Centyl K 2.5 mg/573 mg modified-release tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Bendroflumethiazide; Potassium chloride

Disponibil de la:

KARO PHARMA AB

Codul ATC:

C03AB; C03AB01

INN (nume internaţional):

Bendroflumethiazide; Potassium chloride

Dozare:

2.5/573 milligram(s)

Forma farmaceutică:

Modified-release tablet

Zonă Terapeutică:

Thiazides and potassium in combination; bendroflumethiazide and potassium

Statutul autorizaţiei:

Marketed

Data de autorizare:

1978-04-01

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CENTYL
® K 2.5 MG/573 MG MODIFIED-RELEASE TABLETS
bendroflumethiazide/potassium chloride
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
In this leaflet,
Centyl
®
K modified-release tablets will be called Centyl
K.
WHAT IS IN THIS LEAFLET
1.
What Centyl
®
K is and what it is used for
2.
What you need to know before you take Centyl
®
K
3.
How to take Centyl
®
K
4.
Possible side effects
5.
How to store Centyl
®
K
6.
Contents of the pack and other information
1.
WHAT CENTYL
® K IS AND WHAT IT IS USED FOR
Centyl K contains two different types of active substances. One is
called bendroflumethiazide, it is a
diuretic (water tablet). The other active substance is called
potassium chloride. It is a potassium
supplement. The two medicines work at the same time in different ways.
Centyl K works by removing any excess water from your body. It will
make you go to the toilet more.
This means you will also lose potassium from your body. The potassium
chloride in Centyl K
is a
supplement to replace some of the potassium you may lose.
Centyl K is used to treat:
• Oedema which occurs as a result of heart, kidney or liver
problems. Oedema means that there is too
much water in your body. Oedema can cause symptoms such as swollen
ankles or trouble breathing.
• High blood pressure (hypertension). Your doctor may also decide to
give you other blood pressure
lowering medicines as well as this medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CENTYL
® K
DO NOT TAKE
CENTYL K
-
If you are aller

Caracteristicilor produsului

Health Products Regulatory Authority
27 October 2023
CRN00DQ8T
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Centyl K 2.5 mg/573 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg of bendroflumethiazide and 573mg of
potassium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet
Green, film-coated, oval shaped tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Centyl K is indicated as a diuretic:
• In the management of oedema such as that which arises from
cardiac, renal or hepatic origin.
• In the management of hypertension alone or in combination with
other antihypertensives.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Hypertension:_ 1-2 tablets once daily.
_Oedema:_ Initial dosage 1-4 tablets once daily. Maintain with 1-2
tablets daily.
Method of administration
For oral administration.
Centyl K should be taken in the morning to avoid nocturia.
The tablets should be taken with or after meals with at least a full
glass of water or other fluid
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.

Addison’s disease.

Severe renal impairment or anuria (see section 4.4).

Severe hepatic impairment (see section 4.4).

Established arthritis urica.

Severe dehydration electrolyte imbalance including hypercalcaemia,
hyponatraemia, hyperchloraemia,
hyperkalaemia or any situation which might lead to hyperkalaemia.

Ulcer or obstruction of the gastrointestinal tract.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hypersensitivity
Bendroflumethiazide is a sulphonamide, which should be considered by
prescribers in relation to hypersensitivity.
Renal Impairment, Hepatic impairment and Urinary tract obstruction
Thiazide diuretics should be used with caution in patients with mild
or moderate renal or hepatic impairment and in patients
with potential obstruction of the urinary tract (see section 4