Consumer medicine information

1. Why am I using APOHEALTH Nausea Relief?

APOHEALTH Nausea Relief contains the active ingredient prochlorperazine. APOHEALTH Nausea Relief is used to treat nausea associated with migraine (severe headache). For more information, see Section 1. Why am I using APOHEALTH Nausea Relief? in the full CMI.

2. What should I know before I use APOHEALTH Nausea Relief?

Do not use if you have ever had an allergic reaction to prochlorperazine or any of the ingredients listed at the end of the CMI.
Talk to your doctor 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 Nausea Relief? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APOHEALTH Nausea Relief 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 Nausea Relief?

• Your doctor or pharmacist will tell you how much APOHEALTH Nausea Relief you will need to take each day.

• The usual recommended dose for nausea associated with migraine is 1 or 2 tablets two to three times a day.

5. What should I know while using APOHEALTH Nausea Relief?

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking APOHEALTH Nausea Relief. Some common side effects include constipation, dry mouth, drowsiness, trembling, rigid posture, twitching and blurry vision.
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

Prochlorperazine maleate.

2 Qualitative and Quantitative Composition

Each tablet contains the active ingredient prochlorperazine maleate 5 mg and are intended for oral administration.
Ingredient with known effects. Contain sugars (as lactose).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

5 mg tablet. White to off-white, circular, uncoated tablet with '5' debossed on one side (AUST R 186540).

4 Clinical Particulars

4.9 Overdose

Symptoms. Overdosage with phenothiazines may cause CNS depression progressing from drowsiness to coma with areflexia. Patients with early or mild intoxication may experience restlessness, confusion and excitement. Other symptoms include hypotension, tachycardia, hypothermia, pupillary constriction, restlessness, tremor, muscle twitching, spasm or rigidity, convulsions, muscular hypotonia, difficulty in swallowing or breathing, cyanosis, and respiratory and/or vasomotor collapse, possibly with sudden apnoea. There is no information available regarding lethal dose in humans.
High doses cause depression of the central nervous system, presenting as lethargy, dysarthria, ataxia, stupor, reduction in consciousness into coma, convulsions; mydriasis; cardiovascular symptoms (related to risk of QT interval prolongation), such as hypotension, ventricular tachycardia and arrhythmia; respiratory depression; hypothermia. These effects may be potentiated by other medicines or by alcohol. Anticholinergic syndrome is of importance. Extremely serious parkinsonian syndrome may occur.
Treatment. In the event of overdose of prochlorperazine, take all appropriate measures immediately.
1. Acute dystonic reactions. Intramuscular benztropine (or another antiparkinsonian agent) should be given immediately (adults: 1 to 2 mg i.m.; children: 0.2 mg i.m. initially with increments if necessary).
2. Overdosage. Emesis should not be induced, not only because the antiemetic action of prochlorperazine prevents the effect of the emetic agent, but also because the sedative and extrapyramidal side effects increase the risk of pulmonary aspiration should vomiting occur. Management is generally supportive with particular attention to the possibility of obstructed ventilation, severe hypotension, hypothermia, cardiac arrhythmias, convulsions and prolonged deep sedation. Acute dystonic reactions usually occur early (if at all); treatment is with anticholinergic agents, as above.
Adrenaline must not be used as it may cause a paradoxical further lowering of blood pressure.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

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

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPROMAL.gif Chemical name: 2-chloro-10-[3-(4-methylpiperazin-1-yl)propyl]-10H-phenothiazine bis[hydrogen (Z)-butenedioate].
Chemical properties: Prochlorperazine maleate contains 62% of the active base prochlorperazine. It is an odourless, non-hydroscopic, white or almost white, fine granular powder, which becomes coloured on exposure to light. It is sparingly soluble (about 0.1%) in water, ethanol or methanol and is insoluble in ether or chloroform.
Molecular formula: C₂₀H₂₄ClN₃S.2C₄H₄O₄.
Molecular weight: 373.943 (anhydrous); 606.09 (maleate salt).
CAS number. 84-02-6.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes

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