Indapamide 2.5mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-05-2020
Summary of Product characteristics
(SPC)
07-07-2020
Public Assessment Report
(PAR)
27-03-2006
Active ingredient:
Indapamide hemihydrate
Available from:
Actavis UK Ltd
ATC code:
C03BA11
INN (International Name):
Indapamide hemihydrate
Dosage:
2.5mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02020100; GTIN: 5012617018151
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
INDAPAMIDE 2.5MG TABLETS
INDAPAMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMAION 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. 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
WHAT IS IN THIS LEAFLET:
1.
What Indapamide is and what it is 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 IS AND WHAT IT IS USED FOR
Indapamide Tablets are a sugar coated tablets containing indapamide as
the active ingredient.
Indapamide is a diuretic (water tablet) which belongs to a group of
medicines called
sulphonamides. Diuretics increase the amount of water and salts
(mostly sodium and
chlorides) you pass in your urine. This essentially reduces blood
pressure.
Indapamide tablets are used to:
−
treat high blood pressure (essential hypertension)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDAPAMIDE TABLETS
DO NOT TAKE INDAPAMIDE TABLETS:
−
if you are allergic to indapamide, sulphonamides, or any of the other
ingredients of this
medicine (listed in section 6)
−
if you suffer from
-
severe kidney failure
-
severe impairment of the liver function
-
hepatic encephalopathy
−
This is a liver disease causing symptoms that affect your central
nervous system such as
changes in mood, confusion or drowsiness
-
hypokalaemia (low potassium levels in your blood)
−
if you recently suffered a stroke
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Indapamide
Tablets:
−
if your liver is not workin
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Summary of Product characteristics
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 Ph. Eur.
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 sec
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