Low Centyl K 1.25 mg/573 mg modified-release tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Bendroflumethiazide; Potassium chloride

Доступна с:

KARO PHARMA AB

код АТС:

C03AB; C03AB01

ИНН (Международная Имя):

Bendroflumethiazide; Potassium chloride

дозировка:

1.25/573 milligram(s)

Фармацевтическая форма:

Modified-release tablet

Терапевтические области:

Thiazides and potassium in combination; bendroflumethiazide and potassium

Статус Авторизация:

Marketed

Дата Авторизация:

1997-11-14

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOW CENTYL
® K 1.25 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, Low Centyl
®
K modified-release tablets will be called Low Centyl
K.
WHAT IS IN THIS LEAFLET
1.
What Low Centyl® K is and what it is used for
2.
What you need to know before you take Low Centyl® K
3.
How to take Low Centyl® K
4.
Possible side effects
5.
How to store Low Centyl® K
6.
Contents of the pack and other information
1.
WHAT LOW CENTYL
® K IS AND WHAT IT IS USED FOR
Low 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.
Low 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 Low Centyl
K
is a supplement to replace some of the potassium you may lose.
Low Centyl K is used:
To treat 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 LOW CENTYL
® K
DO NOT TAKE
LOW
CENTYL K:
•
If you are allergic (hypersensitive) to bendroflumethiazide or
potassium chloride, or any of the
other ingredients of this medicine (listed in section 6).
•
If yo

Характеристики продукта

Health Products Regulatory Authority
27 October 2023
CRN00DQ8T
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Low Centyl K 1.25 mg/573 mg modified-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25mg of bendroflumethiazide and 573mg of
potassium chloride.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
Light yellow, film-coated, oval shaped tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Low Centyl K is indicated in the management of hypertension alone or
in combination with other antihypertensives.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_ Hypertension: 1 tablet daily.
Method of administration
For oral administration.
The tablets should be taken with or after meals with at least a full
glass of water or 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 4.3).
Potassium levels
With long-term treatment, potassium blood levels should be monitored
and consideration should be given to fluid and
electrolyte status especially in elderly patients. Depending on the
results, potassium containing food or ext