Macrogol interacts in the following cases:
There is a possibility that the absorption of other medicinal products could be transiently reduced during use with macrogol. The therapeutic effect of medicinal products with a narrow therapeutic index may be particularly affected (e.g antiepileptics, digoxin and immunosuppressive agents).
Hypersensitivity reactions (rash, urticaria, and oedema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.).
There are limited amount of data (less than 300 pregnancy outcomes) for the use of macrogol in pregnant women.
No effects during pregnancy are anticipated, since systemic exposure to macrogol is negligible. Macrogol can be used during pregnancy.
There are no data on the excretion of Peglax in breast milk. No effects on the breast fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to macrogol is negligible. Peglax can be used during breast feeding.
No fertility studies were conducted however since macrogol is not significantly absorbed no effects are anticipated.
Macrogol has no influence on ability to drive and use machines.
Undesirable effects are listed under headings of frequency using the following categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
The undesirable effects listed below have been reported during clinical trials (including 600 adult patients) and post-marketing use. Generally, adverse reactions have been minor and transitory and have mainly concerned the gastrointestinal system:
Very rare: Hypersensitivity reactions (Pruritus, Rash, Face oedema, Quincke oedema, Urticaria, Anaphylactic shock)
Not known: Erythema
Not known: Electrolytes disorders (Hyponatremia, Hypokalaemia) and or dehydration, especially in elderly patients
Common: Abdominal pain and/or distension, Diarrhoea, Nausea
Uncommon: Vomiting, Urgency to defecate, Fecal incontinence
The undesirable effects listed below have been reported during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use. As in adult population, adverse reactions have generally been minor and transitory and have mainly concerned the gastrointestinal system:
Not known: Hypersensitivity reactions (Anaphylactic shock, Angioedema, Urticaria, Rash, Pruritus)
Common: Abdominal pain, Diarrhoea*
Uncommon: Vomiting, Bloating, Nausea
* Diarrhoea may cause perianal soreness
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