Candesartan 2mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Candesartan cilexetil

Tilgængelig fra:

Crescent Pharma Ltd

ATC-kode:

C09CA06

INN (International Name):

Candesartan cilexetil

Dosering:

2mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 02050502; GTIN: 5017123682308 5017123682131

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN CILEXETIL 8 MG TABLETS
CANDESARTAN CILEXETIL 16 MG TABLETS
CANDESARTAN CILEXETIL 32 MG TABLETS
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..
•
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 CILEXETIL
DO NOT TAKE CANDESARTAN CILEXETIL
-
if you are allergic to candesartan cilexetil or any o

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Candesartan 2 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 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