| Section 4.4:
From:
The lactose content should be taken into account when treating patients with lactose intolerance.
To:
Lactulose should be administered with care to patients who are intolerant to lactose (see 6.1).
The dose normally used in constipation should not pose a problem for diabetics. The dose used in the treatment of (pre)coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
It should be taken into account that the exoneration reflex could be disturbed during the treatment.
In case of insufficient therapeutic effect after several days, consultation of a physician is advised.
Section 4.6:
From:
Pregnancy: Wide clinical experience, together with data from animal reproduction studies has not revealed any increase in embryotoxic hazard to the foetus, if used in the recommended dosage during pregnancy. If drug therapy is needed during pregnancy, the use of this drug is acceptable.
Lactation: This product can be used by nursing mothers feeding their offspring.
To:
Limited data on pregnant patients indicate neither malformative nor foeto/neonatal toxicity.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
The use of lactulose may be considered during pregnancy if necessary.
Lactation
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.
Duphalac can be used during breast-feeding.
Section 5.3
From:
The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed appear to be more related to the effect of bulk in gastrointestinal tract than to a more specific toxic activity.
To:
The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk in the gastrointestinal tract than to a more specific toxic activity. In reproduction and teratology experiments in rabbits, rats or mice no adverse effects were found.
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