|
Section 4.4 (addition of text)
Extrapyramidal disorders , drowsiness, decreased level of consciousness, confusion and hallucination occur more frequently when high doses of metoclopramide are used (see adverse reactions).
Section 4.6 (addition of text in bold)
Metoclopramide: data on pregnant patients (> 1000) indicate no malformative nor foeto/ neonatal toxicity during 1rst trimester of pregnancy. A limited amount of data on pregnant patients (> 300) indicate no neonatal toxicity in other trimesters. Animal studies do not indicate reproductive toxicity.
Exposure of pregnant women to the individual active components indicates no adverse effect on pregnancy or on the health of the foetus/new born child. To date, no epidemiological data are available for the combination product. Paramax should only be used during pregnancy when there are compelling reasons and like all drugs avoid use in the first and second trimester unless the physician believes the benefits outweigh the risk. Thereafter, patients should follow the advice of their doctor regarding its use.
During lactation, metoclopramide and paracetamol are excreted in breast milk and adverse reactions in the breast-fed baby cannot be excluded. A decision should be made whether to discontinue breast-feeding or to abstain from Paramax treatment.
Section 4.8 (addition of text)
Drowsiness, decreased level of consciousness, confusion, hallucination.
Depression
Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulfur-releasing drugs.
|
