Lopid (Gemfibrozil) Drug / Medicine Information

Gemfibrozil

Consumer Medicine Information

What LOPID is used for

LOPID helps to lower high triglycerides, cholesterol and other fats.

Everyone has cholesterol in their blood. It's a type of blood fat needed by the body for things such as building cell walls, making bile acids (which help to digest food) and some hormones. However, too much cholesterol can be a problem.

Cholesterol is present in many foods and is also made in your body by the liver. If your body does not balance the amount of cholesterol it needs with the amount of cholesterol eaten, then your cholesterol levels become too high.

High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.

There are different types of cholesterol. LDL cholesterol is the "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.

When you have high levels of "bad" cholesterol it may "stick" to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard areas, called plaque, on the walls of your blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to several types of heart and blood vessel disease, heart attack, angina and stroke.

There is another type of blood fat called triglyceride which is a source of energy. High levels of triglyceride can be associated with a low level of "good" cholesterol and may increase your risk of heart disease.

In most patients, LOPID reduces the bad cholesterol and triglyceride and can actually raise the good cholesterol.

LOPID does not reduce the cholesterol that comes from fat in food.

Therefore, when you are taking LOPID, you also need to follow a low fat diet and other measures, such as exercise and weight control.

In most people, there are no symptoms of high triglyceride or cholesterol levels. Your doctor can measure your levels with a simple blood test.

How LOPID works

The exact way in which LOPID works is not known, but it is thought to reduce the amount of triglycerides made in the body.

LOPID belongs to a group of medicines known as fibric acid derivatives.

Your doctor will have explained why you are being treated with LOPID.

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 LOPID for another reason.

Ask your doctor if you have any questions about why LOPID has been prescribed for you.

There is not enough information to recommend the use of Lopid in children.

LOPID is not addictive.

Before you take LOPID

Do not take it if you:

have an allergy to LOPID or any other medicine containing gemfibrozil, 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, difficulty breathing.

are pregnant, think of getting pregnant

are breast-feeding

Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby.

are taking medicine to treat diabetes such as repaglinide or rosiglitazone

have severe liver disease

have severe kidney disease

have gallstones or gallbladder disease

experienced an increased sensitivity to the sun while taking a medicine called fibrates, a type of medicine used to prevent heart disease.

Symptoms of photosensitivity are sunburn (redness, itching, swelling and blistering of your skin) much quicker than normal.

Do not take LOPID if the packaging is torn or shows signs of tampering

If the product is past the expiry date or damaged, return it to your pharmacist.

If you take this medicine after the expiry date has passed, it may not work or it may make you unwell.

Talk to your doctor if you are not sure whether you should start taking LOPID.

Before you start to take it

You must tell your doctor if:

1. you are pregnant, intend to become pregnant or plan to breast feed

LOPID should not be used during pregnancy or while breast-feeding,

2. you have any other health problems / medical conditions, including:

liver problems

kidney problems

gall stones or gall bladder problems

diabetes

a thyroid condition

muscle pain, tenderness or weakness from other medicines used to treat triglycerides or cholesterol.

3. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

4. to monitor your lipid levels while taking LOPID. Remind your doctor to periodically conduct blood tests for you.

Taking other medicines

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

Some medicines may interfere with LOPID. These include:

medicines which thin your blood, such as warfarin. Your doctor may need to adjust the amount of blood thinning medication

other medicines to treat high triglycerides or cholesterol. Your doctor may choose not to use LOPID together with other prescription medicines for cholesterol lowering

medicines used to treat diabetes such as repaglinide or rosiglitazones.

These medicines may be affected by LOPID or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking LOPID.

Tell your doctor about any of the above before you take LOPID.

How to take LOPID

Use LOPID only when prescribed by your doctor.

LOPID has been prescribed for you by your doctor for a very specific purpose.

Follow all directions given to you by your doctor and pharmacist carefully.

These directions may differ from the information contained in this leaflet.

Ask your doctor or pharmacist for help if you do not understand the instructions on the bottle.

How much to take

The normal dose of LOPID is one 600 mg tablet twice a day.

How and when to take it

Swallow LOPID with a glass of water or other liquid. Do not crush or chew the tablets.

Take one tablet in the morning and one in evening.

The tablets are best taken on an empty stomach, half an hour before food. Taking the tablets half an hour before food means the medicine is absorbed faster into your body. If taking the tablets on an empty stomach makes you feel unwell, you may take them with food.

How long to take it

You may have to take this kind of medicine for the rest of your life.

LOPID helps to regulate your levels of triglycerides and cholesterol. It does not cure your condition. Therefore you must continue to take it as directed by your doctor if you expect to keep your levels controlled. If you stop taking LOPID, your levels may become abnormal again.

If you forget to take it

If you forget to take a dose, take it as soon as you remember, as long as it is more than 6 hours before your next dose.

If it is less than 6 hours before your next dose, skip the dose you missed. Take your following dose at the normal time.

Talk to your doctor or pharmacist if you are not sure whether to skip the dose or if you have trouble remembering when to take your medicine.

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

If you take too much (overdose)

Immediately telephone your Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much LOPID. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers of these places handy.

While you are using LOPID

Things you must do

Have your triglyceride and cholesterol levels checked when your doctor says to make sure that LOPID is working.

Tell your doctor and pharmacist that you are taking LOPID if you are about to start on any new medicine.

Tell your doctor if you are pregnant, a nursing mother, or thinking about becoming pregnant. If you become pregnant while taking LOPID, stop taking LOPID and contact your doctor immediately.

Things you must not do

Do not give LOPID to anyone else, even if they have the same condition as you.

Do not use LOPID to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how LOPID affects you.

LOPID generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, LOPID may cause dizziness in some people.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LOPID.

LOPID helps most people with high cholesterol and triglyceride problems, but 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.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

These are mild but more frequent side effects of LOPID.

heartburn

stomach and abdominal (belly) pain

nausea (feeling sick) and vomiting

skin rash

constipation or diarrhoea

dizziness, tiredness and headache

change in taste

depression

decreased libido

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

These are serious but rare, side effects. You may need urgent medical attention.

swelling of the face, lips, mouth throat or neck which may cause difficulty in swallowing and breathing

painful, weak or tender muscles

temporary paralysis or weakness of muscles

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.

intense and sudden pain in the upper right part of the abdomen, recurrent painful attacks for several hours after meals, abdominal bloating (inflammation of the gall bladder)

liver problems can also occur and may be serious. Your doctor may do blood tests to check your liver.

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 (for example, changes in white blood cells, low blood platelet count) can only be found when your doctor does tests from time to time to check your progress.

Do not be alarmed by this list of side effects. You may not experience any of them.

After Using LOPID

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 your tablets or any other medicine in the bathroom or near a sink.

Do not leave your tablets in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep your tablets where young children cannot reach them.

A locked cupboard at least one and a half metres off the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking LOPID, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Further information

This is not all the information that is available on LOPID. If you have any more questions or are not sure about anything, ask your doctor or pharmacist.

Product Description

What it looks like

LOPID tablets are white oval-shaped tablets, marked with "PD-737" on one side.

LOPID tablets come in bottles of 60.

Ingredients

Active Ingredients

The active ingredient of LOPID is gemfibrozil. Each LOPID tablet contains 600 mg of gemfibrozil.

Inactive Ingredients

The inactive ingredients:

colloidal anhydrous silica

pregelatinized maize starch

calcium stearate

microcrystalline cellulose

hydroxypropylcellulose

polysorbate 80

hypromellose

macrogol 3350

methyl hydroxybenzoate

propyl hydroxybenzoate

opaspray white

candelilla wax

LOPID tablets do not contain gluten.

Manufacturer

LOPID is supplied in Australia by:

Pfizer Australia Pty Limited

38-42 Wharf Road

WEST RYDE NSW 2114

Tel: 1800 675 229

Australian Registration Number

AUST R 57053

This leaflet was prepared in October 2009

* Registered trademark of Pfizer