SUMMARY CMI
PHARMACOR EZETIMIBE
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 PHARMACOR EZETIMIBE?
PHARMACOR EZETIMIBE contains the active ingredient ezetimibe. PHARMACOR EZETIMIBE is used to help lower cholesterol levels. For more information, see Section 1. Why am I using PHARMACOR EZETIMIBE? in the full CMI.
2. What should I know before I take PHARMACOR EZETIMIBE?
Do not use if you have ever had an allergic reaction to PHARMACOR EZETIMIBE 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 take PHARMACOR EZETIMIBE? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with PHARMACOR EZETIMIBE 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 PHARMACOR EZETIMIBE?
- The recommended dose is 10mg once a day.
- For the best effect take PHARMACOR EZETIMIBE at about the same time each day.
More instructions can be found in Section 4. How do I use PHARMACOR EZETIMIBE? in the full CMI.
5. What should I know while using PHARMACOR EZETIMIBE?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using PHARMACOR EZETIMIBE? in the full CMI.
6. Are there any side effects?
PHARMACOR EZETIMIBE helps most people with high cholesterol, 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 like swelling of the face, skin rash and hives, unexplained muscle aches etc. 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
PHARMACOR EZETIMIBE
Active ingredient(s): [Ezetimibe]
Consumer Medicine Information (CMI)
This leaflet provides important information about using PHARMACOR EZETIMIBE. 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 PHARMACOR EZETIMIBE.
Where to find information in this leaflet:
1. Why am I using PHARMACOR EZETIMIBE?
2. What should I know before I take PHARMACOR EZETIMIBE?
3. What if I am taking other medicines?
4. How do I use PHARMACOR EZETIMIBE?
5. What should I know while using PHARMACOR EZETIMIBE?
6. Are there any side effects?
7. Product details
1. Why am I using PHARMACOR EZETIMIBE?
PHARMACOR EZETIMIBE contains the active ingredient ezetimibe. PHARMACOR EZETIMIBE helps to lower cholesterol levels.
PHARMACOR EZETIMIBE used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately.
PHARMACOR EZETIMIBE may be taken alone or with other cholesterol-lowering medicines known as HMG-CoA reductase inhibitors (or statins), in addition to diet.
In people who have high levels of plant sterols in their blood (which doctors call sitosterolaemia), PHARMACOR EZETIMIBE helps to lower these levels.
Cholesterol
Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called 'bad' cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries.
This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.
HDL cholesterol is often called 'good' cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.
Triglycerides
Triglycerides are another form of fat in your blood that may increase your risk for heart disease.
High cholesterol can be treated in two main ways:
Lifestyle Changes: this includes a cholesterol-lowering diet, increasing physical activity, and weight management. Ask your doctor for advice before increasing physical activity.
Medicines: cholesterol-lowering medicines are used together with lifestyle changes to help lower cholesterol.
How PHARMACOR EZETIMIBE works
PHARMACOR EZETIMIBE reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol.
PHARMACOR EZETIMIBE works by decreasing the absorption of cholesterol in the small intestine. Statins lower cholesterol in a different way, by reducing the amount of cholesterol made in the liver.
PHARMACOR EZETIMIBE adds to the cholesterol-lowering effect of statins.
For patients with heart disease and a history of a heart attack or hospitalisation for unstable angina (chest pain), PHARMACOR EZETIMIBE combined with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalisation for chest pain.
Your doctor may have prescribed PHARMACOR EZETIMIBE for another reason. Ask your doctor if you have any questions about why PHARMACOR EZETIMIBE has been prescribed for you.
PHARMACOR EZETIMIBE is not addictive.
2. What should I know before I take PHARMACOR EZETIMIBE?
Warnings
Do not use PHARMACOR EZETIMIBE if:
- you are allergy to PHARMACOR EZETIMIBE or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include skin rash, itchiness, shortness of breath, swelling of the face, lips, mouth, tongue or throat. Always check the ingredients to make sure you can use this medicine.
- the packaging is torn or shows signs of tampering
- the expiry date on the pack has passed. If you take this medicine after the expiry date has passed, it may not work.
- you have active liver disease
- you are pregnant or breast feeding.
Do not use PHARMACOR EZETIMIBE together with fenofibrate if:
- you have gall bladder disease.
Check with your doctor if you:
- have, or have had, any other medical conditions, including liver disease. If you are prescribed PHARMACOR EZETIMIBE, your doctor will do a blood test to make sure you have no problems with your liver.
- take any medicines for any other condition
- have allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
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 intend to become pregnant. If there is a need to consider using PHARMACOR EZETIMIBE during pregnancy, your doctor will discuss the risks and benefits of taking it.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known if PHARMACOR EZETIMIBE passes into breast milk.
Use in Children and Adolescents
- PHARMACOR EZETIMIBE is used in children and adolescents (10 to 17 years of age) to treat familial hypercholesterolaemia, a type of high cholesterol that is hereditary (i.e., passed on through families)
- PHARMACOR EZETIMIBE is not recommended in children under 10 years of age as there have been very few studies of its effects in these children.
Your doctor will assess whether PHARMACOR EZETIMIBE is suitable for your child. Depending on the pubertal development of your child, PHARMACOR EZETIMIBE may not be suitable for him or her.
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.
Some medicines should not be taken with PHARMACOR EZETIMIBE, including some fibrate medicines used to lower cholesterol levels e.g., gemfibrozil. However, the fibrate medicine fenofibrate can be taken with PHARMACOR EZETIMIBE.
Some medicines may interfere with PHARMACOR EZETIMIBE and affect how it works.
You may need different amounts of your medicine, or you may need to take different medicines or take your medicines at different times.
Medicines that may increase the effect of PHARMACOR EZETIMIBE include:
- Ciclosporin, used to suppress the immune system.
Medicines that may reduce the effect of PHARMACOR EZETIMIBE include:
- Bile acid sequestrants, such as colestyramine, used to lower cholesterol levels.
PHARMACOR EZETIMIBE may interfere with some medicines and affect how they work:
- Warfarin or fluindione, used to prevent blood clots.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PHARMACOR EZETIMIBE.
4. How do I use PHARMACOR EZETIMIBE?
How much to take
- The recommended dose is 10mg taken once a day.
Swallow PHARMACOR EZETIMIBE with a glass of water. - Take PHARMACOR EZETIMIBE only when prescribed by your doctor.
- Follow the instructions provided and use PHARMACOR EZETIMIBE until your doctor tells you to stop.
- PHARMACOR EZETIMIBE helps lower your cholesterol. It does not cure your condition. Therefore, you must continue to take it as directed by your doctor if you expect to lower your cholesterol and keep it down.
- You may have to take cholesterol lowering medicine for the rest of your life. If you stop taking PHARMACOR EZETIMIBE, your cholesterol levels may rise again.
When to take PHARMACOR EZETIMIBE
- PHARMACOR EZETIMIBE can be taken at any time of the day, however, take it at about the same time each day.
- Taking PHARMACOR EZETIMIBE at the same time each day will have the best effect. It will also help you remember when to take the dose.
- Your doctor may ask you to take PHARMACOR EZETIMIBE with other cholesterol-lowering medicines, such as statins, to help you better control your cholesterol.
- If you are taking a statin, PHARMACOR EZETIMIBE can be taken at the same time as the statin.
- If you are taking a bile acid sequestrant, such as cholestyramine, take your PHARMACOR EZETIMIBE either at least two hours before or four hours after taking the bile acid sequestrant.
- It does not matter if you take PHARMACOR EZETIMIBE with or without food.
If you forget to take PHARMACOR EZETIMIBE
PHARMACOR EZETIMIBE should be taken regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then go back to taking your tablet(s) as you would normally.
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.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist. If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
If you use too much PHARMACOR EZETIMIBE
If you think that you have used too much PHARMACOR EZETIMIBE, 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.
5. What should I know while using PHARMACOR EZETIMIBE?
Things you should do
If you become pregnant while taking PHARMACOR EZETIMIBE, tell your doctor.
If you are prescribed PHARMACOR EZETIMIBE, your doctor will do blood tests to check that there are no problems with your liver.
Remind any doctor, dentist or pharmacist you visit that you are taking PHARMACOR EZETIMIBE.
Things you should not do
- Do not give PHARMACOR EZETIMIBE to anyone else, even if they have the same condition as you.
- Have your blood fats checked when your doctor says, to make sure PHARMACOR EZETIMIBE is working. Even if you are taking medicines to treat high cholesterol, it is important to have your cholesterol measured regularly. You should also know your cholesterol levels and goals.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how PHARMACOR EZETIMIBE affects you.
There have been side effects reported with PHARMACOR EZETIMIBE that may affect your ability to drive or operate machinery. Individual responses to PHARMACOR EZETIMIBE may vary.
Looking after your medicine
- Keep your tablets in the blister pack or bottle pack until it is time to take them. If you take the tablets out of the blister pack or bottle pack they may not keep well.
- Store below 25°C. Store in dry place.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it 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
Less serious side effects | What to do |
Muscle/skeleton-related:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
These side effects are very rare. | Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
| Tell your doctor immediately if you notice any of these side effects. These may be serious side effects and you may need urgent medical attention. |
In adolescent patients (10 to 17 years of age) there have been no studies longer than one year of the effect of taking PHARMACOR EZETIMIBE in combination with simvastatin on bone development, growth, social and emotional development, or fertility
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 PHARMACOR EZETIMIBE contains
Active ingredient (main ingredient) | 10 mg ezetimibe per tablet |
Other ingredients (inactive ingredients) |
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Do not take this medicine if you are allergic to any of these ingredients.
What PHARMACOR EZETIMIBE looks like
PHARMACOR EZETIMIBE comes as a white to off white capsule shaped, flat faced, beveled edge tablets, debossed with 'A25' on one side and plain on other side.
PHARMACOR EZETIMIBE tablets are packed in PVC/ACLAR-Alu Blister Pack and HDPE bottle with PP child resistant closure.
Pack size*:10 tablets or 30 tablets in blister pack
30 tablets or 90 tablets in bottle pack
* Not all pack size may be marketed.
Supplier
PHARMACOR EZETIMIBE is supplied in Australia by:
PHARMACOR PTY. LTD
CHATSWOOD, NSW, 2067,
Australia
Australian Register Number:
PHARMACOR EZETIMIBE 10 mg bottle pack - AUST R 276974
PHARMACOR EZETIMIBE 10 mg blister pack - AUST R 276975
This leaflet was prepared in 03/2025
Published by MIMS May 2025