CANDESARTAN MYLAN

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

CANDESARTAN CILEXETIL

Pieejams no:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATĶ kods:

C09CA06

SNN (starptautisko nepatentēto nosaukumu):

CANDESARTAN CILEXETIL

Deva:

16 Milligram

Zāļu forma:

Tablets

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

candesartan

Autorizācija statuss:

Not Marketed

Autorizācija datums:

2011-08-26

Lietošanas instrukcija

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CANDESARTAN MYLAN 4 MG TABLETS
CANDESARTAN MYLAN 8 MG TABLETS
CANDESARTAN MYLAN 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 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 Mylan is and what it is used for
2.
What you need to know before you take Candesartan Mylan
3.
How to take Candesartan Mylan
4.
Possible side effects
5.
How to store Candesartan Mylan
6.
Contents of the pack and other information
1.
WHAT CANDESARTAN MYLAN IS AND WHAT IT IS USED FOR
Candesartan Mylan contains the active substance candesartan which
belongs to a group of medicines
known as angiotensin II receptor antagonists that lower blood
pressure. It works by making your blood
vessels relax and widen (which helps to lower your blood pressure). It
also makes it easier for your
heart to pump blood to all parts of your body.
Candesartan Mylan 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 MYLAN
DO NOT TAKE CANDESARTAN MYLAN:

if you are allergic to candesartan cilexetil or any of the

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Candesartan Mylan 16mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg candesartan cilexetil.
Excipient with known effect
Each tablet contains 74.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off white, round, biconvex tablet debossed with “M over
C6” on one side and plain with a break line on the
other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
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).
Treatment of hypertension in children and adolescents aged 6 to < 18
years.
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 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 volume
depletion (see