Description
CADIVASTĀ®Ā
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.
1. Why am I taking CADIVAST?
CADIVAST contains the active ingredient amlodipine besilate and atorvastatin calcium trihydrate. It is used to treat high blood
pressure and high cholesterol (fat in the blood) and angina (a certain type of chest pain). CADIVAST is also used to help reduce the risk of having a heart attack or stroke 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). For more information, see Section 1. Why am I taking CADIVAST? in the full CMI.
2. What should I know before I take CADIVAST?
Do not use if you have ever had an allergic reaction to CADIVAST or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become
pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take CADIVAST? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with CADIVAST and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I take CADIVAST?
CADIVAST is taken once a day. Your doctor will decide which strength is suitable for you. More instructions can be found in Section 4. How do I take CADIVAST? in the full CMI.
5. What should I know while taking CADIVAST?
Things you should do:
⢠Remind any doctor, dentist or pharmacist you visit that you are taking CADIVAST.
⢠Follow the directions from your doctor about regular testing.
Things you should not do:
⢠Do not stop taking this medicine suddenly.
⢠Do not take CADIVAST to treat any other conditions unless your doctor tells you to.
⢠Be careful driving or operating machinery until you know how CADIVAST affects you.
⢠CADIVAST may cause dizziness or drowsiness in some people and affect alertness.
⢠Avoid drinking large quantities of alcohol.
Looking after your medicine
⢠Keep your tablets in a cool dry place where the temperature stays below 25°C.
⢠Keep your tablets in the pack until it is time to take them.
⢠Keep CADIVAST where children cannot reach it.
For more information, see Section 5. What should I know while taking CADIVAST? in the full CMI.
6. Are there any side effects?
Speak to your doctor if you have any of these: headache; flushing; dizziness; tiredness or weakness; drowsiness or sleepiness; stomach pain or nausea (feeling sick); constipation, diarrhoea, wind; heartburn, indigestion; urine infection; stuffy or runny nose; nose bleeds; rash.
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you have any of these: symptoms of allergy such as skin rash, itching, swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing and breathing; shortness of breath; unexpected muscle pain, tenderness or weakness not caused by exercise (particularly if you also feel unwell or have a fever); changes in heart beat either fast, slow or irregular; chest pain; 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; severe upper stomach pain often with nausea and vomiting.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
CADIVASTĀ®
Active ingredient(s): amlodipine (as besilate) and atorvastatin (as calcium trihydrate)
Consumer Medicine Information (CMI)
This leaflet provides important information about taking
CADIVAST. You should also speak to your doctor or
pharmacist if you would like further information or if you
have any concerns or questions about taking CADIVAST.
1. Why am I taking CADIVAST?
CADIVAST contains the active ingredient amlodipine and
atorvastatin.
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.
Atorvastatin belongs to a group of medicines called statins.
It works by reducing the amount of cholesterol made by the
liver. It reduces the ‘bad’ cholesterol and can raise the ‘good’
cholesterol. Atorvastatin also helps to protect you from a
heart attack or stroke.
CADIVAST may be used alone, or in combination with other
medicines, to treat your condition.
CADIVAST is used to treat:
⢠high blood pressure and high cholesterol (fat in the
blood)
⢠angina (a certain type of chest pain)
⢠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,
CADIVAST is used to help reduce the risk of having a
heart attack or stroke.
Ask your doctor if you have any questions about why
this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
Use in children
There is not enough information to recommend the use of this
medicine for children.
Use in the elderly
If you are 65 years or older, you should be especially
careful while taking CADIVAST. 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.
What is high blood pressure?
There are usually no symptoms of high blood pressure
(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.
What is cholesterol?
Everyone has cholesterol in their 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, 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. Sometimes, the plaque can
detach from the vessel wall and float in the bloodstream; it
can then reach a smaller vessel and completely block it. 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, CADIVAST is used to treat high cholesterol
and high triglycerides together.
In most people, there are no symptoms of abnormal
cholesterol or triglyceride levels. Your doctor can measure
your levels with a simple blood test.
What is 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. CADIVAST is used to treat chronic
angina.
CADIVASTĀ®
Pregnancy and breastfeeding
2.
What should I know before I take
CADIVAST?
Warnings
Do not take CADIVAST if you:
⢠are allergic to any medicine containing amlodipine
⢠are allergic to any medicine containing atorvastatin
⢠are allergic to any of the ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic reaction may
include:
o shortness of breath
o wheezing or difficulty breathing
o swelling of the face, lips, tongue or other parts of the
body
o rash, itching or hives on the skin.
Always check the ingredients to make sure you can take
this medicine.
⢠have active liver disease
⢠are pregnant or intend to become pregnant
⢠are breastfeeding or intend to breastfeed
⢠are taking the antibiotic fusidic acid hemihydrate which is
used to treat infections
⢠are taking the antivirals glecaprevir/pibrentasvir for the
treatment of hepatitis C.
Do not give this medicine to children.
Safety and effectiveness in children have not been
established.
Do not take this medicine after the expiry date printed on the
pack or if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start taking this
medicine, talk to your doctor.
Check with your doctor if you:
⢠have or have had any of the following medical conditions:
o heart disease such as heart failure
o liver problems
o kidney problems
o muscle pain, tenderness or weakness from other
medicines used to treat cholesterol or triglycerides
o vision problems, eye muscle weakness and drooping
eyelid
o breathing problems
o 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.
⢠have allergies to any other medicines, foods,
preservatives or dyes
⢠take medicines for any other condition
⢠Tell your doctor if you are consuming alcohol
regularly.
Your doctor will ask you to have your liver function
tested before you start to take CADIVAST.
During treatment, you may be at risk of developing certain
side effects. It is important you understand these risks and
how to monitor for them. See additional information under
Section 6. Are there any side effects?
Do not take this medicine if you are pregnant or intend to
become pregnant.
Check with your doctor if you are pregnant or intend to
become pregnant.
If you are a woman of child-bearing age and are taking this
medicine, use a proven method of birth control to avoid
pregnancy.
This medicine may affect your developing baby if you take it
during pregnancy.
Do not take this medicine if you are breastfeeding or intend to breastfeed.
Talk to your doctor if you are breastfeeding or intend to
breastfeed.
This medicine may pass into breast milk and there is a
possibility that your baby may be affected.
Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above,
tell him/her before you start taking CADIVAST.
What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other
medicines, including any medicines, vitamins or supplements
that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with CADIVAST and affect
how it works.
You may need different amounts of your medicines, or you
may need to take different medicines. Your doctor will advise
you.
Tell your doctor or pharmacist if you are taking:
⢠other calcium channel blockers. These medicines include
amlodipine which is also in CADIVAST; other calcium
channel blockers include medicines with the active
ingredient felodipine or nifedipine.
⢠other statins. These medicines include atorvastatin
which is also in CADIVAST. Other statins include
medicines with active ingredient fluvastatin, pravastatin,
rosuvastatin, simvastatin or simvastatin containing
medicines.
Check with your doctor or pharmacist if you are unsure.
Tell your doctor or pharmacist if you are taking any of
the following:
⢠digoxin, a medicine used to treat some heart problems
⢠the antibiotics erythromycin, clarithromycin, rifampicin or
fusidic acid hemihydrate
⢠phenytoin, a medicine used to treat epilepsy (seizures)
⢠oral contraceptives for birth control
⢠other medicines to treat high cholesterol or triglycerides
(fats)
⢠other medicines to treat high blood pressure
⢠some medicines to treat low potassium
⢠ciclosporin, tacrolimus, sirolimus or everolimus,
medicines used to suppress the immune system
⢠temsirolimus, a medicine used to treat kidney cancer
⢠some medicines used to treat some fungal infections,
such as ketoconazole or itraconazole
CADIVASTĀ®
⢠protease inhibitors for the treatment of HIV infections
and/or Hepatitis C, such as efavirenz, fosamprenavir,
ritonavir, boceprevir, telaprevir, tipranavir/ritonavir,
elbasvir/grazoprevir and simprevir
⢠HCV non-structural protein 5A (NS5A)/5B (NS5B)
inhibitors such as daclatasvir and ledipasvir
⢠letermovir
⢠diltiazem, a medicine used to treat angina
⢠antacids, medicines used to treat reflux or ulcers
⢠spironolactone, a medicine used to treat high blood
pressure and certain types of swelling
⢠vitamin B3
⢠colchicine, a medicine used to treat a disease with
painful swollen joints caused by uric acid crystals
⢠ticagrelor, a medicine used to prevent blood clots.
It is also possible that CADIVAST may be affected by some
medicines used to treat heart palpitations (or arrhythmias)
and St John’s Wort.
If you have not told your doctor about any of the above,
tell him/her before you start taking CADIVAST.
Your doctor and pharmacist have more information on
medicines to be careful with or avoid while taking CADIVAST.
Check with your doctor or pharmacist if you are not sure
about what medicines, vitamins or supplements you are
taking and if these affect CADIVAST.
