Selectol Tablets 200 mg

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

CELIPROLOL HYDROCHLORIDE

Disponible desde:

Sanofi-Aventis Ireland Limited T/A SANOFI

Código ATC:

C07AB; C07AB08

Designación común internacional (DCI):

CELIPROLOL HYDROCHLORIDE

Dosis:

200 milligram(s)

formulario farmacéutico:

Tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

Beta blocking agents, selective; celiprolol

Estado de Autorización:

Marketed

Fecha de autorización:

1989-02-01

Información para el usuario

_créé le_
_par_
_modifié le_
_par_
_Laboratoires_
_Pays_
13/11/2018
S VUKOVIC
SANOFI
IRLANDE
_Couleur_
_Nbre/Réf._
1
BLEU REFLEX BLUE U
_Version N°_
1
_Type Article_
NOTICE DOUBLE
SELECTOL
R784860
200MG & 400MG
CPRS
_Nom du produit_
_Référence article_
_Dosage_
_Quantité_
_N° version Logo/Name_
_N° version Country Ex._
_N° plan Dimensionnel_
_N° plan positionnement_
_Dimensions_
_Taille mini_
_caractères_
A1 -
19.06.2006
CRIE -
V1 -
09/2012
1-606062
COM-P606062-1D
150 X 210 MM
9 PTS
_Numéro de Pages_
1 /
4
_Code sécurité_
R784860
COMPIÈGNE
COMPIÈGNE
- 1 -
R784860
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP.
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 further
questions,
ask your
doctor
or
your
pharmacist.
• This
medicine has
been prescribed for
you
only.
Do not
pass
it
onto 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
Selectol
is
and what
it
is
used for
2. What
you need to know before you take
Selectol
3. How to take Selectol
4. Possible side effects
5. How to store Selectol
6. Contents
of
the pack and other
information
1. WHAT SELECTOL IS AND WHAT IT IS
USED FOR
WHAT
SELECTOL
IS
The name of
your
medicine is
Selectol
200mg
or
400mg Tablets
(called Selectol
throughout
this
leaflet).
Selectol
contains
a medicine called
celiprolol
hydrochloride.
This
belongs
to a
group of
medicines
called beta-blockers.
HOW SELECTOL
WORKS
It
works
by slowing your
heart
rate or
lowering your
blood pressure.
SELECTOL
CAN BE USED TO
It
is
used to treat
high blood pressure
(hypertension)
and chest
pain (angina).
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE SELECTOL
DO NOT
TAKE THIS
MEDICINE AND TELL
YOUR
DOCTOR
IF:
• You are allergic (hype

Ficha técnica

Health Products Regulatory Authority
20 November 2018
CRN008K19
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Selectol Tablets 200 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg celiprolol hydrochloride.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
A white, film coated, heart shaped tablet with a distinctive
heart-shaped logo on one
side, ‘200’ and a bisect line on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Uses
Mild to moderate hypertension.
Management of angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The route of administration is oral.
_Adults_
The usual dose is 200 mg once daily in the morning. In the case of an
inadequate
response the dose may be increased to 400 mg daily.
It is important to take Selectol one hour before or two hours after
food with a glass
of water. If the treatment is to be discontinued, reduce the dosage
gradually over a
period of 1-2 weeks.
_Hypertension_
In hypertensive patients, additional treatment with other
anti-hypertensive agents
according to clinical guidelines is possible, in particular with
diuretics. When a
Health Products Regulatory Authority
20 November 2018
CRN008K19
Page 2 of 12
combination is initiated an increased monitoring of the blood pressure
is
recommended.
_Elderly_
The pharmacokinetics of celiprolol is not significantly different in
the elderly people
however a close monitoring of elderly patients should be exercised, as
renal and
hepatic funcations may be decreased in this population.
_Hepatic impairment_
Limited data is available in patients with hepatic impairment (see
section 5.2)
_Renal impairment_
Celiprolol may be used in patients with mild to moderate degrees of
reduced renal
function. For patients with a creatinine clearance 15-40ml per minute,
heart rate
should be monitored and treatment should be reconsideredin case of
bradycardia
(less than 50-55 beats per minute at rest).
Celiprolol is not recommended in patients