Guttalax picosulfate drops 7.5 mg/ml bottle 30 ml

• active ingredient: sodium picosulfate, monohydrate;
• 1 ml contains sodium picosulfate monohydrate 7.5 mg;
• excipients: sodium benzoate (E 211); sorbitol solution, non-crystallizing (E 420); citric acid, monohydrate; sodium citrate, dihydrate; purified water.

• Hypersensitivity to the active substance, other triarylmethanes or to any of the excipients of the drug.
• Dynamic or mechanical intestinal obstruction.
• Severe diseases of the abdominal organs with pain and/or fever (e.g. appendicitis), which may be accompanied by nausea and vomiting.
• Acute inflammatory bowel diseases.
• Severe dehydration.
• Rare hereditary intolerance to any of the drug’s excipients.

Guttalax® Picosulfate should not be prescribed to children under 4 years of age.

Guttalax® Picosulfate should not be used in patients with rare hereditary fructose intolerance.

In conditions associated with impaired water and electrolyte balance (e.g. severe renal impairment), Guttalax® Picosulfate should be taken only under medical supervision.

Skin and subcutaneous tissue disorders: frequency unknown: skin reactions (angioedema, drug toxicoderma, rash, itching).

Immune system disorders: frequency unknown: allergic reactions.

Nervous system disorders: Uncommon: dizziness; frequency unknown: syncope.

Gastrointestinal disorders: very common: diarrhea; common: abdominal discomfort, abdominal pain, abdominal cramps; uncommon: nausea, vomiting.

Dosage. Unless otherwise prescribed, the dose for adults is 10 – 18 drops (corresponding to 5 – 10 mg of sodium picosulfate). The dose for children aged 4 years and over is 5 – 9 drops (corresponding to 2.5 – 5 mg of sodium picosulfate).

It is recommended to start with the lowest dose. The dose can be adjusted up to the maximum recommended dose to ensure regular bowel movements. The maximum daily dose should not be exceeded, which is 18 drops for adults or 9 drops for children aged 4 years and over.

Guttalax Picosulfate should not be used continuously (daily) or for long periods of time without determining the cause of constipation.

Oral administration. It is advisable to take GUTTALAX PICOSULFATE in the evening. The drug can be taken with or without liquid. After using the drops, bowel movements usually occur approximately 10 – 12 hours later.

Use during pregnancy or breastfeeding

Adequate clinical studies in pregnant women have not been conducted. Animal studies have shown reproductive toxicity at daily doses of 10 mg/kg and above. For safety reasons, Guttalax Picosulfate should be avoided during pregnancy if possible.

Clinical data show that neither the active metabolite bis-(parahydroxyphenyl)-pyridyl-2-methane (BHPM) nor its glucuronides are excreted in breast milk. Therefore, Guttalax Picosulfate can be used during breastfeeding.

Children

The drug is used in children aged 4 years and older only as prescribed by a doctor.

Ability to influence reaction speed when driving vehicles or other mechanisms

No studies have been conducted on the effect of the drug on the ability to drive vehicles and operate other mechanisms.

However, patients should be warned about the possibility of developing adverse events such as dizziness and/or syncope due to a vasovagal reaction (e.g. in response to abdominal cramps). If abdominal cramps occur, patients should avoid potentially hazardous activities such as driving or operating machinery.

Overdose may result in loose stools (diarrhea), abdominal cramps, and clinically significant loss of fluid, potassium, and other electrolytes.

In acute overdose, the effects may be minimized or eliminated by inducing vomiting or gastric lavage shortly after ingestion. Fluid replacement and correction of electrolyte balance may be considered. Antispasmodics may be used.

Isolated cases of colonic mucosal ischemia have been reported with sodium picosulfate doses significantly higher than those recommended for the treatment of constipation.

Chronic overdose of Guttalax Picosulfate (as with other laxatives) may result in chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and kidney stone formation. Renal tubular damage, metabolic alkalosis, and muscle weakness resulting from hypokalemia have been reported with prolonged laxative abuse.

Concomitant use of high doses of Guttalax Picosulfate and diuretics or corticosteroids may increase the risk of electrolyte imbalance, which may lead to increased sensitivity to cardiac glycosides.

Concomitant use with antibiotics may weaken the laxative effect of Guttalax Picosulfate.

Store out of the reach of children at a temperature not exceeding 25 °C.