Patients with rare hereditary problems of fructose intolerance should not take this medicine. Contains sorbitol 4.7 g per dose, a source of 1.175 g fructose.

Sunset Yellow (E110) may cause allergic reactions.

4.5 Interaction with other medicinal products and other forms of interaction
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. The hepato-toxicity of paracetamol may be potentiated by excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. Pharmacological interactions involving paracetamol with a number of other drugs have been reported. These are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.

Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported:

Monoamine oxidase inhibitors (including moclobemide)
 Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors (see contraindications).
 
Sympathomimetic amines
 Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.
 
Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)
 Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased.
 
Tricyclic antidepressants (e.g. amitriptyline)
 May increase the risk of cardiovascular side effects with phenylephrine.
 
Ergot alkaloids (ergotamine and methylsergide)
 Increased risk of ergotism
 
Digoxin and cardiac glycosides
 Increase the risk of irregular heartbeat or heart attack
 

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 Pregnancy and lactation
This product should not be used during pregnancy without medical advice.

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. The safety of guaiphenesin and phenylephrine during pregnancy has not been established.

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

The amount of alcohol in the product should be taken into account by pregnant or lactating women.

4.7 Effects on ability to drive and use machines
Patients should be advised not to drive or operate machinery if affected by dizziness.

The amount of alcohol in this product may impair the ability to drive or use machines.

4.8 Undesirable effects
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Events reported from extensive post-marke