CADATIN

Main information

  • Trade name:
  • CADATIN 10/40
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CADATIN 10/40
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 179142
  • Last update:
  • 14-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179142

CADATIN 10/40 amlodipine (as besilate) and atorvastatin (as calcium) 10mg/40mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

11/07/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. CADATIN 10/40

Product Type

Single Medicine Product

Effective date

14/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

CADATIN (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses

presented. The indications for amlodipine are: 1. Hypertension: Amlodipine is indicated for the first line treatment of hypertension and can be used as the

sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from

the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting

enzyme inhibitor. 2. Angina: Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy

or in combination with other antianginal drugs. The indications for atorvastatin are: 1. Atorvastatin is indicated as an adjunct to diet for the treatment of

patients with hypercholesterolaemia. Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled

diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be

identified and treated. 2. Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include

diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see Clinical Trials, Prevention of

cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. These effects do not replace the need to independently

control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

blue oval film-coated tablets debossed with "Pfizer" on one side and "CDT"

and "104" on the other.

Active Ingredients

amlodipine besilate

13.87 mg

Atorvastatin calcium

43.4 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 09:19:43 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Public Summary

Page 2 of

Produced at 29.11.2017 at 09:19:43 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

CADATIN™

5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40 and 10/80

Amlodipine Besilate and Atorvastatin Calcium

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Cadatin.

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 Cadatin

against the benefits it is expected to

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 Cadatin is used

for

Cadatin is used to treat high blood

pressure and high cholesterol (fat in

the blood). Cadatin can also be used

for angina (a certain type of chest

pain). Cadatin 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, Cadatin is

used to help reduce the risk of having

a heart attack or stroke.

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, Cadatin 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. Cadatin is used

to treat chronic angina.

How Cadatin works

Cadatin contains a combination of

two medicines. One is amlodipine

and the other is 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

CADATIN™

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.

Ask your doctor if you have any

questions about why Cadatin has

been prescribed for you.

Your doctor may have prescribed it

for another reason.

Cadatin is not addictive.

This medicine is available only with

a doctor's prescription.

Use in Children

There is not enough information to

recommend the use of this medicine

in children.

Before you take

Cadatin

When you must not take it

Do not take Cadatin if you have an

allergy to:

any medicine containing

amlodipine

any medicine containing

atorvastatin

any of the ingredients listed at the

end of this leaflet.

Some of the symptoms of an

allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

Do not take Cadatin if you have

active liver disease.

Do not take this medicine 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

unborn developing baby if you take it

during pregnancy.

Do not take this medicine if you

are breastfeeding or intend to

breastfeed.

This medicine passes into breast milk

and may affect your baby.

Do not take Cadatin if you are

taking the antibiotic fusidic acid

which is used to treat infections.

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 it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking Cadatin, talk to

your doctor.

Before you start to take it

Your doctor will ask you to have

your liver function tested before you

start to take Cadatin.

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

heart problems, including heart

failure

liver problems

kidney problems

muscle pain, tenderness or

weakness from other medicines

used to treat cholesterol or

triglycerides

breathing problems

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.

Tell your doctor if you are

consuming alcohol regularly.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Cadatin.

Taking other medicines

Tell your doctor or pharmacist if:

you are taking other calcium

channel blockers. These

medicines include amlodipine

which is also in Cadatin; other

calcium channel blockers include

medicines with the active

ingredient felodipine or

nifedipine. Check with your

doctor or pharmacist if you are

unsure.

you are taking other statins.

These medicines include

atorvastatin which is also in

Cadatin. Other statins include

medicines with the 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 other

medicines, including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

Cadatin or may affect how well 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 any of the

following:

digoxin, a medicine used to treat

some heart problems

CADATIN™

the antibiotics erythromycin,

clarithromycin, rifampicin or

fusidic acid

phenytoin, a medicine used to

treat epilepsy (seizures)

oral contraceptives for birth

control

other medicines to treat high

cholesterol or triglycerides

other medicines to treat high

blood pressure

some medicines to treat low

potassium

cyclosporin, 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

protease inhibitors for the

treatment of HIV infection and or

Hepatitis C, such as efavirenz,

fosamprenavir, ritonavir and

boceprevir

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.

It is also possible that Cadatin may

be affected by some medicines used

to treat heart palpitations (or

arrhythmias) and St John's Wort.

Your doctor and pharmacist have

more information on medicines to be

careful with or to avoid while taking

Cadatin.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Cadatin.

How to take Cadatin

Take Cadatin exactly as your

doctor has prescribed.

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

Your doctor may discuss with you

the need to be on a diet.

Follow your agreed diet plan

carefully.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

Cadatin is taken once a day. Your

doctor will decide which strength is

suitable for you. This will depend on

your blood pressure, cholesterol and

triglyceride levels.

Your doctor may need to adjust your

dose after your blood pressure and

the fat levels in your blood have been

checked. It is important that you keep

your appointments to have these tests

done.

How to take it

Swallow the tablet whole with a

full glass of water.

Do not chew or crush the tablets.

When to take it

Take your medicine once a day at

about the same time each day,

either morning or evening.

Taking it at the same time each day

will have the best effect. It will also

help you to remember when to take

Cadatin can be taken with or without

food.

How long to take it

Take Cadatin every day and

continue taking it for as long as

your doctor tells you.

Cadatin helps to lower cholesterol

levels and blood pressure and control

the symptoms of angina but it does

not cure your condition.

It is important to keep taking your

medicine even if you feel well. If you

stop taking Cadatin, your blood

pressure and cholesterol levels may

rise again.

If you forget to take it

If it is less than 12 hours before

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 medicine 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 an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

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 -

for advice, or go to Accident and

Emergency at the nearest hospital

if you think you or anyone else

may have taken too much Cadatin.

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.

CADATIN™

While you are taking

Cadatin

Things you must do

Keep all of your doctor's

appointments so that your progress

can be checked.

Follow the directions from your

doctor about regular testing.

Your cholesterol and triglyceride

levels and your liver function tests

need to be checked regularly while

you are taking this medicine.

This helps to make sure that Cadatin

is working and to avoid some

possible side-effects.

Your blood pressure may also be

checked regularly.

Tell any other doctors, dentists and

pharmacists who treat you that

you are taking Cadatin.

If you are about to start any new

medicine, tell your doctor or

pharmacist that you are taking

Cadatin.

If you become pregnant while

taking Cadatin, stop taking it and

tell your doctor immediately.

Things you must not do

Do not take Cadatin to treat any

other conditions unless your doctor

tells you to.

Do not give this medicine 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 Cadatin may increase

your chance of getting liver

problems.

Avoid eating large quantities of

grapefruit or drinking large

quantities of grapefruit juice.

Grapefruit juice contains one or more

components that alter the metabolism

of some medicines, including

Cadatin.

Drinking very large quantities (over

1.2 litres) of grapefruit juice each day

while taking Cadatin increases your

chance of getting side effects.

Be careful driving or operating

machinery until you know how

Cadatin affects you.

This medicine may cause dizziness

or drowsiness in some people and

affect alertness.

If you have any of these symptoms,

do not drive, operate machinery or

do anything else that could be

dangerous.

Things that would be helpful

for your condition

Some self-help measures suggested

below may assist your condition.

Your doctor or pharmacist can give

you more information about these

measures.

Weight: While you are taking

Cadatin, you may need to follow

a diet plan agreed to with your

doctor. This may include

measures to lose some weight.

Exercise: Regular exercise can

help lower your cholesterol levels

and blood pressure and can

strengthen your heart. It is

important not to overdo it. Before

commencing regular exercise you

should consult your doctor who

will suggest the most suitable

exercise for you. If you

experience any discomfort when

exercising, see your doctor.

Alcohol: Excessive alcohol intake

can raise your cholesterol levels

or affect your liver function,

which could increase the chance

of you getting unwanted side

effects. Your doctor may discuss

with you whether you should

reduce the amount of alcohol you

drink.

Smoking: Smoking increases the

risk of you suffering from heart

problems. Your doctor may

advise you to stop smoking.

Salt: Your doctor may advise you

to watch the amount of salt in

your diet. To reduce your salt

intake, avoid using salt at the

table or in cooking.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Cadatin.

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.

It can be difficult to tell whether side

effects are the result of taking

Cadatin, effects of your condition or

side effects of other medicines you

may be taking. For this reason it is

important to tell your doctor of any

change in your condition.

Do not be alarmed by the list of

possible side effects.

You may not experience any of them.

Tell your doctor if...

Ask your doctor or pharmacist for

advice if you experience any of the

following and they worry you:

headache

flushing

dizziness

tiredness or weakness

drowsiness or sleepiness

stomach pain or nausea (feeling

sick)

constipation, diarrhoea, wind

heartburn, indigestion or wind

urine infection

headache

stuffy or runny nose

nose bleeds

rash.

These are the more common side

effects of Cadatin. All side effects

should be reported to a health

professional.

CADATIN™

Tell your doctor as soon as

possible if...

Tell your doctor as soon as possible

if you notice any of the following:

swelling of the ankles, feet, face

or hands

muscle and joint pain, muscle

weakness

symptoms of liver disease such as

itching, yellowing of the skin and

eyes and dark coloured urine

feeling weak and tired,

excessively thirsty and passing

more urine

dizziness or lightheadedness on

standing up from a sitting or lying

position

problems with breathing,

including shortness of breath,

persistent cough and fever

eye pain or change in vision

changes in mood, feeling anxious

or nervous.

These are serious side effects that

may require medical attention.

Go to hospital if...

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

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

tingling in the hands or feet

changes in heartbeat either fast,

slow or irregular

chest pain associated with

exertion (angina) that lasts longer,

is more severe or occurs more

often

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.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Other side effects not listed above

may also occur in some people.

Ask your doctor or pharmacist to

answer any questions you may

have.

If you are 65 years or older, you

should be especially careful while

taking Cadatin. 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.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking Cadatin

Storage

Keep your tablets in the pack until

it is time to take them.

If you take your tablets out of the

pack they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store Cadatin 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 Cadatin 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 Cadatin, or the tablets have

passed their expiry date, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

Cadatin Tablets are available in eight

strengths:

Cadatin 5/10 - white, oval, film

coated tablets debossed with

"Pfizer" on one side and "CDT"

and "051" on the other

Cadatin 5/20 - white, oval, film

coated tablets debossed with

"Pfizer" on one side and "CDT"

and "052" on the other

Cadatin 5/40 - white, oval, film

coated tablets debossed with

"Pfizer" on one side and "CDT"

and "054" on the other

Cadatin 5/80 - white, oval, film

coated tablets debossed with

"Pfizer" on one side and "CDT"

and "058" on the other

Cadatin 10/10 - blue, oval, film

coated tablets debossed with

"Pfizer" on one side and "CDT"

and "101" on the other

Cadatin 10/20 - blue, oval, film

coated tablets debossed with

"Pfizer" on one side and "CDT"

and "102" on the other

Cadatin 10/40 - blue, oval, film

coated tablets debossed with

"Pfizer" on one side and "CDT"

and "104" on the other

Cadatin 10/80 - blue, oval, film

coated tablets debossed with

CADATIN™

"Pfizer" on one side and "CDT"

and "108" on the other.

A box contains 30 tablets.

Ingredients

Active ingredients

Cadatin tablets contain the following

strength combinations of the active

ingredients amlodipine/atorvastatin:

5 mg/10 mg

5 mg/20 mg

5 mg/40 mg

5 mg/80 mg

10 mg/10 mg

10 mg/20 mg

10 mg/40 mg

10 mg/80 mg.

Other ingredients

Cadatin tablets also contain:

calcium carbonate

croscarmellose sodium

microcrystalline cellulose

pregelatinised maize starch

polysorbate 80

hyprolose

colloidal silicon dioxide

(anhydrous)

magnesium stearate

Opadry II complete film coating

system 85F28751 White or

Opadry II complete film coating

system 85F10919 Blue.

Cadatin does not contain gluten,

sugar or lactose.

Supplier

Cadatin is supplied in Australia by:

Pfizer Australia Pty Ltd

ABN 5000 8422 348

38-42 Wharf Road

West Ryde NSW 2114

Australia

Toll Free Number: 1800 675 229

Australian Registration

Numbers

Cadatin 5/10 - AUST R 179136

Cadatin 5/20 - AUST R 179137

Cadatin 5/40 - AUST R 179138

Cadatin 5/80 - AUST R 179139

Cadatin 10/10 - AUST R 179140

Cadatin 10/20 - AUST R 179141

Cadatin 10/40 - AUST R 179142

Cadatin 10/80 - AUST R 179144

Date of preparation

This leaflet was prepared in August

2017.

™ Trademark

© Pfizer Australia Pty Ltd 2017

CADATIN™