NORMASE 66.7 G/100 ML SYRUP 200 ML PET BOTTLE WITH DOSING GLASS

Name
NORMASE 66.7g/100ml syrup
Lactulose


What it is and what it is used for
Normase contains lactulose, a laxative that draws water into the intestine and makes stools softer.
Normase is indicated for the short-term treatment of occasional constipation.
Talk to your doctor if you or your child does not feel better or if you or your child feels 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 section 6);
• you have abdominal pain, even of unknown origin;
• you have episodes of nausea or vomiting;
• you have a blockage or narrowing of the intestine (intestinal stenosis);
• you have blood loss from the rectum (last part of the intestine), of unknown origin;
• you suffer from a severe state of dehydration (excessive loss of water from the body);


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

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:
• when 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 the laxative fails to produce effects.
• if he is elderly or not in good health.

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 that 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).


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).
• cramp-like abdominal pain (sudden, painful contractions of the intestine)*,
• flatulence (air),
• 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, 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.