Lactulosum espefa
PolandTable of Contents
Patient Information Leaflet
LACTULOSUM ESPEFA, 2.5 g/5 ml, syrup
Lactulosum liquidum
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as your doctor or pharmacist has recommended.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any side effects, including any possible side effects 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, contact your doctor.
Leaflet Contents
- What Lactulosum Espefa is and what it is used for
- What you need to know before taking Lactulosum Espefa
- How to take Lactulosum Espefa
- Possible side effects
- How to store Lactulosum Espefa
- Contents of the pack and other information
1. What Lactulosum Espefa is and what it is used for
How the medicine works:
Lactulosum Espefa contains a laxative substance called lactulose. It softens the stool and facilitates its passage by drawing water into the intestine. Lactulose lowers the pH in the large intestine, thereby reducing blood ammonia levels in patients with liver insufficiency in pre-coma or coma states (hepatic encephalopathy).
Lactulose is not absorbed into the body.
Indications:
- Constipation (slowed intestinal movements, hard and dry stools);
- For stool softening (e.g. in case of hemorrhoids (piles), or following surgery on the large intestine or anus);
- Hepatic encephalopathy (liver disease causing confusion, tremor, reduced consciousness level, including coma).
2. Important information before using Lactulosum Espefa
When not to use Lactulosum Espefa:
- if the patient is allergic (hypersensitive) to lactulose or to any of the excipients listed in section 6;
- in patients with intestinal obstruction;
- in patients with gastrointestinal perforation or risk of gastrointestinal perforation (e.g. acute inflammatory bowel disease such as ulcerative colitis, Crohn's disease);
- in patients with galactosaemia;
- in patients with lactose, galactose or fructose intolerance.
If in doubt, consult a doctor or pharmacist before taking the medicine.
Warnings and precautions
Before starting treatment with Lactulosum Espefa, discuss with a doctor or pharmacist if the patient has any medical conditions, especially:
- abdominal pain of unknown origin;
- gastrocardiac syndrome (Roemheld syndrome) – a condition in which accumulation of gas in the gastrointestinal tract or disturbances in normal gastric passage cause cardiac symptoms;
- diabetes mellitus.
Patients with Roemheld syndrome: if bloating or increased flatulence occurs after taking the medicine, treatment should be discontinued and medical advice sought. In such cases, treatment should be supervised by a physician.
Prolonged use of an inappropriate dose (causing more than 2–3 bowel movements per day) or improper use may lead to diarrhoea and electrolyte imbalance.
If there is no improvement after a few days or if the patient feels worse, consult a doctor.
Children
In exceptional cases, a doctor may prescribe Lactulosum Espefa for children under 14 years of age, infants and newborns. In such cases, treatment must be supervised by a physician. Lactulosum Espefa is generally not recommended for infants and young children, as it may disrupt normal bowel rhythm.
Lactulosum Espefa and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Concomitant use of lactulose:
- with antacids may reduce lactulose-induced lowering of intestinal pH;
- with oral anticoagulants (e.g. acenocoumarol, phenprocoumon) may enhance the effect of these drugs;
- with droperidol – increases the risk of lactulose-induced hypokalaemia and hypomagnesaemia (low serum potassium and magnesium levels) and enhances the risk of cardiotoxic effects;
- with cardiac glycosides – may enhance their effect due to reduced serum potassium levels, especially when lactulose is used in high doses;
- with liquorice root – increases the risk of hypokalaemia.
Since lactulose lowers colonic pH, drugs with pH-dependent release may not function properly.
Lactulose may increase potassium loss caused by other medicines (diuretics, corticosteroids and the antibiotic amphotericin B).
Lactulosum Espefa with food and drink
Lactulosum Espefa can be taken with or without food. There are no restrictions regarding food or drink intake.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Lactulosum Espefa may be used during pregnancy and breastfeeding.
No effect on fertility is expected.
Driving and operating machinery
Lactulosum Espefa has no influence on the ability to drive or operate machinery.
Lactulosum Espefa contains lactose, galactose and small amounts of fructose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
3. How to use Lactulosum Espefa
This medicine should be used exactly as described in the patient leaflet or as recommended by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
During treatment with laxatives, it is recommended to drink an adequate amount of fluids (approximately 2 l/day, i.e. 6–8 glasses).
This medicine is taken orally.
The medicine may be mixed with water, fruit juice or milk before administration.
Doses should be taken daily at the same time.
The medicine should be swallowed promptly. Do not retain in the oral cavity.
Recommended dose:
Constipation or for softening of stools
| Initial daily dose | Maintenance daily dose | |
| Adults and adolescents | 20–60 ml (10–30 g lactulose) | 20–40 ml (10–20 g lactulose) |
| Children (7–14 years) | 20 ml (10 g lactulose) | 15–20 ml (7.5–10 g lactulose) |
| Children (1–6 years) | 5–15 ml (2.5–7.5 g lactulose) | 5–15 ml (2.5–7.5 g lactulose) |
| Infants under 1 year | up to 5 ml (up to 2.5 g lactulose) | up to 5 ml (up to 2.5 g lactulose) |
After a few days, the initial dose may be adjusted to the maintenance dose based on the treatment response obtained. The therapeutic effect may occur after a few days (2–3 days) of treatment.
Hepatic encephalopathy
Adults:
40–60 ml 3–4 times daily.
High doses of the medicinal product used in hepatic encephalopathy may cause diarrhoea.
Dosage should be individually adjusted, modified every 2–3 days, so that the number of loose stools does not exceed 2 to 3 per day.
Elderly population and patients with renal and hepatic impairment
No special dosage recommendations.
Overdose of Lactulosum Espefa
In case of overdose, diarrhoea and abdominal pain may occur. If a dose higher than recommended has been taken, consult a doctor or pharmacist.
Missed dose of Lactulosum Espefa
If a dose of Lactulosum Espefa has been missed, take the next dose at the scheduled time.
Do not use a double dose to make up for the missed dose.
Discontinuation of Lactulosum Espefa
Do not discontinue or alter treatment without consulting a doctor.
If you have any further doubts concerning the use of this medicinal product, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Very common (may affect more than 1 in 10 people)
- diarrhoea
Common (may affect up to 1 in 10 people)
- abdominal distension (swollen stomach)
- 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
Flatulence with passage of wind may occur during the first few days of treatment. This usually
resolves after a few days.
When higher than recommended doses are used, abdominal pain and diarrhoea may occur.
In such cases, the dose should be reduced.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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 reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store Lactulosum Espefa
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Shelf-life after first opening the bottle: 90 days
Store below 25°C.
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 help protect the environment.
6. Contents of the package and other information
What Lactulosum Espefa contains
- The active substance is lactulose. 5 ml of syrup contains 2.5 g of lactulose.
- The other ingredients (excipients) are: orange flavour, purified water.
What Lactulosum Espefa looks like and contents of the pack
Brown glass bottle with an aluminium cap, in a cardboard box with patient leaflet, with a measuring spoon made of polypropylene.
Brown glass bottle with a polyethylene cap with an induction sealing liner, in a cardboard box with patient leaflet, with a measuring spoon made of polypropylene.
150 ml – 1 bottle of 150 ml
Marketing Authorisation Holder and Manufacturer:
Chemiczno-Farmaceutyczna Spółdzielnia Pracy ESPEFA
ul. J. Lea 208
30-133 Kraków, Poland
tel. 12 639 27 27
Information for blind and partially sighted people: 800-007-777