Candesartan cilexetil 8mg Tablets

País: Malta

Idioma: inglés

Fuente: Malta Medicines Authority

Ingredientes activos:

CANDESARTAN CILEXETIL

Disponible desde:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Código ATC:

C09CA06

Designación común internacional (DCI):

CANDESARTAN CILEXETIL 8 mg

formulario farmacéutico:

TABLET

Composición:

CANDESARTAN CILEXETIL 8 mg

tipo de receta:

POM

Área terapéutica:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Estado de Autorización:

Authorised

Fecha de autorización:

2013-08-12

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN CILEXETIL 2 MG TABLETS
CANDESARTAN CILEXETIL 4 MG TABLETS
CANDESARTAN CILEXETIL 8 MG TABLETS
CANDESARTAN CILEXETIL 16 MG TABLETS
CANDESARTAN CILEXETIL 32 MG TABLETS
candesartan cilexetil
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 Candesartan cilexetil is and what it is used for
2.
What you need to know before you take Candesartan cilexetil
3.
How to take Candesartan cilexetil
4.
Possible side effects
5.
How to store Candesartan cilexetil
6.
Contents of the pack and other information
1.
WHAT CANDESARTAN CILEXETIL IS AND WHAT IT IS USED FOR
The name of your medicine is Candesartan cilexetil. The active
ingredient is candesartan cilexetil. This
belongs to a group of medicines called angiotensin II receptor
antagonists. It works by making your blood
vessels relax and widen. This helps to lower your blood pressure. It
also makes it easier for your heart to
pump blood to all parts of your body.
This medicine is used for:
•
treating high blood pressure (hypertension) in adult patients and in
children and adolescents aged 6 to
<18 years.
•
Candesartan cilexetil can be used to treat adult heart failure
patients with reduced heart muscle function
when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or
in addition to ACE-inhibitors
when symptoms persist despite treatment and mineralocorticoid receptor
antagonists (MRA) cannot be
used. (ACE-inhibitors and MRAs are medicines used to treat heart
failure).
2.
WHAT YOU NEED TO KNOW B

Ficha técnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Candesartan cilexetil 2 mg tablets
Candesartan cilexetil 4 mg tablets
Candesartan cilexetil 8 mg tablets
Candesartan cilexetil 16 mg tablets
Candesartan cilexetil 32 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg candesartan cilexetil.
Each tablet contains 4 mg candesartan cilexetil.
Each tablet contains 8 mg candesartan cilexetil.
Each tablet contains 16 mg candesartan cilexetil.
Each tablet contains 32 mg candesartan cilexetil.
Excipient with known effect: Lactose monohydrate.
Each tablet contains 140 mg lactose monohydrate.
Each tablet contains 138 mg lactose monohydrate.
Each tablet contains 133.95 mg lactose monohydrate.
Each tablet contains 125.60 mg lactose monohydrate.
Each tablet contains 251.20 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
_Candesartan cilexetil_
_2 mg tablets _
White to off-white, biconvex, uncoated, round shaped [diameter 7.3 mm]
tablets debossed with
"CN2" on one side and plain on other side.
_Candesartan cilexetil 4 mg tablets _
White to off-white, biconvex, uncoated, round shaped [diameter 7.3 mm]
tablets debossed with
"CN" and “4” separated by score-line on one side and plain on
other side. The tablet can be divided
into equal doses.
_Candesartan cilexetil 8 mg tablets _
Pale pink, biconvex, uncoated, round shaped [diameter 7.3 mm] tablets
debossed with "CN" and
“8” separated by score-line on one side and plain on other side.
The tablet can be divided into equal
doses.
_Candesartan cilexetil 16 mg tablets _
Yellow, biconvex, uncoated, round shaped [diameter 7.3 mm] tablets
debossed with "CN" and “16”
separated by score-line on one side and plain on other side. The
tablet can be divided into equal
doses.
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_Candesartan cilexetil 32 mg tablets _
Yellow, biconvex, uncoated, round shaped [diameter 10 mm] tablets
debossed with "CN" and “32”
separated by score-line on one side and plain on