Celiprolol 400mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

Compra'l ara

Descargar Fitxa tècnica (SPC)
06-03-2014

ingredients actius:

Celiprolol hydrochloride

Disponible des:

CST Pharma Ltd

Codi ATC:

C07AB08

Designació comuna internacional (DCI):

Celiprolol hydrochloride

Dosis:

400mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02040000; GTIN: 5055946802404

Informació per a l'usuari

                                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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Celiprolol Hydrochloride is and what it is used for
2.
What you need to know before you take Celiprolol Hydrochloride
3.
How to take Celiprolol Hydrochloride
4.
Possible side effects
5.
How to store Celiprolol Hydrochloride
6.
Contents of the pack and other information.
1.
WHAT CELIPROLOL HYDROCHLORIDE IS AND WHAT IT IS USED FOR
The name of your medicine is Celiprolol Hydrochloride 200 mg or 400 mg
Tablets (called Celiprolol Hydrochloride
throughout this leaflet).
Celiprolol Hydrochloride contains a medicine called celiprolol
hydrochloride. This belongs to a group of medicines
called beta-blockers. It works by slowing your heart rate or lowering
your blood pressure. It is used to treat high
blood pressure (hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELIPROLOL HYDROCHLORIDE
DO NOT TAKE CELIPROLOL HYDROCHLORIDE IF YOU:
•
are allergic to celiprolol hydrochloride or any of the ingredients of
this medicine (listed in section 6). Signs of an
allergic reaction include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
•
have suffered an allergic reaction to a beta-blocker (propranolol,
sotalol, timolol etc.) in the past
•
suffer from an irregular/very slow heartbeat (known as bradycardia) or
low blood pressure (hypotension)
•
suffer from heart failure which is not under control (heart failure is
a condition in which your heart is not pumping
blood as well as it should), have
                                
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Fitxa tècnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celiprolol Hydrochloride Tablets, 400 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg tablet contains celiprolol hydrochloride 400 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White film-coated, round biconvex tablets, 12 mm diameter, imprinted
‘CL 400’ on
one side and ‘G’ on the other.
4.1. THERAPEUTIC INDICATIONS
Celiprolol hydrochloride is indicated for the management of mild to
moderate hypertension and for
prophylaxis of angina pectoris.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults _
_Hypertension _
The initial dose is 200 mg orally, taken once daily with a glass of
water. Celiprolol should be taken
on rising, 30 minutes before meals, or 2 hours after meals. If the
response is inadequate, the dose may
be increased to two 200 mg tablets in one single administration of 400
mg or one 400 mg tablet 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 of the blood
pressure is recommended.
Treatment with celiprolol should not be discontinued abruptly, but
should be discontinued gradually
(i.e. over a period of 15 days), as discontinuing treatment abruptly
may lead to an acute worsening of
the patient’s condition.
_Angina Pectoris _
The initial dose is 200 mg orally, taken once daily with a glass of
water. Celiprolol should be taken
on rising, 30 minutes before meals, or 2 hours after meals. If the
response is inadequate, the dose may
be increased to two 200 mg in one single administration of 400 mg, or
one 400 mg tablet once daily,
after 2 to 4 weeks of treatment with 200 mg once daily. Treatment with
celiprolol should be
discontinued gradually (i.e. over a period of 15 days), as
discontinuing treatment abruptly may lead to
an acute worsening of the patient’s condition, especially in 
                                
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