Ezetimibe/Simvastatin
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about ZEKLEN. 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 ZEKLEN 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 ZEKLEN is used for
ZEKLEN 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.
Triglycerides
Triglycerides are another form of fat in your blood that may increase your risk for heart disease.
How ZEKLEN works
ZEKLEN reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol.
ZEKLEN works by decreasing the absorption of cholesterol in the small intestine and by reducing the amount of cholesterol made in the liver. ZEKLEN does not help you lose weight.
Your doctor may have prescribed ZEKLEN for another reason. Ask your doctor if you have any questions about why ZEKLEN has been prescribed for you.
ZEKLEN is not addictive.
Use in Children and Adolescents
ZEKLEN 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).
ZEKLEN 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 ZEKLEN is suitable for your child. Depending on the pubertal development of your child, ZEKLEN may not be suitable for him or her.
Before you take ZEKLEN
When you must not take it
Do not take ZEKLEN if:
you have an allergy to ZEKLEN 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.
you are pregnant or breast feeding.
ZEKLEN 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 ZEKLEN, talk to your doctor.
Before you start to take it
Tell your doctor if:
1. you are pregnant or intend to become pregnant.
ZEKLEN should not be used during pregnancy.
2. you are breast-feeding.
ZEKLEN 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.
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.
If you have not told your doctor about any of the above, tell them before you take any ZEKLEN.
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 ZEKLEN. 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 ZEKLEN temporarily or permanently.
Some medicines and ZEKLEN may interfere with each other. These include:
certain hepatitis C antiviral agents, such as elbasvir, or grazoprevir
bile acid sequestrants, such as cholestyramine, 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)
These medicines may be affected by ZEKLEN, may affect how well it works, or may increase the risk of side effects with ZEKLEN. 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 ZEKLEN.
You should also tell any doctor who is prescribing a new medication for you that you are taking ZEKLEN.
How to take ZEKLEN
How much to take
Take ZEKLEN only when prescribed by your doctor.
The recommended dose in adults (18 years and over) is one ZEKLEN 10/10, 10/20, 10/40 or 10/80 tablet once a day, in the evening. Your doctor will adjust your ZEKLEN dose depending on your response.
The recommended dose in adolescents (10 to 17 years of age) with familial hypercholesterolaemia is one ZEKLEN 10/10, 10/20 or 10/40 tablet once a day, in the evening. The maximum recommended dose in adolescents is 10/40 mg.
Because of the increased risk of muscle problems, the ZEKLEN 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 ZEKLEN 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 it
ZEKLEN 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, ZEKLEN 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 ZEKLEN about the same time each day.
Taking ZEKLEN 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 ZEKLEN with other cholesterol lowering agents such as bile acid sequestrants.
If you are taking a bile acid sequestrant, such as cholestyramine, take your ZEKLEN either at least two hours before or four hours after taking the bile acid sequestrant.
How long to take it
ZEKLEN 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 ZEKLEN, 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 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 ZEKLEN. Do this even if there are no signs of discomfort or poisoning.
While you are using ZEKLEN
Things you must do
If you become pregnant while taking ZEKLEN, stop taking it and tell your doctor immediately.
Have your blood fats checked when your doctor says, to make sure ZEKLEN 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 ZEKLEN.
If you are about to have elective surgery, tell your doctor that you are taking ZEKLEN.
Your doctor may suggest stopping the tablets a few days before surgery.
Things you must not do
Do not give ZEKLEN 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 may increase your chance of ZEKLEN causing liver problems.
Grapefruit juice should be avoided while taking ZEKLEN.
Grapefruit juice contains one or more components that alter the metabolism of some medicines, including ZEKLEN.
Be careful driving or operating machinery until you know how ZEKLEN affects you.
There have been side effects reported with ZEKLEN that may affect your ability to drive or operate machinery. Individual responses to ZEKLEN 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.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ZEKLEN.
ZEKLEN 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.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor immediately or go to accident and emergency at your nearest hospital, if you notice any of the following:
swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing
These are serious side effects. If you have them, you may have had a serious allergic reaction to ZEKLEN. You may need urgent medical attention or hospitalisation. Serious side effects are rare.
Tell your doctor immediately if you notice any of the following:
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.
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.
Liver problems can also occur and may be serious. Your doctor may do blood tests to check your liver
Tell your doctor immediately if you notice any of the following symptoms of liver problems:
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 the following:
unexplained muscle aches, tenderness or weakness, not caused by exercise (in very rare cases this may not go away after stopping ZEKLEN).
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 ZEKLEN, 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.
Serious side effects are rare.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.
Tell your doctor if you notice any of the following:
Headache
Nausea
Muscle aches
Dizziness
Feeling tired
Cough
Stomach irritation
Diarrhoea
Decreased appetite
Hot flush
Hypertension
Pain
These are the more common side effects of ZEKLEN or of either ezetimibe or simvastatin.
Tell your doctor if you notice any of the following:
Depression
Tingling or numbness of the hands or feet
Trouble sleeping
Poor memory
Confusion
Erectile dysfunction
Breathing problems including persistent cough and/or shortness of breath, that may also occur with fatigue, unexplained weight loss or fever
These are rare side effects of ezetimibe or simvastatin.
In adolescent patients (10 to 17 years of age) there have been no studies longer than 1 year of the effect of taking ZEKLEN 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.
After using ZEKLEN
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 ZEKLEN in a cool dry place where the temperature stays below 25°C. 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 ZEKLEN or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
ZEKLEN comes in four types of tablets:
ZEKLEN 10/10 - 10mg Ezetimibe/10mg Simvastatin: White to off-white, capsule shaped, biconvex compressed tablet marked with "311".
ZEKLEN 10/20 - 10mg Ezetimibe/ 20mg Simvastatin: White to off-white, capsule shaped, biconvex compressed tablet marked with "312".
ZEKLEN 10/40 - 10mg Ezetimibe/ 40mg Simvastatin: White to off-white, capsule shaped, biconvex compressed tablet marked with "313".
ZEKLEN 10/80 - 10mg Ezetimibe/ 80mg Simvastatin: White to off-white, capsule shaped, biconvex compressed tablet marked with "315".
A starter pack of ZEKLEN contains 5 or 10 tablets. A trade pack contains 30 tablets.
Ingredients
Active ingredient:
ZEKLEN 10/10 -
10mg ezetimibe/10mg simvastatin per tablet
ZEKLEN 10/20 -
10mg ezetimibe/20mg simvastatin per tablet
ZEKLEN 10/40 -
10mg ezetimibe/ 40mg simvastatin per tablet
ZEKLEN 10/80 -
10mg ezetimibe/ 80mg simvastatin per tablet
Inactive ingredients:
butylated hydroxyanisole
citric acid monohydrate
croscarmellose sodium
hypromellose
lactose monohydrate
magnesium stearate
microcrystalline cellulose
propyl gallate
ZEKLEN does not contain gluten, sucrose, tartrazine or any other azo dyes.
