If urine is collected within 24 hours of a dose of this product, a metabolite may cause a colour interference with laboratory determinations of 5 hydroxyindoleacetic acid (5-HIAA) and vanillymandelic acid (VMA).
4.6 Fertility, pregnancy and lactation
This product should not be used during pregnancy without medical advice.

PARACETAMOL

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. This product should not be used whilst breast feeding without medical advice.

GUAIFENESIN

The safety of guaifenesin in pregnancy and lactation has not been fully established but this constituent is not thought to be hazardous. However the product should only be used in pregnancy when considered essential by the doctor.

PHENYLEPHRINE HYDROCHLORIDE

Due to the vasconstrictive properties of Phenylephrine, the product should be used with caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

The safety of phenylephrine during pregnancy has not been established.

Phenylephrine is excreted in breast milk but not in a clinically significant amount. This product should not be used whilst breast feeding without medical advice.

4.7 Effects on ability to drive and use machines
None known

Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8 Undesirable effects
The active ingredients are usually well tolerated in normal use.

PARACETAMOL

Very rare cases of serious skin reactions have been reported.

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by MedDRA System Organ Class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Body System
 Undesirable effect
 
Blood and lymphatic system disorders
 Thrombocytopenia
 
  Agranulocytosis
 
  These are not necessarily causally related to paracetamol
 
Immune system disorders
 Anaphylaxis
 
  Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome, toxic epidermal necrolysis
 
Respiratory, thoracic and mediastinal disorders
 Bronchospasm*
 
Hepatobiliary disorders
 Hepatic dysfunction
 
Gastrointestinal disorders
 Acute pancreatitis
 

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

GUAIFENESIN

The frequency of these events is unknown but considered likely to be rare.

&nbs