Selectol 200mg Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

CELIPROLOL HYDROCHLORIDE

Διαθέσιμο από:

Lexon (UK) Ltd

Φαρμακολογική κατηγορία (ATC):

C07AB; C07AB08

INN (Διεθνής Όνομα):

CELIPROLOL HYDROCHLORIDE

Δοσολογία:

200 milligram(s)

Φαρμακοτεχνική μορφή:

Tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Beta blocking agents, selective; celiprolol

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-06-30

Φύλλο οδηγιών χρήσης

SELECTOL 200MG TABLETS
(celiprolol hydrochloride)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
*
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. Do not pass it onto others.
It
may harm them, even if their symptoms are the same as yours.
*
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
What Selectol is and what it is used for
What you need to know before you take Selectol
How to take Selectol
Possible side effects
How to store Selectol
Contents of the pack and other information
WHAT SELECTOL IS AND WHAT IT IS USED FOR
WHAT SELECTOL IS
The name of your medicine is Selectol 200mg 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).
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SELECTOL
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
*
You are allergic (hypersensitive) to celiprolol or any of the other
ingredients
in Selectol (see Section 6: Contents of the pack and other
information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
*
You have or have had episodes of asthma or wheezing
*
You have a very slow heart beat (bradycardia) or low blood pressure
(hypotension)
*
You have heart problems – such as a condition where there is an
impairment with the heart’s ability to conduct electrical impulses,
if your
heart is not pumping blood as well as it should do, abnormal heart
rhythm, difficulty breathing and swollen ankles
*
A condition which results in a tum

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Selectol 200mg Tablets
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
_Product imported from Greece_
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
As per PA0540/126/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/126/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Mannitol
Microcrystalline Cellulose
Croscarmellose Sodium
Magnesium Stearate
Film coating
Opadry Y – 1 – 7000 containing:
Titanium dioxide (E171)
Hydroxpropyl cellulose
Polyethylene glycol 400
Opadry YS-1-7006 containing:
Polyethylene glycol 400
Hydroxypropyl cellulose
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister 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 original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Al/PVC strips, in an outer box.
Pack sizes: 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL