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Granisetron Apotex

Contains the active ingredient granisetron
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Granisetron Apotex. It does not contain all the information that is known about Granisetron Apotex. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is Granisetron APOTEX Solution for injection. It contains the active ingredient granisetron.
Granisetron is given to stop you feeling sick (nauseous) or being sick (vomiting). It is especially useful when you need to have medical treatment that may cause you to feel or be sick, for example, chemotherapy, radiotherapy or surgery.
Granisetron belongs to a group of medicines called anti-emetics.
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.
There is no evidence that this medicine is addictive.

Before you are given this medicine

When you must not be given it

You must not be given this medicine if:
You are hypersensitive to, or have had an allergic reaction to, granisetron or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: 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; fainting; or hay fever-like symptoms.
If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

Before you are given it

Before you are given this medicine, tell your doctor if:

1. You have allergies to:

any other medicines
any other ingredients listed at the end of this leaflet.

2. You have or have had any medical conditions, especially the following:

You have severe constipation.
You have been given granisetron before, and you became unwell.
You may need to be given another medicine instead.
You have a heart condition related to changes in the rhythm or rate of your heart beat.

3. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

4. You are currently breastfeeding or you plan to breastfeed. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.

5. You are planning to have surgery or an anaesthetic.

6. You are currently receiving or are planning to receive dental treatment.

7. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with granisetron. These include:
Phenobarbitone, a medicine used to treat epilepsy.
Phenobarbitone may be affected by granisetron or may affect how well granisetron works. You may need different amounts of your medicine, or you may need to take a different medicine.
Other medicines not listed above may also interact with granisetron.

How this medicine is given

How much is given

Your doctor will decide what dose of this medicine you will receive. This will depend on your condition and other factors, such as your weight and whether you are taking any other medicines.

How it is given

Granisetron injection is given as a fast or slow injection into a vein (intravenous 'drip'). It must only be given by a nurse or doctor.

If you take too much (overdose)

As granisetron is given to you in a hospital under the supervision of your doctor, it is very unlikely that you will receive an overdose.
However, if you experience severe side effects tell your doctor immediately.
Symptoms of an overdose may include the side effects listed below in the 'Possible side effects' section but are usually of a more severe nature.
Ask your doctor if you have any concerns.

While you are being given this medicine

Things you must do

Tell any doctor or nurse that you have been given this medicine if:
you are about to be started on any new medicine
you are pregnant or are planning to become pregnant
you are breastfeeding or are planning to breastfeed
you are about to have any blood tests
you are going to have surgery or an anaesthetic.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

Things you must not do

Do not:
Do not take any other medicines, whether they require a prescription or not, without first telling your doctor.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you.
Be careful when drinking alcohol while you are being given granisetron.
Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you drink while you are being given granisetron.
If you drink alcohol, dizziness or light-headedness may be worse.

Possible side effects

Tell your doctor as soon as possible if you do not feel well when you are given granisetron or if you have any questions or concerns.
This medicine helps most people with nausea and vomiting, but it may have unwanted side effects in a few people.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor if you notice any of the following:
headache
unusual tiredness or weakness
dizziness or light-headedness
drowsiness
constipation
agitation
nervousness
difficulty in sleeping
abdominal pain
diarrhoea
altered taste
fever
skin rash
increase in blood pressure.
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
chest pain
changes in your heart beat
severe dizziness or fainting
symptoms of an allergic reaction, such as shortness of breath, wheezing or difficulty breathing; swelling of face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Allergic reactions

If you think you are having an allergic reaction to granisetron, tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
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
fainting
hay fever-like symptoms.

Storage and disposal

Storage

Granisetron solution for injection will be stored in the pharmacy or on the ward. The ampoules are kept in a cool dry place, protected from light where the temperature stays below 25°C.

Disposal

Granisetron solution for injection is used for one dose in one patient only. Any remaining contents should be discarded.

Product description

What Granisetron APOTEX solution for injection looks like

Granisetron is a clear solution for injection in a glass ampoule.
Granisetron ampoules come in pack size of 5 ampoules.

Ingredients

It also contains the following inactive ingredients:
sodium chloride 0.9% in water for injections
citric acid monohydrate
sodium hydroxide
hydrochloric acid
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

Granisetron APOTEX 1mg/1mL solution for injection (Ampoule) : AUST R 217089.
Granisetron APOTEX 3mg/3mL solution for injection (Ampoule) : AUST R 217092.
* Not all strengths may be available.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was last updated in January 2015.