Lactulosum hasco

Package leaflet: Information for the patient

LACTULOSUM HASCO
2.5 g/5 ml, syrup
Lactulosum liquidum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after a few days, or if you feel worse, contact your doctor.

Table of contents

1. What Lactulosum Hasco is and what it is 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. Contents of the pack and other information

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

Lactulosum Hasco syrup contains the active substance lactulosum liquidum, a synthetic disaccharide that is very poorly absorbed from the gastrointestinal tract. Lactulosum liquidum is broken down in the colon (mainly by bacteria of the Lactobacillus and Bacteroides families) into lactic, formic, and acetic acids, as well as carbon dioxide. These acids reduce the pH in the colon from 7 to 5–5.5 and exert a local osmotic effect, leading to water retention in the large intestine. As a result, stool softens, stool mass increases, and intestinal peristalsis is stimulated.

In patients with hepatic encephalopathy, lactulosum liquidum helps reduce ammonia toxicity. The acids produced during the breakdown of lactulosum liquidum lower the pH, promoting the conversion of ammonia into non-absorbable, non-toxic ammonium ions. This leads to their retention in the colon and a reduction in blood ammonia concentration.

Therapeutic indications

• Constipation
• Prevention and treatment of hepatic encephalopathy

2. Important information before using Lactulosum Hasco

When not to use Lactulosum Hasco

• if the patient is allergic to the active substance or to 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.
Prolonged use or use in excessive doses may cause diarrhoea with excessive loss of water and electrolytes, as well as increased blood sodium concentration. In such cases, periodic blood electrolyte tests should be performed, especially when the medicine is used in elderly patients for longer than 6 months.

Lactulosum Hasco and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concurrent administration of neomycin and antacids with liquid lactulose may reduce the effect of liquid lactulose in the colon.
Liquid lactulose may cause decreased serum potassium levels, which may enhance the effect of cardiac glycosides. Liquid lactulose may intensify potassium loss caused by other medicines (diuretics, corticosteroids, and amphotericin B).

Lactulosum Hasco with food and drink
The medicine may be taken with water, fruit juices, or milk.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy and breastfeeding after consulting a doctor.

Driving and operating machinery
There are no studies on the effect of the medicine on the ability to drive and operate machinery.

Lactulosum Hasco contains galactose and lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Lactulosum Hasco

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Oral use.
Constipation
Adults:
Initial dose (for the first three days): 45 ml of syrup (22.5 g of liquid lactulose) once daily before breakfast, or 15 ml three times daily 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) daily.
The dose may then be gradually increased every 3 days until normal bowel movements are achieved.
Children under 3 years:
Initial dose: 5 ml of syrup (2.5 g of liquid lactulose) daily.
The dose may then be gradually increased every 3 days until normal bowel movements are achieved.
Infants:
Initial dose: 2.5 ml of syrup (1.25 g of liquid lactulose) daily.
The dose may then be gradually increased every 3 days until normal bowel movements are achieved.
Hepatic encephalopathy
Adults:
120 to 180 ml of syrup (60 g to 90 g of liquid lactulose) daily, divided into 3 to 4 doses.
High doses of this product used for this indication may cause diarrhea; therefore, the dose should be adjusted so that the number of loose stools does not exceed 2 to 3 per day.
5 ml of syrup corresponds to 0.21 bread units.
A measuring device is supplied with the package.
If you feel that the effect of Lactulosum Hasco is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Lactulosum Hasco
When doses higher than recommended are used, nausea and vomiting may occur.
Taking high doses or prolonged use of the medicine may result in persistent loose stools and may lead to disturbances in water and electrolyte balance.
Missed dose of Lactulosum Hasco
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Lactulosum Hasco may cause abdominal pain with bloating and cramps.
Frequency unknown (frequency cannot be determined from available data):

• allergic reactions, rash, itching, urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lactulosum Hasco

Keep in closed packaging, at a temperature below 25°C.
Slight darkening of the solution does not affect its therapeutic properties.
Store in a place inaccessible and out of sight of children.
Do not use this medicinal product after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicinal products 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. Contents of the packaging and other information

What the medicinal product Lactulosum Hasco contains

• The active substance in the medicinal product is liquid lactulose. 5 ml of syrup contains 2.5 g of liquid lactulose (equivalent to synthetic disaccharide – lactulose).
• Other components (excipients) are: orange flavour 240.016, citric acid monohydrate, purified water.

What Lactulosum Hasco looks like and contents of the pack
Lactulosum Hasco is a syrup.
The medicinal product package (brown glass bottle) contains 150 ml or 500 ml of syrup.
The bottle is placed in a cardboard box together with the package leaflet and a measuring device.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel. (022) 742 00 22
e-mail: [email protected]