EZECREST COMPOSITE PACK

EZECREST COMPOSITE PACK

Active ingredient(s): [Ezetimibe and Rosuvastatin]

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Consumer Medicine Information (CMI)

This leaflet provides important information about using EZECREST COMPOSITE PACK.
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 EZECREST COMPOSITE PACK.

Where to find information in this leaflet:

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

1. Why am I using EZECREST COMPOSITE PACK?

EZECREST COMPOSITE PACK helps to lower cholesterol levels. It is used in people whose cholesterol 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 buildup 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.

How EZECREST COMPOSITE PACK works?

EZECREST COMPOSITE PACK is a combination pack, which contains two different medicines. One is EZECREST EZETIMIBE (ezetimibe) and the other is CRESTABS (rosuvastatin calcium). EZECREST COMPOSITE PACK reduces elevated total-cholesterol, LDL (‘bad’) cholesterol and increases HDL (‘good’) cholesterol. EZECREST 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 EZECREST COMPOSITE PACK for another reason. Ask your doctor if you have any questions about why EZECREST COMPOSITE PACK has been prescribed for you. EZECREST COMPOSITE PACK is not addictive. EZECREST COMPOSITE PACK is available only with a doctor’s prescription.

Use in children

EZECREST COMPOSITE PACK is not recommended for use in children.

2. What should I know before I use EZECREST COMPOSITE PACK?

Do not take EZECREST COMPOSITE PACK if:

• you have an allergy to EZECREST 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 childbearing age and are taking EZECREST 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.
• you are taking any medicine containing fusidic acid (for bacterial infections)
• the expiry date on the pack has passed or if the packaging is torn or shows signs of tampering.

If you take EZECREST COMPOSITE PACK after the expiry date has passed, it may not work.

Return any expired or damaged EZECREST COMPOSITE PACK to your pharmacist for disposal

Do not take EZECREST COMPOSITE PACK together with fenofibrate if:

• you have gall bladder disease.

Do not use EZECREST COMPOSITE PACK 10mg+40mg if you:

• have low thyroid hormone levels (hypothyroidism)
• have a personal or family history of hereditary muscular disorders
• have a previous history of muscular problems from using other medicines used to treat high cholesterol or triglycerides
• have a history of very heavy alcohol consumption
• have severe kidney impairment
• are of Asian descent
• are taking another type of lipid lowering medicine called a fibrate

Before taking EZECREST COMPOSITE PACK, talk to your doctor about situations that can increase rosuvastatin blood levels.

Also talk to your doctor if you are not sure whether you should start taking EZECREST COMPOSITE PACK.

Before you start to take it

Your doctor will ask you to have your liver function tested before you start to take EZECREST 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
• personal or family history of muscle problems
• muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides
• unexplained muscle aches or pains in your muscle
• breathing problems
• low thyroid hormone levels (hypothyroidism)
• diabetes or risk factors for diabetes
• you drink alcohol regularly.
  Excessive alcohol consumption may not be safe in patients taking EZECREST COMPOSITE PACK.
• you have or have had myasthenia gravis (a disease causing general muscle weakness including in some cases muscles used for breathing) or ocular myasthenia (a disease causing eye muscle weakness) as statins may lead to occurrence of myasthenia or aggravate the condition.

If you have not told your doctor about any of the above, tell him/ her before you start taking EZECREST COMPOSITE PACK.

3. What if I am 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 should not be taken with EZECREST COMPOSITE PACK, including:

• fusidic acid, antibiotic used to treat infection
• fenofibrate (a medicine to lower triglyceride levels) if you have gall bladder disease

Some medicines may be affected by EZECREST COMPOSITE PACK, or may affect how well it works, or may increase the risk of side effects with EZECREST 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 colestyramine, used to lower cholesterol levels
• other medicines to lower cholesterol or triglyceride levels, for example, gemfibrozil, other fibrates, Vitamin B3
• warfarin or fluindione, used to prevent blood clots
• HIV protease inhibitors, used to treat HIV infection
• hepatitis C antiviral agents, such as elbasvir or grazoprevir, used to treat the hepatitis C virus infection
• colchicine, used to treat gout
• ciclosporin, used to suppress the immune system
• antacids, used to treat reflux or ulcers. EZECREST COMPOSITE PACK should be taken 2 hours before or 2 hours after taking antacid.
• daptomycin, a medicine used to treat complicated skin and skin structure infections and bacteraemia

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking EZECREST COMPOSITE PACK.

If you have not told your doctor about any of the above, tell them before you start taking EZECREST COMPOSITE PACK.

4. How do I use EZECREST COMPOSITE PACK?

Take EZECREST 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 rosuvastatin which are contained in EZECREST COMPOSITE PACK:

• stop taking your current medicine(s) that contain ezetimibe and/or rosuvastatin 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 EZECREST COMPOSITE PACK.

Your doctor will prescribe a strength that is appropriate for you. It is very important that you take EZECREST COMPOSITE PACK exactly as follows:

Take one EZECREST (ezetimibe) tablet and one CRESTABS (rosuvastatin) tablet at the same time once a day.

If your doctor has increased the strength of EZECREST COMPOSITE PACK tablets you take, do not take multiple doses of any remaining supplies of lower strength EZECREST COMPOSITE PACK tablets instead of the new higher strength tablets as this will result in you taking more medicine (ezetimibe) than you need.

How to take it

Swallow the tablets whole with a full glass of water. Do not chew or crush the tablets.

When to take it

EZECREST COMPOSITE PACK can be taken at any time of the day. However, EZECREST 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 EZECREST COMPOSITE PACK with or without food.

Taking EZECREST COMPOSITE PACK with other cholesterol-lowering agents.

Your doctor may ask you to take EZECREST COMPOSITE PACK with other cholesterol-lowering agents such as bile acid sequestrants.

If you are taking a bile acid sequestrant, such as colestyramine, take EZECREST COMPOSITE PACK either at least two hours before or four hours after taking the bile acid sequestrant.

How long to take it

Take EZECREST COMPOSITE PACK every day and continue taking it for as long as your doctor tells you.

EZECREST COMPOSITE PACK helps to lower your cholesterol levels but does not cure your condition. If you stop taking EZECREST 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 EZECREST COMPOSITE PACK. Do this even if there are no signs of discomfort or poisoning.

You or anyone else may need urgent medical attention.

5. What should I know while using EZECREST COMPOSITE PACK?

Things you must do

If you become pregnant while you are taking EZECREST 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 EZECREST COMPOSITE PACK. This may help prevent unwanted side effects.

Your doctor may adjust your dose depending on the result of the test.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking EZECREST COMPOSITE PACK.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking EZECREST COMPOSITE PACK.

Things you must not do

Do not take EZECREST COMPOSITE PACK to treat any other conditions unless your doctor tells you to.

Do not give EZECREST 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 EZECREST COMPOSITE PACK may increase your chance of getting liver problems.

Be careful driving or operating machinery until you know how EZECREST COMPOSITE PACK affects you.

There have been side effects reported with EZECREST COMPOSITE PACK that may affect your ability to drive or operate machinery.

Individual responses to EZECREST 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.

6. Are there any side effects

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

EZECREST COMPOSITE PACK helps most people with high cholesterol 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.

Less serious side effects

Less serious side effects

What to do

diarrhoea muscle aches, spasms, tiredness or weakness constipation nausea stomach or belly pain heartburn, indigestion or wind aches and pain pain in arms and legs trouble sleeping dizziness headache tingling or numbness of the hands or feet hot flush shortness of breath unusual tiredness or weakness generally feeling unwell memory loss itchy skin decreased appetite dry mouth swelling, especially in the hands and feet cough Tell your doctor if you have been diagnosed with: inflammation of the pancreas gallstones inflammation of the gallbladder elevation in some laboratory blood tests of liver or muscle function depression elevation in blood glucose levels diabetes high blood pressure thyroid function abnormalities

Tell your doctor or pharmacist if you notice any of the following and they worry you. Tell your doctor if you notice a significant increase in your need to urinate or if you are significantly more hungry or thirsty than usual.

Serious side effects

Serious side effects

What to do

skin rash and hives raised red rash, sometimes with circular-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 swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing. chest pain unexpected muscle pain, tenderness, or weakness not caused by exercise, particularly if you also have a fever or generally feel unwell. severe blisters and bleeding of the lips, eyes, mouth, nose or genitals.

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 or if you have any thoughts of harming yourself or committing suicide. You may need urgent medical attention or hospitalisation.

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.

Storage

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store EZECREST 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 EZECREST COMPOSITE PACK or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects as follows: Australia: 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 EZECREST COMPOSITE PACK contains

Active ingredient (main ingredient)	Ezetimibe 10mg + Rosuvastatin 10mg, Ezetimibe 10mg + Rosuvastatin 20mg, Ezetimibe 10mg + Rosuvastatin 40mg
Other ingredients (inactive ingredients)	EZECREST COMPOSITE PACK lactose monohydrate, croscarmellose sodium, crospovidone, microcrystalline cellulose, magnesium stearate, hypromellose and sodium lauryl sulfate. CRESTABS crospovidone, light magnesium oxide, microcrystalline cellulose, lactose monohydrate, magnesium stearate and Opadry II complete film coating system 32K140052 Pink (ARTG PI No. 141463).
Potential allergens	–

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

What EZECREST COMPOSITE PACK looks like

EZECREST EZETIMIBE is White to off white capsule shaped, flat faced, beveled edge tablets, debossed with A25 on one side and plain on other side.

CRESTABS 10 mg are pink color, circular, biconvex, film coated tablets debossed with “R” on one side and “10” on the other side.

CRESTABS 20 mg are pink color, circular, biconvex, film coated tablets debossed with “R” on one side and “20” on the other side.

CRESTABS 40 mg are pink color, oval shape, biconvex, film coated tablets debossed with “R” on one side and “40” on the other side.

EZECREST COMPOSITE PACK is a combination pack containing EZECREST EZETIMIBE (ezetimibe) tablets 10 mg and CRESTABS (rosuvastatin, as calcium) tablets 10, 20, 40 mg.

EZECREST COMPOSITE PACK is supplied in 10-day calendar packs of 10 EZECREST EZETIMIBE (ezetimibe) tablets in PVC/PCTFE(Aclar)/Al blisters and 10 CRESTABS (rosuvastatin, as calcium) tablets in Al/Al blisters. Each carton contains one 10-day calendar pack (for starter packs) or three 10-day calendar packs (for commercial packs).

Who distributes EZECREST COMPOSITE PACK

Pharmacor Pty Ltd.
Suite 803, Level 8, Tower A,
The Zenith, 821 Pacific Highway,
Chatswood, NSW, 2067,
Australia
www.pharmacor.com.au

EZECREST COMPOSITE PACK

Blister composite pack:

10 mg + 10 mg: 375662
10 mg + 20 mg: 375655
10 mg + 40 mg: 375670

This leaflet was prepared in 09/2023