Indapamide 2.5mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Indapamide hemihydrate

Saadav alates:

Genus Pharmaceuticals Ltd

ATC kood:

C03BA11

INN (Rahvusvaheline Nimetus):

Indapamide hemihydrate

Annus:

2.5mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02020100

Infovoldik

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
The name of your medicine is Indapamide 2.5mg Tablets.
They contain the active ingredient called Indapamide.
Indapamide Tablets belong to a group of medicines called
anti-hypertensives. This medicine is used to treat high blood
pressure and works by causing the kidneys to get rid of
unneeded water and salt from the body into the urine.
Indapamide is different from other medicines, 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 TABLETS:
• If you are allergic (hypersensitive) to Indapamide or any
other sulfonamide or to any of the other ingredients of
Indapamide Tablets. See section 6
• If you have or ever had severe kidney failure and/or liver
problems
• 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 the blood
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Indapamide
tablets
• If you have or ever had liver and/or kidney problems
• If you have or ever had hea

Toote omadused

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