Contains the active ingredient, gemfibrozil (gem-FI-broe-zil)
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 . It does not contain all the information that is known about . 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 Chemmart Gemfibrozil is used for
This medicine is used to help reduce high blood levels of cholesterol and triglycerides. It should be used in conjunction with a low fat diet.
Gemfibrozil belongs to a group of medicines known as fibric acid derivatives.
How it works
Cholesterol is a type of fat that is a normal and important substance in your body. It is used to build cell walls, and to make bile acids and hormones. Your body usually makes cholesterol in the liver, but it also comes from food. If the body does not balance the amount of cholesterol it needs with the amount of cholesterol eaten, then your cholesterol level becomes abnormal.
There are different types of cholesterol. LDL cholesterol is "bad" cholesterol that can block your blood vessels. HDL cholesterol is the "good" cholesterol that is thought to remove the bad cholesterol from the blood vessels. Blocking of the blood vessels by "bad" cholesterol can lead to several types of heart and blood vessel disease, heart attack, angina and stroke.
Triglycerides are another type of fat present in the blood and are used as a source of energy. High levels of triglycerides can be associated with a low level of "good" cholesterol and may increase your risk of heart disease.
The exact way in which gemfibrozil works is not known, but it is thought to decrease the amount of triglycerides made by the body. In most patients, gemfibrozil reduces the "bad" cholesterol and triglycerides and can actually raise the "good" cholesterol.
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.
This medicine is not addictive.
It is available only with a doctor's prescription.
Use in children
The safety and effectiveness of gemfibrozil tablets in children have not been established and it should therefore not be used in children.
Before you take Chemmart Gemfibrozil tablets
When you must not take it
Do not take gemfibrozil if you have an allergy to:
any medicine containing gemfibrozil
any ingredients listed at the end of this leaflet
any other similar medicines (such as clofibrate)
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 this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine.
There is a possibility that gemfibrozil may pass into breast milk and that your baby may be affected.
Do not take gemfibrozil if you have or have had any of the following medical conditions:
kidney or liver disease
gall bladder disease
type I hyperlipoproteinaemia (a specific type of blood fats disorder).
Do not take gemfibrozil if you are currently taking:
cerivastatin (a medicine to treat high blood cholesterol levels)
repaglinide (a medicine used to treat diabetes)
any other similar medicines (such as clofibrate).
Do not give this medicine to a child unless directed by the child's doctor.
The safety and efficacy of gemfibrozil in children has not been established.
Do not take this medicine after the expiry date (EXP) 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 gemfibrozil, talk to your doctor.
Before you start taking 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:
diabetes
heart disease
thyroid problems
muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides.
If you have not told your doctor about any of the above, tell him/her before you start taking gemfibrozil.
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 gemfibrozil interfere with each other. These include:
medicines which thin your blood, such as warfarin or aspirin
other medicines to treat high cholesterol or triglyceride levels such as colestipol, atorvastatin, fluvastatin, lovastatin, pravastatin, simvastatin or cerivastatin, or fenofibrate.
Some medicines may be affected by gemfibrozil, or may affect how well it works. You may need different amounts of your medicines, or 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 Chemmart Gemfibrozil
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 bottle, ask your doctor or pharmacist for help.
How much to take
The normal dose of gemfibrozil is one 600 mg tablet taken in the morning and in the evening.
How to take it
Swallow the tablets whole with a full glass of water.
These tablets should not be crushed or chewed.
When to take it
Take your medicine on an empty stomach, for example half an hour before food or 2 hours after food.
Food can interfere with the absorption of this medicine. If taking gemfibrozil tablets on an empty stomach makes you feel unwell then you may take them with food.
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.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it.
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 it as soon as you remember and then go back to taking it 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 (Tel: 13 11 26 for Australia and Tel: 0800 764 766 for New Zealand)) 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 gemfibrozil.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include:
abdominal cramps
diarrhoea
joint and muscle pain
nausea or vomiting.
While you are taking it
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking gemfibrozil.
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 the surgery.
If you become pregnant while you are taking gemfibrozil, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may perform some tests such as cholesterol and triglyceride levels and other blood tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Speak to your doctor about taking other measures to control your cholesterol and triglyceride levels, such as following a low fat diet, exercise and other forms of weight control.
Gemfibrozil does not reduce the amount of cholesterol or other types of fat absorbed from food. Therefore, it is important to take other measures that will help regulate your cholesterol and triglyceride levels.
Things you must not do
Do not take gemfibrozil 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 gemfibrozil affects you.
Gemfibrozil may cause dizziness or light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery, or do anything else that could be dangerous.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking gemfibrozil.
This medicine helps most people with high cholesterol or triglyceride levels, but it 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 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:
mild abdominal (belly) pain or discomfort
heartburn, nausea or vomiting
headache
dizziness
constipation
changes in the sense of taste
reduction in libido
tingling in the hands or feet
blurred vision.
The above list includes the 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:
unusual tiredness
painful, weak or tender muscles
signs of frequent infections such as fever, chills, sore throat or mouth ulcers.
The above list includes serious side effects which 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:
signs of an allergic reaction such as 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
severe stomach or abdominal pain
yellowing of the skin and/or eyes, also called jaundice
rash with excessive peeling or shedding of skin
fast or irregular heartbeats, also called palpitations.
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. Some of these side effects can only be found when your doctor does tests from time to time to check your progress.
After using Chemmart Gemfibrozil tablets
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 25°C.
Do not store Chemmart Gemfibrozil or any 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.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
Product description
What it looks like
Chemmart Gemfibrozil tablets are white to off-white, oval, biconvex, film-coated tablet. Engraved APO & 034 with bisect score on one side, 600 on the other side.
Each bottle contains 60 tablets.
Ingredients
Chemmart Gemfibrozil contains 600 mg of gemfibrozil as the active ingredient.
It also contains the following inactive ingredients:
methylcellulose
croscarmellose sodium
anhydrous colloidal silica
magnesium stearate
hypromellose
hydroxypropylcellulose
macrogol 8000
titanium dioxide.
This medicine does not contain gluten, lactose, sucrose, tartrazine or other azo dyes.
Australian Registration Number
Chemmart Gemfibrozil Tablets:
AUST R 73848
Sponsor
Apotex Pty Ltd
66 Waterloo Road
North Ryde NSW 2113
Australia
Distributor
Symbion Pharmacy Services Pty Ltd
48-58 Overseas Drive
Noble Park North VIC 3174
Australia
Chemmart is a registered trade mark of Symbion Pharmacy Services Pty Ltd.
This leaflet was prepared in:
May 2010
