PORTOLAC "66.67 G/100 ML SYRUP" 1 BOTTLE 200 ML"

Name
Portolac 66.67 g/100 ml syrup
Lactitol monohydrate


What is it and what is it for?
Portolac contains the active ingredient lactitol monohydrate, which belongs to a group of medications called osmotic laxatives. This medicine works by increasing the water content in the intestine, thus promoting the passage of soft, 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 does 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 your 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 breastfed children and children with fructose intolerance (another type of sugar).

If you or your child have fecal impaction (a hard, bulky blockage of 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 medical intervention for diagnosis, medication prescription, and monitoring during therapy.
Consult your doctor:
• when the constipation you or your child suffer from is chronic or particularly stubborn. In this case, your doctor will advise you to treat the constipation first with a high-fiber diet, 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 any 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 fluid-electrolyte 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 severe cases, you may experience severe water loss from your body (dehydration) or a decrease in potassium in your blood. You may therefore experience 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 doctor should try to determine the optimal dosage at the beginning of treatment.

Children
In children and infants the medicine can only be used 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 gas, and rarely abdominal pain or sometimes abdominal bloating. These effects tend to decrease or disappear after a few days of regular use of Portolac.

The following side effects may occur according to 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 the stomach and intestines
• anal itching.

Reporting of side effects
If you experience 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.