PHARMACOR EZETIMIBE SIMVASTATIN

PHARMACOR EZETIMIBE SIMVASTATIN

Active ingredient(s): EZETIMIBE SIMVASTATIN

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Consumer Medicine Information (CMI)

This leaflet provides important information about using EZETIMIBE SIMVASTATIN. 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 EZETIMIBE SIMVASTATIN.

Where to find information in this leaflet:

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

1. Why am I using PHARMACOR EZETIMIBE SIMVASTATIN?

PHARMACOR EZETIMIBE SIMVASTATIN helps to lower cholesterol and triglyceride levels. It is used in people whose cholesterol levels are too high and when diet alone cannot lower these levels adequately.

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.

Your doctor may have prescribed PHARMACOR EZETIMIBE SIMVASTATIN for another reason. Ask your doctor if you have any questions about why PHARMACOR EZETIMIBE SIMVASTATIN has been prescribed for you.

PHARMACOR EZETIMIBE SIMVASTATIN is not addictive.

Triglycerides

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

Use in Children and Adolescents

PHARMACOR EZETIMIBE SIMVASTATIN 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 SIMVASTATIN is not recommended for use in children under 10 years of age, as there have been no studies of its effects in this age group.

Your doctor will assess whether PHARMACOR EZETIMIBE SIMVASTATIN is suitable for your child. Depending on the pubertal development of your child, PHARMACOR EZETIMIBE SIMVASTATIN may not be suitable for him or her.

2. What should I know before I take PHARMACOR EZETIMIBE SIMVASTATIN?

When you must not take it

Do not use PHARMACOR EZETIMIBE SIMVASTATIN if:

• you have an allergy to PHARMACOR EZETIMIBE SIMVASTATIN or any of the ingredients listed at the end of this leaflet.
  Symptoms of an allergic reaction may include skin rash, itchiness, and shortness of breath, swelling of the face, lips, mouth, tongue or throat.
• you are pregnant or breast feeding.
  PHARMACOR EZETIMIBE SIMVASTATIN is contraindicated (i.e. should not be used) during pregnancy and breastfeeding. If you take this medicine during pregnancy and breastfeeding, your baby may absorb this medicine and it may affect your baby’s normal development causing foetal malformations (birth defects) or irreversible damage.
• you have active liver disease or repeated blood tests indicating possible liver problems.
• you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides.
• You are taking certain medicines such as gemfibrozil, ciclosporin, danazol, fusidic acid and strong CYP3A4 inhibitors like itraconazole and ketoconazole. Please see the section “Taking other medicines” in this CMI for more information.
• 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.

If you are not sure whether you should start taking PHARMACOR EZETIMIBE SIMVASTATIN, talk to your doctor.

Before you start to take it

Tell your doctor if:

1. you are pregnant or intend to become pregnant.

PHARMACOR EZETIMIBE SIMVASTATIN should not be used during pregnancy.

2. you are breast-feeding.

PHARMACOR-EZETIMIBE SIMVASTATIN should not be used while breast feeding.

3. 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.

4. you are Asian.
5. you are taking niacin or a niacin-containing product.
6. you have, or have had, any medical conditions, including liver disease or liver problems.

Your doctor will do a blood test to make sure you have no problems with your liver.

7. you have kidney disease, diabetes or any other medical problems.
8. you drink alcohol regularly.
9. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
10. 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 them before you take any PHARMACOR EZETIMIBE SIMVASTATIN.

See additional information under Section 6. Are there any side effects?

3. What if I am taking other medicines?

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

Some medicines should not be taken with PHARMACOR-EZETIMIBE SIMVASTATIN.

These include:

• nefazodone, used to treat depression
• medicines containing cobicistat, a drug used in the treatment of HIV infection.
• protease inhibitors, including indinavir, nelfinavir, ritonavir,
• saquinavir, used to treat HIV infection
• certain hepatitis C virus protease inhibitors (such as boceprevir or telaprevir)
• gemfibrozil, used to treat high cholesterol levels
• ciclosporin, used to suppress the immune system
• danazol
• erythromycin, clarithromycin, telithromycin and fusidic acid, antibiotics used to treat infections
• ketoconazole, itraconazole, posaconazole and voriconazole used to treat certain fungal infections

If you are taking any of the above, your doctor may suggest stopping PHARMACOR EZETIMIBE SIMVASTATIN temporarily or permanently.

Some medicines and PHARMACOR EZETIMIBE SIMVASTATIN may interfere with each other.

These include:

• Certain hepatitis C antiviral agents, such as elbasvir, or grazoprevir
• bile acid sequestrants, such as colestyramine, used to lower cholesterol levels.
• other medicines to lower cholesterol levels, for example, other fibrates, nicotinic acid (also known as niacin).
• Warfarin, fluindione, or other drugs used to prevent blood clots
• colchicine, used for gout
• verapamil, used to treat high blood pressure and angina
• diltiazem, used to treat angina
• amiodarone, used to treat irregular heart beat
• amlodipine, used to treat high blood pressure and angina
• digoxin, used to treat heart failure
• lomitapide (a drug used to treat a serious and rare genetic cholesterol condition)
• daptomycin, a drug used to treat complicated skin and skin structure infections and bacteraemia.

These medicines may be affected by PHARMACOR EZETIMIBE SIMVASTATIN, may affect how well it works, or may increase the risk of side effects with PHARMACOR EZETIMIBE SIMVASTATIN. You may need different amounts of your medicine, or you may need to take different medicines or take your medicines at different times.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking PHARMACOR EZETIMIBE SIMVASTATIN.

You should also tell any doctor who is prescribing a new medication for you that you are taking PHARMACOR EZETIMIBE SIMVASTATIN.

4. How do I take PHARMACOR EZETIMIBE SIMVASTATIN?

How much to take

Take PHARMACOR EZETIMIBE SIMVASTATIN only when prescribed by your doctor.

The recommended dose in adults (18 years and over) is one PHARMACOR EZETIMIBE SIMVASTATIN10/10, 10/20, 10/40 or 10/80 tablet once a day, in the evening. Your doctor will adjust your PHARMACOR EZETIMIBE SIMVASTATIN dose depending on your response.

The recommended dose in adolescents (10 to 17 years of age) with familial hypercholesterolaemia is one PHARMACOR EZETIMIBE SIMVASTATIN 10/10, 10/20 or 10/40 tablet once a day, in the evening. The maximum recommended dose in adolescents is 10/40mg.

Because of the increased risk of muscle problems, the PHARMACOR EZETIMIBE SIMVASTATIN 10/80 tablet is only for patients at high risk of heart disease problems who have not yet reached their cholesterol goal on lower doses.

Swallow PHARMACOR EZETIMIBE SIMVASTATIN with a glass of water.

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

They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

When to take PHARMACOR EZETIMIBE SIMVASTATIN

PHARMACOR EZETIMIBE SIMVASTATIN should be taken once a day, in the evening.

The liver produces its greatest amount of cholesterol when the body is at rest and when there is no dietary intake. For most people this is at night when asleep. Therefore, PHARMACOR EZETIMIBE SIMVASTATIN is more effective when taken in the evening. A good time would be after your evening meal. However, it does not matter whether you take it before or after food.

However, take PHARMACOR EZETIMIBE SIMVASTATIN about the same time each day.

Taking PHARMACOR EZETIMIBE SIMVASTATIN at the same time each day will have the best effect. It will also help you remember when to take your dose.

Your doctor may ask you to take PHARMACOR EZETIMIBE SIMVASTATIN with other cholesterol lowering agents such as bile acid sequestrants.

If you are taking a bile acid sequestrant, such as colestyramine, take your PHARMACOR EZETIMIBE SIMVASTATIN either at least two hours before or four hours after taking the bile acid sequestrant.

How long to take it

PHARMACOR EZETIMIBE SIMVASTATIN 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 SIMVASTATIN, your cholesterol level 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 tablet as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

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

If you have trouble remembering to take your tablet, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or 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 PHARMACOR EZETIMIBE SIMVASTATIN. Do this even if there are no signs of discomfort or poisoning.

5. What should I know while using PHARMACOR EZETIMIBE SIMVASTATIN?

Things you must do

If you become pregnant while taking PHARMACOR EZETIMIBE SIMVASTATIN, stop taking it and tell your doctor immediately.

Have your blood fats checked when your doctor says, to make sure PHARMACOR EZETIMIBE SIMVASTATIN 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.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking PHARMACOR EZETIMIBE SIMVASTATIN.

If you are about to have elective surgery, tell your doctor that you are taking PHARMACOR EZETIMIBE SIMVASTATIN.

Your doctor may suggest stopping the tablets a few days before surgery.

Things you must not do

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

Things to be careful of

Drinking alcohol

Avoid drinking large quantities of alcohol.

Drinking large quantities of alcohol may increase your chance of PHARMACOR EZETIMIBE SIMVASTATIN causing liver problems.

Grapefruit juice should be avoided while taking PHARMACOR EZETIMIBE SIMVASTATIN.

Grapefruit juice contains one or more components that alter the metabolism of some medicines, including PHARMACOR EZETIMIBE SIMVASTATIN.

Be careful driving or operating machinery until you know how PHARMACOR EZETIMIBE SIMVASTATIN affects you.

There have been side effects reported with PHARMACOR EZETIMIBE SIMVASTATIN that may affect your ability to drive or operate machinery. Individual responses to PHARMACOR EZETIMIBE SIMVASTATIN may vary.

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.

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the blister pack they may not keep well.

Keep PHARMACOR EZETIMIBE SIMVASTATIN in a cool dry place where the temperature stays below 25°C. Protect from light. Store in original packaging. Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

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 PHARMACOR EZETIMIBE SIMVASTATIN or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

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
Headache Nausea Muscle aches Dizziness Feeling tired Cough Stomach irritation Diarrhoea Decreased appetite Hot flush Hypertension Pain	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
swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing skin rash and hives raised red rash, sometimes with target-shaped lesions dark coloured urine light coloured bowel motions joint pain bleeding or bruising more easily than normal steady abdominal pain with nausea and vomiting	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.
feel tired or weak loss of appetite upper belly pain dark urine yellowing of the skin or the white of your eyes.	Tell your doctor immediately if you notice any of the following symptoms of liver problems
Depression Tingling or numbness of the hands or feet Trouble sleeping Poor memory Confusion Blurred vision and impaired vision Erectile dysfunction Breathing problems including persistent cough and/or shortness of breath, that may also occur with fatigue, unexplained weight loss or fever Gynaecomastia (breast enlargement in men) (very rare) Muscle rupture (very rare) Rash that occurs on the skin or sores in the mouth (lichenoid drug eruptions) (very rare)	These are rare side effects of ezetimibe or simvastatin.
Unexplained muscle aches, tenderness or weakness, not caused by exercise (in very rare cases this may not go away after stopping PHARMACOR EZETIMIBE SIMVASTATIN). 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 that can lead to death. You may need urgent medical attention. The risk of muscle breakdown is greater at higher doses of PHARMACOR EZETIMIBE SIMVASTATIN, particularly the 10/80 mg dose. The risk of muscle breakdown is also greater for older patients (65 years of age and older), female patients, patients with kidney problems, and patients with thyroid problems.	Tell your doctor immediately if you notice the following Symptoms

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

In adolescent patients (10 to 17 years of age) there have been no studies longer than 1 year of the effect of taking PHARMACOR EZETIMIBE SIMVASTATIN on bone development, growth, social and emotional development, or fertility.

Do not be alarmed by these lists of possible side effects. You may not experience any of them.

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 SIMVASTATIN contains

Active ingredient (main ingredient)	EZETIMIBE SIMVASTATIN 10 / 10, 10 / 20, 10 / 40, 10 / 80 mg
Other ingredients (inactive ingredients)	lactose monohydrate microcrystalline cellulose croscarmellose sodium Sodium Lauryl Sulfate hypromellose citric acid monohydrate propyl gallate Butylated Hydroxyanisole

PHARMACOR EZETIMIBE SIMVASTATIN does not contain gluten, sucrose, tartrazine or any other azo dyes.

What PHARMACOR EZETIMIBE SIMVASTATIN looks like

PHARMACOR EZETIMIBE SIMVASTATIN comes in four types of tablets:

PHARMACOR EZETIMIBE SIMVASTATIN10/10 – 10mg Ezetimibe/10mg Simvastatin:

White to off white, capsule shaped tablets debossed with “A029” on one side and plain on other side.

PHARMACOR EZETIMIBE SIMVASTATIN 10/20 – 10mg Ezetimibe/ 20mg Simvastatin:

White to off white, capsule shaped tablets debossed with “A028” on one side and plain on other side.

PHARMACOR EZETIMIBE SIMVASTATIN 10/40 – 10mg Ezetimibe/ 40mg Simvastatin:

White to off white, capsule shaped tablets debossed with “A027” on one side and plain on other side.

PHARMACOR EZETIMIBE SIMVASTATIN 10/80 – 10mg Ezetimibe/ 80mg Simvastatin:

White to off white, capsule shaped tablets debossed with “A026” on one side and plain on other side.

A starter pack of PHARMACOR EZETIMIBE SIMVASTATIN contains 10 tablets. A trade pack contains 30 tablets.

Supplier

PHARMACOR EZETIMIBE SIMVASTATIN is supplied in Australia by:

Pharmacor Pty Ltd
Suite 803, Level 8, Tower A, The Zenith, 821 Pacific Highway, Chatswood NSW 2067 Australia

Australian Register Number:

PHARMACOR EZETIMIBE SIMVASTATIN

PHARMACOR EZETIMIBE SIMVASTATIN
10/10 Blister – AUST R 299002

PHARMACOR EZETIMIBE SIMVASTATIN
10/10 Bottle – AUST R 299015

PHARMACOR EZETIMIBE SIMVASTATIN
10/20 Blister – AUST R 299009

PHARMACOR EZETIMIBE SIMVASTATIN
10/20 Bottle – AUST R 299010

PHARMACOR EZETIMIBE SIMVASTATIN
10/40 Blister – AUST R 299000

PHARMACOR EZETIMIBE SIMVASTATIN
10/40 Bottle – AUST R 299001

PHARMACOR EZETIMIBE SIMVASTATIN
10/80 Blister – AUST R 299011

PHARMACOR EZETIMIBE SIMVASTATIN
10/80 Bottle – AUST R 299007

This leaflet was prepared in 01/2024.