Candesartan 8mg 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:

8mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 02050502; GTIN: 5060570900297

Selebaran informasi

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

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Candesartan
8mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg candesartan cilexetil.
Each tablet contains 129.80 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Candesartan 8mg tablets are white biconvex tablets with a score line
on one
side and embossing C8 on the same side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Candesartan 8mg 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
8mg
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 8mg 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 8mg
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 possible v