Consumer medicine information

1. Why am I using APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1mg/1mL oral liquid?

APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid contains the active ingredient Promethazine hydrochloride. APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid is used to treat a number of conditions: allergies - allergic contact dermatitis, hives, hayfever, bites and stings; respiratory symptoms due to allergies - runny nose; nausea and vomiting - motion sickness; sedation - for short-term use under the advice of a pharmacist or doctor.
For more information, see Section 1. Why am I using APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid? in the full CMI.

2. What should I know before I use APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?

Do not use if you have ever had an allergic reaction to APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1mg/1mL oral liquid or any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1mg/1mL oral liquid?

• Dosage varies according to the condition being treated and the individual's response.

• This product must not be used in children under 6 years of age.

5. What should I know while using APOHEALTH Children's Antihistamine Promethazine Hydrochloride 1 mg/1 mL oral liquid?

6. Are there any side effects?

Side effects of promethazine associated with cholinergic blockage include dryness of the eyes, mouth and nose, blurred vision, urinary hesitancy and retention, constipation and tachycardia.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Promethazine hydrochloride.

2 Qualitative and Quantitative Composition

APOHealth Children's Antihistamine promethazine hydrochloride oral liquid contains promethazine hydrochloride 5 mg/5 mL.
Excipients with known effect: maltitol liquid, sodium benzoate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sugar free, alcohol free clear, golden syrupy solution containing orange flavour.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, reversible intellectual disability and cognition deficit in children less than 6 years of age. Convulsions may occur in both adults and children: coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. The chief sign of acute poisoning from ingestion of an overdose of APOHealth Children's Antihistamine promethazine hydrochloride 1 mg/1 mL oral liquid is unconsciousness, which is commonly delayed. In addition, convulsions, hallucinations, delirium, acute anxiety, psychotic reactions, extreme hyperaesthesia and hyperalgesia with extensor plantar responses may occur. Anticholinergic action may cause tachycardia, flushed skin, dry mouth and sometimes mydriasis and urinary retention.
In adults, CNS depression is more common, with drowsiness, coma, convulsions, progressing to respiratory failure or cardiovascular collapse.
High doses can cause ventricular arrhythmias including QT prolongation and torsade de pointes (see Section 4.8 Adverse Effects (Undesirable Effects)).
In infants and children, CNS stimulation predominates over CNS depression causing ataxia, excitement, tremors, psychoses, hallucinations, convulsions and possibly hyperpyrexia, which may be followed by deepening coma and cardiorespiratory collapse.
Treatment. Similar to that of other phenothiazines. In the event of overdose of promethazine, take all appropriate measures immediately. For information on the management of overdose, contact the Poisons Information Centre (in Australia call 13 11 26).
Symptomatic supportive therapy is indicated and maintenance of adequate ventilation should be instituted if necessary.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Promethazine hydrochloride is a white or faintly yellow, practically odourless, crystalline powder. It is very soluble in water, freely soluble in alcohol and in chloroform, and practically insoluble in ether.
Chemical structure. Promethazine hydrochloride has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPROHYD.gif CAS number. 58-33-3.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (Schedule 3).

Summary Table of Changes

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