GUTTALAX*ORAL DROPS 15ML 7.5MG/ML

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 act by stimulating bowel movements, accelerating the passage of intestinal content.

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

Consult your doctor if you do not feel better or 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 suffer from acute, severe abdominal pain, with or without fever, such as appendicitis (inflammation of the appendix, part of the intestine), and severe abdominal pain associated with nausea and vomiting;
- if you and/or your child suffer from obstruction or narrowing of the intestine (intestinal stenosis) or bile ducts (where bile, a substance involved in some digestive processes, flows);
- if you and/or your child suffer from acute inflammation of the stomach and intestine;
- 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 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 the assumption 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 blocking the flow of bile);
- if you and/or your child suffer from reduced liver function (hepatic insufficiency).

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

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

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

In particular, consult your doctor:
• when the need for the laxative results from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that has lasted for more than two weeks or when the use of the laxative fails to produce effects;
• in cases of episodes of chronic or recurrent constipation;
• if you are 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 can cause serious side effects. This medicine, like other stimulant laxatives, does not help with weight loss.

Laxative abuse
Laxative abuse (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutrients.
In the most severe cases, dehydration (fluid loss) or hypokalemia (decrease in blood potassium levels) may occur, which can lead to cardiac or neuromuscular dysfunction, especially if you are concurrently taking cardiac glycosides, diuretics, or corticosteroids.
Laxative abuse, especially contact laxatives (stimulant laxatives), can cause dependence (and therefore a possible need to progressively increase the dosage), chronic constipation, and loss of normal bowel function (intestinal atony).

Children and adolescents
Do not administer Guttalax to children aged between 3 and 12 years without first consulting a 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 occurring after taking sodium picosulfate seem attributable to a reflex response (resulting, for example, from abdominal pain or defecation);
• 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), drug-induced eruptions, rash, itching;
• fainting (syncope). Cases of fainting occurring after taking sodium picosulfate seem attributable to a reflex response (resulting, for example, from abdominal pain or defecation).

Additionally, you may occasionally experience the following effects, which occur more frequently in cases of severe constipation:
• abdominal cramps (cramping pain);
• severe abdominal pain with cramps (abdominal colic).

These side effects are generally temporary.

Reporting of side effects
If you get any side effects, including those 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.