Celiprolol 400mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Parsisiųsti Pakuotės lapelis (PIL)
09-06-2018
Parsisiųsti Prekės savybės (SPC)
09-06-2018

Veiklioji medžiaga:

Celiprolol hydrochloride

Prieinama:

Sun Pharma UK Ltd

ATC kodas:

C07AB08

INN (Tarptautinis Pavadinimas):

Celiprolol hydrochloride

Dozė:

400mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02040000; GTIN: 5015525031724

Pakuotės lapelis

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CELIPROLOL HYDROCHLORIDE 200 MG TABLETS
CELIPROLOL HYDROCHLORIDE 400 MG TABLETS
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 an abnormal heart rhythm,
difficulty breathing and swollen
ankles

suffer from missed heart beats (heart block) or other heart problems
or you suffer from hardened arteries

have severe kidney problems

have,or have had, episodes of asthma, wheezing or other severe
breathing problems

have a rare tumour called a phaeochromocytoma that is not being
treated

have abnormal levels of acid in your blood (metabolic acidosis),
u
                                
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Prekės savybės

                                OBJECT 1
CELIPROLOL HYDROCHLORIDE 400 MG FILM COATED
TABLETS
Summary of Product Characteristics Updated 03-Aug-2017 | Ranbaxy (UK)
Limited a Sun
Pharmaceutical Company
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
200 mg 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 th
                                
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