Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What this medicine is used for

The name of your medicine is APO-Metoclopramide. It contains the active ingredient metoclopramide hydrochloride (as monohydrate).

Metoclopramide works 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.

In adults over 20 years old metoclopramide is used:

• to treat nausea and vomiting caused by infectious diseases, kidney disease, child birth, 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 to 20 years old this medicine is used when other therapies haven't worked to:

• treat severe vomiting of known cause or following chemotherapy or radiation treatment
• help with passing tubes into the intestine.

These tablets should not be used for children under 15 years of age.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

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

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:

• any medicine containing metoclopramide
• any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

Do not give this medicine to a child under the age of 15 years. Safety and effectiveness in children younger than 15 years have not been established.

Do not take this medicine if you have any of the following medical conditions:

• 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
• phaeochromocytoma (an adrenaline - producing tumour of the adrenal gland)
• epilepsy (fits or seizures)
• porphyria (a rare blood pigment disorder)

Do not take this medicine if you take other medication such as antipsychotic/neuroleptic medication and certain antidepressants that can cause movement disorders (extrapyramidal reactions).

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• Parkinson’s disease
• liver or kidney problems
• high blood pressure
• depression.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

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

Some medicines and metoclopramide may interfere with each other. These include:

• tranquilizers or anti-anxiety medications
• strong pain relievers (e.g. codeine or morphine)
• phenothiazines, used to treat mental and emotional disorders
• sedatives or sleeping medication
• atropine-like medications (e.g. some cold preparations, relief of stomach cramps or spasms, travel sickness)
• tetracycline antibiotics
• paracetamol
• levodopa
• digoxin
• cyclosporin used to help prevent organ transplant rejection or to treat certain problems with the immune system

These medicines may be affected by metoclopramide or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your age and your condition and whether you are taking any other medicines.

The total daily dosage of metoclopramide, especially for young adults, should not normally exceed 0.5 mg/kg bodyweight (maximum 30 mg daily).

Space the doses as evenly as possible throughout the day.

20 + years
10 mg every 8 hours.

15 to 20 years (second line)
5 mg to 10 mg every 8 hours.

Young adults are very sensitive to the effects of this medicine.

Your doctor will normally start treatment at the lower dose.

Tablets should not be used in children less than 15 years of age.

Elderly patients are very sensitive to the effects of this medicine.

Do not exceed the prescribed dose, and where prolonged therapy is necessary, patients should be regularly reviewed.

How to take it

Swallow the tablets with a full glass of water.

The 10 mg tablets can be broken in half (along the break line).

When to take it

Take your medicine 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.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

Maximum treatment duration is 5 days.

If you forget to take it

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

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

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

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

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include drowsiness, confusion, tremor, twitching or uncontrolled spasm of muscles, feelings of anxiety or restlessness, headache, vertigo, nausea, vomiting, constipation, weakness, low blood pressure and dry mouth.

While you are taking this medicine

Things you must do

If your vomiting or nausea persists, tell your doctor.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all your doctor's appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take this medicine 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 as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Things to be careful of

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.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, it may make you sleepy.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following:

• drowsiness, tiredness
• restlessness
• dizziness or headache
• bowel irregularities
• insomnia
• anxiety
• agitation

Tell your doctor as soon as possible if you notice any of the following:

• 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 - this may be a sign of tardive dyskinesia, a movement disorder which can be potentially irreversible
• fast heartbeat
• increasing number of infections
• elevated temperature with no clear cause
• breast enlargement or milk secretions
• depression
• urinary incontinence and frequency

These may be serious side effects and you may need medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• sudden uncontrolled muscle spasm, stiffness of the arms or legs, muscle spasm of the face, locked-jaw or upturned eyes
• shuffling walk, slowing of all movement, muscle tremor
• neuroleptic malignant syndrome, a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions
• yellowing of the skin (jaundice)
• symptoms of an allergic reaction including cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin

These are very serious side effects and you may need urgent medical attention or hospitalisation.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

Other side effects not listed above may occur in some patients.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot see or reach it. A locked cupboard at least one-anda-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Metoclopramide Tablets look like

10 mg tablets:
APO-Metoclopramide 10 mg tablets are white to off-white, circular, biconvex film-coated tablets with break line on both sides. AUST R 196502.

Available in blister packs of 25 and 100.

Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 10 mg of metoclopramide hydrochloride (as monohydrate) as the active ingredient.

It also contains the following inactive ingredients:

• maize starch
• pregelatinised maize starch
• microcrystalline cellulose
• colloidal anhydrous silica
• stearic acid
• hypromellose
• macrogol 6000
• titanium dioxide
• purified talc

This medicine is gluten-free, lactosefree, sucrose-free, tartrazine-free and free of other azo dyes.

Sponsor

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia
Tel: 1800 195 055
Web: www.arrotex.com.au

This leaflet was last updated in January 2024

Published by MIMS March 2024

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

4.1 Therapeutic Indications

Adults (20 years and over).

Young adults.

4.2 Dose and Method of Administration

Metoclopramide injection is unavailable in this brand, however this formulation is available in other brands. Information obtained from this formulation is included in the PI for prescriber information.
Where correct dosing requires this formulation, refer to the specific product information for these formulations for complete dosage and administration instructions.

Patients with normal renal and hepatic function.

Medical indications.

20 years and over.

15-20 years.

Diagnostic indications.

20 years and over.

15-19 years.

Patients with impaired renal and hepatic function.

4.3 Contraindications

Metoclopramide should not be used in the following situations.
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 may increase the frequency and severity of seizures;
patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of extrapyramidal reactions may be increased;
metoclopramide tablets should not be used in children below 15 years of age.

4.4 Special Warnings and Precautions for Use

Persistent tardive dyskinesia.

Dystonic reactions.

Neuroleptic malignant syndrome (NMS).

Prolactin levels.

Other.

Use in hepatic impairment.

Use in 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

Patients should be cautioned about engaging in activities requiring mental alertness for a few hours after the drug has been administered.

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).
A single instance of supraventricular tachycardia following intramuscular administration has been reported. There have been very rare (less than 1 in 10,000) cases of abnormalities of cardiac conduction (such as bradycardia and heart block) in association with intravenous metoclopramide. Atrial fibrillation (AF), oedema, tachycardia and palpitations have been associated with the use of metoclopramide. This event is in association with intravenous administration of other brands.
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. 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 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.
There have been a few cases of neutropenia, leucopenia and agranulocytosis generally without clear cut relationship to metoclopramide.
Methaemoglobinaemia has also been reported.
Sulfhaemoglobinaemia in adults.
Hyperthermia has also been observed.
Raised serum prolactin levels have been observed during metoclopramide therapy; this effect is similar to that noted with many other compounds. Galactorrhoea and breast enlargement have also been observed during metoclopramide 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, when metoclopramide was administered with other drugs with known hepatotoxic potential, cases of hepatotoxicity characterised by such findings as jaundice and altered liver function tests were reported.

Reporting suspected adverse effects.

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 A-V 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

5.1 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

Microcrystalline cellulose, colloidal anhydrous silica, maize starch, stearic acid, pregelatinised maize starch, hypromellose, macrogol 6000, titanium dioxide, 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

Tablets should be stored below 25°C. Protect from light.

6.5 Nature and Contents of Container

10 mg film coated tablets (AUST R 196502).

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