Lisinopril/Hydrochloorthiazide STADA 10/12,5 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; LISINOPRIL 2-WATER SAMENSTELLING overeenkomend met ; ; LISINOPRIL 10 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

C09BA03

INN (Algemene Internationale Benaming):

HYDROCHLOORTHIAZIDE 12,5 mg/stuk ; LISINOPRIL 2-WATER SAMENSTELLING overeenkomend met ; ; LISINOPRIL 10 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MAÏSZETMEEL ; SILICIUMDIOXIDE (E 551),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Lisinopril And Diuretics

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MANNITOL (D-) (E 421); SILICIUMDIOXIDE (E 551);

Autorisatie datum:

2003-08-22

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
LISINOPRIL/HYDROCHLOROTHIAZIDE STADA 10/12.5 MG, TABLETTEN
lisinopril and hydrochlorothiazide
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 gets, 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 Lisinopril/Hydrochlorothiazide <...> is and what it is used
for
2. What you need to know before you take
Lisinopril/Hydrochlorothiazide <...>
3. How to take Lisinopril/Hydrochlorothiazide <...>
4. Possible side effects
5. How to store Lisinopril/Hydrochlorothiazide <...>
6. Contents of the pack and other information
1. WHAT LISINOPRIL/HYDROCHLOROTHIAZIDE <...> IS AND WHAT IT IS USED
FOR
Lisinopril/Hydrochlorothiazide <...> is a combination of lisinopril
and hydrochlorothiazide.
Lisinopril is a blood pressure lowering (antihypertensive) drug. It
belongs to a group of
medicines called angiotensin converting enzyme (ACE) inhibitors. It
works by relaxing the
blood vessels, making it easier for the blood to flow through them.
Hydrochlorothiazide is a water tablet belonging to the class of the
thiazide diuretics. It makes
the kidneys produce more urine and reduces thereby the blood volume.
LISINOPRIL/HYDROCHLOROTHIAZIDE <...> IS USED TO:
•
treat high blood pressure (essential hypertension).
Lisinopril/Hydrochlorothiazide <...> should be used in patients whose
blood pressure is not
adequately controlled on lisinopril alone (or hydrochlorothiazide
alone).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LISINOPRIL/HYDROCHLOROTHIAZIDE <...>
DO NOT TAKE LISINOPRIL/HYDROCHLOROTHIAZIDE <...>
•
if you are allergic to lisinopri

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Lisinopril/Hydrochloorthiazide STADA 10/12,5 mg, tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lisinopril/Hydrochlorothiazide <...> 10 mg/12.5 mg; each tablet
contains: lisinopril dihydrate
equivalent to lisinopril 10 mg and hydrochlorothiazide 12.5 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
10 mg /12.5 mg
White, round, biconvex scored tablets with imprint C 10 on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Lisinopril/Hydrochlorothiazide <...> fixed dose combination (10 mg
lisinopril and 12.5 mg
hydrochlorothiazide) is indicated in patients whose blood pressure is
not adequately controlled
on lisinopril alone (or hydrochlorothiazide alone).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The selection of a suitable antihypertensive dose of lisinopril and
hydrochlorothiazide will
depend upon the clinical evaluation of the patient.
Lisinopril/Hydrochlorothiazide
<...>
should be taken once daily.
The
tablets
should be
administered every day at roughly the same time.
The administration of the fixed combination lisinopril and
hydrochlorothiazide is usually
recommended after dosage titration with the individual components.
When clinically appropriate a direct change from monotherapy to fixed
combination may be
considered.
10 mg/12.5 mg tablets may
be
administrated
in patients
whose blood pressure
is
not
adequately controlled by 10 mg lisinopril alone.
20 mg/12.5 mg tablets may
be
administrated
in patients
whose blood pressure
is
not
adequately controlled by 20 mg lisinopril alone.
A maximum daily dose of 40 mg lisinopril/ 25 mg hydrochlorothiazide
should not be exceeded.
_Diuretic Pre-treatment _
The diuretic therapy should be stopped two to three days prior to the
start of a treatment with
Lisinopril/Hydrochlorothiazide. If this is not possible, treatment
should be started with lisinopril
alone, in a 5 mg dose.
_Renal impairments: _
The combinati