Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about CADUET.
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 CADUET 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 CADUET is used for
CADUET is used to treat high blood pressure and high cholesterol (fat in the blood). CADUET can also be used for angina (a certain type of chest pain) and high cholesterol levels. CADUET can be used in people who have high blood pressure and coronary heart disease (CHD) or who are at risk of CHD (for example, if they have diabetes, a history of stroke, or small blood vessel disease). In these people, CADUET is used to help reduce the risk of having a heart attack or stroke.
CADUET is able to treat these conditions because it contains a combination of two medicines. One is amlodipine and the other is atorvastatin.
Amlodipine is used to lower high blood pressure (hypertension). There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems.
Amlodipine belongs to a group of medicines called calcium channel blockers. They work by relaxing your blood vessels, making it easier for your heart to pump blood around the body and help increase the supply of blood and oxygen to your heart. Calcium channel blockers do not change the amount of calcium in your blood or bones.
Amlodipine is also used to treat angina. Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms or neck, and sometimes to the shoulders and back. The pain of angina is due to a shortage of oxygen to the heart. Amlodipine is not for the relief of a sudden attack of angina. Your doctor will have given you other medication to treat this.
Atorvastatin, the other medicine in CADUET, belongs to a group of medicines called HMG-CoA reductase inhibitors and is used to lower high cholesterol.
Everyone has cholesterol in his or her blood. It is a type of blood fat needed by the body for things such as building cell lining, making bile acids (which help to digest food) and some hormones. However, too much cholesterol can be a problem.
Cholesterol is present in many foods and is also made in your body by the liver. If your body makes too much cholesterol or you take too much cholesterol in your diet, then your level becomes too high.
High cholesterol is more likely to occur with certain diseases or if you have a family history of high cholesterol.
There are different types of cholesterol. LDL, or low-density lipoprotein, is the 'bad' cholesterol that can block your blood vessels. HDL, or high-density lipoprotein, cholesterol is the 'good' cholesterol that is thought to remove the bad cholesterol from the blood vessels.
When you have high levels of 'bad' cholesterol in your blood, it may begin to 'stick' to the inside of your blood vessels instead of being carried to the parts of the body where it is needed. Over time, this can form hard areas, also called plaque, on the walls of your blood vessels, making it more difficult for the blood to flow. This blocking of your blood vessels can lead to several types of blood vessel disease, heart attack, angina and stroke.
There is another type of blood fat called triglyceride that is a source of energy. However, high levels of triglyceride can be associated with a low level of 'good' cholesterol and may increase your risk of heart disease.
In some patients, atorvastatin is used to treat high cholesterol and high triglycerides together.
When you are taking CADUET, you also need to follow a low fat diet. Your doctor may suggest other ways to help control your condition such as exercise, weight control and stopping smoking.
In most people, there are no symptoms of abnormal cholesterol or triglyceride levels. Your doctor can measure your levels with a simple blood test.
Ask your doctor if you have any questions about why CADUET has been prescribed for you. Your doctor may have prescribed CADUET for another reason.
CADUET is not addictive.
This medicine is only available with a doctor's prescription.
Before you take CADUET
When you must not take it
Do not take CADUET if:
You are taking other calcium channel blockers. These medicines include amlodipine (as Norvasc) as this is also in CADUET; other calcium channel blockers are felodipine (Plendil ER, Agon SR, Felodur ER), or nifedipine (Adalat, Adalat Oros, Nifecard, Nifedipine-BC, Nifehexal, Nyefax, SBPA Nifedipine). (Not all brands are given). Check with your doctor or pharmacist if you are unsure
You are taking other HMG-CoA reductase inhibitors. These medicines include atorvastatin (as Lipitor) as this is also in CADUET. Other HMG-CoA reductase inhibitors are fluvastatin (Lescol, Vastin), pravastatin (Pravachol), simvastatin Lipex, Zocor) or simvastatin containing medicines (Vytorin). (Not all brands are given). Check with your doctor or pharmacist if you are unsure
you have ever had an allergic reaction to CADUET or other calcium channel blockers
You have ever had an allergic reaction to CADUET or other HMG-CoA reductase inhibitors used to lower cholesterol
You are allergic to any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction to CADUET may include a skin rash similar to hives, itchiness, shortness of breath, swelling of the face, lips or tongue
you are pregnant or breastfeeding. Your baby may absorb this medicine in the womb or from breast milk and therefore there is a possibility of harm to the baby
you have active liver disease
you have had muscle pain, tenderness or weakness from other medicines used to treat high cholesterol or triglycerides
CADUET is not recommended for use in children, as there are no studies of its effects in children.
If you are not sure whether you should be taking CADUET, talk to your doctor.
Do not take CADUET if:
the packaging shows signs of tampering or does not look quite right
the expiry date marked on the packaging has passed, even though the tablets may look all right
If it has expired or is damaged, return it to your pharmacist for disposal.
Before you start to take it
Tell your doctor if:
you have any health/medical problems, including:
heart disease such as heart failure
muscle pain, tenderness or weakness from other medicines used to treat cholesterol or triglycerides
a type of stroke called a haemorrhagic stroke or a type of stroke called a lacunar stroke
This medicine may increase the risk of you having another haemorrhagic stroke.
If you have not told your doctor about any of these medical conditions, tell him/her before you take CADUET.
Tell your doctor:
If you are consuming alcohol regularly
you are allergic to any foods, dyes, preservatives or any other medicines
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines and CADUET may interfere with each other.
These include the following:
digoxin, a medicine used to treat some heart problems
the antibiotics erythromycin, clarithromycin and rifampicin
phenytoin, a medicine used to treat epilepsy
oral contraceptives for birth control
other medicines to treat high cholesterol or triglycerides
cyclosporin, a medicine used to suppress the immune system
some medicines used to treat some fungal infections
efavirenz and protease inhibitors for the treatment of HIV infection
diltiazem, a medicine used to treat angina
These medicines may be affected by CADUET or may affect how well it works. Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking CADUET.
If you have not told your doctor about any of the above, tell him/her before you take CADUET.
Avoid drinking large quantities of grapefruit juice. Grapefruit juice contains one or more components that alter the metabolism of some medicines, including CADUET.
Drinking very large quantities (over 1.2 litres) of grapefruit juice each day increases your chance of CADUET causing side effects.
It is also possible that CADUET may be affected by some medicines used to treat heart palpitations (or arrhythmias) and St John's Wort.
How to take CADUET
Take CADUET exactly as your doctor has prescribed.
Follow all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box ask your doctor or pharmacist for help.
How much to take
Your doctor will decide the dose you should take. This will depend on your blood pressure, cholesterol and triglyceride levels.
CADUET is available in eight strengths; CADUET 5mg/10mg, CADUET 5mg/20mg, CADUET 5mg/40mg, CADUET 5mg/80mg, CADUET 10mg/10mg, CADUET 10mg/20mg, CADUET 10mg/40mg and CADUET 10mg/80mg. Your doctor will start you on one of these tablet strengths. Your doctor may need to adjust this dose after your blood pressure and cholesterol and fat levels in your blood have been checked. It is important that you keep your appointment to have these tests done.
How to take it
Swallow the tablet whole with a full glass of water.
Take your tablet once a day at about the same time each day, either morning or evening. Taking your tablet at the same time each day will have the best effect. It will also help you to remember when to take it.
CADUET can be taken with or without food.
How long to take it
You must take CADUET every day. Continue taking your medicine for as long as your doctor tells you. CADUET helps to lower cholesterol levels and blood pressure and control the symptoms of angina but does not cure your condition.
You may have to take this kind of medicine for the rest of your life.
If you stop taking CADUET, your blood pressure and cholesterol levels may rise again.
If you forget to take it
If you miss a dose and it is less than 12 hours from when you should take it, take it straight away, and then continue as normal the next day. Otherwise, skip that day's dose but be sure to take the next day's dose when it is due.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of getting an unwanted side effect.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre - the telephone number is 131 126 or go to Accident and Emergency (Casualty) at your nearest hospital if you think you or anyone else may have taken too much CADUET. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep telephone numbers of these facilities handy.
If you take too many tablets, you may feel dizzy, lightheaded or faint and have an irregular heartbeat.
While you are using it
Things you must do
Have your cholesterol and triglyceride levels checked when your doctor says. This helps to make sure that CADUET is working.
Tell any other doctors, dentists and pharmacists who are treating you that you are taking CADUET.
If you are about to start any new medicine, tell your doctor or pharmacist that you are taking CADUET.
If you become pregnant while taking CADUET tell your doctor immediately.
Things you must not do
Do not take CADUET to treat any other conditions unless your doctor says to.
Do not give this medicine to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery until you know how CADUET affects you. CADUET may cause dizziness or drowsiness in some people and affect alertness.
If this occurs, do not drive, operate machinery or do things that could be dangerous if you are not alert.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CADUET. CADUET helps most people but it may have some 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.
Do not be alarmed by the list of possible side effects. You may not experience any of them.
Tell your doctor if you experience any of the following and they worry you:
swelling of the ankles, feet, face or hands
drowsiness or sleepiness
stomach pain or nausea
constipation, diarrhoea, wind
heartburn or indigestion
These are the more common side effects of CADUET.
Tell your doctor immediately or go to the casualty department of your nearest hospital if you notice any of the following.
swelling of the face, lips, mouth throat or neck which may cause difficulty in swallowing and breathing
unexpected muscle pain, tenderness or weakness not caused by exercise
tingling in the hands or feet
changes in heart beat either fast or slow
shortness of breath
symptoms of allergy such as skin rash, itching
symptoms of liver disease such as itching, yellowing of the skin and eyes, and dark coloured urine
These are rare, possibly serious side effects. Your may need urgent medical attention.
Tell your doctor if you experience any of the following:
feeling nervous, depressed or moody
changes in vision or sight
loss or thinning of hair
ringing in the ears
These may or may not be due to CADUET but you should tell your doctor if they worry you.
Tell your doctor if you notice any other effects. This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.
If you notice any other symptoms that worry you, check with your doctor.
Ask your doctor or pharmacist if you don't understand anything in this list.
If you are 65 years or older, you should be especially careful while taking CADUET. Report any side effects promptly to your doctor. Some people in this age group may be more likely to experience side effects such as swelling of the feet and ankles, muscle cramps and dizziness.
After taking CADUET
Keep your tablets in the pack until it is time to take them. If you take your tablets out of the pack they will not keep as well.
Keep your tablets in a cool dry place where temperatures stay below 30 °C.
Do not store CADUET or any other medicine in the bathroom or near a sink.
Do not leave your medicines on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep CADUET 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.
If your doctor tells you to stop taking CADUET, or the tablets have passed their expiry date, ask your pharmacist what to do with any left over.
What it looks like
CADUET Tablets are available in eight strengths:
CADUET 5 mg/10mg - white, oval, film coated tablets debossed with "Pfizer" on one side and "CDT"and "051" on the other
CADUET 5 mg/20 mg - white, oval, film coated tablets debossed with "Pfizer" on one side and "CDT" and "052" on the other
CADUET 5 mg/40mg - white, oval, film coated tablets debossed with "Pfizer" on one side and "CDT" and "054" on the other
CADUET 5 mg/80 mg - white, oval, film coated tablets debossed with "Pfizer" on one side and CDT and "058" on the other
CADUET 10mg/10 mg - blue, oval, film coated tablets debossed with "Pfizer" on one side and "CDT" and "101" on the other
CADUET 10 mg/20 mg blue, oval, film coated tablets debossed with "Pfizer" on one side and "CDT" and "102" on the other
CADUET 10 mg/40 mg blue, oval, film coated tablets debossed with "Pfizer" on one side and "CDT" and "104" on the other
CADUET 10 mg/80 mg. blue, oval, film coated tablets debossed with "Pfizer" on one side and "CDT" and "108" on the other
A box contains 30 tablets.
CADUET 5 mg/10 mg Tablets contain amlodipine besylate equivalent to amlodipine 5 mg and atorvastatin calcium equivalent to atorvastatin 10mg
CADUET 5 mg/20 mg Tablets contain amlodipine besylate equivalent to amlodipine 5 mg and atorvastatin calcium equivalent to atorvastatin 20 mg
CADUET 5 mg/40 mg Tablets contain amlodipine besylate equivalent to amlodipine 5 mg and atorvastatin calcium equivalent to atorvastatin 40 mg
CADUET 5 mg/80 mg Tablets contain amlodipine besylate equivalent to amlodipine 5 mg and atorvastatin calcium equivalent to atorvastatin 80 mg
CADUET 10 mg/10 mg Tablets contain amlodipine besylate equivalent to amlodipine 10 mg and atorvastatin calcium equivalent to atorvastatin 10mg
CADUET 10 mg/20 mg Tablets contain amlodipine besylate equivalent to amlodipine 10 mg and atorvastatin calcium equivalent to atorvastatin 20 mg
CADUET 10 mg/40 mg Tablets contain amlodipine besylate equivalent to amlodipine 10 mg and atorvastatin calcium equivalent to atorvastatin 40 mg
CADUET 10 mg/80 mg Tablets contain amlodipine besylate equivalent to amlodipine 10 mg and atorvastatin calcium equivalent to atorvastatin 80 mg
Inactive Ingredient The inactive ingredients are:
colloidal silicon dioxide (anyhydrous)
Opadry II complete film coating system 85F28751 White
Opadry II complete film coating system 85F10919 Blue
CADUET does not contain gluten, sugar or lactose.
CADUET is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 5000 8422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free Number: 1800 675 229
Australian Registration Numbers:
CADUET 5mg/10mg - AUST R 100695
CADUET 5mg/20mg - AUST R 100696
CADUET 5mg/40mg - AUST R 100697
CADUET 5mg/80mg - AUST R 100698
CADUET 10mg/10mg - AUST R 100700
CADUET 10mg/20mg - AUST R 100701
CADUET 10mg/40mg - AUST R 100702
CADUET 10mg/80mg - AUST R 100703
This leaflet was prepared July 2008
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