Contains the active ingredient gemfibrozil (gem-FI-broe-zil)
Consumer Medicine Information
For a copy of a large print leaflet, Ph: 1800 195 055
What is in this leaflet
This leaflet answers some common questions about GenRx Gemfibrozil. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist.
The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.
Ask your doctor or pharmacist:
- if there is anything you do not understand in this leaflet,
- if you are worried about taking your medicine, or
- to obtain the most up-to-date information.
You can also download the most up to date leaflet from www.apotex.com.au.
All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with the medicine. You may need to read it again.
What this medicine is used for
The name of your medicine is GenRx Gemfibrozil.
It contains the active ingredient gemfibrozil.
It is used to treat:
- high triglycerides and cholesterol levels.
It should be used in conjunction with a low fat diet.
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.
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.
This medicine is not addictive.
It is available only with a doctor’s prescription.
Use in children
This medicine should not be used in children. The safety and effectiveness of gemfibrozil tablets in children have not been established.
Before you take this medicine
Do not take this medicine if:
- You have or have had any of the following:
– liver disease
– severe kidney disease
– gall bladder or biliary tract disease
– type I hyperlipoproteinaemia (a specific type of blood fats disorder)
– sensitivity to the sun while taking gemfibrozil or any other fibrates (similar medicines such as clofibrate.
- You are pregnant.
Gemfibrozil may affect your developing baby if you take it during pregnancy.
- You are breastfeeding.
Gemfibrozil may pass into human breast milk.
- You are currently taking:
– repaglinide (a medicine used to treat diabetes)
- You are hypersensitive to, or have had an allergic reaction to, gemfibrozil or 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; 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.
- The expiry date (EXP) printed on the pack has passed.
- The packaging is torn, shows signs of tampering or it does not look quite right.
Before you start taking it
Before you start taking this medicine, tell your doctor if:
- You have allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes.
- You have or have had any medical conditions, especially the following:
- liver problems
- kidney problems
- gall stones or gall bladder problems
- heart disease
- thyroid problems
- personal or family history of muscular disorders
- muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides
- alcohol abuse.
- You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant.
- You are currently breastfeeding or you plan to breast-feed. Do not take this medicine whilst breastfeeding.
- You are planning to have surgery or an anaesthetic.
- You are currently receiving or are planning to receive dental treatment.
- 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 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, simvastatin, lovastatin, pravastatin and rosuvastatin.
- medicines used to treat diabetes such as repaglinide or rosiglitazones.
- bexarotene a medicine used to treat cancer. If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with gemfibrozil.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take this medicine
Follow all directions given to you by your doctor.
They may differ from the information contained in this leaflet.
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
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
The tablets are best taken on an empty stomach, half an hour before food. Food can interfere with the absorption of this medicine.
However, 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.
Make sure you have enough to last over weekends and holidays.
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 experiencing side effects.
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)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor, or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to Accident and Emergency at the nearest hospital.
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
- joint and muscle pain
- nausea or vomiting.
While you are taking this medicine
Things you must do
Tell your doctor that you are taking 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 breast-feed
- you are about to have any blood tests
- you are going to have surgery or an anaesthetic or are going into hospital.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Things you must not do
- Give this medicine to anyone else, even if their symptoms seem similar to yours.
- Take your medicine to treat any other condition unless your doctor tells you to.
- Stop taking your medicine, or change the dosage, without first checking with your doctor.
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.
Possible Side effects
Tell your doctor as soon as possible if you do not feel well while you are taking gemfibrozil or if you have any questions or concerns.
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.
Mostly, these are mild:
- mild abdominal (belly) pain or discomfort
- heartburn, nausea or vomiting
- headache, dizziness or tiredness
- constipation or diarrhoea
- changes in the sense of taste
- reduction in libido
- tingling in the hands or feet
- blurred vision
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to Accident and Emergency at your nearest hospital:
- painful, weak or tender muscles
- temporary paralysis or weakness of muscles
- signs of frequent infections such as fever, chills, sore throat or mouth ulcers
- signs of kidney disease such as passing little or no urine
- signs of anaemia, such as tiredness, being short of breath and looking pale
- signs of frequent infections such as fever, chills, sore throat or mouth ulcers
- tingling in the hands or feet.
- 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.
These are very serious side effects and you may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to gemfibrozil, do not take any more of this medicine and 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
- hay fever-like symptoms.
Storage and disposal
Keep your tablets in the original packaging until it is time to take it. If you take the tablets out of the original packaging they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store your 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.
If your doctor tells you to stop taking this medicine or the expiry date has passed, your pharmacist can dispose of the medicine safely.
What it GenRx Gemfibrozil looks like
GenRx 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.
Available in bottles of 60 tablets.
GenRx Gemfibrozil contains 600 mg of gemfibrozil as the active ingredient.
It also contains the following inactive ingredients:
- croscarmellose sodium
- anhydrous colloidal silica
- magnesium stearate
- macrogol 8000
- titanium dioxide.
This medicine does not contain gluten, lactose, sucrose, tartrazine or other azo dyes.
Australian Registration Number
- GenRx Gemfibrozil tablets:
AUST R 73850
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
GenRx is a registered trade mark of Apotex Pty Ltd.
This leaflet was prepared in November 2012.
Published by MIMS April 2013