DUPHALAC*SYR 200ML66.7G/100ML

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 bowel motility.
DUPHALAC is indicated in adults and children for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or feel worse after 7 days.

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

Warnings and precautions
Consult your doctor or pharmacist before using DUPHALAC.

Health education notes
First of all, it should 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 suffer from constipation if they do not have a bowel movement every day.
This is a mistaken belief, as this situation is completely normal for a large number of individuals.
Instead, consider that constipation occurs when bowel movements are reduced compared to one's personal habits and are associated with the passage of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.
The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of medicines, 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 has lasted for more than two weeks, or when the use of the 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 the most severe cases, dehydration (excessive loss of water from the body) or hypokalemia (decrease in blood potassium) may occur, which can 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 progressively increase the dosage), chronic constipation and intestinal atony (loss of normal bowel functions).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. You can take this medicine during pregnancy and breastfeeding.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone 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 unknown frequency (frequency cannot be estimated from the available data):
• flatulence (gas)*,
• abdominal pain (stomach ache)*,
• nausea,
• vomiting,
• diarrhea (mainly due to excessive dosages),
• electrolyte imbalance (alteration of the amount of salts in the blood) due to diarrhea,
• allergic reactions,
• 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 side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.