Lactulosum Polfarmex

Package Leaflet: Information for the Patient

LACTULOSUM POLFARMEX, 7.5 g/15 ml, Syrup

Lactulosum

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 you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.
If after a few days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet:

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

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

Lactulosum Polfarmex contains lactulose - a synthetic disaccharide that is not absorbed in the gastrointestinal tract. It inhibits putrefaction processes and the production of ammonia, and by lowering the pH of the colon environment, it reduces the absorption of ammonium salts, which are excreted in the stool.
As a result of osmosis, it leads to an increase in the volume of intestinal contents, stimulates intestinal peristalsis, and has a laxative effect.
Lactulosum Polfarmex is indicated for use:

• in chronic constipation;
• in acute liver failure with pre-coma and coma;
• in chronic liver failure with elevated blood ammonia levels.

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

2. Important information before using Lactulosum Polfarmex

When not to use Lactulosum Polfarmex:

• if the patient is allergic to the active substance (lactulose) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has intestinal obstruction;
• if the patient has galactosemia.

Warnings and precautions

Before starting to use Lactulosum Polfarmex, discuss it with your doctor or pharmacist.
In the case of long-term use, periodic monitoring of electrolyte levels in serum (potassium, chlorides) is recommended, especially in elderly patients.
Talk to your doctor, even if the above warnings refer to situations that have occurred in the past.

Lactulosum Polfarmex and other medicines

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.
Since lactulose lowers the pH in the colon, medicines whose release depends on pH may be inactivated.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy and breastfeeding only if necessary.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Lactulosum Polfarmex, syrup contains excipients - ethanol (aroma component), fructose, lactose, galactose, sulfites, and butylhydroxyanisole

Ethanol
Lactulosum Polfarmex contains a mango aroma, liquid, whose component is ethanol (alcohol). This medicine contains 0.00963 g of alcohol (ethanol) in each 15 ml of syrup.

Adults

Laxative

• Adults - a dose of 45 ml of syrup contains 29.07 mg of ethanol. The amount of alcohol (ethanol) in 45 ml is equivalent to less than 1 ml of beer or 1 ml of wine.
• Adults - a dose of 15 ml of syrup contains 9.63 mg of ethanol. The amount of alcohol (ethanol) in 15 ml is equivalent to less than 1 ml of beer or 1 ml of wine. In liver failure
• Adults - a dose of 180 ml contains 116.28 mg of ethanol. The amount of alcohol (ethanol) in 180 ml is equivalent to less than 3 ml of beer and 2 ml of wine.

Children

• Infants - a dose of 2.5 ml of syrup contains 1.615 mg of ethanol. The amount of alcohol (ethanol) in 2.5 ml of syrup is equivalent to less than 1 ml of beer or 1 ml of wine.
• Children up to 3 years - a dose of 5 ml of syrup contains 3.23 mg of ethanol. The amount of alcohol (ethanol) in 5 ml of syrup is equivalent to less than 1 ml of beer or 1 ml of wine.
• Children over 3 years - a dose of 15 ml of syrup contains 9.69 mg of ethanol. The amount of alcohol (ethanol) in 15 ml contains less than 1 ml of beer or 1 ml of wine.

Fructose
Lactulosum Polfarmex contains 0.075 g of fructose in each 15 ml of syrup.
Lactulosum Polfarmex contains 0.9 g of fructose in the maximum daily dose.
Fructose contained in the medicine may have a harmful effect on teeth.
Lactose
If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine. The medicine contains 0.75 g of lactose in 15 ml.
Lactulosum Polfarmex contains 9 g of lactose in the maximum daily dose. This should be taken into account in patients with diabetes.
Galactose
If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.
The medicine contains 1.125 g of galactose in each 15 ml of syrup.
Lactulosum Polfarmex contains 13.5 g of galactose in the maximum daily dose.
Sulfites
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Lactulosum Polfarmex

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Laxative:
orally, usually 30-45 ml (2-3 tablespoons) before breakfast or 15 ml (1 tablespoon) 3 times a day before meals. After achieving the effect - 15 ml of syrup on an empty stomach.
In liver failure:
orally, 100-180 ml per day in 4-6 doses.

Use in children

Laxative:
initially, infants - 2.5 ml; children up to 3 years - 5 ml; over 3 years - 15 ml 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. It is recommended to administer the syrup with lactulose after diluting it with water or fruit juice.

Using a higher than recommended dose of Lactulosum Polfarmex

There are no data on overdose of the medicine.

Missing a dose of Lactulosum Polfarmex

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In the initial period of use, abdominal pain may occur. Sometimes, after using large doses, nausea, diarrhea, and bloating are observed.
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 possible side effects not listed in this leaflet, 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
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, you can help provide more information on the safety of this medicine.

5. How to store Lactulosum Polfarmex

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not freeze.
Shelf life after opening the bottle: 3 months.
Do not use this medicine after the expiry date stated on the carton and bottle after the words "EXP". 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. Contents of the pack and other information

What Lactulosum Polfarmex contains

The active substance of the medicine is lactulose. 15 ml of syrup contains 7.5 g of lactulose.
The other ingredients are: citric acid monohydrate, mango aroma, liquid (contains, among others, ethanol and butylhydroxyanisole), purified water.

What Lactulosum Polfarmex looks like and contents of the pack

The bottle contains 150 ml of syrup.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: