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


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

Guttalax is used in adults, children aged 3 years and above 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 the 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 suffer from acute, severe abdominal pain, with or without fever, such as appendicitis (inflammation of the appendix, a part of the intestine), and severe tummy 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 your child suffer from severe water loss from your 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 the intake of one of the excipients (see "Guttalax contains sorbitol, sodium benzoate and sodium");
- 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 breast-feeding, see section "Pregnancy, breast-feeding and fertility".


Warnings and precautions
Talk to your doctor or pharmacist before taking/giving Guttalax to your child.
Cases of dizziness and/or fainting (syncope) have been reported after taking Guttalax. The data relating to these cases suggest that the events, rather than a phenomenon related to the intake of Guttalax, could be interpreted as a manifestation of "fainting (syncope) from defecation" (attributable to the effort of the act of defecation), or as a reflex response to abdominal pain related to constipation itself.
As with all laxatives, do not take/give your child Guttalax daily or for prolonged periods without first having your doctor evaluate the cause of the constipation. Treatment of chronic or recurrent constipation always requires the intervention of a doctor for diagnosis, prescription of drugs and monitoring during therapy.

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.

Do not use this medicine to try to lose weight. This medicine does not reduce the absorption of calories from the intestine and may cause serious side effects. This medicine, like other stimulant laxatives, does not help you lose weight.

Laxative abuse
Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea with consequent 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 cause 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)
• diarrhea;
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 due to taking the medicine, 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 the evacuation of stool).

Additionally, 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 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.