Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking PRAMIN?
PRAMIN contains the active ingredient metoclopramide hydrochloride. PRAMIN is used
to manage nausea and vomiting.
2. What should I know before I take PRAMIN?
Do not take if you are allergic to medicines containing metoclopramide hydrochloride
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.
3. What if I am taking other medicines?
Some medicines may interfere with PRAMIN and affect how it works.
4. How do I take PRAMIN?
Adults 20 years and over - 1 tablet every 8 hours.
Adolescents: 15 to 19 years - ½ to 1 tablet every 8 hours.
The dose varies with the age of the patient and reason for use. Children and adolescents
are very sensitive to the effects of PRAMIN. Your doctor will normally start the treatment
at the lower dose.
5. What should I know while taking PRAMIN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking PRAMIN.
Tell your doctor if nausea and vomiting persist.
Tell your doctor if you become pregnant while taking PRAMIN.
If you are going to have surgery, tell the surgeon or anaesthetist you are taking
PRAMIN.
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Things you should not do
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Do not exceed the recommended dose.
Do not give this medicine to anyone else, even if they have the same condition as
you.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how PRAMIN
affects you.
PRAMIN may cause dizziness, light-headedness, tiredness or drowsiness in some people.
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Drinking alcohol
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Drinking alcohol whilst taking PRAMIN may make you sleepy.
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Looking after your medicine
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Store in a cool dry place where the temperature stays below 30°C.
Keep your tablets in the original container until it is time to take them.
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6. Are there any side effects?
Less serious side effects include drowsiness, tiredness, restlessness, dizziness, headache, bowel irregularities,
insomnia, anxiety and agitation.
Some of the more 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 or irregular heartbeat, depression, and swelling of hands, ankles or feet.
Active ingredient(s):
metoclopramide hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking PRAMIN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking PRAMIN.
Where to find information in this leaflet:
1. Why am I taking PRAMIN?
PRAMIN contains the active ingredient metoclopramide hydrochloride. PRAMIN belongs to a group of medicines called anti-emetics and is thought to work
by blocking the action of a chemical in the brain which causes nausea and vomiting.
It also increases the muscle contractions in the stomach and upper intestine.
PRAMIN is used in adults 20 years and over to:
treat nausea and vomiting caused by infectious diseases, migraine, kidney disease,
childbirth, 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. E.g., certain stomach problems
associated with diabetes.
with X-rays to help diagnose problems of the stomach and/or intestines.
help with passing tubes into the intestine.
PRAMIN is used in young adults and children over 1 year of age to:
treat vomiting of known cause or following chemotherapy or radiation treatment.
help with passing tubes into the intestine.
2. What should I know before I take PRAMIN?
Warnings
Do not take PRAMIN if you:
are allergic to metoclopramide hydrochloride, or any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
wheezing or shortness of breath
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
rash, itching or hives on the skin
Always check the ingredients to make sure you can take this medicine.
have active bleeding from the stomach and/or digestive tract.
have a blockage of the stomach and/or digestive tract.
have had recent surgery of the stomach and/or digestive tract.
have phaeochromocytoma (an adrenaline producing tumour of the adrenal gland).
have epilepsy (fits or seizures).
take other medication likely to cause extrapyramidal effects, such as antipsychotic/neuroleptic
medication and certain antidepressants that can cause movement disorders. This reaction
may include trembling and a sudden onset of uncontrollable muscle spasms affecting
the eyes, head, neck and body.
Check with your doctor if you:
have any other medical conditions including:
Parkinson's disease - a condition affecting muscle control and movement
liver or kidney problems
high blood pressure
asthma
depression
breast cancer
take any medicines for any other condition
have allergies to any other medicines, foods, dyes or preservatives.
Your doctor may want to take special care if you have any of these conditions.
If you have not told your doctor about any of the above, tell him/her before you start
taking PRAMIN.
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.
Your doctor will discuss the risks and benefits of taking this medicine during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
PRAMIN passes into breast milk and can affect the flow of your breast milk. Your doctor
will discuss the risks and benefits of taking this medicine when breastfeeding.
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 and PRAMIN may interfere with each other. These include:
medicines used to help you sleep (tranquilisers) and/or to relieve anxiety
pain relievers (e.g., paracetamol, codeine or morphine)
sedatives or sleeping medication
atropine-like medications (e.g., some cold preparations, travel sickness medicines,
stomach cramp medicines)
tetracycline antibiotics,
levodopa, a medicine used in the treatment of Parkinson's disease
digoxin, a medicine used to treat heart failure
ciclosporin, a medicine used to help prevent organ transplant rejection
monoamine oxidase inhibitors, a group of medicines used to treat depression
certain medicines used to treat mental disorders, including lithium, thioridazine
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect PRAMIN.
4. How do I take PRAMIN?
How much to take
Follow all directions given to you by your doctor and pharmacist carefully. They may
differ from the information contained in this leaflet.
The dose of PRAMIN varies with the age of the patient and reason for use.
Do not exceed the prescribed dose.
Adults 20 years and over - 1 tablet every 8 hours.
Adolescents: 15 to 19 years - ½ to 1 tablet every 8 hours.
The daily dosage of PRAMIN, especially for children and adolescents, should not normally
exceed 0.5mg/kg bodyweight or 30 mg daily.
Children and adolescents are very sensitive to the effects of PRAMIN. Your doctor
will normally start the treatment at the lower dose. Do not exceed the prescribed
dose in these age groups.
If you are taking PRAMIN before a diagnostic procedure your doctor will give you your
dose.
This will usually be a single dose of 1-2 tablets depending on your age.
If you have significant kidney or liver impairment your doctor may prescribe a lower
dose.
When to take PRAMIN
PRAMIN is best taken 30 minutes before symptoms are likely to occur or 30 minutes
before meals. Space the doses of PRAMIN evenly throughout your day.
Your doctor may tell you to take PRAMIN only when required for each occasion of nausea
and vomiting.
How to take PRAMIN
Swallow the tablets with a full glass of water.
The tablets can be broken in half (along the break-line).
How long to take PRAMIN
Your doctor will advise you how long to take PRAMIN. The maximum recommended treatment
duration is 5 days.
If you forget to take PRAMIN
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking
your tablet as you would normally.
Do not take a double dose to make up for the dose you 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 take too much PRAMIN
If you think that you or anyone else has taken too much PRAMIN, urgent medical attention
may be needed.
Symptoms of an overdose may include drowsiness, confusion, dizziness, headache, agitation,
nausea, vomiting, constipation, tremor, twitching or uncontrolled spasm or muscles.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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 taking PRAMIN?
Things you should do
Call your doctor if:
nausea and vomiting persist.
you become pregnant while taking PRAMIN.
If you are going to have surgery, including dental surgery, tell the surgeon, anaesthetist
or dentist that you are taking PRAMIN.
It may affect other medicines used during the surgery.
If you have any liver function tests or other tests, tell your doctor.
PRAMIN may affect the results of some tests.
Remind any doctor, dentist or pharmacist you visit that you are taking PRAMIN.
Things you should not do
Do not use PRAMIN to treat any other conditions unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PRAMIN
affects you.
PRAMIN 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.
Combining PRAMIN and alcohol can make you sleepy.
Looking after your medicine
Keep your tablets in the original container until it is time to take them. If you
take the tablets out of the original container they may not keep well.
PRAMIN should be stored in a cool dry place below 30°C 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.
Heat or dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date or if the packaging is torn or shows
signs of tampering.
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
Very serious side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking PRAMIN even if you do not think that it is connected with the medicine.
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.
If you are over 65 years of age, you may have an increased chance of getting side
effects.
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.
There is no evidence that PRAMIN is addictive.
What PRAMIN contains
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Active ingredient
(main ingredient)
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metoclopramide hydrochloride 10mg (as hydrate)
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Other ingredients
(inactive ingredients)
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lactose anhydrous
pregelatinised maize starch
microcrystalline cellulose
colloidal anhydrous silica
magnesium stearate
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Potential allergens
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lactose
trace amounts of sulfites
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Do not take this medicine if you are allergic to any of these ingredients.
What PRAMIN looks like
PRAMIN is a white, normal convex tablet marked "ME" over "10" on one side and "G"
on the reverse (AUST R 364450).
Available in blister packs of 25 tablets.
Who distributes PRAMIN
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in June 2024.
PRAMIN_cmi\Jun24/00