Pramin

contains the active ingredient metoclopramide hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Pramin.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

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

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

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

What Pramin is used for

Pramin is used to control nausea and vomiting associated with:

• other medicines
• kidney disease
• radiation or chemotherapy treatment
• cancer
• childbirth
• infectious diseases
• surgery.

Pramin is also used in the management of certain stomach problems associated with diabetes.

This medicine 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 small intestine.

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.

Pramin is not recommended for use in children under the age of 20 unless your doctor tells you otherwise. This is because they are at a greater risk of experiencing side effects.

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

There is no evidence that Pramin is addictive.

Before you take Pramin

When you must not take it

Do not take Pramin if you are allergic to medicines containing metoclopramide hydrochloride or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take Pramin if you:

• have phaeochromocytoma - a rare tumour of the adrenal glands which sit near the kidneys
• have epilepsy (fits or convulsions)
• are bleeding from the stomach or intestine
• have a blockage or perforation of the digestive tract
• have had recent surgery on the stomach and/or digestive tract
• are taking medicines likely to cause extrapyramidal effects, such as antipsychotics. This reaction may include trembling and a sudden onset of uncontrollable muscle spasms affecting the eyes, head, neck and body.

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, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of taking this medicine during pregnancy.

Tell your doctor if you are breastfeeding or wish 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.

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

• breast cancer
• kidney problems
• liver problems
• Parkinson's disease - a condition affecting muscle control and movement
• depression
• high blood pressure.

Your doctor may want to take special care if you have any of these conditions.

Tell your doctor if you plan to have surgery. Pramin should not be taken immediately after certain types of operations.

If you have not told your doctor about any of the above, tell him/her before you start taking Pramin.

Taking other medicines

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

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

• certain medicines used to treat mental disorders, including lithium, thioridazine
• pain relievers such as codeine, morphine and paracetamol
• a group of medicines used to prevent travel sickness and for stomach cramps
• medicines used to relieve anxiety, to help you sleep
• levodopa, a medicine used in the treatment of Parkinson's disease
• digoxin, a medicine used to treat heart failure
• tetracycline, an antibiotic
• cyclosporin, a medicine used to help prevent organ transplant rejection
• monoamine oxidase inhibitors, a group of medicines used to treat depression.

These medicines may be affected by Pramin 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 Pramin

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

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

How much to take

The usual dose is 10 mg (one tablet) three times a day (every 8 hours).

Your doctor may advise you to take a different dose. This depends on your condition and whether or not you are taking any other medicines.

Patients with liver or kidney problems may need smaller doses.

How to take it

Swallow the tablets with a full glass of water.

When to take it

Pramin is best taken 30 minutes before symptoms are likely to occur or 30 minutes before each meal. Space the doses of Pramin evenly throughout the day.

Your doctor may tell you to take Pramin only when required for each occasion of nausea or vomiting.

If you forget to take it

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 tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

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

How long to take it for

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

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 you or anyone else may have taken too much Pramin. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much Pramin, you may experience drowsiness, dizziness, agitation, nausea, vomiting, and unusual movements, such as trembling and shaking of the hands and feet, and uncontrolled movements of the tongue, mouth or jaw.

While you are taking Pramin

Things you must do

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

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

If your symptoms do not improve or if they become worse, tell your doctor.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you plan to have surgery, including dental surgery, tell your surgeon, anaesthetist or dentist that you are taking Pramin.

If you need to have any liver function tests or other tests, tell your doctor. Pramin may affect the results of some tests.

Things you must not do

Do not use Pramin 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.

Things to be careful of

Be careful driving or operating machinery until you know how Pramin affects you. Pramin may cause drowsiness, dizziness or lightheadedness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Avoid drinking alcohol while taking Pramin. Combining Pramin and alcohol can make you more sleepy.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Pramin. Like all other medicines, Pramin may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age, you may have an increased chance of getting 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
• fatigue, tiredness
• anxiety, restlessness, agitation
• trouble sleeping
• diarrhoea, constipation
• headache, dizziness
• breast enlargement, unusual secretion of breast milk.

The above list includes the more common or mild side effects of Pramin.

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

• yellowing of the skin or eyes
• fast or irregular heart beat
• swelling of hands, ankles or feet.

The above list includes serious side effects which may require medical attention. Serious side effects are rare.

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

• uncontrolled and repeated movements of the face, jaw or tongue, arms or legs. This may be a sign of tardive dyskinesia, a movement disorder which can be potentially irreversible.
• trembling of the hands or legs, shuffling walk
• symptoms of an allergic reaction such as, skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath
• a sudden increase in body temperature, extremely high blood pressure, stiff muscles and severe convulsions. These could be signs of a serious side effect called neuroleptic malignant syndrome.

These are rare yet serious side effects and may need urgent medical attention.

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 patients.

After taking Pramin

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30 degrees C.

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

Keep Pramin 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

Pramin is a round white tablet marked "ME" over "10" on one side and "G" on the reverse.

Each bottle contains 25 tablets.

Ingredients

The active ingredient in Pramin is metoclopramide hydrochloride. Each Pramin tablet contains 10 mg of metoclopramide hydrochloride.

The tablets also contain:

• lactose anhydrous
• starch - pregelatinised maize
• cellulose - microcrystalline
• silica - colloidal anhydrous
• magnesium stearate.

The tablets are gluten free.

Manufacturer

Pramin is made in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037
Phone: (02) 9298 3999

www.alphapharm.com.au

Medical Information
Phone: 1800 028 365

Australian registration number:
Pramin - Aust R 17661

This leaflet was prepared on
30 April 2009.

Published by MIMS/myDr July 2009

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