Celectol 400mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Celiprolol hydrochloride

Tilgjengelig fra:

CST Pharma Ltd

ATC-kode:

C07AB08

INN (International Name):

Celiprolol hydrochloride

Dosering :

400mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02040000; GTIN: 5055946805894

Informasjon til brukeren

CELECTOL
400MG TABLETS / CELIPROLOL HYDROCHLORIDE 400MG TABLETS
(celiprolol hydrochloride)
READ ALL OF THIS LEA
FLET 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.
Please note that the leaflet also contains information about other
strengths
of the medicine Celectol 200mg Tablets or Celiprolol Hydrochloride
200mg
Tablets.
WHAT IS IN THIS LEAFLET:
What Celectol is and what it is used for
What you need to know before you take Celectol
How to take Celectol
Possible side effects
How to store Celectol
Contents of the pack and other information
WHAT CELECTOL IS AND WHAT IT IS USED FOR
WHAT CELECTOL IS
The name of your medicine is Celectol 200 or 400 Tablets. Celectol
contains a medicine called celiprolol hydrochloride. This belongs to a
group
of medicines called beta-blockers.
HOW CELECTOL WORKS
It works by slowing your heart rate or lowering your blood pressure.
WHAT CELECTOL IS USED FOR
It is used to treat high blood pressure (hypertension).
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELECTOL
DO NOT TAKE CELECTOL IF:
*
You are allergic (hypersensitive) to celiprolol or any of the other
ingredients in Celectol (listed in section 6). 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 asthma or wheezing.
*
You have a very slow heart beat (bradycardia).
*
You have heart problems – where you have diffculty breathing and
swollen ankles.
*
You have kidney problems.
*
You have a tumour of the adrenal gland (phaeochromocytoma) and your
blood pressure has not yet been t

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celectol 400 Tablets (Celiprolol Hydrochloride 400mg Tablets for
“own
label” distribution).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Celiprolol Hydrochloride 400 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White film coated biconvex heart shaped tablets engraved with the
Celectol
logo on one face with 400 on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The management of mild to moderate hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The initial dose is 200 mg orally taken once daily with a glass of
water.
Celectol should preferably be taken first thing in the morning, 30
minutes
before food or 2 hours after a meal. If response is inadequate, the
dose may be
increased to 400 mg once daily according to the therapeutic response.
In
hypertensive
patients
additional
treatment
with
other
anti-hypertensive
agents is possible, in particular with diuretics. When a combination
is initiated
an increased monitoring the blood pressure is recommended.
Elderly
Dosage as for adults. However close monitoring of elderly patients
should be
exercised, as renal and hepatic functions may be decreased in this
population.
Paediatric population
Not recommended.
Renal impairment
Dosage
may
require
adjustment
(see
section
4.4).
For
patients
with
a
creatinine clearance 15 – 40 ml per minute, heart rate should be
monitored and
treatment must be reconsidered in case of bradycardia (less than 50
– 55 beats
per minute at rest) (see section 4.3). Celiprolol is not recommended
in patients
with a creatinine clearance less than 15 ml per minute (see section
4.3).
Method of administration
Oral administration.
4.3
CONTRAINDICATIONS
As with other beta-adrenoceptor antagonists, celiprolol should not be
used in
cases of:
•
Hypersensitivity to the active substance or any of the excipients (see
section 6.1).
•
Cardiogenic shock, uncontrolled heart failure, sick-sinus syndrome,
(including sino-atrial blo