Neo-Naclex 2.5mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Bendroflumethiazide

Prieinama:

Advanz Pharma

ATC kodas:

C03AA01

INN (Tarptautinis Pavadinimas):

Bendroflumethiazide

Dozė:

2.5mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02020100; GTIN: 5021691110095

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEO-NACLEX®-K 2.5MG/630MG TABLETS
BENDROFLUMETHIAZIDE AND 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 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 of the side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
This product is called NEO-NACLEX®-K 2.5mg/630mg TABLETS. It will be
referred to as
NEONACLEX® for ease hereafter.
WHAT IS IN THIS LEAFLET:
1. What NEO-NACLEX® is and what it isused for
2. What you need to know before you take NEO-NACLEX®
3. How to take NEO-NACLEX®
4. Possible side effects
5. How to store NEO-NACLEX®
6. Contents of the pack and other information
1. WHAT NEO-NACLEX® IS AND WHAT IT IS USED FOR
NEO-NACLEX® belong to a group of medicines called diuretics. They
make the kidneys remove water
from the body.
NEO-NACLEX® are used to treat:
• Oedema, which is a build-up of fluid in the body. This may occur
in many situations, for instance
with liver and kidney problems or with heart failure (when the heart
doesn’t pump efficiently)
• Raised blood pressure (hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEO-NACLEX®
DO NOT TAKE NEO-NACLEX®
• if you are allergic to bendroflumethiazide or potassium chloride
or any of the other ingredients of this
medicine (listed in section 6).
• have a serious liver or kidney disorder (your doctor will advise
you)
• have high levels of potassium (hyperkalaemia) or calcium
(hypercalcaemia) in your blood.
Your doctor will advise you
• suffer from serious complications from diabetes (diabetic
keto-acidosis)
• have a disease of the adrenal glands causing weakn

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Neo-Naclex-K 2.5mg/630mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5mg Bendroflumethiazide in the white layer and
630mg
Potassium chloride in the pink layer, providing 330mg elemental
potassium
(8.4 mEq).
3.
PHARMACEUTICAL FORM
Film coated, two-layered white and pink tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Essential hypertension _
The mechanism whereby the thiazides exert their antihypertensive
effect has
not been clearly established. In non-oedematous patients there may be
little
noticeable
diuretic
effect.
Neo-Naclex-K
may
be
used
as
the
sole
anti-
hypertensive agent, or as an adjunct to other anti-hypertensive drugs
whose
action may be enhanced.
_Oedema. _
Neo-Naclex-K inhibits the renal tubular absorption of salt and water
by its
action at the beginning of the distal convoluted tubule. Sodium and
chloride
ions are excreted in equivalent proportions. Because potassium
excretion is
promoted, metabolic alkalosis may occur secondary to hypokalaemia.
There
is no important effect upon carbonic anhydrase. Neo-Naclex-K causes a
steady
diuresis lasting about 12 hours. It is indicated in the treatment of
oedema
associated
with
conditions
such
as
congestive
heart
failure,
nephrotic
syndrome and cirrhosis of the liver.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
When Neo-Naclex-K is added to other antihypertensive drugs, the dosage
of
the latter can usually be reduced as the Neo-Naclex-K takes effect.
_Essential hypertension _
1 tablet once daily, alone or in conjunction with other
anti-hypertensive
agents.
_Oedema: _
2 tablets once daily in the morning usually produce the desired effect
without
diuresis interfering with sleep. The dose can be increased to 4
tablets, if
required. During the first few days of treatment, there is usually a
large
increase in urinary volume, which diminishes as treatment continues.
Maintenance-Many patients will respond adequately to a daily dose of 1
to 2
t