Atacand 16 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Candesartan cilexetil

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

C09CA; C09CA06

INN (International Name):

Candesartan cilexetil

Dosage:

16 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Angiotensin II antagonists, plain; candesartan

Authorization status:

Marketed

Authorization date:

2002-04-29

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Atacand 4 mg tablets
Atacand 8 mg tablets
Atacand 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.
WHAT IS IN THIS LEAFLET
:
1.
What Atacand is and what it is used for
2.
What you need to know before you take Atacand
3.
How to take Atacand
4.
Possible side effects
5.
How to store Atacand
6.
Contents of the pack and other information
1.
WHAT ATACAND IS AND WHAT IT IS USED FOR
The name of your medicine is Atacand. 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.
Atacand 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 MRAs are medicines used to
treat heart
failure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATACAND
DO NOT TAKE ATACAND:
•
if you are allergic to candesartan cilexetil or any of the other
ingredients of this
medicine (listed in section 6).
•
if you are more than 3 months pregnant (it is also better to avoid
Atacand in

Summary of Product characteristics

Health Products Regulatory Authority
15 August 2023
CRN00DLDP
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atacand 16 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg candesartan cilexetil.
Excipient with known effect
Each tablet contains 80.7 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round (diameter 7 mm), pink tablets with a score and marked A/CH on
one side and marked 016 on the other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atacand is indicated for:

The treatment of primary hypertension in adults.

The 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 Angiotensin Converting Enzyme
(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 Atacand 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.
Atacand 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 Atacand.
_Elderly_
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