Celiprolol 400mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-07-2017
Summary of Product characteristics
(SPC)
31-07-2017
Active ingredient:
Celiprolol hydrochloride
Available from:
Teva UK Ltd
ATC code:
C07AB08
INN (International Name):
Celiprolol hydrochloride
Dosage:
400mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02040000; GTIN: 5017007341512
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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celiprolol hydrochloride 400 mg film coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 400 mg celiprolol hydrochloride.
EACH TABLET CONTAINS 3.6MG LACTOSE.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, capsule shaped, biconvex film coated tablets, debossed
with
‘400’ on one side of the breakline and a deep breakline on the
other side.
THE TABLET CAN BE DIVIDED INTO EQUAL DOSES.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Celiprolol is indicated for the treatment of hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Adults: _The initial dose is 200 mg orally, taken once daily with a
glass of water.
Celiprolol should be taken on rising, one hour before meals, or 2
hours after meals. If
response is inadequate, the dose may be increased to 400 mg once
daily, after 2 to 4
weeks of treatment with 200mg once daily. It may take several weeks of
treatment
for the anti-hypertensive effect of celiprolol to be fully
established. There is no limit
for the duration of treatment. This depends on the nature and severity
of the disease.
Treatment with celiprolol should not be discontinued abruptly, but
should be
discontinued gradually (i.e. over a period of 7-10 days), as
discontinuing treatment
abruptly may lead to an acute worsening of the patient’s condition.
In hypertensive patients, additional treatment with other
anti-hypertensive agents
according to clinical guidelines is possible, in particular with
diuretics. When a
combination is initiated an increased monitoring of the blood pressure
is
recommended
_Elderly: _
The pharmacokinetics of celiprolol is not significantly different in
the elderly people
however a close monitoring of elderly patients should be exercised, as
renal and
hepatic functions may be decreased in this population
_Dosage in renal impairment: _The dosage of celiprolol should be
reduced by half in
patients with creatinine clear
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