Indapamide 2.5mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
24-02-2023
Summary of Product characteristics
(SPC)
24-02-2023
Public Assessment Report
(PAR)
13-08-2010
Active ingredient:
Indapamide hemihydrate
Available from:
Zentiva 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: 5000283650010 5000283650027
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
INDAPAMIDE 2.5MG TABLETS
Indapamide hemihydrate
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
symptoms 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.
• Your doctor may have given you this medicine before from another
company. It may have looked slightly different.
However, either brand will have the same effect.
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
3. How to take indapamide
4. Possible side effects
5. How to store indapamide
6. Contents of the pack and other information
1. WHAT INDAPAMIDE IS AND WHAT IT IS USED FOR
The name of your medicine is Indapamide 2.5mg Tablets (called
indapamide throughout this leaflet). It belongs to a
group of medicines called diuretics (water tablets).
Indapamide can be used for treating:
• High blood pressure (hypertension). It may be used on its own or
in combination with other medicines for high blood
pressure.
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 lower
blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDAPAMIDE
Do not take indapamide if you:
• are allergic (hypersensitive) to indapamide, any other sulfonamide
or to any of the other ingredients of this medicine
(listed in section 6)
• have severe kidney disease
• have severe liver disease or suffer from a c
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indapamide 2.5 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg indapamide hemihydrate
Excipient with known effect:
Each tablet contains 103.1 mg of spray dried lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Round, white, film-coated tablet with S6 stamped on one side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of essential hypertension in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
The dosage is one tablet, containing 2.5 mg indapamide hemihydrate,
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 2.5 mg 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
.
Special populations
_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) _
In the elderly, the plasma creatinine must be adjusted in relation to
age, weight and
gender. Elderly patients can be treated with
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