Atecor CT 50 mg/12.5 mg Film-coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Chlortalidone; Atenolol

Dostupné z:

Rowex Ltd

ATC kód:

C07CB; C07CB03

INN (Medzinárodný Name):

Chlortalidone; Atenolol

Dávkovanie:

50 mg/12.5 milligram(s)

Forma lieku:

Film-coated tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Beta blocking agents, selective, and other diuretics; atenolol and other diuretics

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1999-11-26

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
ATECOR-CT 50 MG/12.5 MG & 100 MG/25 MG FILM-COATED TABLETS
ATENOLOL/CHLORTALIDONE
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 or pharmacist.

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 Atecor-CT is and what it is used for
2. What you need to know before you take Atecor-CT
3. How to take Atecor-CT
4. Possible side effects
5. How to store Atecor-CT
6. Contents of the pack and other information.
1 WHAT ATECOR-CT IS AND WHAT IT IS USED FOR
Atecor-CT is used to treat high blood pressure (hypertension). It
contains two different medicines
called atenolol and chlortalidone.
• Atenolol belongs to a group of medicines called
‘beta-blockers’. It works by slowing down your
heartbeat and making it beat with less force.
• Chlortalidone belongs to a group of medicines called water tablets
(diuretics). It works by
increasing the amount of urine made by your kidneys.
These medicines work together to lower your blood pressure.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATECOR-CT
DO NOT TAKE ATECOR-CT IF:
• you are allergic to atenolol, chlortalidone or any of the other
ingredients of this medicine (listed in
section 6)
• you are allergic to sulphonamide derived medicines e.g. some
antibiotics
• you have heart failure that has not been treated or is not under
control. Signs may include
shortness of breath and swelling of your ankles.
• you have a second or third degree heart block (you may have a
pacemaker)
• you have sick sinus syndrome or a very slow or a very uneven
heartbeat
• you have ver

Súhrn charakteristických

Health Products Regulatory Authority
08 August 2023
CRN00DQMF
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atecor CT 50 mg/12.5 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg of atenolol and 12.5mg of
chlortalidone.
Excipients with known effect:
Each tablet contains 1.8mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex, film-coated tablet with a score-notch on one
side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atecor-CT tablets are indicated for the treatment of hypertension. The
combination product may be suitable for use when
satisfactory control of arterial blood pressure cannot be obtained
with either a diuretic or a beta-blocking agent used alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
When clinically appropriate direct change from monotherapy to the
fixed combination may be considered in patients whose
blood pressure is not adequately controlled.
POSOLOGY:
ADULTS
The usual maintenance dose of Atecor-CT 50 mg/12.5 mg is one tablet
daily. There is little or no further fall in blood pressure
with increased dosage, and where necessary, another antihypertensive
drug, such as a vasodilator, can be added.
Patients can be transferred directly to Atecor-CT 50 mg/12.5 mg
tablets from other antihypertensive treatments, with the
exception of clonidine (see section 4.4).
OLDER PEOPLE
Dosage requirements are often lower in this age group.
PAEDIATRIC POPULATION
Children and Adolescents (<18 years)
There is no paediatric experience with Atecor-CT tablets; therefore,
this preparation is not recommended for children.
RENAL IMPAIRMENT
Due to the properties of the chlortalidone component, Atecor-CT
tablets has reduced efficacy in the presence of renal
insufficiency.
This fixed dose combination should thus not be administrated to
patients with severe renal impairment (see section 4.3).
HEP