Candesartan 16mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Candesartan cilexetil

Tersedia dari:

Medical Valley Invest AB

Kode ATC:

C09CA06

INN (Nama Internasional):

Candesartan cilexetil

Dosis:

16mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02050502; GTIN: 5060570900303

Selebaran informasi

The name of your medicine is Candesartan Cilexetil. The active
substance 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 to:
•
treat high blood pressure (hypertension) in adult patients and
in children and adolescents aged 6 to <18 years.
•
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).
DO NOT TAKE CANDESARTAN CILEXETIL
•
if you are allergic to candesartan cilexetil or to any of the
ingredients of this medicine (listed in section 6)
•
if you are more than 3 months pregnant. (it is also better to
avoid Candesartan Cilexetil in early pregnancy – see
pregnancy section)
•
if you have severe liver disease or biliary obstruction (a
problem with the drainage of the bile from the gall bladder).
•
if you have DIABETES or IMPAIRED KIDNEY FUNCTION and YOU
ARE TREATED WITH a blood pressure lowering medicine
containing ALISKIREN.
•
if the patient is a child under 1 year of age.
If you are not sure if any of these apply to you, talk to your
doctor or pharmacist before taking Candesartan Cilexetil.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE taking Candesartan
Cilexetil:
•
if you have heart, liver or kidney problems, or are on dialysis
•
if you have recently had a kidney transplant
•
if you are vomiting, have recently had severe vomiting, or
have diarrhoea
•
if you have a disease of the adrenal gland called Conn’s
syndrome (also called primary hyperaldosteronism).
•
if you have low blood pressure
•
if you have ever had a stroke
•
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Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Candesartan
16mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg candesartan cilexetil.
Each tablet contains 121.80 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Candesartan 16mg tablets are White biconvex tablets with a score line
on one
side and embossing C16 on the same side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Candesartan 16mg Tablets is indicated for the:
-
Treatment of essential hypertension in adults
-
Treatment of hypertension in children and adolescents aged 6 to <18
years.
-
The treatment of adult patients with heart failure and impaired left
ventricular
systolic
function
(left
ventricular
ejection
fraction
≤
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 sections
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
16mg
Tablets 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 16mg Tablets 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 additive antihypertensive effect with various doses
of Candesartan
16mg Tablets.
_Elderly population _
No initial dose adjustment is necessary in elderly patients.
_Patients with intravascular volume depletion: _
An initial dose of 4 mg may be considered in patients at risk for
hypotension, such as
patients with poss