Candesartan 8mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Candesartan cilexetil

Διαθέσιμο από:

Crescent Pharma Ltd

Φαρμακολογική κατηγορία (ATC):

C09CA06

INN (Διεθνής Όνομα):

Candesartan cilexetil

Δοσολογία:

8mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02050502; GTIN: 5017123679131

Φύλλο οδηγιών χρήσης

THIS COLOUR PROOF IS NOT COLOUR BINDING. FOLLOW PANTONE SHADE
REFERENCE FOR ACTUAL COLOUR MATCHING.
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN 2 MG TABLETS
CANDESARTAN 4 MG TABLETS
CANDESARTAN 8 MG TABLETS
CANDESARTAN 16 MG TABLETS
CANDESARTAN 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 is and what it is used for
2.
What you need to know before you take Candesartan
3.
How to take Candesartan
4.
Possible side effects
5
How to store Candesartan
6.
Contents of the pack and other information 1.
WHAT CANDESARTAN IS AND WHAT IT IS USED FOR
The name of your medicine is Candesartan. 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.
-
treating 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 BEFORE YOU TAKE CANDESARTAN
Do not take Candesarta

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Candesartan 8 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg candesartan cilexetil.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Candesartan 2 mg Tablets are white to off-white, round tablets
(diameter ~5.5 mm).
Candesartan 4 mg Tablets are white to off-white, round tablets with a
break line on
one side.
Candesartan 8 mg Tablets are light red, round tablets with a break
line on one side
and debossed with T/T on the same side.
Candesartan 16 mg Tablets are red, round tablets with a break line on
one side and
debossed with C/C on the same side.
Candesartan 32 mg Tablets are red, round tablets with a break line on
one side.
4 mg, 8 mg, 16 mg, 32 mg -The tablet can be divided into equal doses.
4.1
THERAPEUTIC INDICATIONS
Candesartan cilexetil is indicated for the:
•
Treatment of primary hypertension in adults.
•
The treatment of hypertension in children and adolescents aged 6 to
< 18 years.
•
Treatment of adult patients with heart failure and impaired left
ventricular
systolic function (left ventricular ejection fraction, LVEF
≤
40%) when ACE
inhibitors are not tolerated or as add-on therapy to ACE-inhibitors in
patients
with symptomatic heart failure, despite optimal therapy, when
mineralocorticoid receptor antagonists are not tolerated (see section
4.2, 4.4,
4.5 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology in Hypertension
The recommended initial dose and usual maintenance dose of Candesartan
is 8 mg
once daily. Most of the antihypertensive effect is attained within 4
weeks. In some
patients whose blood pressure is not adequately controlled, the dose
can be increased
to 16 mg once daily and to a maximum of 32 mg once daily. Therapy
should be
adjusted according to blood pressure response.
Candesartan may also be administered with other antihypertensive
agents (see
sections 4.3, 4.4, 4.5 and 5.1). Addition of hydrochlorothiazide has
been shown to
have an additiv