Consumer medicine information

Emexlon 10 mg Tablets

Metoclopramide hydrochloride

BRAND INFORMATION

Brand name

Emexlon

Active ingredient

Metoclopramide hydrochloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Emexlon 10 mg Tablets.

1. Why am I using EMEXLON?


EMEXLON contains the active ingredient metoclopramide hydrochloride. EMEXLON is used to treat nausea and vomiting.
For more information, see Section 1. Why am I using EMEXLON? in the full CMI.

2. What should I know before I use EMEXLON?


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

3. What if I am taking other medicines?


Some medicines may interfere with EMEXLON 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 EMEXLON?

  • Adults 20 years and over: take 1 tablet every 8 hours.
  • Adolescents: 15 to 19 years: take ½ to 1 tablet every 8 hours.

More instructions can be found in Section 4. How do I use EMEXLON? in the full CMI.

5. What should I know while using EMEXLON?

Things you should do
  • Remind any doctor, dentist, or pharmacist you visit that you are using EMEXLON.
  • Tell your doctor if nausea and vomiting persist.
  • Tell your doctor if you become pregnant while taking EMEXLON.
  • If you are going to have surgery, tell the surgeon or anaesthetist that you are taking EMEXLON.
Things you should not do
  • Do not exceed the recommended dose.
Driving or using machines
  • Be careful driving or operating machinery until you know how EMEXLON affects you.
  • This medicine may cause dizziness, light-headedness, tiredness or drowsiness in some people.
Drinking alcohol
  • Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, it may make you sleepy.
Looking after your medicine
  • Keep your medicine in the pack until it is time to take it. If you take the tablets out of the pack, they may not keep well.
  • Keep your tablets in a cool dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using EMEXLON? in the full CMI.

6. Are there any side effects?


The common side effects include drowsiness, tiredness, restlessness, dizziness, headache, bowel irregularities, insomnia, anxiety and agitation.
Serious side effects include uncontrolled or repeated movements, (e.g., sucking or smacking of the lips, darting of the tongue, chewing movements, uncontrolled movements of the arms or legs), fast heartbeat, depression, or swelling of hands, ankles, or feet.
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.

BRAND INFORMATION

Brand name

Emexlon

Active ingredient

Metoclopramide hydrochloride

Schedule

S4

 

1 Name of Medicine

Metoclopramide hydrochloride monohydrate.

2 Qualitative and Quantitative Composition

Emexlon film coated tablets come in two strengths and contain either 5 mg or 10 mg of metoclopramide hydrochloride (as monohydrate).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Emexlon film coated tablets containing metoclopramide hydrochloride (as monohydrate) 10 mg are white to off-white, circular, biconvex film-coated tablets with breakline on both sides.
Emexlon film coated tablets containing metoclopramide hydrochloride (as monohydrate) 5 mg are white to off-white, circular, biconvex film-coated tablets plain on both sides.

4 Clinical Particulars

4.9 Overdose

Overdose of metoclopramide hydrochloride (as monohydrate) 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 hydrochloride (as monohydrate) overdose have included feelings of anxiety or restlessness, headache, vertigo, nausea, vomiting, constipation, weakness, hypotension and xerostomia. Haemodialysis appears ineffective in removing metoclopramide hydrochloride (as monohydrate). Similarly, continuous ambulatory peritoneal dialysis does not remove significant amounts of the drug.
For information on the management of overdose, contact the Poisons 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. Chemical name: N-(diethyl-aminoethyl)-2-methoxy-4-amino-5-chlorbenzamide monohydrochloride monohydrate.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMETMON.gif Molecular 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/EMEXLOST.gif