, you may experience stomach pain and diarrhoea; in such cases, stop treatment, drink fluids, and consult a doctor.
If you forget to take Portolac EPS
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
At the beginning of treatment, Portolac EPS may cause abdominal discomfort, especially intestinal gas, and rarely abdominal pain or sometimes bloating. These effects tend to decrease or disappear after a few days of regular use of Portolac EPS.
Your doctor may decide to reduce the dose in case of diarrhoea.
The following side effects may occur, with the frequency listed below:
Rare (may affect up to 1 in 1,000 people)
- vomiting
- diarrhoea
- abdominal pain
- bloating
- intestinal gas production.
Very rare (may affect up to 1 in 10,000 people)
- nausea
- abnormal stomach or intestinal sounds
- anal itching.
Reporting of side effects
If you experience any side effect, including those 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/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Portolac EPS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Portolac EPS 10 g powder for oral solution: this medicine requires no special storage conditions.
Portolac EPS 200 g powder for oral solution: do not store above 25 °C. Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Portolac EPS contains
Portolac EPS 10 g powder for oral solution
- The active substance is: lactitol monohydrate (each sachet contains 10 g of lactitol monohydrate)
Portolac EPS 200 g powder for oral solution
- The active substance is: lactitol monohydrate (each jar contains 200 g of lactitol monohydrate)
No other components are present.
Description of the appearance of Portolac EPS and package contents
Portolac EPS is a white, odourless powder for oral solution, available in packs of 20 sachets of 10 g and in a jar of 200 g.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia, 70 – 00181 ROMA
Manufacturer
LAMP SAN PROSPERO S.p.A., Via della Pace 25/A – 41030 San Prospero (MO)
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio 22 - 60131 Ancona
November 2024
Package leaflet: Information for the patient
Portolac EPS 66.67 g/100 ml syrup
Lactitol monohydrate
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Portolac EPS is and what it is used for
- What you need to know before taking Portolac EPS
- How to take Portolac EPS
- Possible side effects
- How to store Portolac EPS
- Contents of the pack and other information
1. What Portolac EPS is and what it is used for
Portolac EPS contains the active substance lactitol monohydrate, which belongs to a group of medicines called antidotes. These act by inhibiting the production and intestinal absorption of certain toxic substances, including ammonia.
Portolac EPS is indicated for:
- the prevention and treatment, during both acute and stable phases, of disturbances in brain function caused by impaired liver function (portosystemic encephalopathy), which leads to the accumulation of certain toxic substances.
- the prevention and treatment of pre-hepatic coma and hepatic coma caused by severe forms of portosystemic encephalopathy.
- the treatment of a serious liver disease (hepatic cirrhosis).
2. What you need to know before taking Portolac EPS
Do not take Portolac EPS
- if you are allergic to lactitol monohydrate or to any of the other ingredients of this medicine (listed in section 6)
- if you have reduced intestinal motility (e.g. intestinal obstruction, etc.)
- if you have or suspect you may have intestinal damage
- if you have any abdominal pain of unknown cause
- if you have rectal bleeding
- if you suffer from a hydro-electrolytic imbalance (altered concentrations of fluids and salts in the body)
- if you have galactose intolerance (a type of sugar).
Do not give Portolac EPS to breastfed infants or to 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 are scheduled to undergo electrocautery procedures (a medical procedure used to remove tissue) in the intestine
- if you develop nausea or flatulence (gas in the abdomen)
- if you have undergone ileostomy or colostomy (surgical procedures creating an abdominal opening to allow feces to be expelled 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 prolonged period, as your doctor may want to regularly monitor your blood electrolyte levels.
It is important to correct any existing hydro-electrolytic imbalance (altered concentrations of fluids and salts in the body) before starting treatment with a laxative.
To prevent diarrhea, your doctor should aim to determine the optimal dosage at the beginning of treatment to achieve two bowel movements per day in patients with cirrhosis.
Lactitol has negligible caloric value (2 kcal/g or 8.5 kJ/g) and does not affect insulin levels or blood glucose levels; therefore, it can be administered to diabetic patients.
Children
Use Portolac EPS in children and infants only if recommended by a doctor.
Other medicines and Portolac EPS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking:
- neomycin (a medicine used to treat infections) and antacids (medicines used to treat stomach acidity). If you are being treated for cirrhosis, avoid taking these medicines with Portolac EPS;
- cardiac glycosides (medicines used to treat heart conditions), as their toxic effects may be increased;
- medicines that, when taken together with Portolac EPS, increase potassium loss, for example:
- thiazide diuretics (medicines that increase urine production);
- corticosteroids (anti-inflammatory agents);
- carbenoxolone (a medicine used to treat ulcers);
- amphotericin B (a medicine used to treat fungal infections).
Portolac EPS with food and drinks
If you experience nausea, take Portolac EPS with meals.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During the first three months of pregnancy, take Portolac EPS only if clearly needed and under medical supervision.
Breastfeeding
If you are breastfeeding, consult your doctor before taking Portolac EPS.
Effects on ability to drive and use machines
Portolac EPS does not affect the ability to drive vehicles or operate machinery.
Portolac EPS contains:
- benzoic acid: This medicine contains 30 mg of benzoic acid per dose (37.5 ml), equivalent to 30 mg/37.5 ml. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in infants up to 4 weeks of age;
- sodium: This medicine contains less than 1 mmol (23 mg) of sodium per dose and per maximum daily dose, i.e., essentially 'sodium-free'.
3. How to take Portolac EPS
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Adults
Your doctor will prescribe the appropriate dose of Portolac EPS depending on the stage and severity of the disease.
For prevention and stable phases of the disease
The recommended dose is 0.3 g/kg body weight per day, equivalent to approximately 30 ml of Portolac EPS syrup
(corresponding to 2 dosing cups filled up to the 15 ml mark), to be taken as a single
evening dose.
For treatment of decompensated and acute phases of the disease
The recommended dose is 0.4–0.8 g/kg body weight per day, equivalent to a total of 45–90 ml of Portolac EPS
syrup. You should take 3–6 dosing cups (filled up to the 15 ml mark) three times daily,
during main meals.
Depending on individual needs, your doctor may increase or decrease the above doses by prescribing 7.5 ml of
syrup (7.5 ml mark on dosing cup) more or less per day.
The duration of treatment will be determined by your doctor according to your response and clinical condition.
Instructions for use
Use the provided dosing cup, filled up to the mark corresponding to the prescribed dose.
Clean the dosing cup thoroughly after each use before storing it back in the package.
Use in children and adolescents
Use Portolac EPS in children and infants only if recommended by a doctor.
If you take more Portolac EPS than you should
In case of accidental ingestion/overdose of Portolac EPS, contact your doctor immediately or go to the nearest hospital.
If an excessive dose is accidentally ingested, you may experience abdominal pain and diarrhoea; in such cases,
discontinue treatment, drink fluids, and consult a doctor.
If you forget to take Portolac EPS
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
At the beginning of treatment, Portolac EPS may cause abdominal discomfort, especially with intestinal gas emission, and rarely abdominal pain or sometimes bloating. These effects tend to decrease or disappear after a few days of regular use of Portolac EPS.
Your doctor may decide to reduce the dose in case of diarrhoea.
The following side effects may occur, according to the following frequency:
Rare (may affect up to 1 in 1,000 people)
- vomiting
- diarrhoea
- abdominal pain
- abdominal bloating
- intestinal gas production.
Very rare (may affect up to 1 in 10,000 people)
- nausea
- abnormal sounds from stomach and intestine
- anal pruritus.
Reporting of side effects
If you experience any side effect, including those 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/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Portolac EPS
Keep this medicine out of the sight and reach of children.
After first opening, use the medicine within 12 months.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Portolac EPS contains
- The active substance is: lactitol monohydrate 66.67 g (100 ml of syrup contains 66.67 g of lactitol monohydrate)
- The other components are: benzoic acid; sodium hydroxide; purified water.
Description of the appearance of Portolac EPS and contents of the pack
Portolac EPS is a syrup and appears as a clear, colourless and odourless solution. It is available in a 500 ml bottle with a closure cap and supplied with a dosing syringe.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 – 00181 ROMA
Manufacturer
Doppel Farmaceutici S.r.l., via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)
A.C.R.A.F. S.p.A., Via Vecchia del Pinocchio 22 - 60131 ANCONA