LACTULOSE TE*OS 200ML670MG/ML

Lactulose Teva 670 mg/ml oral solution

What it is and what it is used for
Lactulose Teva is an aqueous solution of lactulose, a sugar belonging to the class of medicines called osmotic laxatives, capable of facilitating intestinal motility and softening stools, thus making evacuation easier.
Lactulose Teva is used for the short-term treatment of occasional constipation, if a diet rich in fiber (bran, vegetables and fruit) supplemented with a significant amount of liquids and adequate physical exercise is not sufficient.

What you need to know before taking the medicine
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 solve the problem of constipation.
Many people think they suffer from constipation if they don't have a bowel movement every day. This is an incorrect belief since 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 emission of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.

Do not take Lactulose Teva
- if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6);
- in the presence of acute abdominal pain or pain of unknown origin, nausea or vomiting, intestinal blockage (apart from normal constipation) or narrowing of some parts of the intestine (intestinal stenosis), rectal bleeding of unknown origin, severe dehydration;
- if you suffer from a severe genetic disease that prevents the digestion of galactose (galactosemia);
- if you suffer from acute inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), subocclusive syndromes, perforation or risk of perforation of the digestive system, abdominal pain of undetermined cause.

Warnings and precautions
Talk to your doctor or pharmacist before using Lactulose Teva. During treatment with laxatives, you should drink a sufficient amount of liquids (about 2 liters per day, equivalent to 6 - 8 glasses).

Abuse of laxatives (i.e., frequent or prolonged use or excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients for your body.
In the most severe cases, dehydration or a decrease in potassium levels in the blood (hypokalemia) may occur, which can lead to cardiac or neuromuscular dysfunction, especially in the case of concomitant treatment with drugs called cardiac glycosides, diuretics or corticosteroids (see also paragraph "Other medicines and Lactulose Teva").
Furthermore, laxative abuse, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).

Pay particular attention and ask your doctor for advice before taking Lactulose Teva if:
- you have suffered from constipation for a prolonged period of time. Your doctor will examine you before starting treatment with Lactulose Teva. In fact, recurrent difficulty in defecating could be a sign of a more serious illness (such as severe inflammatory gastrointestinal disease), especially if accompanied by symptoms such as abdominal pain, vomiting and fever;
- the need to take a laxative results from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks;
- you are an elderly patient or in poor health;
- you suffer from a disease affecting the gastrointestinal system and the heart, called Roemheld's Syndrome;
- you suffer from symptoms such as bloating due to excessive gas accumulation (flatulence) in the intestine;
- you are diabetic; in people with diabetes being treated with high doses of lactulose, the dose of antidiabetic medicines needs to be adjusted.

Contact your doctor when the use of the laxative fails to produce effects.
Always follow the instructions in this leaflet to determine the most suitable dose and treatment time for your case.
Always keep in mind that prolonged use of this laxative, the use of excessive doses or abuse can cause diarrhea and electrolyte imbalance (the distribution of mineral salts in your body).
The treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of medicines and monitoring during therapy.

If you are an elderly patient or in poor general condition, inappropriate long-term use of lactulose can alter the mineral salt balance.

Lactulose Teva may contain milk sugar (lactose), galactose or fructose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Children
In children under 12 years of age, the medicine can only be used after consulting a doctor.
Normally, Lactulose Teva should not be administered to infants and young children, as it can disturb the normal reflex that stimulates the passage of feces.
If in doubt, ask your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

When taking a dose higher than prescribed, abdominal pain and diarrhea may occur. In this case, the dosage must be reduced.
In case of taking excessive doses for a long time, electrolyte imbalance due to diarrhea may occur.

Very common (may affect more than 1 in 10 people):
mild abdominal pain*, flatulence*.

Common (may affect up to 1 in 10 people):
diarrhea* with mineral salt loss (electrolyte disturbances), vomiting*, nausea*.

Rare (may affect up to 1 in 1,000 people):
too high sodium level in the blood (hypernatremia).

Not known (frequency cannot be estimated from the available data):
isolated cramp-like pain or abdominal colic, more frequent in cases of severe constipation**; alteration of blood mineral salt levels (electrolyte imbalance), caused by diarrhea, allergic reactions, rash, itching, urticaria.

*mainly following excessive dosages.
** occasionally appear during the first days of treatment and normally disappear after a few days.

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.