Candesartan cilexetil 2mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CANDESARTAN CILEXETIL

Available from:

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

ATC code:

C09CA06

INN (International Name):

CANDESARTAN CILEXETIL 2 mg

Pharmaceutical form:

TABLET

Composition:

CANDESARTAN CILEXETIL 2 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2013-08-12

Patient Information leaflet

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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

Summary of Product characteristics

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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