Lactulosum Aflofarm

Leaflet attached to the packaging: patient information

Lactulosum Aflofarm,7.5 g/15 ml, syrup
Lactulosum liquidum

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 this patient leaflet or according to the doctor's or pharmacist's instructions.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Lactulosum Aflofarm contains the active substance liquid lactulose, which has a laxative effect. Lactulose is a synthetic sugar, a derivative of lactose. It is not absorbed from the gastrointestinal tract, but is broken down in the colon by intestinal bacteria. This causes water absorption to be retained and the stool to be softened. It increases intestinal peristalsis. The effect of lactulose begins 24 to 48 hours after administration. The medicine is in the form of a syrup.

Indications:

• chronic constipation;
• hepatic encephalopathy.

2. Important information before taking Lactulosum Aflofarm

When not to take Lactulosum Aflofarm:

• 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 intestinal obstruction (except for constipation);
• if the patient has galactosemia (a severe genetic disease that prevents the digestion of galactose).

Warnings and precautions

Before starting to take Lactulosum Aflofarm, the patient should discuss it with their doctor or pharmacist:

• -if the patient does not tolerate milk sugar - lactose;
• -if the patient is diabetic, as the medicine contains small amounts of lactose and galactose;
• -if the patient is elderly (over 65 years old);
• if the product is taken for more than 6 months, the electrolyte levels in the blood (potassium, chlorides) should be monitored.

During treatment with laxatives, the patient should drink an adequate amount of fluids.

Lactulosum Aflofarm and other medicines

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

• The effect of some medicines may change if they are taken at the same time as Lactulosum Aflofarm. In this situation, the doctor may adjust the treatment or dosage recommendations. One such medicine is 5-aminosalicylic acid (5-ASA) (used, for example, in the treatment of colitis and Crohn's disease).
• Neomycin enhances the effect of lactulose in the treatment of hepatic encephalopathy.
• Lactulose may increase potassium deficiency caused by other medicines taken at the same time. When cardiac glycosides (such as digoxin) are taken at the same time, their effect may be enhanced.

Lactulosum Aflofarm with food and drink

The medicine can be taken with water, fruit juices, or milk.

Pregnancy and breastfeeding

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.

Driving and using machines

The medicine does not affect driving or using machines.
Lactulosum Aflofarm contains fructose, galactose, lactose, sodium benzoate, sodium, ethanol
and benzyl alcohol

Fructose

The medicine contains 0.1636 g of fructose in 15 ml of syrup.
If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, the patient should consult their doctor before taking the medicine or giving it to their child.
The fructose in the medicine may harm teeth.

Galactose

The medicine contains 2.454 g of galactose in 15 ml of syrup.
The medicine contains 29.45 g of galactose in 180 ml of syrup (the maximum daily dose for adults).
This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Lactose

The medicine contains 1.636 g of lactose (0.818 g of glucose and 0.818 g of galactose) in 15 ml of syrup.
The medicine contains 19.632 g of lactose (9.816 g of glucose and 9.816 g of galactose) in 180 ml of syrup (the maximum daily dose for adults). This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium benzoate

The medicine contains 28.35 mg of sodium benzoate in 15 ml of syrup.

Sodium

The medicine contains 54.28 mg of sodium (the main component of table salt) in 180 ml of syrup (the maximum daily dose for adults). This corresponds to 2.71% of the maximum recommended daily intake of sodium in the diet for adults.

Ethanol

This medicine contains approximately 0.934 mg of ethanol (per dose of 15 ml) which is equivalent to 0.007% (v/v). The amount of ethanol in a dose of this medicine is equivalent to less than 3 ml of beer or 3 ml of wine.

Benzyl alcohol

The medicine contains 0.038 mg of benzyl alcohol in 15 ml of syrup.
Benzyl alcohol may cause allergic reactions.
It should not be given to young children (under 3 years) for more than a week without the advice of a doctor or pharmacist.
Pregnant or breastfeeding women, as well as patients with liver or kidney disease, should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

3. How to take Lactulosum Aflofarm

This medicine should always be taken exactly as described in this patient leaflet or according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose

To dose the medicine, the measuring cup provided with the packaging should be used. This allows for the exact dose to be measured.

Constipation

Adults:

the usual initial daily dose (for the first three days) is 45 ml of syrup taken once before breakfast or 15 ml three times a day before meals. After the effect is achieved, a maintenance dose of 15 ml of syrup should be taken on an empty stomach.

Children over 3 years:

initially 5 to 15 ml of syrup per day, the dose can be gradually increased every 3 days to achieve the desired effect.

Children under 3 years:

initially 5 ml of syrup per day, the dose can be gradually increased every 3 days to achieve normal bowel movements.

Infants:

initially 2.5 ml of syrup per day, the dose can be gradually increased every 3 days to achieve normal bowel movements.
If abdominal bloating occurs, the dose should be reduced to a level tolerated by the child.

Hepatic encephalopathy

Adults:

120 ml to 180 ml of syrup per day in 3 to 4 divided doses.
High doses of the medicine used in hepatic encephalopathy may cause diarrhea. The dose should be adjusted so that the number of loose stools does not exceed 2 to 3 per day.
Lactulose is absorbed from the gastrointestinal tract in 0.2%, so there is no need to change the dosage in patients with renal failure.

Method of administration

The medicine should be taken orally.
The medicine can be taken with water, fruit juices, or milk.

Taking a higher dose of Lactulosum Aflofarm than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor.
Overdose symptoms may occur: diarrhea and abdominal cramps.

Missing a dose of Lactulosum Aflofarm

The patient should take the syrup as soon as possible and take the next dose at the usual time.
A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur

Common(occurring in more than 1 in 100 patients):

• flatulence (especially at the beginning of treatment);
• intestinal cramps, belching, abdominal discomfort;
• nausea and vomiting.

Rare(occurring in less than 1 in 10,000 patients):

• electrolyte imbalance.

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

• allergic reactions;
• rash, itching, hives.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should consult their doctor or pharmacist.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.

5. How to store Lactulosum Aflofarm

The medicine should be stored out of sight and reach of children.
It should be stored at a temperature below 25°C. It should not be stored in the refrigerator or frozen.
It should be stored in the original packaging.
The medicine should not be used after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the month stated.
The shelf life after first opening the packaging is 28 days.
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 packaging and other information

What Lactulosum Aflofarm contains

• The active substance of the medicine is liquid lactulose. 15 ml of syrup contains 7.5 g of liquid lactulose.
• The other ingredients are: flavor and aroma enhancer strawberry AR 0012/F (contains ethanol, benzyl alcohol), sodium benzoate (E211), citric acid (E330), purified water.

What Lactulosum Aflofarm looks like and what the packaging contains

The medicine is in the form of a syrup.
The packaging of the medicine is a brown glass bottle with an aluminum cap and a measuring cup, in a cardboard box.
The packaging contains 150 ml or 300 ml of syrup.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
Krzywa 2
95-030 Rzgów
Date of last revision of the leaflet:15.01.2025