PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LACTULOSE ALTER 66.7% oral solution

Lactulose
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take 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 you experience any side effects, including those not listed in this leaflet, contact 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 Alter is and what it is used for
What you need to know before taking Lactulose Alter
How to take Lactulose Alter
Possible side effects
How to store Lactulose Alter
Contents of the pack and other information

1. What Lactulose Alter is and what it is used for

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

2. What you need to know before taking Lactulose Alter

Do not take Lactulose Alter

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Lactulose Alter.
Health education notes: Please note that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can resolve constipation problems. Many people believe they suffer from constipation if they cannot defecate every day. This is a mistaken belief, as this condition is completely normal for many people.
Instead, consider that constipation occurs when bowel movements are reduced compared to personal habits and are associated with the passage of hard stools. If episodes of constipation occur repeatedly, you should consult your doctor.
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medications, and monitoring during therapy.
Consult your doctor before taking this medicine in the following cases:

if the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting for more than two weeks, or when the use of the laxative fails to produce effects;
if you are elderly or debilitated;
if you have diabetes, because this medicine may contain other types of sugars (lactose, galactose, tagatose);
if you suffer from a gastrointestinal disorder called meteorism (excessive production and accumulation of gas in the intestine). In this case, start treatment with the lowest dose; this dose may then be gradually increased according to your condition;
if you suffer from constipation that lasts for long periods (chronic) or is frequent.

Prolonged use of laxatives may cause persistent diarrhoea, resulting in loss of water, mineral salts and other essential nutrients for the body.
In severe cases, dehydration (excessive loss of water from the body) or hypokalaemia (decreased potassium levels in the blood) may occur, which can cause problems to the heart, nerves and muscles (cardiac or neuromuscular dysfunction), especially if used concomitantly with medicines used for heart rate disorders (cardiac glycosides), medicines used to lower blood pressure (diuretics), or corticosteroid anti-inflammatory drugs.
Abuse of laxatives may lead to dependence (need to continually increase dosage), chronic constipation and intestinal atony (loss of normal intestinal function).
Children
Lactulose Alter should be used in children under 12 years of age only after consulting a doctor.
Other medicines and Lactulose Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking other medicines at the same time as Lactulose Alter, as it may reduce the intestinal transit time and therefore the absorption of other medicines taken orally.
If you are taking other medicines, take the laxative at least 2 hours after taking the other medicine.
Pay particular attention and inform your doctor if you are taking the following medicines:

Neomycin and other antibiotics (medicines used to treat bacterial infections);
antacids, used to reduce acidity;
digitalis, a medicine used to treat heart rhythm disorders.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy and breastfeeding, take this medicine only if necessary and always under direct medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or use machinery.
LACTULOSE ALTER contains sodium benzoate
This medicine contains 17.7 mg of sodium benzoate per 15 ml dose, equivalent to 1.18 mg/ml.
This medicine contains 11.8 mg of sodium benzoate per 10 ml dose, equivalent to 1.18 mg/ml.
This medicine contains 5.9 mg of sodium benzoate per 5 ml dose, equivalent to 1.18 mg/ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

3. How to take Lactulose Alter

Take this medicine exactly as described in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Shake the bottle well before use. Take the medicine preferably in the morning on an empty stomach or in the evening before a meal.

Duration of treatment
Take this medicine as infrequently as possible and for no longer than 7 consecutive days. If you do not notice any improvement, consult your doctor, who will evaluate your condition and consider whether prolonged treatment is necessary.
The correct dose is the lowest amount sufficient to produce easy bowel movements. Initially, take the lowest recommended dose, which may be increased according to need.

Method of administration
If taking a single daily dose, it is preferable to take it in the evening. If the dose is divided into two daily administrations, take it preferably in the morning and in the evening.

Use in adults
The recommended dose is 15 ml (= 10 g of lactulose) per day, which may be doubled or halved depending on your response to treatment and your health condition.

Use in children
This medicine should be used in children only when absolutely necessary and under medical prescription.
In children, the recommended dose is 10 ml (= 6.6 g of lactulose) per day, according to medical prescription and depending on age and severity of the condition.
In infants, the recommended dose is 5 ml (= 3.3 g of lactulose) per day, according to medical prescription.

If you take more Lactulose Alter 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 Alter
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor if you experience any of the following side effects:
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):
Electrolyte loss (blood salts), allergic reactions, skin rash, pruritus, urticaria.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via 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 Alter

Validity after first opening the bottle: 2 months
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lattulosio Alter contains
The active substance is lactulose. 100 ml of oral solution contain 66.7 g of lactulose.
The other ingredients are: sodium benzoate, purified water.
Description of the appearance of Lattulosio Alter and contents of the pack
Pack containing one 180 ml bottle of oral solution with a graduated polypropylene dosing cup
graduated from 2.5 ml to 30 ml.
Marketing Authorization Holder
Laboratori Alter S.r.l. - Via Egadi, 7 - 20144 Milano – Italy.
Manufacturer
ICE S.p.A., Canton Moretti 29, 10090 S. Bernardo d'Ivrea (TO) – Italy.
Consorzio Farmaceutico e Biotecnologico Bioprogress S.r.L. – Strada Paduni, 240 - 03012 Anagni (FR)
January 2026