Normalac

1. What is Normalac and what is it used for

The medicine contains the active substance lactulose, which is a synthetic disaccharide that is not broken down in the small intestine. Lactulose reaches the large intestine unchanged, where it is broken down by bacteria into carbon dioxide and low-molecular-weight organic acids (such as lactic acid, acetic acid, and formic acid).
These acids cause:

• a decrease in pH in the large intestine, thereby increasing acidity, which has a significant impact on many metabolic processes and the balance of the intestinal flora;
• a natural regulation of bowel movements, by increasing the water content in the stool.

Indications for use:

• hepatic encephalopathy (neuropsychiatric disorders caused by liver damage, especially liver cirrhosis);
• constipation (regulation of bowel movements).

2. Important information before taking Normalac

When not to take Normalac

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has galactosemia (a congenital disorder of sugar metabolism - inability to convert galactose to glucose);
• if the patient has intestinal obstruction (severe crampy abdominal pain, vomiting, bloating, the patient does not pass gas or stool);
• if the patient has acute inflammatory bowel diseases, including ulcerative colitis and proctitis, Crohn's disease (characterized by chronic diarrhea).

Warnings and precautions

• Normalac should not be taken if abdominal pain, nausea, and vomiting occur.
• Before taking Normalac, the patient should tell their doctor: if they have persistent constipation,
• if they have diabetes (see section: The medicine contains lactose monohydrate, galactose, fructose).

In case of long-term use of Normalac, the patient should contact their doctor, who may prescribe a blood test (electrolyte level determination).
Children
In special cases, the doctor may prescribe Normalac for use in children, infants, or newborns. Normalac can be given to infants and young children only on the advice of a doctor, as it may disrupt the natural bowel movement reflex.
In such cases, treatment will be closely monitored by the doctor.

Normalac and other medicines

The patient should tell their pharmacist or doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Before taking Normalac, the patient should inform their doctor if they are taking:

• neomycin (an antibiotic used to treat infections);
• digoxin (a medicine used to treat heart failure and heart rhythm disorders), as Normalac may increase its toxic effects, especially if taken in large doses;
• laxatives, as they should not be taken at the same time as Normalac.

Pregnancy, breastfeeding, and fertility

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 taking this medicine.
No adequate studies have been conducted on the safety of using the medicine during pregnancy and breastfeeding, so the patient should consult their doctor or pharmacist before taking the medicine.

Driving and using machines

Normalac has no effect on the ability to drive vehicles or operate machinery.

Normalac contains lactose monohydrate, galactose, fructose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
3.How to take Normalac
This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally, with water, fruit juices, or milk. A single dose 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 liters/day, i.e., 6-8 glasses).

Recommended dose

Hepatic encephalopathy (only in adults)
Initial dose: 3-4 times a day, 30-45 ml.
The 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 Normalac in children (under 18 years) with hepatic encephalopathy.
Constipation

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.
Use in children:
Laxatives in children, infants, and newborns should be used in special cases and under medical supervision, as they may disrupt the natural bowel movement reflex.
Normalac should not be given to children (under 14 years) without consulting a doctor, who will prescribe the medicine and ensure treatment supervision.
To measure the dose of the medicine, the measuring cup provided with the packaging should be used.
Elderly patients and patients with renal and hepatic impairment:
There are no special dosage recommendations.

Taking a higher dose of Normalac than recommended

In case of taking a higher dose of Normalac than recommended, the patient should contact their doctor.
Overdose of the medicine may cause osmotic diarrhea (caused by absorption disorders) and crampy abdominal pain. These symptoms will resolve after discontinuation of the medicine.

Missing a dose of Normalac

The patient should continue taking the medicine, without increasing the next dose.
The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Normalac can cause side effects, although not everybody gets them.

The following side effects may occur.

Common(occurring in 1 to 10 people in 100):

• excessive gas, abdominal pain, diarrhea, bloating,especially when the medicine is taken in large doses.

Frequency not known:

• electrolyte imbalances(sodium, potassium) caused by diarrhea. In such cases, the patient should contact their doctor (see section: Warnings and precautions).
• allergic reactions, rash, itching, urticaria.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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.
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 Normalac

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C.
Storing the medicine at low temperatures may cause it to thicken. After warming up, the consistency of the medicine will return to its original state.
Any darkening of the solution does not affect the therapeutic properties.
The medicine should not be used after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Normalac contains

• The active substance of the medicine is lactulose. 15 ml of syrup contains 10.0 g of lactulose and small amounts of lactose monohydrate (1.0 g). The medicine contains trace amounts of other sugars (galactose 1.5 g, tagatose 0.4 g, fructose 0.1 g, epilactose 1.0 g).
• Other ingredients are: citric acid monohydrate, vanilla flavor N.7-bis, purified water.

What Normalac looks like and what the package contains

The medicine is a yellow syrup with a sweet taste.
Medicine packaging:

• a brown glass bottle containing 150 ml of medicine, with an aluminum cap and a polyethylene seal, placed in a cardboard box with a patient leaflet and a PP measuring cup,
• a PET bottle containing 200 ml of medicine, with an HPDE cap, placed in a cardboard box with a patient leaflet and a PP measuring cup.

Marketing authorization holder and manufacturer:

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Località Granatieri, 50018 Scandicci (Florence), Italy

To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
Molteni Farmaceutici Polska Sp. z o.o.
ul. Józefa Korzeniowskiego 39,
30-214 Kraków,
Tel.: (12) 653 15 71 or 653 15 72

Date of last revision of the leaflet: 04/2022