Caduet 10/10mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMLODIPINE, ATORVASTATIN

Available from:

Pfizer Hellas S.A.

ATC code:

C10BX03

INN (International Name):

AMLODIPINE, ATORVASTATIN

Pharmaceutical form:

FILM-COATED TABLET

Composition:

AMLODIPINE 10 milligram(s) ; ATORVASTATIN 10 milligram(s)

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2006-05-26

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET
Page 2 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
CADUET 5 MG/10 MG AND 10 MG/10 MG FILM-COATED TABLETS
Amlodipine besilate/Atorvastatin calcium trihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Caduet is and what it is used for
2.
What you need to know before you take Caduet
3.
How to take Caduet
4.
Possible side effects
5.
How to store Caduet
6.
Contents of the pack and other information
1.
WHAT CADUET IS AND WHAT IT IS USED FOR
Caduet is used to prevent cardiovascular events (e.g. angina, heart
attacks) in patients with high
blood pressure, who have additional cardiovascular risk factors such
as smoking, being overweight,
increased blood cholesterol, a family history of heart disease, or
diabetes. The existence of such risk
factors associated with high blood pressure puts patients at an
increased risk of having
cardiovascular events.
Caduet is a product that contains two active ingredients amlodipine
(calcium antagonist) and
atorvastatin (statin) and is to be used when your doctor considers it
appropriate to use both
medications. Amlodipine is used to treat high blood pressure
(hypertension) and atorvastatin lowers
cholesterol.
High blood pressure (hypertension) is a medical condition when blood
pressure is persistently found
to be abnormally high and is one of the risk factors for
cardiovascular events (angina, heart attack,
stroke).
Cholesterol is a naturally occurring substance in the body necessary
for normal growth. However, if
ther

Summary of Product characteristics

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 24
1. NAME OF THE MEDICINAL PRODUCT
CADUET 10 mg/10 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besilate) and 10 mg
atorvastatin (as atorvastatin calcium trihydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
Blue film-coated tablets, oval shape, debossed with ‘Pfizer’ on
one side and CDT 101 on the other
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CADUET is indicated for prevention of cardiovascular events in
hypertensive patients, with three
concomitant cardiovascular risk factors normal to mildly elevated
cholesterol levels, without
clinically evident coronary heart disease where combined use of
amlodipine and a low dose of
atorvastatin is considered appropriate, in accordance with current
treatment guidelines (see section
5.1)
CADUET should be used when response to diet and other non
pharmacological measures is
inadequate
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CADUET is for oral use.
The usual starting dose is 5 mg/10 mg once daily.
If a patient is identified as needing greater blood pressure control,
10 mg/10 mg once daily can be
administered.
Doses may be taken at any time of day with or without food.
CADUET can be used either alone or in combination with
anti-hypertensive drugs, but should not
be taken in combination with another calcium channel blocker, or
another statin.
_Renal impairment _
No dose adjustment is required in patients with impaired renal
function (see section 4.4 and section
5.2).
Page 3 of 24
_Hepatic impairment _
CADUET is contra-indicated in patients with active liver disease (see
section 4.3).
_Paediatric population_
Safety and efficacy of CADUET have not been established in children
and adolescents. Therefore,
the use of CADUET is not recommended in these populations.
_Elderly patients _
It is unnecessary to adjust the dose in elderly patients (see section
5.