Icorvida SR 1.5mg Prolonged-release Tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Indapamide

Beszerezhető a:

KRKA, d.d., Novo mesto

ATC-kód:

C03BA; C03BA11

INN (nemzetközi neve):

Indapamide

Adagolás:

1.5 milligram(s)

Gyógyszerészeti forma:

Prolonged-release tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Sulfonamides, plain; indapamide

Engedélyezési státusz:

Marketed

Engedély dátuma:

2012-02-03

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ICORVIDA SR 1.5 MG PROLONGED-RELEASE TABLETS
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 Icorvida SR is and what it is used for
2.
What you need to know before you take Icorvida SR
3.
How to take Icorvida SR
4.
Possible side effects
5.
How to store Icorvida SR
6.
Contents of the pack and other information
1.
WHAT ICORVIDA SR IS AND WHAT IT IS USED FOR
Icorvida SR is a drug that reduces blood pressure by promoting the
excretion of urine and by dilating
blood vessels.
Icorvida SR is used to treat increased blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ICORVIDA SR
DO NOT TAKE ICORVIDA SR
-
if you are allergic to indapamide or any of the other ingredients of
this medicine or to other
drugs of the same type (called sulphonamides) (listed in section 6).
-
if you have severe impairment of kidney function.
-
if you have severe impairment of liver or suffer from a condition
called hepatic encephalopathy
(degenerative disease of the brain).
-
if you have low level of potassium in your blood.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Icorvida SR.
-
if you have impairment of liver function.
-
if you have diabetes.
-
if you have gout.
-
if you have impairment of kidney function.
-
if you have any heart rhythm problems.
-
if you need to have a test to check how well your parathyroid gland is
working.
If you experience a decrease in vision or eye pain. These could be
symptoms of fluid accumulation in
the vascu

Termékjellemzők

Health Products Regulatory Authority
09 May 2023
CRN00DGDT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Icorvida SR 1.5mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 1.5 mg indapamide.
Excipient with known effect
Each prolonged-release tablet contains 97.58 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White, round, slightly biconvex film coated-tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Icorvida SR is indicated in essential hypertension in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One tablet per 24 hours, preferably in the morning, to be swallowed
whole with water and not chewed.
At higher doses the antihypertensive effect of indapamide is not
enhanced but the excretion of salt is increased (saluretic
effect).
Special populations
_Elderly_
In the elderly, this plasma creatinine must be adjusted in relation to
age, weight and gender. Elderly patients can be treated
with Icorvida SR when renal function is normal or only minimally
impaired.
_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.
_Paediatric population_
The safety and efficacy of Icorvida SR in children and adolescents
have not been established. No data are available.
Method of administration
Indapamide is administered orally.
4.3 CONTRAINDICATIONS
Indapamide is contraindicated in:

hypersensitivityto the active substance, to other sulfonamides or to
any of the excipients listed in section 6.1;
Health Products Regulatory Authority
09 May 2023
CRN00DGDT
Page 2 of 8

severe renal failure;

hepatic encephalopathy or severe impairment of l