SUMMARY CMI

AUSGEM

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using AUSGEM?

AUSGEM contains the active ingredient gemfibrozil. AUSGEM is used to used to help regulate cholesterol and triglycerides which are fat-like substances in the blood.

For more information, see Section 1. Why am I using AUSGEM? in the full CMI.

2. What should I know before I use AUSGEM?

Do not use if you have ever had an allergic reaction to gemfibrozil or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use AUSGEM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AUSGEM and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use AUSGEM?

• The usual dose of AUSGEM to regulate the fats in your blood is ONE tablet twice a day.
• The tablet should be taken with a glass of water half an hour before breakfast and half an hour before the evening meal.

More instructions can be found in Section 4. How do I use AUSGEM? in the full CMI.

5. What should I know while using AUSGEM?

For more information, see Section 5. What should I know while using AUSGEM? in the full CMI.

6. Are there any side effects?

Common side effects includes: • weakness, confusion, feeling depressed or sad, dizziness, sleepiness, aching muscles, muscle tenderness or weakness, not caused by exercise, painful, swollen joints, tiredness, headache, skin rash, change in taste, nausea and/or vomiting, heartburn, stomach pains, diarrhoea, constipation, blurred vision or eyesight, increase in the number of infections such as colds or bladder infections, decreased interest in sex or inability to have sexual intercourse, swelling with fluid in tissues, swelling around the neck. Serious side effects includes: increased feeling or sensitivity, especially on the skin, pinkish, itchy swellings on the skin, also called hives or nettle rash, yellowing of the skin and/or eyes, tingling or numbness in the hands or feet, spinning sensation, sudden onset of severe stomach pain in the lower right hand side of the stomach with tenderness or muscle tightness, signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers. Very serious side effects: signs of anaemia, such as tiredness, being short of breath, dizziness and looking pale, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing, sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

AUSGEM

Active ingredient(s): gemfibrozil

Consumer Medicine Information (CMI)

This leaflet provides important information about using AUSGEM. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using AUSGEM.

Where to find information in this leaflet:

1. Why am I using AUSGEM?
2. What should I know before I use AUSGEM?
3. What if I am taking other medicines?
4. How do I use AUSGEM?
5. What should I know while using AUSGEM?
6. Are there any side effects?
7. Product details

1. Why am I using AUSGEM?

AUSGEM contains the active ingredient gemfibrozil. AUSGEM belongs to group of medicines known as fibric acid derivatives.

AUSGEM is used to help regulate cholesterol and triglycerides which are fat-like substances in the blood.

Everyone has cholesterol in their blood. It is a type of blood fat needed by the body for many things, such as making bile acids (which help digest food) and some hormones. However, having too much cholesterol in the blood can contribute to the development of heart disease.

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 you obtain from your food, then your cholesterol becomes too high.

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

When you have high levels of cholesterol, this fat 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 a “plaque”) on the lining of your blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to heart disease (such as heart attack and angina), and stroke.

There are different types of cholesterol, called LDL and HDL. LDL cholesterol is the harmful or “bad” cholesterol that can block your blood vessels. HDL cholesterol is the beneficial or “good” cholesterol that is thought to remove the LDL (“bad”) cholesterol from the blood vessels.

High levels of triglycerides may also increase your risk of heart disease, as these fats can be associated with a low level of the beneficial or “good” cholesterol.

In most patients, AUSGEM reduces the bad cholesterol and increases the good cholesterol.

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

When you are taking AUSGEM, 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 cholesterol. Your doctor can measure your cholesterol with a simple blood test.

The exact way in which AUSGEM works is not known, but it is thought to work by reducing the amount of triglycerides made in the body.

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

2. What should I know before I use AUSGEM?

Warnings

Do not use AUSGEM if:

• you are allergic to gemfibrozil, or any of the ingredients listed at the end of this leaflet.
  Some of the symptoms of allergic reaction may include skin rash, itching or hives; shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body.
• you have severe liver disease
• you have severe kidney disease
• you have gall bladder disease
• you are pregnant or breast-feeding
• you have a lipid disorder called “type I hyperlipoproteinaemia”
• you have had muscle pain, tenderness or weakness from other medicines that treat high cholesterol or triglycerides.
• you are taking the drug cerivastatin (i.e. ‘Kazak’ or ‘Lipobay’).
• you are taking the drug repaglinide (i.e. ‘NovoNorm’).

This medicine is not suitable for children.

Check with your doctor if you:

• suffer from any other medical condition which your doctor does not know about, including thyroid problems or diabetes.
• take any medicines for any other condition.
  If you are taking medicines to “thin” the blood, the dose of these medicines may need to be adjusted. If you are taking another medication to lower the fats in your blood, you should tell your doctor, as AUSGEM may not be suitable with these medicines.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or breast-feed during the course of your treatment. Your baby may absorb this medicine in the womb or from breast milk and there is a possibility that this may be harmful to the baby.

3. What if I am taking other medicines?

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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect AUSGEM.

4. How do I use AUSGEM?

How much to take

• The usual dose of AUSGEM to regulate the fats in your blood is ONE tablet twice a day.
• Follow the instructions provided and use AUSGEM until your doctor tells you to stop.

When to take AUSGEM

• AUSGEM tablet should be taken with a glass of water half an hour before breakfast and half an hour before the evening meal.

If you forget to use AUSGEM

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

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

AUSGEM helps lower your cholesterol and triglyceride levels. It does not cure your condition. You must continue to take this medicine for as long as your doctor recommends.

If you stop taking your medication before your doctor tells you to, your cholesterol and triglyceride levels may rise again. Some people need to take medicines to lower their fat levels for the rest of their lives.

If you use too much AUSGEM

If you think that you have used too much AUSGEM, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much AUSGEM you may have the following symptoms: abdominal cramps, nausea, vomiting and diarrhoea.

5. What should I know while using AUSGEM?

Things you should do

• Follow all the directions given to you by your doctor carefully. Your doctor may have prescribed this medicine for another reason
• Remind any doctor, dentist or pharmacist you visit that you are using AUSGEM.

While you are taking it

Your doctor will ask you to have blood tests while you are taking AUSGEM. This is to check on a number of conditions including your fat levels. This is the way your doctor will know if the medicine is working for you.

The blood tests will also tell your doctor if AUSGEM is affecting your blood or liver. In some patients, this medication can affect your blood cells which may cause anaemia or make you more prone to infection. This medicine may also affect your liver.

Although these unwanted effects only occur in some patients and are generally temporary, it is important that you help your doctor check on your health by keeping these appointments.

Call your doctor straight away if you:

• If you become pregnant while you are taking AUSGEM

Things you should not do

• Do not give AUSGEM to anyone else, even if they have the same condition as you.
• Do not use it to treat any other complaints unless your doctor tells you to.
• Do not use AUSGEM if the packaging is torn or shows signs of tampering.
• Do not use this medicine if the expiry date on the pack has passed.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how AUSGEM affects you.

AUSGEM generally does not cause any problems with your ability to drive a car or operate machinery. However, as with any medicine, it may cause dizziness in some people.

Drinking alcohol

Avoid drinking large quantities of alcohol. Drinking large quantities of alcohol may increase the chance of AUSGEM causing you liver problems.

Looking after your medicine

• Keep your tablets in a cool dry place where the temperature stays below 30°C.
• Keep your tablets in the bottle until it is time to take them.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Very Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What AUSGEM contains

Do not take this medicine if you are allergic to any of these ingredients.

What AUSGEM looks like

AUSGEM is a white, oval, biconvex, film-coated tablet scoreline on one side and plain on the other. (Aust R 62099).

Who distributes AUSGEM

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
Australia
www.arrotex.com.au

This leaflet was prepared in September 2024.

Published by MIMS October 2024

1 Name of Medicine

Gemfibrozil.

2 Qualitative and Quantitative Composition

Ausgem tablets contain 600 mg of gemfibrozil.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ausgem tablets are white, oval, biconvex, film coated tablet with a scoreline on one side and plain on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Ausgem is indicated as an adjunct to diet and other therapeutic measures for the following conditions:
Severe hypertriglyceridaemia (types IV and V) in those who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Dyslipidaemia associated with diabetes.
Reduction of risk of coronary heart disease in patients with type IIa and IIb hypercholesterolaemia.
Because of potential toxicity such as malignancy, gallbladder disease, abdominal pain leading to appendectomy and other abdominal surgeries, an increased incidence in non-coronary mortality, and the 29% increase in all-cause mortality seen with the chemically and pharmacologically related drug, clofibrate, the potential benefits of gemfibrozil in treating type IIa patients with elevations of LDL-cholesterol only is not likely to outweigh the risks. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (> 1.2 mmol/L), both gemfibrozil and placebo subgroups had similar incidences of serious coronary events.

Note.

4.2 Dose and Method of Administration

The recommended dose for adults is 600 mg twice daily (total daily dose 1200 mg) administered half an hour before the morning and evening meals. The tablets should be taken whole without halving.
For patients who cannot tolerate gemfibrozil when given half an hour before food, Ausgem may be taken with food. The bioavailability of gemfibrozil is higher when administered half an hour before food.

4.3 Contraindications

Hepatic or severe renal dysfunction, including primary biliary cirrhosis.
Pre-existing gallbladder disease (see Section 4.4 Special Warnings and Precautions for Use).
Hypersensitivity to Ausgem.
Pregnant or lactating women.
Type I hyperlipoproteinaemia.
Concurrent use of cerivastatin, due to a risk of myopathy and rhabdomyolysis (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Concurrent use of repaglinide, due to a potentially serious pharmacokinetic interaction between repaglinide and gemfibrozil.

4.4 Special Warnings and Precautions for Use

Because of chemical, pharmacological and clinical similarities between gemfibrozil and clofibrate the adverse findings seen with clofibrate in two large clinical studies may also apply to gemfibrozil. The physician should be aware that in one of these studies, the Coronary Drug Project, 1000 subjects with previous myocardial infarction were treated for 5 years with clofibrate, there was no difference in mortality between the clofibrate-treated subjects and 3000 placebo-treated subjects. However, twice as many clofibrate-treated patients developed cholelithiasis and cholecystitis requiring surgery than the placebo patients. In the other study, conducted by the World Health Organisation (WHO), 5000 subjects without known coronary heart disease were treated with clofibrate for 5 years and followed one year on. There was a statistically significant (29%) higher total mortality in the clofibrate-treated patients than in a comparable placebo-treated control group.
This excess mortality was due to a 33% increase in non-cardiovascular causes, including malignancy, post-cholecystectomy complications, and pancreatitis. The higher risk of clofibrate-treated subjects for gallbladder disease was confirmed in this study.
During the Helsinki Heart Study and in the one and a half years follow-up period since the trial was completed, mortality from any cause was 59 (2.9%) in the gemfibrozil group and 55 (2.7%) in the placebo group. Mortality from any cause during the double-blind portion of the study was 44 deaths in the gemfibrozil group and 43 in the placebo group. Because of the more limited size of the Helsinki Heart Study, this result is not statistically significantly different from the 29% excess mortality seen in the clofibrate group in the separate WHO study. Non-coronary heart disease related mortality showed a 58% greater trend in the gemfibrozil group (43 vs 27 patients in the placebo group, p = 0.056).
In the Helsinki Heart Study, the incidence of total malignancies discovered during the trial and in the one and a half years since the trial was completed was 39 in the gemfibrozil group and 29 in the placebo group (difference not statistically significant). This includes 5 basal cell carcinomas in the gemfibrozil group and none in the placebo group (p = 0.06); historical data predicted an expected 4.7 cases in the placebo group. GI malignancies and deaths from malignancies were not statistically different between gemfibrozil and placebo subgroups. Follow-up of the Helsinki Heart Study participants will provide further information on cause-specific mortality and cancer morbidity.
A gallstone prevalence substudy of 450 Helsinki Heart Study participants showed a trend towards a greater prevalence of gallstones during the study within the gemfibrozil-treatment group (7.5% vs 4.9% for the placebo group, a 55% excess for the gemfibrozil group). A trend toward a greater incidence of gallbladder surgery was observed for the gemfibrozil group (17 vs 11 subjects, a 54% excess). This result did not differ statistically from the increased incidence of cholecystectomy observed in the WHO study in the group treated with clofibrate. Both clofibrate and gemfibrozil may increase cholesterol excretion into the bile leading to cholelithiasis. If cholelithiasis is suspected, gallbladder studies are indicated. Ausgem therapy should be discontinued if gallstones are found.
Since reduction of mortality from coronary artery disease has not been demonstrated and because hepatic and interstitial cell testicular tumours were shown to increase in rat studies, Ausgem should only be administered to those patients described in Section 4.1 Therapeutic Indications. If a significant serum response is not obtained, Ausgem should be discontinued.

Concomitant anticoagulants.

Concomitant HMG-CoA reductase inhibitors.

Cataracts.

Initial therapy.

Long-term therapy.

Continued therapy.

Cholelithiasis.

Haematological changes.

Cardiac arrhythmias.

Use in hepatic impairment.

Hepatobiliary disease.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Caution should be exercised when anticoagulants are given in conjunction with Ausgem. The dosage of the anticoagulant should be reduced to maintain the prothrombin time at the desired level to prevent bleeding complications. Frequent prothrombin determinations are advisable until it has been definitely determined that the prothrombin level had stabilised (see Section 4.4 Special Warnings and Precautions for Use).
There have been reports of severe myositis and myoglobinuria (rhabdomyolysis) when gemfibrozil and HMG-CoA reductase inhibitors were used concomitantly. It may be seen as early as three weeks after the initiation of combined therapy or after several months. In most subjects who have had an unsatisfactory lipid response to either drug alone, the possible benefit of combined therapy with HMG-CoA reductase inhibitors and gemfibrozil does not outweigh the risks of severe myopathy, rhabdomyolysis and acute renal failure. There is no assurance that periodic monitoring of creatine kinase will prevent the occurrence of severe myopathy and kidney damage (see Section 4.4 Special Warnings and Precautions for Use).
The risk of serious toxicity is increased if gemfibrozil is used concomitantly with other fibrates. Such combination therapy should be used with caution only in patients with severe combined dyslipidaemia who have high cardiovascular risk and no history of muscular disease. Patients should be monitored closely for signs of muscle toxicity, although toxicity may occur even in the presence of such monitoring.
Reduced bioavailability of gemfibrozil may result when given simultaneously with colestipol. Administration of the drugs two hours or more apart is recommended.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

In the double-blind controlled phase of the Helsinki Heart Study, during which 2,046 patients received gemfibrozil for up to five years, the following adverse reactions were statistically more frequent in the gemfibrozil treated patients; expressed as (% gemfibrozil/ % placebo).

Gastrointestinal reactions (34.2%/23.8%).

Cardiovascular.

Probable.

Gastrointestinal.

Central nervous system.

Ocular.

Genitourinary.

Musculoskeletal.

Clinical laboratory.

Haematological.

Immunological.

Dermatological.

Not established.

General.

Cardiovascular.

Gastrointestinal.

Central nervous system.

Ocular.

Genitourinary.

Clinical laboratory.

Haematological.

Immunological.

Dermatological.

Reporting suspected adverse effects.

4.9 Overdose

Signs and symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The tablets also contain the following excipients: polysorbate 80, microcrystalline cellulose, crospovidone, pregelatinized maize starch, povidone, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate and sodium lauryl sulphate.
The tablet coating contains (Opadry II Complete film coating system Y-22-7719 White, ARTG PI No: 2578) contains polydextrose, hypromellose, titanium dioxide, triacetin and macrogol 8000.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf-life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C, protect from light.

6.5 Nature and Contents of Container

Ausgem film coated tablets 600 mg are available in bottles (HDPE) of 60's.
Bottles are supplied with a child resistant closure (pp Cap).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

It is a white, waxy powder with a melting point of 58°C to 61°C. The solubility in water and acid is 0.0019% (w/v). The solubility in dilute base is over 1%.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes