Lactulose-mip

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Lactulose-MIP, 9.75 g/15 ml (650 mg/ml), syrup

Lactulose

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after a few days, or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Lactulose-MIP and what is it used for

Lactulose is a disaccharide composed of D-galactose and fructose. It is a mildly laxative medicine with an osmotic effect. The laxative effect of lactulose is due to two processes:

• sugar and acids cause changes in osmotic pressure (increased volume of intestinal contents), which indirectly affects the stimulation of intestinal peristalsis;
• acids directly stimulate intestinal peristalsis.

It is assumed that the effect of lactulose in reducing blood ammonia levels is due to the following processes:

• the breakdown of lactulose reduces the pH value, leading to the ionization of ammonia. This process leads to the formation of non-absorbable and non-toxic ammonium ions, reducing the absorption of ammonia from the colon;
• the increased concentration of carbohydrates and the resulting acidification of the intestinal contents lead to the replacement of proteolytic bacteria with sacharolytic bacteria, resulting in less ammonia production;
• the reduced pH value in the intestine causes ammonia to pass directly from the blood into the acidic intestinal contents;
• the administration of lactulose leads to an increased concentration of carbohydrates in the colon. This results in a relative deficit of nitrogen for the entire bacterial flora, which is then compensated for by the use of ammonia from the breakdown of microorganisms.

In the case of hepatic encephalopathy, lactulose reduces blood ammonia levels by about 25-50%. The therapeutic effect may occur after a few hours to a few days.
Indications for use:

• constipation;
• prevention and treatment of hepatic encephalopathy.

2. Important information before using Lactulose-MIP

When not to use Lactulose-MIP

• 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 gastrointestinal inflammation;
• if the patient has galactosemia;
• if the patient has water and electrolyte balance disorders.

Warnings and precautions

Before starting to use Lactulose-MIP, you should consult a doctor or pharmacist.
Caution should be exercised in infants and young children with autosomal recessive hereditary fructose intolerance. In the case of such a disease, incomplete breakdown of fructose leads to fructosuria (excretion of fructose in the urine) and hypoglycemia (reduced blood sugar levels), as well as liver, kidney, and brain function disorders related to hypoglycemia.
15 ml of syrup contains up to 2.4 g of carbohydrates (including fructose, galactose, lactose), which corresponds to 0.2 bread units, so the medicine should be used with caution in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.
The medicine should not be used in patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
If the patient has been previously diagnosed with hereditary fructose intolerance - a rare genetic disease in which the patient's body does not break down fructose, they should consult a doctor before taking the medicine.

Other medicines and Lactulose-MIP

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Lactulose reduces the pH in the large intestine and may weaken the effect of medicines whose release depends on the pH in the colon. Lactulose may increase potassium loss caused by other medicines (diuretics, corticosteroids, and amphotericin B). Lactulose may cause a decrease in serum potassium levels, which may enhance the effect of cardiac glycosides.

Pregnancy and breastfeeding

According to current knowledge, this medicine can be used as recommended during pregnancy and lactation.
Before using any medicine, you should consult a doctor.

Driving and using machines

Lactulose-MIP does not affect the ability to drive vehicles or operate machinery.

3. How to use Lactulose-MIP

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. In case of doubts, you should consult a doctor or pharmacist.
The dosage should be adjusted individually to the patient's needs, disease severity, and course.
Lactulose should be taken orally. The syrup is dosed using the attached measuring cup. If the doctor does not recommend otherwise, the following dosage regimen should be used:
Constipation

The dosage should be adjusted so that the patient has a soft stool. The medicine can be taken in a single daily dose or in two divided doses. In the case of a single daily dose, it should be taken at the same time, e.g., during breakfast.
After a few days, the initial dose may be adjusted to a maintenance dose based on the response to treatment. The therapeutic effect may occur after a few days (2-3 days of treatment).
If there is no adequate therapeutic effect after this time, you should consult a doctor.
If the patient has been treated with laxatives for a longer period, they should be discontinued gradually.

Use in children

Laxatives can be used in children, infants, and newborns only in special cases and under medical supervision, as they may affect the normal rhythm of bowel movements.
Lactulose-MIP should not be given to children under 14 years without consulting a doctor.
Elderly patients and patients with kidney and liver disorders:
There are no special dosage recommendations.
Hepatic encephalopathy (only in adults)
Initial dose: 3-4 times a day, 30-45 ml (19.5-29.25 g of lactulose).
This dose may be adjusted to a maintenance dose to achieve a soft stool 2-3 times a day.
Use in children:
There are no available data on the use of Lactulose-MIP in children (under 18 years) with hepatic encephalopathy.
Method of administration
Lactulose-MIP can be taken after mixing with water or other liquids. The medicine can be taken independently of meals.
A single dose of lactulose should be swallowed without being held in the mouth for too long.
During the use of laxatives, it is recommended to drink a large amount of fluids (about 1.5-2 l/day, i.e., 6-8 glasses).
The laxative effect may occur after 2 to 10 hours. If the dose is insufficient, it may take 24 to 48 hours to produce the first stool. The duration of treatment depends on the course of the disease.
If you feel that the effect of Lactulose-MIP is too strong or too weak, you should consult a doctor.

Using a higher dose of Lactulose-MIP than recommended

After an overdose, diarrhea, electrolyte loss, and abdominal cramps may occur.
If necessary, the doctor will administer symptomatic treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
Abdominal pain, bloating. In the case of using too high doses: nausea, vomiting, diarrhea.
Very rare (affects less than 1 in 10,000 people):
Hypernatremia (elevated blood sodium levels, during the treatment of hepatic encephalopathy), electrolyte balance disorders (due to diarrhea).
Frequency not known (frequency cannot be estimated from the available data):
Allergic reactions, rash, itching, urticaria.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Lactulose-MIP

Store in a temperature below 25°C.
Shelf life after first opening the bottle: 12 months.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lactulose-MIP contains

• The active substance of the medicine is lactulose. 15 ml of syrup contains 9.75 g of lactulose.
• The medicine does not contain any other ingredients.

What Lactulose-MIP looks like and what the packaging contains

The medicine is in the form of a syrup.
The syrup is packaged in PET bottles with a PE or PE/PP cap in a cardboard box.
The packaging contains 200 ml of syrup. A PP dosing cup with a capacity of 5-30 ml is attached to the packaging.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Austria, the country of export:

MIP Pharma Austria GmbH
Maria-Theresien-Str. 7/II
6020 Innsbruck
Austria

Manufacturer:

Chephasaar GmbH
Mühlstr. 50
D-66386 St. Ingbert
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian marketing authorization number, country of export:1-25932
Parallel import authorization number:473/21

Date of leaflet approval: 01.09.2023