Lactulosum Hasco

Package Leaflet: Information for the Patient

LACTULOSUM HASCO

2.5 g/5 ml, syrup
Lactulosum liquidum

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after a few days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Lactulosum Hasco and what is it used for
• 2. Important information before using Lactulosum Hasco
• 3. How to use Lactulosum Hasco
• 4. Possible side effects
• 5. How to store Lactulosum Hasco
• 6. Package contents and other information

1. What is Lactulosum Hasco and what is it used for

Lactulosum Hasco syrup contains the active substance – liquid lactulose, which is a synthetic disaccharide that is absorbed in very small amounts from the gastrointestinal tract. Liquid lactulose is broken down in the colon (mainly by bacteria of the Lactobacillusand Bacteroidesfamilies) into lactic acid, acetic acid, and carbon dioxide. These acids reduce the pH in the colon from 7 to 5-5.5 and exhibit a local osmotic effect, causing water to be retained in the large intestine. As a result, the stool is softened and its mass increased, and intestinal peristalsis is stimulated.
In patients with liver encephalopathy, liquid lactulose reduces the toxicity of ammonia. The acids produced by the breakdown of liquid lactulose lower the pH, causing the conversion of ammonia to non-absorbable and non-toxic ammonium ions, which are retained in the colon and reduce the ammonia concentration in the blood.

Indications

• constipation
• prevention and treatment of liver encephalopathy

2. Important information before using Lactulosum Hasco

When not to use Lactulosum Hasco

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in case of intestinal obstruction.

Warnings and precautions

If the initial dose causes nausea, it should be reduced.
Long-term or excessive use may cause diarrhea with excessive water and electrolyte loss, and increased sodium levels in the blood. In such cases, periodic blood tests for electrolyte levels should be performed, especially in elderly patients using the medicine for more than 6 months.

Lactulosum Hasco and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Concomitant administration of neomycin and antacids with liquid lactulose may reduce the effect of lactulose in the colon.
Liquid lactulose may decrease potassium levels in the serum, which may enhance the effect of cardiac glycosides. Liquid lactulose may increase potassium loss caused by other medicines (diuretics, corticosteroids, and amphotericin B).

Lactulosum Hasco with food and drink

The medicine can be taken with water, fruit juices, or milk.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The medicine can be used during pregnancy and breastfeeding after consulting a doctor.

Driving and using machines

There are no studies on the effect of the medicine on the ability to drive and use machines.

Lactulosum Hasco contains galactose and lactose

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to use Lactulosum Hasco

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Oral administration.
Constipation
Adults:
Initial dose (for the first three days): 45 ml of syrup (22.5 g of liquid lactulose) per day, taken once before breakfast or 15 ml three times a day before meals.
Maintenance dose: 15 ml of syrup (7.5 g of liquid lactulose) on an empty stomach.
Children over 3 years:
Initial dose: 5 to 15 ml of syrup (2.5 g to 7.5 g of liquid lactulose) per day.
Then the dose can be gradually increased every 3 days to achieve normal bowel movements.
Children under 3 years:
Initial dose: 5 ml of syrup (2.5 g of liquid lactulose) per day.
Then the dose can be gradually increased every 3 days to achieve normal bowel movements.
Infants:
Initial dose: 2.5 ml of syrup (1.25 g of liquid lactulose) per day.
Then the dose can be gradually increased every 3 days to achieve normal bowel movements.
Liver encephalopathy
Adults:
120 to 180 ml of syrup (60 g to 90 g of liquid lactulose) per day, divided into 3 to 4 doses.
High doses of the product used for this indication may cause diarrhea, so the dose should be adjusted to keep the number of loose stools below 2 to 3 per day.
5 ml of syrup corresponds to 0.21 bread units.
A measuring cup is included with the package.
If you feel that the effect of Lactulosum Hasco is too strong or too weak, consult your doctor or pharmacist.

Using a higher dose of Lactulosum Hasco than recommended

In case of using higher doses than recommended, nausea and vomiting are observed.
Taking large doses or long-term use can lead to persistent loose stools and may cause water and electrolyte imbalance.

Missing a dose of Lactulosum Hasco

Do not take a double dose to make up for a missed dose.
If you have any further doubts about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Lactulosum Hasco may cause abdominal pain with bloating and cramps.
Frequency not known(frequency cannot be estimated from the available data):

• allergic reactions, rash, itching, hives.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lactulosum Hasco

Store in closed containers, at a temperature below 25°C.
Any darkening of the solution does not affect its therapeutic properties.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Lactulosum Hasco contains

• The active substance of the medicine is liquid lactulose. 5 ml of syrup contains 2.5 g of liquid lactulose (calculated as synthetic disaccharide – lactulose).
• The other ingredients (excipients) are: orange flavor 240.016, citric acid monohydrate, purified water.

What Lactulosum Hasco looks like and what the package contains

Lactulosum Hasco is a syrup.
The medicine package (brown glass bottle) contains 150 ml or 500 ml of syrup.
The bottle is placed in a cardboard box with a leaflet and a measuring cup.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel. (022) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet: 05/2022