Lactulose-mip

Leaflet attached to the packaging: patient information

Lactulose-MIP, 9.75 g/15 ml, syrup

Lactulose

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet 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 those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after a few days, or if the patient feels worse, contact a doctor.

Table of contents of the leaflet:

• 1. What is Lactulose-MIP and what is it used for
• 2. Important information before taking Lactulose-MIP
• 3. How to take Lactulose-MIP
• 4. Possible side effects
• 5. How to store Lactulose-MIP
• 6. Package contents 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 (increasing the 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 a decrease in ammonia absorption from the colon;
• under the influence of increased carbohydrate concentration and resulting acidification of the intestinal contents, proteolytic bacteria in the intestine are replaced by saccharolytic bacteria, resulting in less ammonia production;
• the reduced pH in the intestine causes ammonia from the blood to pass directly into the acidic intestinal contents;
• the administration of lactulose leads to an increase in carbohydrate concentration in the colon. This creates a relative nitrogen deficiency for the entire bacterial flora, which is then compensated 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 taking Lactulose-MIP

When not to take Lactulose-MIP

• if the patient is allergic to lactulose or any other component 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 Lactulose-MIP, 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 fructose breakdown leads to fructosuria (excretion of fructose in the urine) and hypoglycemia (low blood sugar levels), as well as liver, kidney, and brain function disorders associated with 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 syndrome.
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

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 lowers 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 directed during pregnancy and lactation.
Before taking any medicine, consult a doctor.

Driving and operating machinery

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

3. How to take Lactulose-MIP

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The dosage should be individualized according to the patient's needs, disease severity, and progression.
Lactulose should be taken orally. The syrup is dosed using the attached measuring cup. Unless otherwise directed by a doctor, the following dosing schedule should be used:
Constipation

The dosage should be adjusted so that the patient passes a soft stool. The medicine can be taken in a single daily dose or in two divided doses. If taken in a single 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, 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 2-3 soft stools per day.
Use in children:
There is 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, consult a doctor.

Use of a higher than recommended dose of Lactulose-MIP

Overdose may cause diarrhea, electrolyte loss, abdominal cramps.
If necessary, the doctor will provide symptomatic treatment.

4. Possible side effects

Like all medicines, Lactulose-MIP can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
Abdominal pain, bloating. When taking too high doses: nausea, vomiting, diarrhea.
Very rare (affects less than 1 in 10,000 people):
Hypernatremia (elevated sodium levels in the blood, during treatment of hepatic encephalopathy), electrolyte imbalance (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 those not listed in the 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, Al. 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lactulose-MIP

Store in a temperature below 25°C.
Shelf life after opening the bottle: 12 months.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". 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 Lactulose-MIP contains

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

What Lactulose-MIP looks like and what the package contains

The medicine is a syrup.
The syrup is packaged in plastic bottles in a cardboard box.
The package contains 100 ml, 200 ml, 500 ml, or 1000 ml of syrup. A dosing cup with a capacity of 5-30 ml is attached to the package.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
MIP Pharma Polska Sp. z o.o.
ul. Orzechowa 5
80-175 Gdańsk
tel. 58 303 93 62
fax. 58 322 16 13
e-mail: [email protected]
Manufacturer
Chephasaar, Chemisch-pharmazeutische Fabrik GmbH
Mühlstrasse 50
D-66386 St. Ingbert
Germany

Date of the last update of the leaflet: