Name
Portolac 5 g powder for oral solution
Portolac 10 g powder for oral solution
Portolac 200 g powder for oral solution
Lactitol monohydrate


What it is and what it is used for
Portolac contains the active substance lactitol monohydrate, which belongs to a group of medicines called osmotic laxatives. This medicine works by increasing the water content in the intestine, thus promoting the evacuation of soft and bulky stools.

Portolac is indicated in adults and children for the short-term treatment of occasional constipation.

Talk to your doctor if you or your child do not feel better or if you feel worse after 7 days of treatment.


What you need to know before taking the medicine
Do not take/give Portolac to your child
• if you or the child are allergic to lactitol monohydrate or any of the other ingredients of this medicine (listed in section 6);
• if you or your child suffer from reduced intestinal transit (for example blockage of the intestine due to an obstruction);
• if you or your child have or might have an injury to your intestines;
• if you or your child have any stomach pain that you don't know the cause of;
• if you or your child has rectal bleeding;
• if you or your child suffer from hydro-electrolytic imbalance (alteration of the concentrations of liquids and salts present in the body);
• if you or your child have an intolerance to galactose (a type of sugar).

Do not give Portolac to breast-fed children and children with intolerance to fructose (another type of sugar).
If you or your child suffer from faecal impaction (hard, bulky stool in the intestine caused by constipation), this condition must be treated otherwise before using laxatives.


Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Portolac to your child.
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 constipation you or your child suffers from is chronic or particularly stubborn. In this case, your doctor will advise you to treat the constipation first with a diet rich in fibre, sufficient fluid intake or physical activity;
• if you need to undergo electrocautery procedures (medical procedure used to remove parts of tissue) of the intestine;
• if you experience nausea or flatulence (gas in the stomach);
• if you or your child have had an ileostomy or colostomy (surgical techniques that allow an opening in the belly to allow faeces to be eliminated from the outside);
• if your doctor has diagnosed you or your child with an intolerance to some sugars;
• 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 you are elderly and/or debilitated, as your doctor may want to regularly check your blood salt levels.

It is important to treat any hydro-electrolytic imbalance (alteration of the concentrations of fluids and salts present in the body) before starting treatment with a laxative.

Laxative abuse
If you or your child abuse (frequent or prolonged use or excessive doses) laxatives:
• may experience persistent diarrhea resulting in loss of water, mineral salts (especially potassium) and other essential nutrients;
• in more serious cases you may experience a serious loss of water from the body (dehydration) or a decrease in potassium in the blood. You may therefore have heart or muscle problems, especially if you are also taking medicines such as cardiac glycosides, diuretics or corticosteroids, to treat heart disease or inflammation;
• may develop dependence (and, therefore, possible need to progressively increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).

For these reasons, prolonged use of laxatives without interruption should be avoided and the physician should try to determine the optimal dosage at the beginning of treatment.

Children
In children and infants the medicine can be used only after consulting a doctor.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
At the beginning of treatment, Portolac may cause abdominal discomfort, especially with the release of gas from the intestine, and rarely abdominal pain or sometimes abdominal swelling. These effects tend to decrease or disappear after a few days of regular intake of Portolac.

The following side effects may occur with the following frequency:

Rare (may affect up to 1 in 1,000 people)
• vomit
• diarrhea
• stomach pain
• bloating of the belly
• production of gas from the intestine (flatulence).

Very rare (may affect up to 1 in 10,000 people)
• nausea
• abnormal sounds from stomach and intestines
• anal itching.

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.