gemfibrozil 600 mg tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions about Lipazil tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Lipazil tablets against the benefits the medicine is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What LIPAZIL tablets are used for
Lipazil tablets contain gemfibrozil. Gemfibrozil is used to treat abnormal levels of cholesterol and triglyceride.
The exact way that gemfibrozil works is unclear, however, it is thought to reduce the amount of triglyceride made in the body.
Gemfibrozil belongs to a class of medicines called fibrates.
Gemfibrozil does not reduce the cholesterol that enters your body through food. Therefore, when you are taking Lipazil tablets, you also need to follow a low fat diet and other measures such as exercise and weight control.
Lipazil is only available with a doctor’s prescription.
Your doctor will have explained why you are being treated with Lipazil. Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Your doctor may have prescribed Lipazil for another reason. Ask your doctor if you have any questions about why Lipazil has been prescribed for you.
Before you take LIPAZIL tablets
When you must not take Lipazil:
Do not take Lipazil if:
- You have ever had an allergic reaction to:
– Lipazil or any other medicine containing gemfibrozil(e.g. Lopid™, Jezil™, Ausgem™).
– Any other medicines containing fibrate derivates such as fenofibrate.
– Any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include: skin rash, itching, difficulty breathing.
- You are taking repaglinide (Novonorm™) used to treat diabetes.
- You are pregnant or breast feeding.
Your baby may absorb this medicine in the womb or from your breast milk.
There is the possibility that this medicine may harm your baby.
- You have severe liver disease
- You have severe kidney disease
- You have severe gallstones or gall bladder disease
- The expiry date (EXP) on the pack has passed. If you take this medicine after the date has passed, it may have no effect at all or worse, an entirely unexpected effect.
- The packaging is torn or shows signs of tampering.
Do not take Lipazil to treat any other complaints unless your doctor has instructed you to do so.
Do not give Lipazil to children. There is not enough information to recommend the use of Lipazil in children.
Before you start to take Lipazil:
You must tell your doctor if:
- You are allergic to any other medicines or other substances such as foods, dyes or preservatives.
- You intend to become pregnant or breastfeed.
Lipazil should not be used during pregnancy or breastfeeding.
- You have or have ever had any other health problems, including:
- liver problems
- kidney problems
- gall stones or gall bladder disease
- a thyroid condition
- muscle pain, tenderness or weakness from other medicines
It may not be safe to take Lipazil if you have any of these medical conditions.
- You are taking any other medicines.
These include medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Lipazil. These include:
- Medicines used to thin the blood such as warfarin. Your doctor may need to adjust the amount of blood thinning medication.
- Other fibrate medicines such as fenofibrate (Lipidil™).
- Other medicines used to treat abnormal cholesterol or high triglycerides.
These medicines may be affected by Lipazil or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor or pharmacist has a complete list of medicines to avoid while you are taking Lipazil.
Tell your doctor about any of these things before you begin to take Lipazil.
How to take LIPAZIL tablets
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 bottle, consult your doctor or pharmacist.
How to take Lipazil
Swallow the prescribed dose of Lipazil tablets whole with a glass of water. Do not crush or chew the tablets.
The tablets are best taken on an empty stomach half an hour before food.
Taking the tablets on an empty stomach ensures the medicine is absorbed faster. However, if you find that taking Lipazil tablets on an empty stomach makes you feel unwell, you may take them with food.
How long to take LIPAZIL
Lipazil helps to regulate your levels of cholesterol (both LDL and HDL) and triglycerides. It does not cure your condition. You must continue to take Lipazil as directed by your doctor to keep your levels in control. You may have to take a medicine of this type for the rest of your life.
If you forget to take it
If you miss a dose of Lipazil and it is more than 6 hours before your next dose is due, take the missed dose immediately. If it is less than 6 hours before your next dose, skip the missed dose and take your following dose at the normal time.
Do not try to make up for missed doses by taking more than one dose at a time. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to the casualty department at your nearest hospital, if you think that you or anyone else may have taken too many Lipazil tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers of these places/services handy.
While you are taking LIPAZIL tablets
Things you must do
Have your cholesterol and triglyceride levels checked regularly as advised by your doctor.
Tell your doctor immediately if you are pregnant or nursing while taking Lipazil. If you become pregnant while taking Lipazil, contact your doctor immediately and stop taking the medicine.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Lipazil, especially if you have just started taking any new medications.
Things you must not do
Do not give this medicine to anyone else even if their condition seems similar to yours. Do not use Lipazil to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful of driving or operating machinery until you know how Lipazil affects you. Lipazil tablets do not normally cause any problems with your ability to drive a car or operate machinery, however, as with all medicines, Lipazil may cause dizziness in some people.
Check with your doctor or pharmacist as soon as possible if you have any problems while you are taking Lipazil tablets, even if you do not think that the problems are connected with the medicine or are not listed in this leaflet. Lipazil helps most people with cholesterol and triglyceride problems, however, like all medicines, Lipazil can cause side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
While you are taking LIPAZIL
Tell your doctor if you notice any of the following and they worry you.
These are the more frequent side effects of Lipazil:
- heart burn
- stomach or abdominal (belly) pain.
- nausea (feeling sick)
- skin rash
- constipation or diarrhoea
- dizziness, tiredness or headache
- change in taste
- decreased libido
Tell your doctor immediately, or go to the nearest casualty at your local hospital, if you notice any of the following:
- severe pain or discomfort in your belly, burping and wind, indigestion or feeling sick, especially after eating fatty food.
- painful, weak or tender muscles
- signs of anaemia, such as tiredness, being short of breath and looking pale
- swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing (dysphagia) and breathing
- signs of infection such as fever, chills, sore throat or mouth ulcers.
These are serious, but rare, side effects and should not be neglected. You may need urgent medical attention.
Some people may experience other side effects while taking Lipazil. Tell your doctor if you notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
There is no evidence that Lipazil is addictive, however, you should not stop taking Lipazil without your doctor’s permission.
After taking LIPAZIL tablets
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 as well.
Keep Lipazil tablets in a cool dry place where the temperature stays below 30 °C.
Do not store Lipazil tablets or any other medicine in the bathroom, near a sink or near a stove.
Do not leave Lipazil tablets in the car or on a windowsill. Heat and dampness can destroy some medicines.
Keep Lipazil tablets where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Tell your doctor if you have stopped taking the tablets or if the tablets have passed their expiry date. Ask your pharmacist what to do with any tablets that are left over.
What LIPAZIL tablets look like
White, film-coated, biconvex oval shaped tablet with “600”, a breakline and “dp” engraved on one face, the other blank, 9.2mm in diameter, 19mm in length.
Lipazil 600mg tablets are available as bottles of 60 tablets.
Other ingredients (excipients):
Pre-gelatinised maize starch, colloidal anhydrous silica, hydroxypropylcellulose, polysorbate 80, microcrystalline cellulose and calcium stearate.
Hypromellose, macrogol 400, indigo carmine aluminium lake CI 73150 and titanium dioxide.
Lipazil tablets do not contain gluten, lactose or sucrose.
AUST R 62742
Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne VIC 3205
Date of most recent amendment:
Published by MIMS March 2014