Candesartan Crescent 8 mg Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

CANDESARTAN CILEXETIL

Disponible depuis:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

Code ATC:

C09CA06

DCI (Dénomination commune internationale):

CANDESARTAN CILEXETIL 8 mg

forme pharmaceutique:

TABLET

Composition:

CANDESARTAN CILEXETIL 8 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Descriptif du produit:

Licence number in the source country: NOT APPLICAPABLE

Statut de autorisation:

Suspended

Date de l'autorisation:

2020-12-11

Notice patient

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CANDESARTAN CRESCENT
8 MG TABLETS
CANDESARTAN CRESCENT 16 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. THIS INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT
LISTED IN THIS LEAFLET. SEE SECTION 4.
WHAT IS IN THIS LEAFLET
1.
What Candesartan Tablets are and what they are used for
2.
What you need to know before you take Candesartan Tablets
3.
How to take Candesartan Tablets
4.
Possible side effects
5.
How to store Candesartan Tablets
6.
Contents of the pack and other information
1.
WHAT CANDESARTAN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Candesartan Tablets. 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.
Candesartan can be 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 MRA are medicines used to treat heart failure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CANDESARTAN TABLETS
DO NOT TAKE CANDESARTAN TABLETS:
•
if you are allergic to candesartan cilexetil or any of the other
ingredients o

Résumé des caractéristiques du produit

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Candesartan Crescent 8 mg Tablets
Candesartan Crescent 16 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 8 mg candesartan cilexetil.
Each tablet contains 16 mg candesartan cilexetil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Candesartan Crescent 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 Crescent 16 mg Tablets are red, round tablets with a break
line on one side and
debossed with C/C on the same side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
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 4.3, 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 additive
antihypertensive effect with various doses of Candesartan.
_ _
_Elderly population_
No initial dose adjustment is necessary in el