Macrogol aurobindo 10 g - constipation treatment 20 sachets

Product Description

Osmotic laxative.

Indications

Macrogol Aurobindo 10 g powder for oral solution in sachets is a symptomatic treatment of constipation in adults and children aged 8 years and older.

• Treatment of constipation with any medicinal product is only an adjunct to a healthy lifestyle and dietary measures, such as increased fluid and dietary fiber intake, adequate physical activity, and intestinal motility retraining.
• An organic disorder must be ruled out before starting treatment.
• This medicinal product contains macrogol (polyethylene glycol). Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema) have been reported with drugs containing macrogol (polyethylene glycol).
• In case of diarrhea, caution should be exercised in patients predisposed to fluid and electrolyte disorders (e.g., the elderly, patients with impaired hepatic or renal function, or patients taking diuretics), and electrolyte monitoring should be considered.
• Cases of aspiration have been reported when large volumes of polyethylene glycol and electrolytes were administered via nasogastric tube. Neurologically compromised children with oromotor dysfunction are particularly at risk of aspiration.
• Ischemic Colitis: Cases of ischemic colitis, including severe cases, have been reported post-marketing in patients treated with macrogol for bowel preparation. Macrogol should be used with caution in patients with known risk factors for ischemic colitis or in case of concomitant use of stimulant laxatives (such as bisacodyl or sodium picosulfate). Patients who experience sudden abdominal pain, rectal bleeding, or other symptoms of ischemic colitis should be evaluated promptly.
• Macrogol Aurobindo contains sorbitol.
• This medicine contains less than 1 mmol (23 mg) sodium per sachet, i.e., essentially "sodium-free."

Precautions for use:

Macrogol Aurobindo does not contain a significant amount of sugar or polyols and can be prescribed to diabetic patients or patients on a galactose-free diet.

Interactions

There is a possibility that the absorption of other medicinal products may be temporarily reduced during the use of macrogol. The therapeutic effect of medicinal products with a narrow therapeutic index may be particularly affected (e.g., antiepileptics, digoxin, and immunosuppressive agents).

Contraindications

• Hypersensitivity to the active substance or to any of the excipients.
• Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon.
• Digestive tract perforation or risk of digestive tract perforation.
• Ileus or suspected intestinal obstruction, or symptomatic stenosis.
• Painful abdominal syndromes of undetermined origin.

The listed adverse reactions have been reported during clinical trials in 147 children aged 6 months to 15 years and during post-marketing use. As in the adult population, adverse reactions were generally mild and transient, and predominantly involved the gastrointestinal tract.

Undesirable effects

Adverse drug reactions are listed by frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

Adult population:

The listed adverse reactions have been reported during clinical trials (including 600 adult patients) and in post-marketing experience. In general, adverse reactions were mild and transient and mainly involved the gastrointestinal system.

Gastrointestinal disorders:

• Common: abdominal pain, abdominal distension, nausea, diarrhea.
• Uncommon: vomiting, defecation urgency, fecal incontinence.

Metabolism and nutrition disorders:

• Not known: electrolyte disturbances (hyponatremia and hypokalaemia) and/or dehydration, especially in elderly patients.

Immune system disorders:

• Not known: hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, pruritus, erythema).

Disorders Gastrointestinal disorders:

• Common: abdominal pain, diarrhea*.
• Uncommon: vomiting, abdominal distension, nausea.

Immune system disorders:

• Not known: hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, pruritus).

*Diarrhea may cause perianal pain.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions that occur after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Pregnancy and breastfeeding

Pregnancy: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. No effects during pregnancy are anticipated, since systemic exposure to macrogol is negligible. Macrogol can be used during pregnancy.

Breastfeeding: There are no data on the excretion of macrogol in human milk. No effects on breast-fed newborns/infants are anticipated, since systemic exposure to macrogol 4000 in breast-feeding women is negligible. Macrogol can be used during breast-feeding.

Fertility: No fertility studies have been conducted with macrogol; However, since macrogol 4000 is not significantly absorbed, no effects on fertility are expected.

Format

20 Sachets