AMLODIPINE

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

AMLODIPINE AS AMLODIPINE BESILATE

Disponible des:

WPR Healthcare Limited

Codi ATC:

C08CA01

Designació comuna internacional (DCI):

AMLODIPINE AS AMLODIPINE BESILATE

Dosis:

5 Milligram

formulario farmacéutico:

Tablets

Vía de administración:

Oral use

Unidades en paquete:

28 tablets

tipo de receta:

Product subject to prescription which may be renewed (B)

Fabricat per:

TEVA UK Limited

Grupo terapéutico:

Calcium channel blockers, selective calcium channel blockers with mainly vascular effects

Área terapéutica:

amlodipine

indicaciones terapéuticas:

Hypertension. Chronic stable angina pectoris. Vasospastic (Prinzmetal’s) angina

Estat d'Autorització:

Authorised

Data d'autorització:

2015-07-31

Informació per a l'usuari

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE 5 MG TABLETS
AMLODIPINE 10 MG TABLETS
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 AMLODIPINE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE
3.
HOW TO TAKE AMLODIPINE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE AMLODIPINE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT AMLODIPINE IS AND WHAT IT IS USED FOR
Amlodipine contain the active substance amlodipine which belongs to a
group of medicines called calcium antagonists. Amlodipine is used to
treat high blood pressure (hypertension) or a certain type of chest
pain
called angina, a rare form of which is Prinzmetal’s or variant
angina.
In patients with high blood pressure this medicine works by relaxing
blood vessels, so that blood passes through them more easily.
In patients with angina, Amlodipine works by improving blood supply to
the heart muscle which then receives more oxygen and as a result chest
pain is prevented. This medicine does not provide immediate relief of
chest pain from angina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMLODIPINE
DO NOT TAKE AMLODIPINE:

if you are allergic to amlodipine or any of the other ingredients of
this medicine (listed in the section 6), or to any other calcium
antagonists. This may be itching, reddening of the skin or difficulty
in breathing.

if you have severe low blood pressure (hypotension).

if you have narrowing of the aortic heart valve (aortic stenosis) or
cardiogenic shock (a cond

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amlodipine besilate equivalent to 5mg amlodipine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from the UK:_
Round, white tablet. One side is slightly concave with a breakline and
debossed “A5”. The other side is slightly convex
and plain.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
As per PA0749/067/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0749/067/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Calcium hydrogen phosphate anhydrous
Sodium starch glycolate
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Store in the original package in order to
protect from light and moisture. Keep the blister in
the outer carton.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_3_
_1_
_/_
_0_
_7_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_2_
_1_
_6_
_0_
_6_
_7_
_0_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack of 28 tablets contained in a carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
W