Indapamide 2.5mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Indapamide hemihydrate

Boleh didapati daripada:

Waymade Healthcare Plc

Kod ATC:

C03BA11

INN (Nama Antarabangsa):

Indapamide hemihydrate

Dos:

2.5mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 02020100

Risalah maklumat

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).
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.
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 sulphonamide 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.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Indapamide Tablets.
Take special care if you have:
■
liver problems,
■
if you have any heart rhythm problems
or problems with your kidneys,
■
gout (painful inflammation of the joints),
■
diabetes,
■
if you need to have a test to check how
well your parathyroid gland is working.
You should tell your doctor if you have had
photosensitivity reactions.
Your doctor may give you blood tests to
check for low sodium or potassium levels
or high calcium levels.
If you think any of these situations may
apply to you or you have any questions or
doubts about taking your medicine, you
should consult your doctor or pharmacist.
Athletes should be aware that this
medicine contains an active ingredient,
which may give a positive reaction in
doping tests.
OTHER MEDICINES AND INDAPAMIDE
TABLET

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Indapamide Tablets 2.5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Indapamide Ph Eur as indapamide hemihydrate 2.5
mg.
3
PHARMACEUTICAL FORM
Coated tablets.
_Appearance_: white, circular, biconvex, sugar-coated tablet printed
with the
company logo or printed with ‘I’
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of essential hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS: _
The dosage of 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 such as beta-blockers, ACE inhibitors,
methyldopa, clonidine and other adrenergic blocking agents.
_CHILDREN: _
There is no experience of the use of this drug in children.
_ADMINISTRATION: _
Route of administration: Oral.
4.3
CONTRAINDICATIONS
Severe renal failure.
Hepatic encephalopathy or severe impairment of liver function.
Hypokalaemia.
Hypersensitivity to sulphonamides.
Hypersensitivity to the active ingredient or any of the excipients.
Recent cerebrovascular accident
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_WARNINGS: _
When liver function is impaired, thiazide-related diuretics may cause
hepatic
encephalopathy. Administration of the diuretic must be stopped
immediately
if this occurs or there are signs of increasing renal insufficiency.
A slight weight loss has been reported in some patients taking
indapamide.
_PRECAUTIONS: _
-WATER AND ELECTROLYTE BALANCE:
_PLASMA SODIUM: _
This must be measured before starting treatment, then at regular
intervals