GUTTALAX "7.5 MG/ML DROPS, ORAL SOLUTION" 15 ML BOTTLE"

Name
GUTTALAX 7.5 mg/ml oral drops, solution
Sodium picosulfate


What is it and what is it used for?
Guttalax contains sodium picosulfate. It belongs to a group of medications called contact laxatives, which work by stimulating bowel movements, accelerating the passage of intestinal contents.

Guttalax is used in adults, children aged 3 years and over and adolescents for the short-term treatment of occasional constipation.

Contact your doctor if you do not feel better or if you feel worse after 7 days.


What you need to know before taking the medicine
Do not take/give Guttalax to your child.
• if you and/or your child are allergic to sodium picosulfate or any of the other ingredients of this medicine (listed in section 6);
• if you and/or your child suffer from a blockage of the intestinal muscles (paralytic ileus) which prevents normal intestinal transit;
• if you and/or your child have acute, severe abdominal pain, with or without fever, such as appendicitis (inflammation of the appendix, a part of the intestine), and severe stomach pain associated with nausea and vomiting;
• if you and/or your child suffer from obstruction or narrowing of the intestine (intestinal stenosis) or of the biliary tract (where bile, a substance involved in some digestive processes, flows);
• if you and/or your child suffer from acute inflammation of the stomach and intestines; • if you and/or your child suffer from rectal bleeding of unknown origin;
• if you and/or the child suffer from severe loss of water from the body (dehydration);
• if you and/or your child suffer from nausea or vomiting;
• if you and/or your child suffer from a hereditary disease that may be incompatible with taking one of the excipients (see "Guttalax contains sorbitol");
• if you and/or your child suffer from gallstones (presence of small stones that obstruct the flow of bile);
• if you and/or your child suffer from reduced liver function (liver failure).

Do not give Guttalax drops to children under 3 years of age.

If you are pregnant or breastfeeding, see section "Pregnancy, breastfeeding and fertility".


Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Guttalax to your child.

As with all laxatives, do not take/give your child Guttalax daily or for prolonged periods without first consulting your doctor to determine the cause of the constipation. Treatment of chronic or recurrent constipation always requires medical attention for diagnosis, medication prescription, and ongoing monitoring.

In particular, 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;
• in cases of chronic or recurrent constipation;
• if he is elderly or in poor health.

Laxative abuse
Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in loss of water, mineral salts (especially potassium) and other essential nutrients.
In more severe cases, dehydration (loss of fluids) or hypokalemia (decrease in potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular dysfunction, especially if you are taking cardiac glycosides, diuretics or corticosteroids at the same time.
Abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause dependence (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).

Children and adolescents
Do not give Guttalax to children aged 3 to 12 years without first consulting your doctor.


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

The following side effects are listed by frequency:

very common (may affect more than 1 in 10 people) • diarrhoea;

common (may affect up to 1 in 10 people)
• abdominal cramps, abdominal pain and abdominal discomfort;

uncommon (may affect up to 1 in 100 people)
• dizziness. Cases of dizziness that occur after taking sodium picosulfate appear to be attributable to a reflex response (following, for example, abdominal pain or stool evacuation);
• vomiting, nausea;
not known (frequency cannot be estimated from the available data) • hypersensitivity;
• skin reactions such as swelling of the skin and mucous membranes of the face, lips and throat (angioedema), eruptions following drug intake, rash, itching;
• fainting (syncope). Cases of fainting that occur after taking sodium picosulfate appear to be attributable to a reflex response (for example, following abdominal pain or bowel movements). In addition, you may occasionally experience the following effects, which occur more frequently in cases of severe constipation:
• stomach cramps (cramp-like pain);
• severe abdominal pain with cramps (abdominal colic).

These side effects are usually transient.

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.