Lactulosum forte polfarmex

Package leaflet: Information for the user

LACTULOSUM FORTE POLFARMEX, 10 g/15 mL, syrup
Lactulosum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after a few days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

Lactulosum Forte Polfarmex contains an active substance called lactulose. It softens the stool and facilitates its passage by drawing water into the intestine. It is not absorbed into the body.
Lactulosum Forte Polfarmex is used to treat constipation (slowed intestinal movement, hard and dry stools) and to soften stools, for example:

• in case of haemorrhoids (piles);
• after surgery in the anal area or in the large intestine.

Lactulosum Forte Polfarmex is also used in the treatment of hepatic encephalopathy (liver disease causing confusion, tremor, reduced 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:
  • galactosaemia (a serious inherited disorder preventing digestion of galactose);
  • intestinal obstruction (other than ordinary constipation);
  • perforation or risk of perforation of the gastrointestinal tract. If in doubt, consult a doctor or pharmacist before using Lactulosum Forte Polfarmex.

Warnings and precautions
Before starting treatment with Lactulosum Forte Polfarmex, discuss with your doctor or pharmacist if the patient suffers from any medical conditions, especially:

• unexplained abdominal pain;
• inability to digest milk sugar (lactose);
• diabetes.

Do not take Lactulosum Forte Polfarmex if the patient has:

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

In patients with diabetes who are also being treated for hepatic encephalopathy, the dose of Lactulosum Forte Polfarmex will be higher. This higher dose may contain a significant amount of sugar. Therefore, adjustment of antidiabetic medication doses may be necessary.
Please note that during treatment, the defecation reflex may be disturbed.
Chronic use of inappropriate doses (resulting in more than 2–3 soft stools per day) or abuse may lead to diarrhoea and electrolyte disturbances.
During treatment with laxatives, it is recommended to drink an adequate amount of fluids (approximately 2 L/day, i.e. 6–8 glasses).
If there is no improvement or if symptoms worsen after several days of taking Lactulosum Forte Polfarmex, consult a doctor.

Children
In special cases, a doctor may prescribe Lactulosum Forte Polfarmex for use in a child, infant, or newborn. Lactulosum Forte Polfarmex may be administered to infants and young children only on medical advice, as it may interfere with the natural defecation reflex.
In such cases, treatment will be closely supervised by a doctor.

Lactulosum Forte Polfarmex with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Taking Lactulosum Forte Polfarmex with food and drink
Lactulosum Forte Polfarmex may be taken with or without food. There are no restrictions regarding food or drink intake.

Pregnancy, breastfeeding and fertility
Lactulosum Forte Polfarmex may be used during pregnancy and breastfeeding.
No effect on fertility is expected.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Lactulosum Forte Polfarmex has no effect or has a negligible effect on the ability to drive and operate machinery.

Lactulosum Forte Polfarmex contains a small amount of ethanol present as a component of the flavouring
This medicine contains 1.386 mg of alcohol (ethanol) per 1 mL of syrup. At the maximum daily dose, the amount of alcohol is equivalent to:

• in infants under 1 year of age – a dose of 5 mL syrup contains 6.93 mg 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 syrup contains 13.86 mg 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 syrup contains 20.79 mg 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 syrup contains 62.37 mg 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 certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Lactulosum Forte Polfarmex

This medicine should always be taken according to the instructions of your doctor or pharmacist. In case of
doubts, consult your doctor or pharmacist.
Oral administration.
The medicine should be swallowed quickly. Do not retain it in the mouth.
The medicine should be taken at the same time each day.
Dosage for constipation or cases where stool softening is medically required
The dose may be administered once daily, for example during breakfast, or divided into two 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 several days (2–3 days) of treatment.

Use in children
Laxatives in children, infants and newborns should be used only in special cases and under medical supervision, as they may disrupt the natural defecation reflex.
Lactulosum Forte Polfarmex should not be administered to children (under 14 years of age) without consulting a physician, who will prescribe the medicine and supervise the treatment.

Dosage in hepatic encephalopathy (adults only)
The initial dose in hepatic encephalopathy is 30–45 mL 3–4 times daily.
The dosage may be adjusted to a maintenance dose ensuring that the patient has 2–3 soft bowel movements per day.

Use in children
There are no available data on use in children (up to 18 years of age) with hepatic encephalopathy.

Elderly population and patients with renal or hepatic impairment
No special dosage recommendations are required.

Overdose of Lactulosum Forte Polfarmex
In case of overdose, diarrhoea, electrolyte loss and abdominal pain may occur.
If a dose higher than recommended has been taken, consult a physician or pharmacist.

Missed dose of Lactulosum Forte Polfarmex
If a dose of Lactulosum Forte Polfarmex is missed, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

Discontinuation of Lactulosum Forte Polfarmex
Do not discontinue or alter treatment without consulting a physician.
If you have any further questions concerning use of the medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been reported during treatment with Lactulosum Forte Polfarmex:

Very common (may affect more than 1 in 10 people)

• diarrhoea

Common (may affect up to 1 in 10 people)

• abdominal distension
• nausea
• vomiting
• abdominal pain

Uncommon (may affect up to 1 in 100 people)

• electrolyte imbalance due to diarrhoea

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

• allergic reactions, rash, itching, urticaria

Abdominal distension may occur during the first few days of treatment. These usually resolve after a few days.
If doses higher than recommended are used, abdominal pain and diarrhoea may occur.
In such cases, the dose should be reduced.
When high doses are used for prolonged periods (usually only in the treatment of hepatic encephalopathy), patients may develop electrolyte imbalance due to diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Lactulosum Forte Polfarmex

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after:
"EXP".
Shelf life after first opening of the bottle: 18 months.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Lactulosum Forte Polfarmex contains
The active substance is lactulose in the form of liquid lactulose. 1 mL of the medicinal product contains 667 mg of lactulose.
Other components are:
orange flavour (containing orange oil, ethanol, water), purified water.

What Lactulosum Forte Polfarmex looks like and contents of the pack
Lactulosum Forte Polfarmex is a clear syrup, ranging in colour from light yellow to light brownish-yellow, with a characteristic orange taste.
200 mL or 500 mL of Lactulosum Forte Polfarmex syrup in an amber glass type III bottle, with an aluminium screw cap, security ring and LDPE seal, placed in a cardboard box together with the patient leaflet and a polypropylene dosing syringe with graduations facilitating measurement of the appropriate dose: 2.5 mL, 5 mL, 10 mL, 15 mL.

Marketing Authorisation 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]