ezetimibe and atorvastatin calcium
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Atozet Composite Pack. 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 Atozet Composite Pack against the benefits they expect it will 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 Atozet Composite Pack is used for
Atozet Composite Pack helps to lower cholesterol and triglyceride levels. It is used in people whose cholesterol and triglyceride levels are too high and when diet alone cannot lower these levels adequately.
What is high 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.
How Atozet Composite Pack works
Atozet Composite Pack is a combination pack, which contains two different medicines. One is Ezetrol (ezetimibe) and the other is atorvastatin (atorvastatin calcium). Atozet Composite Pack reduces elevated total-cholesterol, LDL (‘bad’) cholesterol and triglycerides and increases HDL (‘good’) cholesterol.
Atozet Composite Pack works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver.
Your doctor may have prescribed Atozet Composite Pack for another reason.
Ask your doctor if you have any questions about why Atozet Composite Pack has been prescribed for you.
Atozet Composite Pack is not addictive.
Atozet Composite Pack does not help you lose weight.
Atozet Composite Pack is available only with a doctor’s prescription.
Use in children
Atozet Composite Pack is not recommended for use in children, as there have been no studies of its effects in children.
Before you take Atozet Composite Pack
When you must not take it
Do not take Atozet Composite Pack if:
- you have an allergy to Atozet Composite Pack or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
– 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. - you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides.
- you are pregnant or intend to become pregnant.
If you are a woman of child-bearing age and are taking Atozet Composite Pack, use a proven method of birth control to avoid pregnancy.
The medicine may affect your developing baby if you take it during pregnancy. - you are breast-feeding.
This medicine may pass into breast milk and affect your baby. - you have active liver disease or repeated blood tests indicating possible liver problems.
- the expiry date on the pack has passed or if the packaging is torn or shows signs of tampering.
If you take Atozet Composite Pack after the expiry date has passed, it may not work.
Return any expired or damaged Atozet Composite Pack to your pharmacist for disposal.
Do not take Atozet Composite Pack together with fenofibrate if you have gall bladder disease.
If you are not sure whether you should start taking Atozet Composite Pack, talk to your doctor.
Before you start to take it
Your doctor will ask you to have your liver function tested before you start to take Atozet Composite Pack.
Tell your doctor if:
- you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
- you have, or have had, any medical condition, including:
– liver problems
Your doctor will do a blood test to make sure you have no problems with your liver.
– kidney problems
– you have unexplained muscle pain, tenderness or weakness not caused by exercise.
This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage that can lead to death.
Your doctor may do a blood test to check for certain muscle problems.
– a type of stroke called a haemorrhagic stroke or a type of stroke called a lacunar stroke.
If you have had one of these strokes before, this medicine may increase the risk of you having a haemorrhagic stroke.
– breathing problems. - you drink alcohol regularly.
If you have not told your doctor about any of the above, tell him/her before you start taking Atozet Composite Pack.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by Atozet Composite Pack, or may affect how well it works, or may increase the risk of side effects with Atozet Composite Pack. You may need different amounts of your medicines, or you may need to take different medicines or take your medicines at different times. Your doctor will advise you.
Tell your doctor if…
Tell your doctor if you are taking any of the following:
- bile acid sequestrants, such as cholestyramine, used to lower cholesterol levels
- other medicines to lower cholesterol or triglyceride levels, for example, gemfibrozil, other fibrates, Vitamin B3
- warfarin, used to prevent blood clots
- erythromycin, clarithromycin, rifampicin or fusidic acid, antibiotics used to treat infection
- some medicines used to treat certain fungal infections, such as ketoconazole or itraconazole
- efavirenz and protease inhibitors for the treatment of HIV infection
- hepatitis C protease inhibitors, for example, telaprevir, boceprevir
- phenytoin, used to treat epilepsy (seizures)
- cyclosporin, used to suppress the immune system
- colchicine, used for gout
- spironolactone, used to treat high blood pressure and certain types of swelling
- diltiazem used to treat angina
- digoxin, used to treat heart failure
- oral contraceptives for birth control
- antacids and cimetidine, used to treat reflux or ulcers.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Atozet Composite Pack.
If you have not told your doctor about any of the above, tell them before you start taking Atozet Composite Pack.
How to take Atozet Composite Pack
Take Atozet Composite Pack only when prescribed by your doctor.
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand these instructions, ask your doctor or pharmacist for help.
If you are currently taking a medicine that contains ezetimibe and/or atorvastatin which are contained in Atozet Composite Pack:
- stop taking your current medicine(s) that contain ezetimibe and/or atorvastatin as this may result in you taking more medicine than you need
- take the remaining medicine(s) to your pharmacist for safe disposal
Check with your doctor if you are not sure about the medicines you are taking.
How much to take
There are two different medicines in Atozet Composite Pack. Your doctor will prescribe a strength that is appropriate for you. It is very important that you take Atozet Composite Pack exactly as follows:
Take one Ezetrol tablet and one MSD Atorvastatin tablet at the same time once a day.
How to take it
Swallow the tablets whole with a full glass of water.
When to take it
Atozet Composite Pack can be taken at any time of the day. However, Atozet Composite Pack should be taken 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.
Take Atozet Composite Pack with or without food.
Taking Atozet Composite Pack with other cholesterol-lowering agents
Your doctor may ask you to take Atozet Composite Pack with other cholesterol-lowering agents such as bile acid sequestrants.
If you are taking a bile acid sequestrant, such as cholestyramine, take your Atozet Composite Pack either at least two hours before or four hours after taking the bile acid sequestrant.
How long to take it
Take Atozet Composite Pack every day and continue taking it for as long as your doctor tells you. Atozet Composite Pack helps to lower your cholesterol levels but does not cure your condition. If you stop taking Atozet Composite Pack your cholesterol levels may rise again.
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 your tablets 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 getting a side effect.
If you are not sure what to do, talk to 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)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Atozet Composite Pack. Do this even if there are no signs of discomfort or poisoning.
You or anyone else may need urgent medical attention.
While you are taking Atozet Composite Pack
Things you must do
If you become pregnant while you are taking Atozet Composite Pack, stop taking it and tell your doctor immediately.
Keep all your doctor’s appointments.
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.
Your doctor will ask you to have your liver function tested from time to time while you are taking Atozet Composite Pack to make sure the medicine is working and to prevent unwanted side effects.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Atozet Composite Pack.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking Atozet Composite Pack.
Things you must not do
Do not take Atozet Composite Pack to treat any other conditions unless your doctor tells you to.
Do not give Atozet Composite Pack to anyone else, even if they have the same condition as you.
Things to be careful of
Avoid drinking large quantities of alcohol. Drinking large quantities of alcohol while taking Atozet Composite Pack may increase your chance of getting liver problems.
Avoid drinking large quantities of grapefruit juice. Grapefruit juice contains one or more components that alter the metabolism of some medicines, including Atozet Composite Pack. Drinking very large quantities (over 1.2 litres) of grapefruit juice each day while taking Atozet Composite Pack increases your chance of getting side effects.
Be careful driving or operating machinery until you know how Atozet Composite Pack affects you. There have been side effects reported with Atozet Composite Pack that may affect your ability to drive or operate machinery. Individual responses to Atozet Composite Pack may vary.
Things that may help your condition
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.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Atozet Composite Pack. Atozet Composite Pack helps most people with high cholesterol levels or triglyceride levels, 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 attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if…
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- diarrhoea
- muscle aches, spasms, tiredness or weakness
- constipation
- frequent bowel movements
- nausea
- stomach or belly pain
- heartburn, indigestion or wind
- aches and pain
- leg cramps
- depression
- trouble sleeping
- influenza
- dizziness
- headache
- tingling or numbness of the hands or feet
- slow heart beat
- hot flush
- shortness of breath
- unusual tiredness or weakness
- generally feeling unwell
- weight gain
- acne
- pain in arms and legs
- swelling
- poor memory
- confusion
The above list includes the more common and uncommon side effects of your medicine. They are usually mild and short-lived.
Tell your doctor immediately if…
Tell your doctor immediately if you notice any of the following:
- skin rash and hives
- raised red rash, sometimes with circle-shaped lesions
- steady abdominal pain with nausea and vomiting
- joint pain
- bleeding or bruising more easily than normal
- yellowing of the skin and eyes
- dark coloured urine
- light coloured bowel motions
- problems with breathing including shortness of breath, persistent cough and fever
These may be serious side effects. You may need urgent medical attention.
Go to hospital if…
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing.
These may be serious side effects. If you have them, you may have had a serious allergic reaction to Atozet Composite Pack. You may need urgent medical attention or hospitalisation. These side effects are very rare. - chest pain.
- unexpected muscle pain, tenderness, or weakness not caused by exercise.
This may be a serious side effect. This is because on rare occasions, muscle problems can be serious including muscle breakdown resulting in kidney damage. You may need urgent medical attention. - sudden severe headache, which may be accompanied by nausea, vomiting, loss of sensation, tingling in any part of the body or ringing in the ears.
- severe blisters and bleeding of the lips, eyes, mouth, nose or genitals.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
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.
If you are prescribed Atozet Composite Pack, your healthcare professional may want to conduct routine blood tests to check your liver function before and after starting treatment.
After taking Atozet Composite Pack
Storage
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store Atozet Composite Pack or any other 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.
Disposal
If your doctor tells you to stop taking Atozet Composite Pack or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
Atozet Composite Pack comes in four different strengths:
- Atozet Composite Pack 10 mg + 10 mg
- Atozet Composite Pack 10 mg + 20 mg
- Atozet Composite Pack 10 mg + 40 mg
- Atozet Composite Pack 10 mg + 80 mg
Ezetrol 10 mg tablet is a white to off-white, capsule-shaped tablet with “414” marked on one side.
Atorvastatin 10 mg is a white to almost white, round biconvex film-coated tablet, debossed with HLA10 on one side.
Atorvastatin 20 mg is a light yellow, round biconvex film-coated tablet, debossed with HLA20 on one side.
Atorvastatin 40 mg is a light yellow, round biconvex film-coated tablet, debossed with HLA40 on one side.
Atorvastatin 80 mg is a light yellow, oval biconvex film-coated tablet, debossed with HLA80 on one side.
Ezetrol 10 mg and Atorvastatin (10, 20, 40 and 80 mg) are supplied in 10-day calendar packs of 10 Ezetrol and 10 Atorvastatin tablets.
A trade pack contains 3 x 10-day calendar packs.
A starter pack contains 1 x 10-day calendar pack.
Ingredients
Ezetrol
Active ingredient:
- Ezetimibe 10 mg per tablet.
Inactive ingredients:
- Croscarmellose sodium
- Magnesium stearate
- Lactose
- Microcrystalline cellulose
- Povidone
- Sodium lauryl sulfate.
Atorvastatin
Active ingredient:
- Atorvastatin (as atorvastatin calcium) 10 mg per tablet.
- Atorvastatin (as atorvastatin calcium) 20 mg per tablet.
- Atorvastatin (as atorvastatin calcium) 40 mg per tablet.
- Atorvastatin (as atorvastatin calcium) 80 mg per tablet.
Inactive ingredients:
- Purified talc
- Microcrystalline cellulose
- Croscarmellose sodium
- Polysorbate 80
- Hydroxypropylcellulose
- Magnesium stearate
- Magnesium oxide heavy
- Colloidial anhydrous silica
- Hypromellose
- Titanium dioxide
- Lactose
- Macrogol 6000
- Iron oxide yellow (contained in 20 mg, 40 mg and 80 mg tablets only)
Date of Preparation
This Consumer Medicine Information was prepared in February 2015.
Ask your pharmacist about any updates.
Supplier
Atozet Composite Pack is supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
ABN 14 000 173 508
Level 1, Building A
26 Talavera Road
Macquarie Park NSW 2113
Australian Registration Numbers
- Atozet Composite Pack 10 mg + 10 mg –
Aust R 196150 - Atozet Composite Pack 10 mg + 20 mg –
Aust R 196151 - Atozet Composite Pack 10 mg + 40 mg –
Aust R 196152 - Atozet Composite Pack 10 mg + 80 mg –
Aust R 196153
A150128 v4
0653C-AUS-2013-008298
Published by MIMS June 2015
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