Lactulosum Orifarm

Package Leaflet: Information for the Patient

Lactulosum Orifarm, 2.5 g/5 ml, Syrup

Lactulosum

Orange Flavor

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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after using one package of Lactulosum Orifarm medicine, there is no improvement or the patient feels worse, they should contact their doctor (this does not apply to chronic constipation).

Table of Contents of the Leaflet

• 1. What is Lactulosum Orifarm and what is it used for
• 2. Important information before using Lactulosum Orifarm
• 3. How to use Lactulosum Orifarm
• 4. Possible side effects
• 5. How to store Lactulosum Orifarm
• 6. Contents of the package and other information

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

Lactulose is a synthetic disaccharide that, when administered orally, is not broken down by digestive enzymes and is practically not absorbed from the gastrointestinal tract. In the large intestine, under the influence of saccharolytic bacteria, lactulose is broken down into organic acids, mainly lactic acid. This leads to acidification of the large intestine contents (pH decreases to around 5). As a result of osmosis, lactulose breakdown products increase the volume of intestinal contents, stimulate peristalsis, and have a laxative effect. The decrease in pH of the large intestine contents reduces the concentration of ammonia in the intestine and increases the concentration of poorly absorbed ammonium ions. Additionally, there is a decrease in the production and increase in the consumption of ammonia by intestinal bacteria, as well as a decrease in ammonia absorption due to the shortening of the intestinal transit time. Consequently, the concentration of ammonia in the blood of patients with liver failure in a pre-coma or coma state (hepatic encephalopathy) decreases. Lactulosum Orifarm is used:

• in chronic constipation;
• in hepatic encephalopathy in liver failure (pre-coma and coma states) in adults.

2. Important information before using Lactulosum Orifarm

When not to use Lactulosum Orifarm:

• if the patient is allergic to lactulose or any of the other ingredients of this medicine (listed in section 6);
• if the patient has intestinal obstruction;
• if the patient has an increased blood galactose level (galactosemia);
• if the patient has lactose intolerance.

Warnings and precautions

Before starting to use Lactulosum Orifarm, the patient should discuss it with their doctor or pharmacist. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient should contact their doctor before taking the medicine or giving it to their child. Sorbitol is a source of fructose. During long-term use of high doses of lactulose in hepatic encephalopathy, the sodium and potassium levels in the serum should be monitored. There is no data on the safety of use in hepatic encephalopathy in children and adolescents (up to 18 years of age).

Lactulosum Orifarm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Since lactulose lowers the pH in the colon, medicines whose release depends on pH may be inactivated. Concurrent use of lactulose:

• with antacids may inhibit the pH-lowering effect of lactulose on intestinal contents;
• with oral anticoagulants (e.g., acenocoumarol, phenprocoumon) enhances the effect of these medicines;
• with doperidone - increases the risk of lactulose-induced hypokalemia and hypomagnesemia, as well as the risk of cardiotoxic effects;
• with licorice root - increases the risk of hypokalemia.

Pregnancy, breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

The medicine does not affect the ability to drive and use machines. Lactulosum Orifarm contains, among others: ethanol, linalool, d-limonene (aroma components), sorbitol, and galactose, lactose, fructose, and sulfites (substances derived from the production process of the active substance).

Sorbitol

The medicine contains 5.3 mg of sorbitol in 5 ml of syrup. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient should contact their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Etanol

The medicine contains 1.4 mg of ethanol in 5 ml of syrup, which is equivalent to 0.034% (v/v). The small amount of alcohol in this medicine will not cause noticeable effects.

Sugars

The medicine contains 375 mg of galactose, 250 mg of lactose, and 25 mg of fructose in 5 ml of syrup. This should be taken into account in patients with diabetes.

Galactose, lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Fructose

If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient should contact their doctor before taking the medicine or giving it to their child.

Sulfites

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Lactulosum Orifarm

15 ml of syrup contains 7.5 g of lactulose, and 5 ml of syrup contains 2.5 g of lactulose. This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Recommended dose

Adults:

In chronic constipation - initial dosing: 20 ml to 40 ml (corresponding to 10 g to 20 g of lactulose) per day in 1 or 2 doses. When dosing once a day in a single dose, 20 ml to 40 ml of the medicinal product is administered, while when dosing twice a day, the patient takes 10 ml to 20 ml of syrup in each dose. After achieving the effect, the dose should be determined individually depending on the patient's needs. In liver failure, pre-coma, or coma states: 120 ml-240 ml (corresponding to 60 g to 120 g of lactulose) in 3 to 4 doses per day. When dosing three times a day, 40 ml to 80 ml of syrup is taken per dose, while when dosing four times a day, 30 ml to 60 ml of syrup is taken per dose. The dosing should be determined individually, changing every 1-2 days, so that the number of bowel movements per day is 2 to 3.

Children:

In chronic constipation - 5 ml to 15 ml (corresponding to 2.5 g to 7.5 g of lactulose) per day. Initial dose: infants - 2.5 ml (corresponding to 1.25 g of lactulose) per day, children up to 3 years - 5 ml (corresponding to 2.5 g of lactulose) per day, children over 3 years - 15 ml (corresponding to 7.5 g of lactulose) per day. Then, the dose of the medicine can be gradually increased every 3 days until normal bowel movements are achieved. If abdominal bloating occurs, the dose should be reduced to a level tolerated by the child.

Laxatives should be used in children under medical supervision.

There is no data on the safety of use in hepatic encephalopathy in children and adolescents (up to 18 years of age). Method of administration Oral administration. It is recommended to administer the syrup after diluting it with water or fruit juice.

Using a higher dose of Lactulosum Orifarm than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist. After an overdose, diarrhea, significant fluid loss, decreased potassium levels, and increased sodium levels in the blood are observed.

Missing a dose of Lactulosum Orifarm

If the medicine is taken regularly and it has not been long since the missed dose, it should be taken as soon as possible. If it is almost time for the next scheduled dose, it should be taken at the appropriate time. A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with an unknown frequency - the frequency cannot be estimated from the available data: allergic reactions, rash, itching, urticaria. The frequency of possible side effects listed below is as follows:

• unknown - the frequency cannot be estimated from the available data.

During the use of lactulose as a laxative in constipation, the following side effects have been observed, especially in the initial period of administration: Gastrointestinal disorders:

• mild, transient bloating, abdominal pain, sometimes nausea. Very rarely, diarrhea has been observed, which resolved after the first 5 hours of treatment.

During the use of lactulose in high doses in hepatic encephalopathy, the following side effects have been observed: Gastrointestinal disorders:

• bloating, abdominal pain, nausea, diarrhea;
• isolated cases of intestinal gas. Metabolism and nutrition disorders:
• decreased potassium levels in the blood (hypokalemia);
• decreased sodium levels in the blood (hyponatremia).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lactulosum Orifarm

Do not store above 25°C. Store in the original, tightly closed package. The medicine should be stored out of sight and reach of children. After opening the bottle for the first time, the medicine should not be stored for more than 2 months. Do not use this medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Lactulosum Orifarm contains

• The active substance of the medicine is lactulose. 5 ml of syrup contains 2.5 g of lactulose.
• The other ingredients (excipients) are: liquid sorbitol, non-crystallizing; citric acid monohydrate; orange aroma (contains: ethanol, linalool, d-limonene); purified water.

What Lactulosum Orifarm looks like and contents of the package

The medicine is a syrup with an orange flavor. The package: a brown glass bottle placed in a cardboard box, containing 150 ml of syrup, closed with a white HDPE cap with a guarantee ring and a transparent LDPE or LDPE and HDPE (dropper) sealing plug.

Marketing authorization holder:

Orifarm Healthcare A/S Energivej 15 5260 Odense S Denmark For more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder: Orifarm Healthcare Sp. z o.o. ul. Przyokopowa 31 01-208 Warsaw Poland [email protected]

Manufacturer:

Orifarm Manufacturing Poland Sp. z o.o. ul. Księstwa Łowickiego 12 99-420 Łyszkowice Poland Date of last revision of the leaflet:07/2023