CADUET 5 mg/10 mg film-coated tablets

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

AMLODIPINE BESILATE, ATORVASTATIN CALCIUM, TRIHYDRATE

Disponível em:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

Código ATC:

C10BX03

DCI (Denominação Comum Internacional):

ATORVASTATIN CALCIUM TRIHYDRATE 10 mg AMLODIPINE BESILATE 5 mg

Forma farmacêutica:

FILM-COATED TABLET

Composição:

ATORVASTATIN CALCIUM TRIHYDRATE 10 mg AMLODIPINE BESILATE 5 mg

Tipo de prescrição:

POM

Área terapêutica:

LIPID MODIFYING AGENTS

Status de autorização:

Authorised

Data de autorização:

2006-05-26

Folheto informativo - Bula

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CADUET 5 MG/10 MG AND 10 MG/10 MG FILM-COATED TABLETS
amlodipine/atorvastatin
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 there is
too much cholesterol in your blood, it can

Características técnicas

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
CADUET 5 mg/10 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 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.
White film-coated tablets, oval shape, debossed with ‘Pfizer’ on
one side and CDT 051 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
antihypertensive 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 sections 4.4 and 5.2).
_Hepatic impairment _
CADUET is contraindicated in patients with active liver disease (see
section 4.3).
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_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
5.2).
_Use in combination with other medi