Imprida HCT
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
29-10-2012
Summary of Product characteristics
(SPC)
29-10-2012
Public Assessment Report
(PAR)
29-10-2012
Active ingredient:
amlodipine, valsartan, hydrochlorothiazide
Available from:
Novartis Europharm Ltd.
ATC code:
C09DX01
INN (International Name):
amlodipine, valsartan, hydrochlorothiazide
Therapeutic group:
Angiotensin II antagonists, plain, Angiotensin II antagonists, combinations
Therapeutic area:
Hypertension
Therapeutic indications:
Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.
Product summary:
Revision: 3
Authorization status:
Withdrawn
Authorization date:
2009-10-15
Patient Information leaflet
146
B. PACKAGE LEAFLET
Medicinal product no longer authorised
147
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMPRIDA HCT 5 MG/160 MG/12.5 MG FILM-COATED TABLETS
amlodipine/valsartan/hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Imprida HCT is and what it is used for
2.
Before you take Imprida HCT
3.
How to take Imprida HCT
4.
Possible side effects
5.
How to store Imprida HCT
6.
Further information
1.
WHAT IMPRIDA HCT IS AND WHAT IT IS USED FOR
Imprida HCT tablets contain three substances called amlodipine,
valsartan and hydrochlorothiazide.
All of these substances help to control high blood pressure.
Amlodipine belongs to a group of substances called “calcium channel
blockers”. Amlodipine
stops calcium from moving into the blood vessel wall, which stops the
blood vessels from
tightening.
Valsartan belongs to a group of substances called “angiotensin-II
receptor antagonists”.
Angiotensin II is produced by the body and makes the blood vessels
tighten, thus increasing the
blood pressure. Valsartan works by blocking the effect of angiotensin
II.
Hydrochlorothiazide belongs to a group of substances called
“thiazide diuretics”.
Hydrochlorothiazide increases urine output, which also lowers blood
pressure.
As a result of all three mechanisms, the blood vessels relax and blood
pressure is lowered.
Imprida HCT is used to treat high blood pressure in adult patients who
are already taking amlodipine,
valsartan and hydrochlorothiazide and who may benefit from taking one
tablet containing all three
substances.
2.
BEFORE YOU TAKE IMPRIDA H
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Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine
besylate), 160 mg of valsartan,
and 12.5 mg of hydrochlorothiazide.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, ovaloid, biconvex tablets with bevelled edge, debossed
“NVR” on one side and “VCL” on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension as substitution therapy in adult
patients whose blood pressure is
adequately controlled on the combination of amlodipine, valsartan and
hydrochlorothiazide (HCT),
taken either as three single-component formulations or as a
dual-component and a single-component
formulation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Imprida HCT is one tablet per day, to be taken
preferably in the morning.
Before switching to Imprida HCT patients should be controlled on
stable doses of the
monocomponents taken at the same time. The dose of Imprida HCT should
be based on the doses of
the individual components of the combination at the time of switching.
The maximum recommended dose of Imprida HCT is 10 mg/320 mg/25 mg.
Special populations
_Renal impairment _
No adjustment of the initial dose is required for patients with mild
to moderate renal impairment (see
sections 4.4 and 5.2). Due to the hydrochlorothiazide component,
Imprida HCT is contraindicated for
use in patients with anuria (see section 4.3) and in patients with
severe renal impairment (glomerular
filtration rate (GFR) <30 ml/min/1.73 m
2
) (see sections 4.3, 4.4 and 5.2).
_Hepatic impairment _
Due to the valsartan component, Imprida HCT is contraindicated in
patients with severe hepatic
impairment (see section 4.3). In patients with mild to moderate
hepatic impairment without
cholestasis, the maxim
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