Consumer medicine information

1. Why am I using APO-Prochlorperazine?

APO-Prochlorperazine contains the active ingredient prochlorperazine. APO-Prochlorperazine is used to treat nausea, vomiting and dizziness due to various causes, including migraine (severe headache). For more information, see Section 1. Why am I using APO-Prochlorperazine? in the full CMI.

2. What should I know before I use APO-Prochlorperazine?

Do not use if you have ever had an allergic reaction to APO-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 APO-Prochlorperazine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-Prochlorperazine 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 APO-Prochlorperazine?

• For adults, the usual recommended dose for nausea and vomiting is 1 or 2 tablets two to three times daily. The usual recommended dose for dizziness is 1 or 2 tablets three to four times daily.

5. What should I know while using APO-Prochlorperazine?

6. Are there any side effects?

Less serious side effects include constipation, dry mouth, drowsiness, restlessness, trembling, rigid posture, mask-like face, slow movements and a shuffling unbalanced walk, uncontrollable twitching, jerking or writhing movements, blurred vision, and low blood pressure. Serious side effects include unusual muscle tone or spasms causing distortion of the body in children, a sudden increase in body temperature, extremely high blood pressure and severe convulsions, shortness of breath, wheezing, difficulty in breathing or swallowing, swelling of the face, lips, tongue or other parts of the body, and a rash, itching or hives on the skin. If you experience any of these serious side effects, go straight to the Emergency Department at your nearest hospital. 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 5 mg prochlorperazine maleate as the active ingredient.
Excipients with known effect. Contains sugars as lactose.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APO-Prochlorperazine 5 mg tablets. APO-Prochlorperazine 5 mg tablets are white to off-white, circular, uncoated tablets with '5' embossed on one side and are intended for oral administration.

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, possible with sudden apnoea. There is no information available regarding lethal dose in man.
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. 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 Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

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

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Prochlorperazine maleate contains 62% of the active base. It is an odourless, nonhygroscopic 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.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPROMAL.gif Chemical name: 2 chloro-10-(3-(4-methyl piperazinyl)-propyl) phenothiazine.
Molecular weight: 606.2.
Molecular formula: C₂₀H₂₄ClN₃S.2C₄H₄O₄.
CAS number. 84-02-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/APOPCLST.gif