Consumer medicine information

1. Why am I using APO-Metoclopramide?

APO-Metoclopramide contains the active ingredient metoclopramide hydrochloride (as monohydrate). APO-Metoclopramide is used to treat nausea and vomiting caused by infectious diseases, kidney disease, childbirth, other medications, cancer, or following surgery, chemotherapy, or radiation treatment.
For more information, see Section 1. Why am I using APO-Metoclopramide? in the full CMI.

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

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

3. What if I am taking other medicines?

Some medicines may interfere with APO-Metoclopramide 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-Metoclopramide?

• APO-Metoclopramide should be used at about same time each day.

• Taking it at same time each day will have the best effect. It will also help you remember when to take it.

• Take the medicine 30 minutes before a meal.

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

6. Are there any side effects?

Common side effects include drowsiness, tiredness, restlessness dizziness or headache, bowel irregularities, insomnia, anxiety and agitation.
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

Metoclopramide hydrochloride monohydrate.

2 Qualitative and Quantitative Composition

Each Metoclopramide film coated tablet contains 10 mg metoclopramide hydrochloride (as monohydrate) as the active ingredient.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White to off-white, circular, biconvex film-coated tablets with breakline on both sides.

4 Clinical Particulars

4.9 Overdose

Overdose of metoclopramide may be expected to produce effects that are extensions of common adverse reactions: drowsiness, disorientation and extrapyramidal side effects. Very rarely AV block has been observed. Management of overdosage consists of close observation and supportive therapy. Antiparkinson and antihistamine/ anticholinergic drugs such as diphenhydramine hydrochloride have effectively controlled extrapyramidal reactions. Other reported effects associated with metoclopramide overdose have included feelings of anxiety or restlessness, headache, vertigo, nausea, vomiting, constipation, weakness, hypotension and xerostomia. Haemodialysis appears ineffective in removing metoclopramide. Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of the drug.
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/CSMETMON.gif Chemical name: N-(diethyl-aminoethyl)-2-methoxy-4-amino-5-chlorbenzamide monohydrochloride monohydrate.
Chemical formula: C₁₄H₂₂ClN₃O₂, HCl, H₂O.
Molecular weight: 354.3.
CAS number. 54143-57-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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