Lactulosum Forte Polfarmex

Package Leaflet: Information for the User

LACTULOSUM FORTE POLFARMEX, 10 g/15 mL, syrup

Lactulosum

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

This medicine should always be taken exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist.

• This 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 those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If after a few days there is no improvement or the patient feels worse, a doctor should be contacted.

Table of Contents of the Package Leaflet

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

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

Lactulosum Forte Polfarmex contains the active substance lactulose, a laxative. It softens the stool and facilitates its passage by drawing water into the intestine. It is not absorbed by the body.

Lactulosum Forte Polfarmex is used to treat constipation (slow bowel movements, hard and dry stools) and to soften the stool, for example:

• if hemorrhoids (anal varices) are present;
• after surgeries in the anal or large intestine area.

Lactulosum Forte Polfarmex is also used to treat hepatic encephalopathy (a liver disease causing confusion, tremors, decreased level of consciousness, including coma).

2. Important information before taking Lactulosum Forte Polfarmex

When not to take Lactulosum Forte Polfarmex

• If the patient is allergic (hypersensitive) to:
• lactulose;
• or any of the other ingredients of this medicine (listed in section 6).
• If the patient has:
• galactosemia (a severe genetic disorder that prevents the digestion of galactose);
• intestinal obstruction (except for normal constipation);
• gastrointestinal perforation or risk of gastrointestinal perforation. In case of doubt, the doctor or pharmacist should be consulted before taking Lactulosum Forte Polfarmex.

Warnings and precautions

Before starting to take Lactulosum Forte Polfarmex, the doctor or pharmacist should be consulted if the patient has any diseases, especially:

• if the patient has unexplained abdominal pain;
• if the patient does not digest lactose (milk sugar);
• if the patient has diabetes.

Lactulosum Forte Polfarmex should not be taken if:

• there is galactose or fructose intolerance;
• there is lactase deficiency type Lapp;
• there is glucose-galactose malabsorption.

In diabetic patients also being treated for hepatic encephalopathy, the dose of Lactulosum Forte Polfarmex will be higher. This higher dose may contain a large amount of sugar. Therefore, it may be necessary to adjust the dose of antidiabetic medicines.

It should be taken into account that during treatment, the bowel movement reflex may be disturbed.

Chronic intake of unadjusted doses (appearance of more than 2-3 soft stools per day) or abuse may lead to diarrhea and electrolyte disturbances.

During the use of laxative medicines, it is recommended to drink an adequate amount of fluids (about 2 L/day, i.e., 6-8 glasses).

In case of taking Lactulosum Forte Polfarmex for several days and no improvement or worsening of symptoms, a doctor should be contacted.

Children

In special cases, a doctor may prescribe Lactulosum Forte Polfarmex for use in children, infants, or newborns. Lactulosum Forte Polfarmex may be given to infants and young children only after a doctor's recommendation, as it may disrupt the natural bowel movement reflex.

In such cases, treatment will be strictly supervised by a doctor.

Lactulosum Forte Polfarmex and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Taking Lactulosum Forte Polfarmex with food and drink

Lactulosum Forte Polfarmex can be taken with or without food. There are no restrictions on food or drink intake.

Pregnancy, breastfeeding, and fertility

Lactulosum Forte Polfarmex can be taken during pregnancy and breastfeeding.

No effect on fertility is anticipated.

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Lactulosum Forte Polfarmex has no influence or negligible influence on the ability to drive and use machines.

Lactulosum Forte Polfarmex contains a small amount of ethanol, which is a component of the orange flavor

This medicine contains 1.386 mg of alcohol (ethanol) per 1 mL of syrup. In the case of the maximum daily dose, the amount of alcohol is equivalent to:

• in infants under 1 year of age - a dose of 5 mL of syrup contains 6.93 mg of ethanol. The amount of alcohol (ethanol) is equivalent to less than 1 mL of beer and less than 1 mL of wine;
• in children aged 1-6 years - a dose of 10 mL of syrup contains 13.86 mg of ethanol. The amount of alcohol (ethanol) is equivalent to less than 1 mL of beer and less than 1 mL of wine;
• in children aged 7-14 years - a dose of 15 mL of syrup contains 20.79 mg of ethanol. The amount of alcohol (ethanol) is equivalent to less than 1 mL of beer and less than 1 mL of wine;
• in adults - a dose of 45 mL of syrup contains 62.37 mg of ethanol. The amount of alcohol (ethanol) is equivalent to less than 2 mL of beer and less than 1 mL of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Lactulosum Forte Polfarmex may contain lactose, galactose, and small amounts of fructose.If the patient has been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.

3. How to take Lactulosum Forte Polfarmex

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.

Oral administration.

The medicine should be swallowed quickly. It should not be kept in the mouth.

The medicine should be taken at the same time of day.

Dosing for constipation or medical reasons for stool softening

The dose can be given once a day, e.g., during breakfast, or in two divided doses.

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

Laxative medicines in children, infants, and newborns should be used in special cases and under medical supervision, as they may disrupt the natural bowel movement reflex.

Lactulosum Forte Polfarmex should not be given to children (under 14 years of age) without consulting a doctor, who will recommend the medicine and ensure treatment supervision.

Dosing for hepatic encephalopathy (only in adults)

The initial dose for hepatic encephalopathy is 30-45 mL 3-4 times a day.

Dosing may be modified to a maintenance dose so that the patient has 2 to 3 soft stools per day.

Use in children

There are no available data on the use in children (under 18 years of age) with hepatic encephalopathy.

Population of elderly and patients with renal and hepatic impairment

There are no special dosing recommendations.

Overdose of Lactulosum Forte Polfarmex

In case of overdose, diarrhea, electrolyte loss, and abdominal pain may occur.

In case of taking a higher dose than recommended, a doctor or pharmacist should be contacted.

Missed dose of Lactulosum Forte Polfarmex

In case of a missed dose, the next dose should be taken at the usual time.

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Lactulosum Forte Polfarmex

Treatment should not be stopped or changed without consulting a doctor.

In case of any further doubts about the use of the medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Lactulosum Forte Polfarmex can cause side effects, although not everybody gets them.

During treatment with Lactulosum Forte Polfarmex, 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

Frequency not known(frequency cannot be estimated from the available data)

• allergic reactions, rash, itching, urticaria

During the first few days of treatment, bloating may occur. It usually disappears after a few days.

In case of taking higher doses than recommended, abdominal pain and diarrhea may occur.

In such a case, the dose should be reduced.

In case of taking high doses for a longer period (usually only in the treatment of hepatic encephalopathy), the patient may experience electrolyte disturbances due to diarrhea.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

PL-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 Lactulosum Forte Polfarmex

The medicine should be stored out of sight and reach of children.

This medicine should not be used after the expiry date stated on the carton and bottle after:

“EXP”.

Shelf-life after first opening the bottle: 18 months.

The expiry date refers to the last day of the month stated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lactulosum Forte Polfarmex contains

The active substance of the medicine is lactulose in the form of liquid lactulose. 1 mL of the medicine contains 667 mg of lactulose.

The other ingredients are:

orange flavor (contains orange oil, ethanol, water), purified water.

What Lactulosum Forte Polfarmex looks like and contents of the pack

Lactulosum Forte Polfarmex is a clear syrup, yellow to light brown-yellow in color, with a characteristic orange flavor.

200 mL of Lactulosum Forte Polfarmex syrup is in an orange glass type III bottle, with an aluminum cap, with a guarantee ring and an LDPE seal, placed in a cardboard box with a patient leaflet and a measuring cup made of polypropylene with a scale to facilitate measuring the correct amount of medicine 2.5 mL, 5 mL, 10 mL, 15 mL.

Marketing authorization holder and manufacturer

Polfarmex S.A.

ul. Józefów 9

99-300 Kutno

Poland

Tel.: +48 24 357 44 44

Fax: +48 24 357 45 45

e-mail: [email protected]

Date of last revision of the package leaflet: