Name
DUPHALAC 66.7 g/ 100 ml syrup
Lactulose


What it is and what it is used for
DUPHALAC contains the active ingredient lactulose, a laxative, which stimulates intestinal motility.
DUPHALAC is indicated in adults and children for the short-term treatment of occasional constipation.
Contact your doctor if you do not feel better or if you feel worse after 7 days.


What you need to know before taking the medicine
Do not use DUPHALAC if you or your child
- you are allergic to lactulose or any of the other ingredients of DUPHALAC (listed in section 6);
- you have abdominal pain, even of unknown origin;
- you have episodes of nausea and vomiting;
- you have intestinal stenosis (obstruction or narrowing of the intestine);
- you have rectal bleeding of unknown origin;
- you suffer from a severe state of dehydration (excessive loss of water from the body);
- have or are at risk of gastrointestinal (stomach and intestine) perforations.


Warnings and precautions
Talk to your doctor or pharmacist before using DUPHALAC.

Health education notes
First of all, it must be kept in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit) can permanently solve the problem of constipation.
Many people think they are constipated if they are unable to have a bowel movement every day.
This is a misconception as this situation is completely normal for a large number of individuals.
Consider, instead, that constipation occurs when evacuations are reduced compared to one's personal habits and are associated with the emission of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.
Treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during therapy.
Consult your doctor if the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasts for more than two weeks or when the use of a laxative fails to produce effects.

Laxative abuse
Frequent or prolonged use or excessive doses of laxatives can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients.
In more serious cases, dehydration (excessive loss of water from the body) or hypokalaemia (decrease in potassium in the blood) may occur, which may cause cardiac or neuromuscular disorders, especially if you are also taking medicines such as cardiac glycosides (medicines used to treat heart problems), diuretics (medicines used to lower blood pressure) or corticosteroids (anti-inflammatories).
Laxative abuse can cause dependence (possible need to gradually increase the dosage), chronic constipation and intestinal atony (loss of normal intestinal functions).

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You can take this medicine during pregnancy and breast-feeding.


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, talk to your doctor or pharmacist. The following side effects have been reported with an unknown frequency (frequency cannot be estimated from the available data):
• flatulence (air)*,
• abdominal pain (stomach ache)*,
• nausea,
• vomit,
• diarrhea (mainly following excessive dosages),
• electrolyte imbalance (alteration of the amount of salts in the blood) due to diarrhea,
• allergic reactions,
• skin rash,
• itching,
• urticaria.
*These effects are more frequent in cases of severe constipation. Furthermore, they are mild and resolve spontaneously after the first few days of treatment.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.