Indapamide 2.5mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Indapamide hemihydrate

Dostupné z:

Niche Generics Ltd

ATC kód:

C03BA11

INN (Medzinárodný Name):

Indapamide hemihydrate

Dávkovanie:

2.5mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02020100; GTIN: 5060020121302 5060020121319

Príbalový leták

WHAT IS IN THIS LEAFLET:
1.
What Indapamide Tablets are and what
they are used for
2.
What you need to know before you take
Indapamide Tablets
3.
How to take Indapamide Tablets
4.
Possible side effects
5.
How to store Indapamide Tablets
6.
Contents of the pack and other
information
1. WHAT INDAPAMIDE TABLETS ARE
AND WHAT THEY ARE USED FOR
This medicine is intended to reduce high
blood pressure (hypertension) in adults.
The tablets contain indapamide as the
active ingredient.
Indapamide is a diuretic. Most diuretics
increase the amount of urine produced by
the kidneys. However, Indapamide is different
from other diuretics, as it only causes a slight
increase in the amount of urine produced. In
addition, indapamide widens blood vessels
so that blood passes through more easily.
This helps to lower blood pressure.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE INDAPAMIDE
TABLETS
DO NOT TAKE INDAPAMIDE 2.5MG TABLETS:
■
if you are allergic to indapamide or any
other sulfonamide drugs or any of the
other ingredients of this medicine (listed
in section 6),
■
if you have severe kidney disease,
■
if you have severe liver disease or suffer
from a condition called hepatic
encephalopathy (liver problems which
affect the brain and central nervous
system),
■
if you have low potassium levels in your
blood.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse
before taking Indapamide Tablets:
■
if you have liver problems,
■
if you have any heart rhythm problems
or problems with your kidneys,
■
if you suffer from gout (painful
inflammation of the joints),
■
if you have diabetes,
■
if you need to have a test to check how
well your parathyroid gland is working,
■
if you experience a decrease in vision or
eye pain. These could be symptoms of
fluid accumulation in the vascular layer
of the eye (choroidal effusion) or an
increase of pressure in your eye and can
happen within hours to weeks of taking
Indapamide tablets. This can lead to
permanent vision loss, if not treated. If
you earlier have had a penicilli

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indapamide 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 2.5mg of the active substance Indapamide.
Excipients with known effect:
Each tablet contains 82.75mg Lactose Monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, round, flat bevelled edge tablet; debossed with I and 2.5 on
one side,
plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indapamide is indicated in adults for the treatment of essential
hypertension.
Indapamide
may
be
used
as
sole
therapy
or
combined
with
other
antihypertensive agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
The dosage is one tablet, containing 2.5mg indapamide, daily, to be
taken in
the morning. The action of Indapamide is progressive and the reduction
in
blood pressure may continue and not reach a maximum until several
months
after the start of therapy. A larger dose than 2.5mg Indapamide daily
is not
recommended as there is no appreciable additional antihypertensive
effect but
a diuretic effect may become apparent. If a single daily tablet of
Indapamide
does not achieve a sufficient reduction in blood pressure, another
antihypertensive agent may be added; those which have been used in
combination with Indapamide include beta-blockers, ACE inhibitors,
methyldopa, clonidine and other adrenergic blocking agents. The co-
administration of Indapamide with diuretics which may cause
hypokalaemia
is not recommended.
There is no evidence of rebound hypertension on withdrawal of
Indapamide
2.5mg Tablets.
_ _
_Renal impairment: (see sections 4.3 and 4.4)_
_: _
In severe renal failure (creatinine clearance below 30 ml/min),
treatment is
contraindicated.
Thiazide and related diuretics are fully effective only when renal
function is
normal or only minimally impaired.
_Hepatic impairment (see sections 4.3 and 4.4): _
In severe hepatic impairment, treatment is contraindicated.
_ _
_Elderly (see section 4.4