Package leaflet: Information for the patient

Lactulose Sandoz 66.7% syrup

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 any not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

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

Lactulose Sandoz contains the active substance lactulose, a sugar belonging to a group of medicines called laxatives, used to facilitate intestinal evacuation.
In adults, this medicine is indicated:

for the short-term treatment of occasional constipation;
for the treatment of intestinal infections caused by certain bacteria such as Salmonella, Shigella, in combination with other medicines (adjunctive treatment).

In children and infants, it is indicated:

for the short-term treatment of occasional constipation;
for the treatment of intestinal disturbances caused by improper diet (putrefactive syndromes);
to promote adequate digestion when discontinuing breastfeeding (during the transition from breast milk to artificial milk).

Consult your doctor if you do not feel better or feel worse after 7 days.

2. What you need to know before taking Lactulose Sandoz

Do not take Lactulose Sandoz

if you are allergic to lactulose or to any of the other ingredients of this medicine (listed in section 6);
if you have galactosaemia, a genetic disorder that prevents the digestion of certain sugars;
if you have an intestinal obstruction or narrowing (stenosis);
if you have abdominal pain of unknown origin, nausea, or vomiting;
if you notice blood of unknown origin in your stools (rectal bleeding);
if you are severely dehydrated;

Warnings and precautions
Talk to your doctor or pharmacist before taking Lactulose Sandoz.
Consult your doctor before taking this medicine in the following cases:

if you have diabetes, because this medicine may contain other types of sugars (lactose, galactose, tagatose);
if you are elderly or debilitated;
if you suffer from intestinal gas (meteorism). In this case, start treatment with the lowest dose, which may be gradually increased depending on your condition;
if you suffer from constipation that lasts for long periods (chronic) or that is frequent;
if 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 the use of a laxative fails to produce results.

Excessive use of laxatives may cause persistent diarrhoea, resulting in loss of water, mineral salts, and other essential nutrients. In severe cases, severe dehydration and low potassium levels in the blood (hypokalaemia) may lead to heart, nerve, and muscle problems (cardiac or neuromuscular dysfunction), especially if you are also taking medicines for heart rhythm disorders (cardiac glycosides), medicines to lower blood pressure (diuretics), or corticosteroid anti-inflammatory drugs.
Abuse of laxatives, particularly stimulant laxatives (contact laxatives), may lead to dependence and tolerance (increasing need for higher doses), chronic constipation, and loss of normal intestinal function (intestinal atony).
Health education notes: Keep in mind that, in most cases, a balanced diet rich in water and fibre (bran, vegetables, and fruit) can resolve constipation. Many people believe they are constipated if they do not have a bowel movement every day. This is a misconception, as this condition is entirely normal for many individuals.
Instead, constipation should be considered when bowel movements are reduced compared to personal habits and are associated with hard stools. If episodes of constipation recur frequently, consult your doctor.
Children
In children under 12 years of age, Lactulose Sandoz should be used only after consulting a doctor.
Other medicines and Lactulose Sandoz
Inform 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 Sandoz, as it may reduce the intestinal transit time and thus the absorption of other orally administered medicines.
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:

broad-spectrum antibacterial agents used to treat bacterial infections.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist 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 operate machinery.
Lactulose Sandoz contains sodium benzoate and sodium
This medicine contains 26.4 mg of sodium benzoate per average daily dose, equivalent to 0.14 mg/ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
Lactulose Sandoz contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take Lactulose Sandoz

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.
Take this medicine preferably with a generous glass of water.
If you are to take the daily dose as a single administration, take the medicine preferably in the evening.
Take this medicine as infrequently as possible and for no more than 7 consecutive days.
If you do not notice any improvement, consult your doctor, who will assess your condition and the possible need for prolonged treatment.
The correct dose is the lowest dose sufficient to produce easy bowel movements. Initially take the lowest recommended dose, which may be increased according to need.

Use in adults
The recommended dose is 1 tablespoon of syrup (15 ml = 10 g of lactulose) or 1 and a half tablespoons of syrup, corresponding to 10–15 g per day, given in two doses. This dosage 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 under 12 years of age only after consulting a doctor.
In children, the recommended dose ranges from approximately 1 coffee spoon to 1 tablespoon of syrup per day, even as a single dose, according to medical prescription and depending on age and severity of the condition.
In infants, the recommended dose is approximately 1 coffee spoon of syrup per day, according to medical prescription.

If you take more Lactulose Sandoz than you should
If you (or someone else) have taken an excessive dose of Lactulose Sandoz, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
Overdose may cause abdominal pain and diarrhoea.

If you forget to take Lactulose Sandoz
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

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:

cramping or colicky abdominal pain, more frequent in cases of severe constipation;
flatulence;
allergic reactions, skin rash, itching, urticaria (frequency not known).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can 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 Sandoz

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.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Sandoz contains

The active substance is lactulose. 100 ml of syrup contain 66.7 g of lactulose.
The other components are: sodium benzoate, purified water.

Description of the appearance of Lattulosio Sandoz and contents of the pack
Pack containing one 180 ml bottle of syrup.
Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)
Manufacturers
ABC Farmaceutici Spa – Via Cantone Moretti, 29 – Ivrea (TO)