Lactulosum Amara

Package Leaflet: Information for the Patient

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 according to the recommendations of a doctor, pharmacist, or nurse.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after a few days or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet:

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

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

Lactulosum Amara contains the active substance lactulose.
Lactulose is a synthetic disaccharide that is not broken down by digestive enzymes and is practically not absorbed from the gastrointestinal tract. It softens the stool and facilitates its movement, causing water to penetrate the intestine.
Lactulosum Amara is used for:

• chronic constipation,
• hepatic encephalopathy in adults (pre-coma and coma states),

If there is no improvement after a few days or the patient feels worse, they should consult their doctor.

2. Important information before using Lactulosum Amara

When not to use Lactulosum Amara:

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

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

Warnings and Precautions

Before starting to use Lactulosum Amara, the patient should discuss it with their doctor, pharmacist, or nurse.
A medical consultation is recommended in case of:

• abdominal symptoms with unexplained pain before starting treatment,
• no visible improvement after a few days of using lactulose.

Chronic use of poorly selected doses or improper use may lead to diarrhea and electrolyte imbalance.
During long-term use of high doses of lactulose in hepatic encephalopathy, sodium and potassium levels in serum should be monitored.

Lactulosum Amara and Other Medicines

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

• antacids may inhibit the lowering of intestinal pH by lactulose,
• oral anticoagulants (e.g., acenocoumarol, phenprocoumon) enhances the effect of these medicines,
• droperidol - increases the risk of hypokalemia and hypomagnesemia caused by lactulose, and increases the risk of cardiotoxic effects (QT interval prolongation, torsades de pointes, and cardiac arrest),
• licorice root - increases the risk of hypokalemia.

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 using this medicine.
The medicine may be used during pregnancy and breastfeeding after consulting a doctor.
No effect on fertility is anticipated.

Driving and Using Machines

Lactulosum Amara has no effect on the ability to drive and use machines.

3. How to Use Lactulosum Amara

This medicine should always be taken exactly as described in this package leaflet for the patient, or according to the recommendations of a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
Daily doses should be adjusted individually. The following information is for guidance only:
Constipation:

As a rule, doses can be reduced after a few days, adjusted to the patient's needs.
The recommended dose should be taken once during breakfast. The first clinical effects may appear only after a few days. This is related to the mechanism of action of lactulose. The use of higher doses or increased frequency of administration may be considered if a positive response is not obtained after the first two days.
Hepatic coma and pre-coma state - only in adults.
Initial dose: 3-4 times a day, 30-45 ml.
Maintenance dose: it should be determined so that the patient has a loose stool 2-3 times a day. The stool pH should be between 5.0 and 5.5.
Safety and efficacy in children (up to 18 years) with hepatic coma have not been established. There are no available data.

Method of Administration:

The dose of the medicine should be measured using the measuring cup attached to the package.
During the use of laxative medicines, it is recommended to drink an adequate amount of fluids (about 2 liters daily, i.e., 6-8 glasses.

Using a Higher Than Recommended Dose of Lactulosum Amara

In case of taking a higher dose than recommended, the patient should consult their doctor or pharmacist.
After an overdose, diarrhea, abdominal pain, significant fluid loss, decreased potassium levels, and increased sodium levels in the blood are observed. In case of an overdose, the administration of the medicine should be stopped. Increased fluid loss due to diarrhea or vomiting may require correction of electrolyte imbalance.

Missing a Dose of Lactulosum Amara

A double dose should not be taken to make up for a missed dose. In case of any further doubts about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Lactulosum Amara can cause side effects, although not everybody gets them.
During the first few days of treatment, bloating may occur. They usually disappear after a few days.
In case of using higher doses than recommended, abdominal pain and diarrhea may occur. In such a case, the dose should be reduced. During long-term use of high doses (usually only in the treatment of hepatic encephalopathy), the patient may experience electrolyte imbalance due to diarrhea.
During the use of Lactulosum Amara, the following side effects have been reported:
Very common(may affect more than 1 in 10 people)

• diarrhea

Common(may affect up to 1 in 10 people)

• bloating
• nausea
• vomiting
• abdominal pain

Uncommon(may affect up to 1 in 100 people)

• electrolyte imbalance due to diarrhea

Reporting Side Effects
If any side effects occur, including any possible side effects not listed in this package leaflet, the patient should inform their doctor, 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
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information on the safety of the medicine can be collected.

5. How to Store Lactulosum Amara

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store in the original, tightly closed package.
Do not use this medicine after the expiry date stated on the carton. 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 Amara Contains

The active substance of the medicine is liquid lactulose.
15 ml of syrup contains 7.5 g of liquid lactulose (Lactulosum liquidum).
1 ml of syrup contains 500 mg of liquid lactulose.
The other ingredients are: strawberry flavor, citric acid monohydrate, purified water.

What Lactulosum Amara Looks Like and What the Package Contains

The medicine is a clear, colorless to brownish-yellow syrup with a characteristic strawberry smell.
Package: Orange glass bottles containing 150 ml, 200 ml, or 500 ml of syrup, closed with polyethylene caps (without a sealing material) or an aluminum cap with a foam polyethylene seal.
The bottles are packed in a cardboard box with a patient information leaflet and a polypropylene measuring cup scaled every 2.5 ml.

Marketing Authorization Holder and Manufacturer

Zakład Farmaceutyczny „Amara” sp. z o.o.
ul. Stacyjna 5
30-851 Kraków
Phone: 012 657 40 40
e-mail: [email protected]

Date of the Last Update of the Package Leaflet: