Metoclopramide hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Metoclopramide Actavis. 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 Metoclopramide Actavis 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 Metoclopramide Actavis is used for
In adults over 20 years this medicine 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.
- 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.
- help with passing tubes into the intestine.
In young adults between 15 to 20 years this medicines is used to and only used as a second line therapy:
- 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.
This medicine 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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
Before you take Metoclopramide Actavis
When you must not take it
Do not take Metoclopramide Actavis 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 take Metoclopramide Actavis if you have any of the following:
- 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).
- have epilepsy (fits or seizures).
- 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 or your child 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
- asthma
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start taking Metoclopramide Actavis.
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 Actavis may interfere with each other. These include:
- tranquilizers or anti-anxiety medications.
- strong pain relievers (e.g. codeine or morphine)
- sedatives or sleeping medication
- atropine-like medications (e.g. some cold preparations, travel sickness medicines)
- tetracycline antibiotics, paracetamol, levodopa
- digoxin.
These medicines may be affected by Metoclopramide Actavis 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 Metoclopramide Actavis
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
Follow your doctor’s instructions about how much Metoclopramide Actavis to use. The dose of Metoclopramide Actavis varies with the age of the patient and with the reason for use.
The total daily dosage of Metoclopramide Actavis, especially for children and young adults, should not normally exceed 0.5mg/kg bodyweight with a maximum of 30mg per day. Space the doses as evenly as possible throughout the day. The maximum length of treatment should be no longer than 5 days.
Tablets
20 + years – Maximum of One 10 mg tablet every 8 hrs
15 to 20 years – One 5 mg to 10 mg tablet every 8 hrs
Tablets should not be used in children less than 15 years of age. Young adults are very sensitive to the effects of Metoclopramide Actavis. Your doctor will normally start treatment at the lower dose.
How to take it
Tablets:
Swallow the tablets with a full glass of water. The tablets can be broken in half (along the breakline).
When to take it
Take the 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
Continue taking the medicine for as long as your doctor tells you.
If you forget to take it
Take it as soon as you remember, and then go back to taking the medicine as you would normally.
Do not take a double dose to make up for the dose that was missed. This may increase the chance of 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 (Australia 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 Metoclopramide Actavis. 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.
While you are using Metoclopramide Actavis
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 Metoclopramide Actavis.
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 while taking this medicine, tell your doctor immediately.
Things you must not do
Do not use Metoclopramide Actavis 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.
Things to be careful of
Be careful driving or operating machinery until you know how Metoclopramide Actavis 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.
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 taking Metoclopramide Actavis. This medicine may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
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 or pharmacist if you notice any of the following and they worry you:
- drowsiness, tiredness
- restlessness
- dizziness, headache
- bowel irregularities
- insomnia
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
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.
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- allergic reaction including fainting, swelling of limbs, face, lips, mouth or throat which may cause difficulty swallowing or breathing.
- 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.
- tardive dyskinesia, uncontrollable twitching or jerking movements of the arms and legs.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.
After taking Metoclopramide Actavis
Storage
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 25ºC.
Do not store Metoclopramide Actavis 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 it where children cannot reach it. A locked cupboard at least one and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
- Metoclopramide Actavis 10 mg tablets are white to off-white, circular, biconvex film-coated tablets with breakline on both sides.
- Metoclopramide Actavis 5 mg tablets are white to off-white, circular, biconvex film-coated tablets plain on both sides.
Ingredients
Metoclopramide Actavis 10 mg tablets contain 10 mg of metoclopramide and the 5 mg tablets contain 5 mg of metoclopramide as the active ingredient.
It also contains:
- Maize Starch
- Pregelatinised maize Starch
- Microcrystalline Cellulose
- Colloidal anhydrous Silica
- Steric acid
- Hypromellose
- Macrogol 6000
- Titanium dioxide
- Purified Talc
Metoclopramide Actavis preparations do not contain sucrose, gluten, tartrazine or any other azo dyes.
Supplier
Actavis Pty Ltd
Level 5, 117 Harrington Street
The Rocks NSW 2000
For further information call 1800 554 414.
Australian Registration Numbers
- METOCLOPRAMIDE ACTAVIS 5 mg –
AUST R 196484 - METOCLOPRAMIDE ACTAVIS 10 mg –
AUST R 196508
This leaflet was prepared in April 2015.
Published by MIMS August 2015