Amoriro 5mg/10mg film-coated Tablets

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

AMLODIPINE, ATORVASTATIN

Dostępny od:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Kod ATC:

C10BX03

INN (International Nazwa):

AMLODIPINE 5 mg ATORVASTATIN 10 mg

Forma farmaceutyczna:

FILM-COATED TABLET

Skład:

AMLODIPINE 5 mg ATORVASTATIN 10 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

LIPID MODIFYING AGENTS

Status autoryzacji:

Withdrawn

Data autoryzacji:

2013-03-07

Ulotka dla pacjenta

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AMORIRO 5 MG/10 MG FILM-COATED TABLETS
AMORIRO 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amoriro is and what it is used for
2.
What you need to know before you take Amoriro
3.
How to take Amoriro
4.
Possible side effects
5.
How to store Amoriro
6.
Contents of the pack and other information
1.
WHAT AMORIRO IS AND WHAT IT IS USED FOR
Amoriro contains two active substances, amlodipine and atorvastatin.
Amlodipine belongs to the
group of medicines called ‘calcium channel blockers’ and is used
to treat high blood pressure
(hypertension). Atorvastatin belongs to a group of medicines called
‘statins’ and is used to reduce
the amount of fats (cholesterol and triglycerides) in the blood.
Amoriro is used for the prevention of cardiovascular (heart and blood
vessels) events (for example
angina pectoris, heart attack or stroke) in people with high blood
pressure who have additional
cardiovascular risk factors, such as tobacco smoking, being
overweight, elevated blood cholesterol
levels, a family history of heart disease or diabetes. If such factors
are present in people with high
blood pressure, there is an increased risk for developing
cardiovascular events.
How Amoriro works
High blood pressure is a condition during which blood pressure stays
abnormally high; it is one of
the risk factors for cardiovascular events (for example angina
pectoris, heart attack or stroke).
Amlodipine work

Charakterystyka produktu

Page 1 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Amoriro 5 mg/10 mg film-coated tablets
Amoriro 10 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg amlodipine (as besilate) and 10
mg atorvastatin (as calcium).
Each film-coated tablet contains 10 mg amlodipine (as besilate) and 10
mg atorvastatin (as
calcium).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White film-coated tablets, oval shaped, biconvex, 4.2 mm x 8.2 mm in
size, with the marking AA
debossed on one side.
Blue film-coated tablets, oval shaped, biconvex, 4.2 mm x 8.2 mm in
size, with the marking AA1
debossed on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoriro 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).
Amoriro should be used when response to diet and other
non-pharmacological measures is
inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual starting dose is amlodipine/atorvastatin 5 mg/10 mg once
daily.
If a patient is identified as needing greater blood pressure control,
amlodipine/atorvastatin
10 mg/10 mg once daily can be administered.
Amoriro 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.
The combination of Amoriro and fibrates should be avoided (see
sections 4.4 and 4.5).
Page 2 of 22
_Patients with renal impairment _
No dose adjustment is required in patients with impaired renal
function (see section 5.2).
_Patients with hepatic impairment _
Amoriro is contra-indicated in patients with active liver disease (see
section 4.3).
_Paediatric population