Indapamide 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indapamide hemihydrate

Available from:

Strides Pharma 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: 5031676003205

Patient Information leaflet

Strides Pharma UK Ltd.
Front & Back Printing. To be supplied in the unfolded size.
PC-TSG/2021/451 - Record Number: 323561
60 GSM Paper.
Pack Insert
150 X 310 MM
1046119
1046552
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1
11.0
INDAPAMIDE TABLETS 2.5 MG
BLACK
Printing clarity to be clear & sharp.
PACKAGE LEAFLET: INFORMATION FOR THE USER
INDAPAMIDE TABLETS 2.5 MG
[Indapamide]
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.
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
Indapamide Tablets contain the active substance
indapamide. Indapamide is a diuretic and is intended
to reduce high blood pressure (hypertension) in adults.
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 TABLETS:
•
If you are allergic to indapamide or any other
sulfonamide or to 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 hepati

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indapamide 2.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Indapamide 2.5mg
Excipient(s) with known effect
Lactose
Sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Co
ate
d
tab
let
White, biconvex, sugar coated tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of essential hypertension
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
The dosage is one tablet, containing 2.5mg indapamide, to be taken
daily 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 of
indapamide daily is not recommended as there is no appreciable
additional
anti-hypertensive 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 anti- hypertensive 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.
Special populations
_ _
_Renal failure (see sections 4.3 and 4.4):_
In severe renal failure (creatinine clearance below 30ml/min),
treatment is contraindicated.
Thiazides 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):_
In the elderly, the plasma creatinine must be adjusted in relation to
age,
weight and gender. Elderly patients can be treated with indapamide
when
renal function is normal or only minimally impaired.
_Paediatric population:_
Indapamide is not recommende