SUMMARY CMI

EMEXLON

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using EMEXLON?

EMEXLON contains the active ingredient metoclopramide hydrochloride. EMEXLON is used to treat nausea, and vomiting caused by infectious diseases, migraine kidney disease, childbirth, other medications, cancer, or following surgery, chemotherapy or radiation treatment, to activate stomach contractions in conditions where there is a need to encourage normal passage of food through the stomach and intestines.

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?

• The total daily dosage of metoclopramide hydrochloride (as monohydrate), especially for children and young adults, should not normally exceed 0.5mg/kg bodyweight or 30mg daily.
• Swallow the tablets with a glass full of water.

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?

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, 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.

FULL CMI

EMEXLON

Active ingredient(s): metoclopramide hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using EMEXLON. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using EMEXLON.

Where to find information in this leaflet:

1. Why am I using EMEXLON?
2. What should I know before I use EMEXLON?
3. What if I am taking other medicines?
4. How do I use EMEXLON?
5. What should I know while using EMEXLON?
6. Are there any side effects?
7. Product details

1. Why am I using EMEXLON?

EMEXLON contains the active ingredient metoclopramide hydrochloride. EMEXLON is acts by blocking the action of a chemical in the brain which causes nausea and vomiting. It also acts in the stomach and upper intestine to increase muscle contractions.

EMEXLON is used in adults over 20 years to treat nausea, and vomiting caused by infectious diseases, migraine kidney disease, childbirth, other medications, cancer, or following surgery, chemotherapy or radiation treatment, to activate stomach contractions in conditions where there is a need to encourage normal passage of food through the stomach and intestines, with X-rays to help diagnose problems of the stomach and/or intestines, to help with passing tubes into the intestine.

In young adults between 15 15 to 20 years EMEXLON is used to treat severe vomiting of known cause or following chemotherapy or radiation treatment and help with passing tubes.

2. What should I know before I use EMEXLON?

Warnings

Do not use EMEXLON if:

• you are allergic to metoclopramide hydrochloride, or any of the ingredients listed at the end of this leaflet.
• Some of the symptoms of allergic reaction include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, togue or other parts of the body, rash, itching or hives on the skin..
• Always check the ingredients to make sure you can use this medicine.
• Active bleeding from the stomach and/or digestive tract.
• Blockage of the stomach and/or digestive tract
• Recent surgery of the stomach and/or digestive tract
• pheochromocytoma (an adrenaline-producing tumour of the adrenal gland)
• epilepsy (fits or seizures)
• take other medication such as antipsychotic/neuroleptic medication and certain antidepressants that can cause movement disorders (extrapyramidal reactions).

Check with your doctor if you:

• have any other medical condition like Parkinson's disease, liver or kidney problem, high blood pressure, asthma.
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with EMEXLON and affect how it works.

• Tranquilizers or anti-anxiety medications
• Strong pain killers (e.g., codeine or morphine)
• Sedatives or sleeping medication.
• Atropine-like medication (e.g., some cold preparations, travel sickness medicines)
• Tetracycline antibiotics, paracetamol, levodopa
• digoxin

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect EMEXLON.

4. How do I use EMEXLON?

How much to take / use

• The dose of Emexlon varies with the age of the patient and with the reason for use.
• The total daily dosage of metoclopramide hydrochloride (as monohydrate), especially for children and young adults, should not normally exceed 0.5mg/kg bodyweight or 30mg daily.
• Space the doses as evenly as possible throughout the day.
• Tablets:
  20 years and over – One tablet (10mg) every 8 hours
  15-20 years – ½ to 1 tablet (5mg to 10mg) every 8 hours

Swallow the tablets with a glass full of water
The tablets can be broken in half (along the break line)
Do not exceed the prescribed dose.

When to take / use EMEXLON

• EMEXLON should be used at about the same time each day. Taking it at the 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 meals.
• Continue taking the medicine for as long as your doctor tells you.

If you forget to use EMEXLON

EMEXLON should be used regularly at the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

If you miss your dose at the usual time, take it as soon as you remember it, and then go back to taking this medicine as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed. This may increase the chance of getting unwanted side effects.

If you are not sure what to do, ask your doctor of pharmacist.

If you have trouble remembering your medicine

If you use too much EMEXLON

If you think that you have used too much Emexlon, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using EMEXLON?

Things you should do

Call your doctor straight away if you:

• If vomiting or nausea persists, tell your doctor
• If you are about to be started on any new medicines, remind your doctor and pharmacist that you are taking Emexlon.
• Tell any other doctor, dentists, and pharmacists who treat you hat you are taking this medicine.
• If you are going to have surgery, tell the surgeons or anesthetists that you are taking this medicine. It may affect other medicines used during surgery.
• If you become pregnant while taking this medicine, tell your doctor immediately.

Remind any doctor, dentist or pharmacist you visit that you are using EMEXLON.

Things you should not do

• Do not stop use EMEXLON to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else, eveN if they have the same condition.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how EMEXLON affects you.

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. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when riding bicycles or climbing trees.

Drinking alcohol

Tell your doctor if you drink 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.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What EMEXLON contains

Emexlon tablets do not contain sucrose, gluten, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What EMEXLON looks like

EMEXLON tablets are white to off-white, circular, biconvex, film-coated tablets with a break line on both sides.

Emexlon tablets are available in a blister pack of 25 tablets or a bottle of 100 tablets.

Emexlon 10 mg blister pack – AUST R 229659

Emexlon 10 mg bottle – AUST R 268301

Who distributes EMEXLON

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia

This leaflet was prepared in January 2024.

Published by MIMS March 2024

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

4.1 Therapeutic Indications

Adults (20 years and over).

Young adults and children over 1 year of age.

4.2 Dose and Method of Administration

Patients with normal renal and hepatic function.

Medical indications: oral.

Young adults: 15-20 years.

Children: 5-14 years.

3-5 years.

1-3 years.

Diagnostic indications.

15-19 years.

9-14 years.

5-9 years.

3-5 years.

1-3 years.

Patients with impaired renal and hepatic function.

4.3 Contraindications

Metoclopramide hydrochloride (as monohydrate) should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g. in the presence of gastrointestinal haemorrhage, mechanical obstruction, or perforation.
Phaeochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumour. Such hypertensive crises may be controlled by phentolamine.
Known hypersensitivity or intolerance to the drug.
Porphyria.
Epilepsy, as metoclopramide hydrochloride (as monohydrate) may increase the frequency and severity of seizures.
Metoclopramide hydrochloride (as monohydrate) should not be administered to patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of extrapyramidal reactions may be increased.
Metoclopramide hydrochloride (as monohydrate) should not be used in children below 1 year of age.

4.4 Special Warnings and Precautions for Use

Persistent tardive dyskinesia.

Dystonic reactions.

Neuroleptic malignant syndrome.

Prolactin levels.

Other.

Use in hepatic/renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The effects of metoclopramide hydrochloride (as monohydrate) on gastrointestinal motility are antagonised by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide hydrochloride (as monohydrate) is given with alcohol, sedatives, hypnotics, narcotics or tranquillisers.
Since metoclopramide hydrochloride (as monohydrate) accelerates abnormally slow gastric and small bowel peristaltic activity, it may change absorption of orally administered drugs. The absorption of drugs from the small bowel may be accelerated (e.g. paracetamol, tetracycline, levodopa), whereas absorption of drugs from the stomach may be diminished (e.g. digoxin).

Compatibility.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

This medicine may cause drowsiness and dizziness which will effect a person's ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

The most frequent adverse reactions to metoclopramide hydrochloride (as monohydrate) are restlessness, drowsiness, fatigue and lassitude, which occur in approximately 10% of patients.
Less frequently, insomnia, headache, dizziness, nausea, or bowel disturbances may occur. Rare (less than 1 in 1,000) cases of acute depression have been reported. Anxiety or agitation may occur especially after rapid injection.
Although uncommon at normal dosage, various extrapyramidal reactions to metoclopramide hydrochloride (as monohydrate), usually of the dystonic type, have been reported. Reactions include: spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of the extraocular muscles including oculogyric crises, unnatural positioning of the head and shoulders and opisthotonos. There may be a generalised increase in muscle tone. The majority of reactions occur within 36 hours of starting treatment and the effects usually disappear within 24 hours of withdrawal of the drug, however, close observation is required and in cases of more severe reactions, an antiparkinson drug such as benztropine or an anticholinergic antihistamine such as diphenhydramine should be given. A fatal dystonic reaction has been reported in a patient who received hexamethylmelamine, cisplatin and high dose metoclopramide hydrochloride (as monohydrate). A fatal cardiorespiratory arrest has occurred in at least one patient with an acute dystonic reaction.
Tardive dyskinesia, which may be persistent, has been reported particularly in elderly patients undergoing long-term therapy with metoclopramide hydrochloride (as monohydrate).
Very rare (less than 1 in 10,000) occurrences of the Neuroleptic Malignant Syndrome have been reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of CPK and must be treated urgently (recognised treatments include dantrolene). Metoclopramide hydrochloride (as monohydrate) should be stopped immediately if this syndrome occurs.
Parkinsonian symptoms, including tremor, rigidity, bradykinesia and akinesia, occur rarely in patients receiving metoclopramide hydrochloride (as monohydrate) but may be associated with usual or excessive doses or with decreased renal function.
There have been isolated reports of hypersensitivity reactions (such as urticaria, maculopapular rash) in patients receiving metoclopramide hydrochloride (as monohydrate).
Methaemoglobinaemia has also been reported. There have been a few cases of neutropenia, leucopenia and agranulocytosis generally without clear cut relationship to metoclopramide hydrochloride (as monohydrate).
Sulfhaemoglobinaemia in adults.
Hyperthermia has also been observed.
Raised serum prolactin levels have been observed during metoclopramide hydrochloride (as monohydrate) therapy; this effect is similar to that noted with many other compounds. Galactorrhoea and breast enlargement have also been observed during metoclopramide hydrochloride (as monohydrate) therapy.
Respiratory failure, secondary to dystonic reaction, acute asthmatic symptoms of wheezing and dyspnoea may occur.
Urinary incontinence and frequency, sexual dysfunction, priapism and muscle spasm may also occur.
Rarely, cases of hepatotoxicity, characterised by such findings as jaundice and altered liver function tests, when metoclopramide hydrochloride (as monohydrate) was administered with other drugs with known hepatotoxic potential.

Reporting suspected adverse effects.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Emexlon contain the following excipients: cellulose microcrystalline, colloidal anhydrous silica, maize starch, stearic acid and pregelatinised maize starch. The coating for the tablets consists of hypromellose, macrogol 6000, titanium dioxide and purified talc.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf-life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Emexlon 10 mg and 5 mg tablets are packed in clear PVDC coated PVC/aluminium blister packs and are available in pack sizes of 10, 20, 25, 30, 50, 60, 100, 125 or 150 tablets*.
Emexlon 10 mg tablets are also available in HDPE bottle pack of 100's and 500's tablets*. The bottle of 100 tablets has a child resistant closure.
* (Not all strengths and pack sizes are marketed in Australia).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes