ENALAPRIL/HCT SANDOZ 20mg/6mg enalapril maleate 20mg and hydrochlorothiazide 6mg tablet blister pack

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

enalapril maleate, Quantity: 20 mg; hydrochlorothiazide, Quantity: 6 mg

Disponível em:

Sandoz Pty Ltd

DCI (Denominação Comum Internacional):

enalapril maleate,Hydrochlorothiazide

Forma farmacêutica:

Tablet, uncoated

Composição:

Excipient Ingredients: magnesium stearate; sodium bicarbonate; maize starch; lactose monohydrate; purified talc

Via de administração:

Oral

Unidades em pacote:

30 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Mild to moderate hypertension. Treatment should not be initiated with this fixed dose combination.

Resumo do produto:

Visual Identification: White, oval, biconvex tablets with snap tab on one side, scored and marked "EN20" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2007-07-11

Folheto informativo - Bula

ENALAPRIL/HCT SANDOZ
®
1
ENALAPRIL/HCT
SANDOZ
®
_20 MG/6 MG TABLETS _
_enalapril maleate and hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Enalapril/HCT
Sandoz 20 mg/6 mg. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Enalapril/HCT Sandoz 20 mg/6 mg
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ENALAPRIL/HCT
SANDOZ 20 MG/6 MG IS
USED FOR
Enalapril/HCT Sandoz 20 mg/6 mg
lowers high blood pressure, which
doctors call hypertension.
Everyone has blood pressure. This
pressure helps to circulate the blood
all around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension (high blood pressure)
when your blood pressure stays
higher than is needed, even when you
are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems. You
may feel fine and have no symptoms,
but eventually hypertension can
cause stroke, heart disease and
kidney failure. Enalapril/HCT
Sandoz 20 mg/6 mg helps to lower
your blood pressure.
_HOW ENALAPRIL/HCT SANDOZ _
_20 MG/6 MG WORKS _
Enalapril/HCT Sandoz 20 mg/6 mg
contains two active ingredients. One
of these is enalapril maleate. It
belongs to a group of medicines
called angiotensin converting
enzyme (ACE) inhibitors. It works
by widening your blood vessels. This
means that blood is able to pass
through them more easily and the
heart doesn't have to pump as hard to
move blood around the body.
The other active ingredient is
hy

Características técnicas

210826-enalapril/hct-sandoz-pi
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
ENALAPRIL/HCT SANDOZ
®
(ENALAPRIL MALEATE/
HYDROCHLOROTHIAZIDE) TABLETS
1
NAME OF THE MEDICINE
Enalapril maleate/ hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Enalapril/HCT Sandoz 20 mg/6 mg tablet contains enalapril maleate
20 mg and
hydrochlorothiazide 6 mg.
_Excipient with known effect: _
Sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Enalapril/HCT Sandoz 20 mg/6 mg are white, oval, biconvex tablets with
snap tab on one side,
scored and marked “EN20” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Mild to moderate hypertension. Treatment should not be initiated with
this fixed dose
combination.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Treatment with Enalapril/HCT 20 mg/6 mg should only be commenced after
titration of the
enalapril component has been shown not to be effective in achieving
the required lowering of
blood pressure.
_HYPERTENSION _
In hypertension, the usual dosage of Enalapril/HCT 20 mg/6 mg is one
tablet, administered
once daily.
_PRIOR DIURETIC THERAPY _
Symptomatic hypotension may occur following the initial dose of
Enalapril/HCT 20 mg/6 mg;
this is more likely in patients who are volume or salt depleted as a
result of prior diuretic
therapy. The diuretic therapy should be discontinued for two to three
days prior to initiation of
therapy with Enalapril/HCT 20 mg/6 mg. Patients receiving concomitant
diuretic and ACE
inhibitor therapy in doses greater than or equal to those contained in
Enalapril/HCT 20 mg/6
mg may be transferred to Enalapril/HCT 20 mg/6 mg without
discontinuation of the diuretic.
METHOD OF ADMINISTRATION
Enalapril/HCT 20 mg/6 mg is supplied as tablets for oral
administration.
210826-enalapril/hct-sandoz-pi
Page 2 of 22
DOSAGE ADJUSTMENT IN:

renal impairment
Thiazides may not be appropriate diuretics for use in patients with
renal impairment and are
ineffective at creatinin