Celiprolol 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Celiprolol hydrochloride

Available from:

Actavis UK Ltd

ATC code:

C07AB08

INN (International Name):

Celiprolol hydrochloride

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5012617013453

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 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celiprolol Hydrochloride Tablets, 200 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 200 mg tablet contains celiprolol hydrochloride 200 mg.
Excipient with known effect: Each 200 mg tablet contains 2 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow film-coated, round biconvex tablets, 9.5 mm diameter, imprinted
‘CL
breakline 200’ on one side and ‘G’ on the other.
4
CLINICAL PARTICULARS
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 200mg 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
200mg
tablets in one single administration of 400mg or one 400mg 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 200mg 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
200mg
in one single administration of 400mg, or one 400mg tablet once daily,
after 2
to 4 weeks of treatment with 200mg once daily. Treatment with
celiprolol
should
be
discontinued
gradually
(i.e.
over
a
period
of
15
days),
as
discont