Package leaflet: information for the patient

LACTULOSE EG 66.7 g/100 ml syrup

Please read this leaflet carefully before taking this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any of the side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

What Lactulose EG is and what it is used for
What you need to know before using Lactulose EG
How to use Lactulose EG
Possible side effects
How to store Lactulose EG
Contents of the pack and other information

1. What Lattulosio EG is and what it is used for

Lattulosio EG contains lactulose, a laxative that stimulates intestinal motility.
This medicine is indicated for the short-term treatment of occasional constipation in adults and
children.
Consult a doctor if you and/or the child do not feel better or feel worse after 7 days.

2. What you need to know before using Lactulose EG

Do not use Lactulose EG if you and/or your child:

are allergic to lactulose or to any of the other ingredients of this medicine (listed in section 6);
have abdominal pain, even of unknown origin;
have episodes of nausea or vomiting;
have intestinal obstruction or narrowing of the intestine (intestinal stenosis);
have unexplained rectal bleeding;
are suffering from severe dehydration (excessive loss of water from the body).

Warnings and precautions
Talk to your doctor or pharmacist before using Lactulose EG.
Health education notes
First of all, it should be noted that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can provide a lasting solution to constipation.
Many people believe they are constipated if they cannot defecate every day.
This is a mistaken belief, as this condition is completely normal for many individuals.
Instead, consider that constipation occurs when bowel movements are reduced compared to your usual personal habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently, consult your doctor.
The treatment of chronic or recurrent constipation always requires medical supervision for diagnosis, prescription of medication, and monitoring during therapy.
Consult your doctor:

when the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or when use of the laxative fails to produce an effect;
if you are elderly or in poor general health.

Laxative abuse
Frequent or prolonged use, or use at excessive doses, of laxatives may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients.
In severe cases, dehydration (excessive loss of water from the body) or hypokalaemia (low blood potassium levels) may occur, which can lead to cardiac or neuromuscular disorders, especially if you are also taking medicines such as cardiac glycosides (medicines used to treat heart problems), diuretics (medicines that lower blood pressure), or corticosteroids (anti-inflammatory medicines).
Abuse of laxatives may lead to dependence (possible need to progressively increase the dose), chronic constipation, and intestinal atony (loss of normal intestinal function).
Other medicines and Lactulose EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking laxatives together with other medicines: if you are taking another medicine, wait at least 2 hours before taking the laxative.
Inform your doctor if you are taking:

neomycin or other antibiotics (medicines used to treat bacterial infections);
digitalis (a medicine used to treat heart conditions).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of this medicine during pregnancy and breastfeeding should only be considered when clearly necessary and under direct medical supervision.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
Lactulose EG contains sodium benzoate (E211)
This medicine contains 1.18 mg of sodium benzoate per ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially 'sodium-free'.
Lactulose EG contains galactose and lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Lactulose EG contains fructose

3. How to use Lactulose EG

Use this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosing
The correct dose is the lowest amount sufficient to produce easy evacuation of soft stools. It is recommended
to initially use the lowest recommended doses. Do not exceed the maximum daily dose recommended.
Adults
The recommended dose is 15 ‐ 30 ml (equivalent to 10 – 20 g of lactulose), taken in one or two
daily administrations.
When necessary, the dose may be increased.
The maximum daily dose is 45 ml (equivalent to 30 g of lactulose).
Adolescents and children ≥ 10 years
The recommended dose is 15 ml (equivalent to 10 g of lactulose), taken in one or two
daily administrations.
The maximum daily dose is 15 ml.
Children 5 ‐ < 10 years
The recommended dose is 10 ml (equivalent to 6.67 g of lactulose), taken in one or two
daily administrations.
The maximum daily dose is 10 ml.
Children > 1 – < 5 years
The recommended dose is 5 ml (equivalent to 3.33 g of lactulose), taken in one or two
daily administrations.
The maximum daily dose is 5 ml.
Children 1 month – 1 year
The recommended dose is 2.5 ml (equivalent to 1.66 g of lactulose), taken as a single
daily administration in the evening.
The maximum daily dose is 2.5 ml.
Treatment duration
Laxatives should be used as infrequently as possible and for no longer than seven days. Use for longer periods
requires a doctor's prescription following appropriate clinical evaluation.
Method of administration
If taken once daily, it is preferable to take it in the evening. If the dose is divided into two daily administrations,
it is preferable to take it in the morning and evening.
If you take more Lactulose EG than you should
In case of accidental ingestion/overdose, abdominal pain and diarrhea may occur. In such cases, stop treatment
and drink fluids to replace fluid and electrolyte losses (salts present in the blood).
If you forget to take Lactulose EG
Do not take a double dose to make up for the missed dose.
If you stop treatment with Lactulose EG
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, consult your doctor or pharmacist.
Very common (may affect more than 1 in 10 people):
Abdominal pain; flatulence (excessive intestinal gas production).
Common (may affect up to 1 in 10 people):
Abdominal distension; urgency to defecate; diarrhoea; nausea; reduced appetite; headache.
Uncommon (may affect up to 1 in 100 people):
Vomiting.
Not known (frequency cannot be estimated from the available data):
Loss of electrolytes (blood salts); allergic reactions, skin rash, itching, urticaria.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lactulose EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Lattulosio EG contains
The active substance is lactulose. 100 ml of syrup contain 66.7 g of lactulose.
The other component is sodium benzoate.
Description of the appearance of Lactulose EG and contents of the pack
Pack containing one 180 ml bottle of syrup with child-resistant cap.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan
Manufacturer
ICE S.p.A., Via Cantone Moretti, 29, Località San Bernardo - 10015 Ivrea (TO) – Italy