Lactulose aflofarm

Package leaflet: Information for the patient

Lactulosum Aflofarm, 7.5 g/15 ml, syrup
Lactulosum liquidum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents

1. What Lactulosum Aflofarm is and what it is 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 pack and other information

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

Lactulosum Aflofarm contains the active substance liquid lactulose, which has a laxative effect. Lactulose is a synthetic sugar derived from lactose. It is not absorbed in the gastrointestinal tract and is only broken down by intestinal bacteria in the colon. This leads to water retention and softening of the stool. It also enhances 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 (other than constipation);
• if the patient has galactosaemia (a serious genetic disorder that prevents the digestion of galactose).

Warnings and precautions
Before starting treatment with Lactulosum Aflofarm, discuss this with your doctor or
pharmacist:

• if the patient cannot digest milk sugar – lactose;
• if the patient has diabetes, as the medicine contains small amounts of lactose and galactose;
• if the patient is elderly (over 65 years of age);
• if the product is used for more than 6 months – serum electrolyte levels (potassium, chlorides) should be monitored.

During treatment with laxatives, it is important to drink adequate amounts of fluids.
Lactulosum Aflofarm with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• The effect of certain medicines may change when used simultaneously with Lactulosum Aflofarm. In such cases, 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 ulcerative colitis and Crohn's disease).
• Neomycin enhances the effect of lactulose during treatment of hepatic encephalopathy.
• Lactulose may worsen hypokalaemia (low potassium levels) caused by other medicines taken at the same time. When used concomitantly with cardiac glycosides (such as digoxin), their effect may be enhanced. Lactulosum Aflofarm with food and drink The medicine may be taken with water, fruit juices or milk. Pregnancy and breastfeeding If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
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 certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child.
The fructose contained in the medicine may be harmful to 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 (maximum daily dose for adults).
This should be taken into account in diabetic patients.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Lactose
The medicine contains 1.636 g of lactose (0.818 g glucose and 0.818 g galactose) in 15 ml of syrup.
The medicine contains 19.632 g of lactose (9.816 g glucose and 9.816 g galactose) in 180 ml of syrup (maximum daily dose for adults). This should be taken into account in diabetic patients.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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 (main component of table salt) in 180 ml of syrup (maximum daily dose for adults). This corresponds to 2.71% of the maximum recommended daily sodium intake in the adult diet.
Ethanol (alcohol)
This medicine contains approximately 0.934 mg of alcohol (ethanol) per dose (15 ml), equivalent to 0.007% (w/v). The amount of alcohol in one 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.
Do not administer to young children (under 3 years of age) for longer than one week without medical or pharmacist advice.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before using this medicine, as higher amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

3. How to take Lactulosum Aflofarm

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose
Use the measuring cup provided with the packaging to measure the dose accurately.

Constipation

Adults:
The usual initial daily dose (for the first three days) is 45 ml of syrup taken once daily before breakfast, or 15 ml three times daily before meals. After achieving the desired effect, maintain with a daily maintenance dose of 15 ml of syrup on an empty stomach.

Children over 3 years of age:
Initially, 5 to 15 ml of syrup per day. The dose may be gradually increased every 3 days until the desired effect is achieved.

Children up to 3 years of age:
Initially, 5 ml of syrup per day. The dose may be gradually increased every 3 days until regular bowel movements are achieved.

Infants:
Initially, 2.5 ml of syrup per day. The dose may be gradually increased every 3 days until regular bowel movements are achieved.
If abdominal distension occurs, reduce the dose to the amount tolerated by the child.

Hepatic encephalopathy

Adults:
120 ml to 180 ml of syrup per day, divided into 3 to 4 doses.
High doses of this 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 by only 0.2%, therefore dose adjustment is not necessary in patients with renal impairment.

Administration method
This medicine is for oral use.
It may be taken with water, fruit juice, or milk.

If you take more Lactulosum Aflofarm than you should
If you take more than the recommended dose, consult your doctor immediately.
Symptoms of overdose may include diarrhea and abdominal cramps.

If you forget to take Lactulosum Aflofarm
Take the missed dose as soon as possible, then take the next dose at the usual time.
Do not take a double dose to make up for a missed one.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur
Common (occurring in more than 1 in 100 patients):

• flatulence with passage of wind (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 unknown (frequency cannot be determined from available data):

• allergic reactions;
• rash, itching, urticaria.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, consult a doctor or pharmacist.
Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorization holder.

5. How to store Lactulosum Aflofarm

Keep this medicine out of sight and reach of children.
Store at a temperature below 25°C. Do not store in a refrigerator or freeze.
Keep in the original packaging.
Do not use this medicine after the expiry date stated on the bottle and carton. The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the container: 28 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Lactulosum Aflofarm contains

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

What Lactulosum Aflofarm looks like and contents of the pack
The medicine is a syrup.
The packaging consists of a brown glass bottle with an aluminium screw cap and a measuring cup, in a cardboard box.
The pack contains 150 ml or 300 ml of syrup.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów