PORTOLAC*OS 20SACHETS 10G

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 ingredient 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 for adults and children 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 of treatment.

What you need to know before taking the medicine
Do not take/do not 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 (e.g., intestinal blockage due to an obstruction);
• if you or your child have or may have an intestinal lesion;
• if you or your child have any stomach pain of unknown cause;
• if you or your child have rectal bleeding;
• if you or your child suffer from hydro-electrolytic imbalance (alteration of the concentrations of fluids and salts present in the body);
• if you or your child suffer from galactose intolerance (a type of sugar).

Do not give Portolac to breastfed infants and children with fructose intolerance (another type of sugar).
If you or your child suffer from faecal impaction (a hard and bulky mass of faeces in the intestine caused by constipation), this condition must be treated in another way before using laxatives.

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Portolac to your child.
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 constipation you or your child suffers from is chronic or particularly stubborn. In this case, your doctor will advise you to treat constipation first with a high-fiber diet, sufficient fluid intake, or physical activity;
• if you need to undergo electrocautery procedures (a medical procedure used to remove tissue parts) of the intestine;
• if you experience nausea or flatulence (gas in the stomach);
• if you or your child have undergone an ileostomy or colostomy (surgical techniques that allow an opening in the abdomen to eliminate faeces from the outside);
• if your doctor has diagnosed you or your child with an intolerance to certain sugars;
• when the need for the laxative results from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting 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 the levels of salts in your blood.

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

Abuse of laxatives
If you or your child abuse (frequent or prolonged use or with excessive doses) laxatives:
• you may experience persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients;
• in the most severe cases you could experience severe dehydration or a decrease in blood potassium. You could 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;
• you can 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 emission from the intestine, and rarely stomach pain or sometimes abdominal bloating. These effects tend to decrease or disappear after a few days of regular Portolac intake.

The following side effects may occur with the following frequency:

Rare (may affect up to 1 in 1,000 people)
• vomiting
• diarrhea
• abdominal pain
• abdominal bloating
• gas production from the intestine (flatulence).

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

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.