Celectol 200mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Активный ингредиент:

Celiprolol hydrochloride

Доступна с:

DE Pharmaceuticals

код АТС:

C07AB08

ИНН (Международная Имя):

Celiprolol hydrochloride

дозировка:

200mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 02040000

тонкая брошюра

                                CELECTOL
200MG TABLETS / CELIPROLOL HYDROCHLORIDE 200MG TABLETS
(celiprolol hydrochloride)
Please note that the leaflet also contains information about other
strengths
of the medicine Celectol 400mg Tablets or Celiprolol Hydrochloride
400mg
Tablets.
PATIENT INFORMATION LEAFLET
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:
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 (called
Celectol
throughout this leaflet). 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 difficulty breathing and
swollen
ankles.
*
You have kidney problems.
*
You have a tumour of th
                                
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Характеристики продукта

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celectol 200 Tablets (Celiprolol Hydrochloride 200mg Tablets for
“own
label” distribution).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Celiprolol Hydrochloride 200 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White film coated biconvex heart shaped tablets engraved with 200 and
a
breakline on one face and the Celectol logo on the other face.
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,
(inclu
                                
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