LACTULOSE POLFARMEX

Package leaflet: Information for the patient

LACTULOSUM POLFARMEX, 7.5 g/15 ml, syrup
Lactulosum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor 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 any adverse reactions occur, including any possible adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
If there is no improvement after a few days, or if the patient feels worse,
you should contact your doctor.

Table of contents of the leaflet:

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

Lactulosum Polfarmex contains lactulose – a synthetic disaccharide which is not absorbed in
the gastrointestinal tract. It inhibits putrefactive processes and ammonia production, and by lowering the pH in the
colon reduces the absorption of ammonium salts, which are then excreted in the faeces.
Due to its osmotic effect, it increases the volume of intestinal contents, stimulates intestinal peristalsis and exerts a laxative action.
Lactulosum Polfarmex is indicated for:

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

If there is no improvement after a few days, or if the patient feels worse, consult your 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 to any of the other ingredients of this medicine (listed in section 6);
• if the patient has intestinal obstruction;
• if the patient has galactosaemia.

Warnings and precautions
Before starting treatment with Lactulosum Polfarmex, discuss this with your doctor or
pharmacist.
With prolonged use, periodic monitoring of serum electrolyte levels (potassium, chlorides) is recommended, especially in elderly patients.
Talk to your doctor, even if the above warnings concern conditions that occurred in the past.
Lactulosum Polfarmex with 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, drugs whose release is pH-dependent may be inactivated.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy and breastfeeding only if clearly needed.
Driving and using machines
Lactulosum Polfarmex has no influence on the ability to drive or operate machinery.
Lactulosum Polfarmex syrup contains excipients – ethanol (flavour component),
fructose, lactose, galactose, sulphites, and butylated hydroxyanisole
Ethanol
Lactulosum Polfarmex contains mango flavouring liquid, which contains ethanol (alcohol). This medicine contains 0.00963 g of alcohol (ethanol) in each 15 ml of syrup.
Adults
Purgative

• Adults – dose of 45 ml syrup contains 29.07 mg ethanol. The amount of alcohol (ethanol) in 45 ml is equivalent to less than 1 ml of beer or 1 ml of wine.
• Adults – dose of 15 ml syrup contains 9.63 mg ethanol. The amount of alcohol (ethanol) in 15 ml is equivalent to less than 1 ml of beer or 1 ml of wine. In hepatic insufficiency
• Adults – dose of 180 ml contains 116.28 mg 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 – dose of 2.5 ml syrup contains 1.615 mg ethanol. The amount of alcohol (ethanol) in 2.5 ml syrup is equivalent to less than 1 ml of beer or 1 ml of wine.
• Children up to 3 years – dose of 5 ml syrup contains 3.23 mg ethanol. The amount of alcohol (ethanol) in 5 ml syrup is equivalent to less than 1 ml of beer or 1 ml of wine.
• Children over 3 years – dose of 15 ml syrup contains 9.69 mg 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 fructose in each 15 ml of syrup.
Lactulosum Polfarmex contains 0.9 g fructose in the maximum daily dose.
Fructose contained in the medicine may have harmful effects on teeth.
Lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicine. The medicine contains 0.75 g lactose in 15 ml.
Lactulosum Polfarmex contains 9 g 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 certain sugars, the patient should
consult a doctor before taking the medicine.
The medicine contains 1.125 g galactose in each 15 ml of syrup.
Lactulosum Polfarmex contains 13.5 g galactose in the maximum daily dose.
Sulphites
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
3. How to use Lactulosum Polfarmex
This medicine should always be taken according to the instructions given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Purgative:
orally, usually 30–45 ml (2–3 tablespoons) before breakfast or 15 ml (1 tablespoon) three times daily before meals. After achieving the desired effect – 15 ml of syrup on an empty stomach.
In hepatic insufficiency:
orally, 100–180 ml per day in 4–6 divided doses.
Use in children
Purgative:
initially, infants – 2.5 ml; children up to 3 years – 5 ml; over 3 years – 15 ml per day. The dose may then be gradually increased every 3 days until normal bowel movements are achieved. If abdominal distension occurs, reduce the dose to a level tolerated by the child. It is recommended to administer lactulose syrup diluted with water or fruit juice.
Use of a higher than recommended dose of Lactulosum Polfarmex
There are no data regarding overdose of the medicine.
Missed dose of Lactulosum Polfarmex
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
In the initial period of use, abdominal pain may occur. Occasionally, following the use of high
doses, nausea, diarrhoea, and flatulence may be observed.
Frequency unknown (frequency cannot be estimated from the available data): allergic reactions,
rash, itching, urticaria.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet,
inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lactulosum Polfarmex

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not freeze.
Keep the medicine for no more than 3 months after first opening the bottle.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the specified 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 is lactulose. 15 ml of syrup contains 7.5 g of lactulose.
The other ingredients are: citric acid monohydrate, liquid mango flavour (containing, 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 authorisation holder and manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: 24 357 44 44
Fax: 24 357 45 45
e-mail: [email protected]