Candesartan/Hydrochlorothiazide 8mg/12.5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE

Available from:

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

ATC code:

C09DA06

INN (International Name):

CANDESARTAN CILEXETIL 8 mg HYDROCHLOROTHIAZIDE 12.5 mg

Pharmaceutical form:

TABLET

Composition:

CANDESARTAN CILEXETIL 8 mg HYDROCHLOROTHIAZIDE 12.5 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2015-07-03

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN/HYDROCHLOROTHIAZIDE 8 MG/12.5 MG TABLETS
CANDESARTAN/HYDROCHLOROTHIAZIDE 16 MG/12.5 MG TABLETS
CANDESARTAN/HYDROCHLOROTHIAZIDE 32 MG/12.5 MG TABLETS
CANDESARTAN/HYDROCHLOROTHIAZIDE 32 MG/25 MG TABLETS
Candesartan cilexetil/hydrochlorothiazide
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/Hydrochlorothiazide is and what it is used for
2.
What you need to know before you take Candesartan/Hydrochlorothiazide
3.
How to take Candesartan/Hydrochlorothiazide
4.
Possible side effects
5.
How to store Candesartan/Hydrochlorothiazide
6.
Contents of the the pack and other information
1.
WHAT CANDESARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR
The name of your medicine is Candesartan/ Hydrochlorothiazide. It is
used for treating high blood
pressure (hypertension) in adult patients. It contains two active
ingredients: candesartan cilexetil
and hydrochlorothiazide. These work together to lower your blood
pressure.
•
Candesartan
cilexetil
belongs
to
a
group
of
medicines
called
angiotensin
II
receptor
antagonists. It makes your blood vessels relax and widen. This helps
to lower your blood
pressure.
•
Hydrochlorothiazide belongs to a group of medicines called diuretics
(water tablets). It helps
your body to get rid of water and salts like sodium in your urine.
This helps to lower your blood
pressure.
Your doctor may prescribe Candesartan/Hydrochlorothiazide if your
blood pressure has not been
properly controlled by candesart

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Candesartan/Hydrochlorothiazide 8 mg/12.5 mg tablets
Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets
Candesartan/Hydrochlorothiazide 32 mg/12.5 mg tablets
Candesartan/Hydrochlorothiazide 32 mg/25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Candesartan/Hydrochlorothiazide 8 mg/12.5 mg tablets:
Each tablet contains 8 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Excipient with known effect: Each tablet contains 110.000 mg lactose
monohydrate.
Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets:
Each tablet contains 16 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Excipient with known effect: Each tablet contains 101.925 mg lactose
monohydrate.
Candesartan/Hydrochlorothiazide 32 mg/12.5 mg tablets:
Each tablet contains 32 mg candesartan cilexetil and 12.5 mg
hydrochlorothiazide.
Excipient with known effect: Each tablet contains 216.000 mg lactose
monohydrate.
Candesartan/Hydrochlorothiazide 32 mg/25 mg tablets:
Each tablet contains 32 mg candesartan cilexetil and 25 mg
hydrochlorothiazide.
Excipient with known effect: Each tablet contains 203.850 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Candesartan/Hydrochlorothiazide 8 mg/12.5 mg tablets:
White to off-white, uncoated capsule shaped tablets [diameter 9.8 mm x
4.6 mm], debossed with ‘J’
and ‘04’ separated by score line on one side and plain with score
line on the other side. The tablet
can be divided into equal doses.
Candesartan/Hydrochlorothiazide 16 mg/12.5 mg tablets:
Pink, uncoated capsule shaped tablets [size 9.8 mm x 4.6 mm], debossed
with ‘J’ and ‘05’ separated
by score line on one side and plain with score line on the other side
The tablet can be divided into
equal doses.
Candesartan/Hydrochlorothiazide 32 mg/12.5 mg tablets:
Yellow, uncoated oval shaped tablets [size 11.3 mm x 6.6 mm], debossed
with ‘J’ and ‘07’
separated by score line on one side a