NORMASE*SYR 200ML 66.7G/100ML

NORMASE 66.7g/100 ml syrup
Lactulose

What it is and what it is used for
Normase contains lactulose, a laxative that draws water into the intestine and softens the stool.
Normase is indicated for the short-term treatment of occasional constipation.
Consult your doctor if you or your child do not feel better or feel worse after 7 days.

What you need to know before taking the medicine
Do not use Normase if:
• you or your child are allergic to lactulose or any of the other ingredients of this medicine (listed in paragraph 6);
• you have abdominal pain, including pain of unknown origin;
• you experience nausea or vomiting;
• you have an obstruction or narrowing of the intestine (intestinal stenosis);
• you have rectal bleeding (from the last part of the intestine) of unknown origin;
• you suffer from severe dehydration (excessive loss of water from the body);

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

Health education notes
First of all, it should be noted that, in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently resolve the problem of constipation.
Many people think they suffer from constipation if they do not have a bowel movement every day.
This is an incorrect belief, as this situation is completely normal for a large number of individuals.
Instead, constipation occurs when bowel movements are reduced compared to one's usual 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:
• 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 the use of a laxative fails to produce effects.
• if you are elderly or in poor health.

Laxative abuse
Frequent or prolonged use, or use with excessive doses, of laxatives can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients.
In more 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 that lower blood pressure) or corticosteroids (anti-inflammatories).
Laxative abuse can cause dependence (a possible need to progressively increase the dosage), chronic constipation, and intestinal atony (loss of normal intestinal function).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with unknown frequency (frequency cannot be estimated from the available data).
• cramping abdominal pain (sudden and painful contractions of the intestine)*,
• flatulence (gas),
• abdominal colic (stomach ache)*,
• 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, 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.