Epalfen EPS

Package leaflet: Information for the patient

EPALFEN EPS 650 mg/ml syrup, 6 g granules for oral solution, 12 g granules for oral solution

Lactulose
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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What EPALFEN EPS is and what it is used for
2. What you need to know before taking EPALFEN EPS
3. How to take EPALFEN EPS
4. Possible side effects
5. How to store EPALFEN EPS
6. Contents of the pack and other information

1. What EPALFEN EPS is and what it is used for

EPALFEN EPS contains the active substance lactulose, a sugar that helps eliminate ammonia, a toxic substance when produced in excess by the body (antihyperammonaemics).
This medicine is indicated for the treatment of:

• severe liver disease (hepatic cirrhosis);
• portosystemic encephalopathy (PSE), a disease caused by impaired liver function and characterized by mental confusion, drowsiness, disorientation.

2. What you need to know before taking EPALFEN EPS

Do not use EPALFEN EPS

• if you are allergic to lactulose or to any of the other ingredients of this medicine (listed in section 6);
• if you have abdominal pain of unknown origin;
• if you are experiencing nausea and vomiting;
• if you have intestinal obstruction or narrowing (stenosis);
• if you notice the presence of blood of unknown origin in your stools (rectal bleeding);
• if you suffer from excessive fluid loss from the body (dehydration);
• if you have galactosemia, a genetic disorder that prevents the digestion of certain sugars (galactose).

Warnings and precautions
Talk to your doctor or pharmacist before taking EPALFEN EPS.
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhea,
leading to loss of water, electrolytes, and other essential nutrients.
Take this medicine with caution and inform your doctor in the following cases:

• if the initial dose has caused you diarrhea, as it will be necessary to immediately reduce the dosage and discontinue treatment if diarrhea persists;
• if you experience frequent episodes of diarrhea with consequent loss of water, as EPALFEN EPS could worsen this condition;
• if you are taking other medicines to facilitate bowel evacuation (laxatives), since the use of other laxatives, especially during the initial phase of treatment, should be avoided;
• if you have diabetes, because the medicine contains other sugars such as lactose, galactose, and tagatose;
• if you are scheduled for intestinal examinations such as rectoscopy or colonoscopy, or require a surgical procedure (electrocauterization), as possible complications may occur due to taking EPALFEN EPS;
• if you are taking other medicines (see section “Other medicines and EPALFEN EPS”).

Other medicines and EPALFEN EPS
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take
any other medicine.
Do not take other medicines to facilitate bowel evacuation (laxatives) during treatment
with EPALFEN EPS, especially during the initial phase of treatment.
Take this medicine with caution and inform your doctor if you are taking:

• medicines used to regulate blood coagulation (coumarin derivatives, acenocoumarol, or phenprocoumon), as EPALFEN EPS may increase their effect, increasing the risk of bleeding;
• medicines used against bacterial infections (broad-spectrum antibacterial agents) or antacids (medicines used to reduce stomach acidity), taken orally, as these medicines may reduce the effect of EPALFEN EPS;
• medicines containing the antibiotic neomycin, due to a possible synergistic effect with EPALFEN EPS (increased activity of both drugs);
• medicines used to improve heart function (digitalis agents), as EPALFEN EPS may increase the risk of adverse effects;
• medicines containing mesalazine (5-ASA) used to relieve inflammation and pain, as lactulose may alter intestinal pH, thereby affecting the efficacy of these medicines.

In general, do not take other medicines together with EPALFEN EPS, as their efficacy may be altered due to lactulose modifying their intestinal transit time.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, this medicine should be used only if necessary and under the
direct supervision of a doctor.
Driving and operating machinery
EPALFEN EPS does not impair the ability to drive or operate machinery.
Lactulose, the active ingredient in EPALFEN EPS, is composed of galactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
EPALFEN EPS syrup contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.
EPALFEN EPS syrup contains sodium benzoate
This medicine contains 11.8 mg of sodium benzoate in 10 ml.
EPALFEN EPS sachets contain lactose and glucose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take EPALFEN EPS

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

• Syrup: the dose may range from 90 to 190 ml per day, taken in 2 or 3 divided doses.
• Sachets: the dose may range from 60 to 120 g per day, taken in 2 or 3 divided doses.

If you take more EPALFEN EPS than you should
If you (or someone else) have taken an excessive dose of EPALFEN EPS, or if you think a child
may have taken this medicine, contact your doctor immediately or go to the nearest hospital
Emergency Department.
Overdose may cause diarrhoea and severe stomach pain (abdominal cramps), which resolve
upon discontinuation of treatment.
If you forget to take EPALFEN 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 everybody gets them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• excessive decrease in blood calcium levels (hypocalcemia);
• excessive increase in blood sodium levels (hypernatremia);
• excessive loss of body fluids (dehydration);
• diarrhea, nausea, and vomiting;
• gas in the stomach (flatulence and bloating);
• severe stomach pain (abdominal cramps);
• allergic reactions;
• skin rash;
• itching;
• hives.

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 .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store EPALFEN EPS

Keep this medicine out of the sight and reach of children.
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.
The syrup, once the bottle has been opened, is valid for 30 days.
Store the oral granulate at a temperature not exceeding 30°C.
The syrup does not require any special storage precautions.
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 EPALFEN EPS contains
EPALFEN EPS 6 g granules for oral solution

• The active substance is lactulose. Each sachet contains 6 g of lactulose.
• The other components are monohydrate citric acid and grapefruit flavour Dry (containing: glucose and lactose).

EPALFEN EPS 12 g granules for oral solution

• The active substance is lactulose. Each sachet contains 12 g of lactulose.
• The other components are monohydrate citric acid and grapefruit flavour Dry (containing: glucose and lactose).

EPALFEN EPS 650 mg/ml syrup

• The active substance is lactulose. 100 ml of syrup contain 65 g of lactulose.
• The other components are sodium benzoate and purified water.

Description of the appearance of EPALFEN EPS and contents of the pack
Carton pack containing 30 sachets of 6 g granules for oral solution.
Carton pack containing 15 sachets of 12 g granules for oral solution.
Bottles of 200 ml and 400 ml of syrup, with tamper-proof cap and dosing cup.
Marketing Authorization Holder
ZAMBON ITALIA s.r.l.
Via Lillo del Duca 10
20091 Bresso (MI)
Manufacturer
ZAMBON S.p.A. – Via della Chimica 9 – Vicenza