ACTIFED Syrup Ref.[50592] Active ingredients: Pseudoephedrine

Posology

Adults and children 12 years and over

10 ml every 4-6 hours, up to four times a day.

Children 6-12 years

5 ml every 4-6 hours, up to three times a day.

Maximum daily dose: 15ml syrup.

A pharmacist or other healthcare professional should be consulted before use in children aged 6 to 12 years.

Use only when simple measures have failed to provide adequate relief.

Use for more than 5 consecutive days is not recommended.

Children under 6 years

This medicine is contraindicated in children under 6 years. [See section 4.3]

The Elderly

There have been no specific studies of ACTIFED Syrup in the elderly. Experience has indicated that normal adult dosage is appropriate.

Hepatic Dysfunction

Caution should be exercised when administering Actifed Syrup to patients with severe hepatic impairment.

Renal Dysfunction

Caution should be exercised when administering Actifed Syrup to patients with mild to moderate renal impairment.

Method of Administration

For oral use.

Symptoms

The effects of acute toxicity from ACTIFED Syrup may include drowsiness, incoordination, weakness, irritability, palpitations, hypertension, convulsions and difficulty with micturition.

Pseudoephedrine

Overdose may result in:

Metabolism and nutrition disorders: hyperglycaemia, hypokalaemia.

Psychiatric disorders: CNS stimulation, insomnia; irritability, restlessness, anxiety, agitation; confusion, delirium, hallucinations, psychoses.

Nervous system disorders: seizures, tremor, intracranial haemorrhage including intracerebral haemorrhage, drowsiness in children.

Eye disorders: mydriasis.

Cardiac disorders: palpitations, tachycardia, reflex bradycardia, supraventricular and ventricular arrhythmias, dysrhythmias, myocardial infarction.

Vascular disorders: hypertension, hypertensive crisis.

Gastrointestinal disorders: nausea, vomiting, ischaemic bowel infarction.

Musculoskeletal and connective tissue disorders: rhabdomyolysis.

Renal and urinary disorders: acute renal failure, difficulty in micturition.

Triprolidine

Overdosage of an H1 receptor antagonist may result in CNS depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures, or dysrhythmias. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures.

Management

The treatment of overdosage is likely to be symptomatic and supportive. Necessary measures should be taken to maintain and support respiration and control convulsions. Catheterisation of the bladder may be necessary.

Alpha-adrenergic blockade may be required to treat hypertensive crises and beta-adrenergic blockade for the control of supra-ventricular dysrhythmias.

If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

3 years.

Do not store above 25°C.

Store in the original container. Keep the bottle tightly closed.

100 ml amber glass bottles with metal roll on closures or HDPE screw caps. Each cap type containing PVDC-lined wads or polyethylene/expanded polyethylene laminated wad.

100 ml amber glass bottles with a 3 piece plastic, child resistant, tamper evident closure fitted with a PVDC faced wad or polyethylene/expanded polyethylene laminated wad.

Not all pack sizes may be marketed.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.