Cheston COLD

For the treatment of perennial rhinitis, seasonal allergic rhinitis (hay fever) and chronic idiopathic urticaria in adults and children aged 12 years and over.

this medicine is contraindicated in patients with hypersensitivity to cetirizine or

its parent compound hydroxyzine.

It is also contraindicated in patients with severe hypertension or coronary artery

disease, patients receiving monoamine oxidase inhibitor (MAO) therapy and in patients

with hepatic dysfunction.

Cetirizine:

No clinically significant drug interactions have been found with theophylline at a low

dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. There was a

small decrease in the clearance of cetirizine caused by a 400-mg dose of theophylline; it

is possible that larger theophylline doses could have a greater effect.

Phenylpropanolamine:

MAO inhibitors increase the effect of sympathomimetic amines, and may prolong and

intensify the effects of antihistamines. Beta-adrenergic amines may reduce the

antihypertensive effects of some drugs e.g. Methyldopa and Reserpine.

Others

this medicine is should be used with caution in patients with hypertension and ischaemic

heart disease. Although investigations indicate that cetirizine does not intensify the

effect of alcohol, it is advisable to avoid alcohol consumption.

Pregnancy

There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response,

ALERID-D should be used in pregnancy only if clearly needed.

Lactation

Cetirizine has been reported to be excreted in human breast milk. ALERID-D is not

recommended for use by lactating mothers.

Paediatric Use

This combination cannot be used in children below the age of 12 years.

Cetirizine

In objective tests of psychomotor function the incidence of sedation with cetirizine was

similar to that of placebo. There have been occasional reports of mild and transient side

effects such as drowsiness, fatigue, headache, dizziness, agitation, dry mouth and

gastro-intestinal discomfort. If desired the dose might be taken as 5mg in the morning

and 5 mg in the evening.

Undesirable effects reported from post-marketing experience are listed in the following

table per System Organ Class and per frequency.

Blood and lymphatic disorders: Very rare: thrombocytopenia.

Cardiac disorders: Rare: tachycardia.

Eye disorders: Very rare: accommodation disorder, blurred vision.

Gastro-intestinal disorders: Uncommon: diarrhoea.

General disorders and administration site conditions: Uncommon: asthenia, malaise;

Rare: oedema.

Immune system disorders: Rare: hypersensitivity; Very rare: anaphylactic shock

Hepatobiliary disorders: Rare: abnormal hepatic function (increased transaminases,

alkaline, phosphatase, ?-GT and bilirubin).

Investigations: Rare: weight increase.

Nervous system disorders: Uncommon: paraesthesia; Rare: convulsions, movement

disorders; Very rare: dysgeusia, syncope.

Psychiatric disorders: uncommon : agitation; rare : aggression, confusion, depression,

hallucination, insomnia.

Renal and urinary disorders: Very rare: dysuria, enuresis, micturition difficulties.

Skin and subcutaneous tissue disorders: Uncommon: pruritus, rash, Rare: urticaria,

Very rare: angioneurotic oedema, erythema multiforme.

Phenylpropanolamine

The incidence of adverse effects is low in patients receiving therapeutic doses of

phenylpropanolamine. The CNS stimulant effects of phenylpropanolamine may result in

nervousness, restlessness, insomnia/ sleeplessness, dizziness and headache. Nausea

and palpitations also may occur. Increases in blood pressure may occur and are

usually proportionate to dosage. At least one manufacturer recommends that blood

pressure be monitored regularly during phenylpropanolamine therapy. In some

patients, severe reactions including headache, feelings of tightness in the chest, greatly

elevated blood pressure, ventricular or atrial premature contractions, and paroxysms of

ventricular and atrial tachycardia have occurred with usual therapeutic doses; these

effects probably represent idiosyncratic reactions to the drug. Excessive doses of

phenylpropanolamine may produce tachycardia, pupillary dilation, excitation, and

arrhythmias; cases of heart attack, stroke, intracranial bleeding, parenchymal cerebral

hemorrhage, seizures, and death possibly associated with phenylpropanolamine also

have been reported. Patients receiving high doses of combination products containing

phenylpropanolamine and an antihistamine (i.e., diphenylpraline, chlorpheniramine)

have experienced acute psychotic (i.e., diphenylpraline, chlorpheniramine) have

experienced acute psychotic reactions and excessive CNS stimulation.