Fosinoprilnatrium/Hydrochloorthiazide 20/12,5 Teva, tabletten 20/12,5 mg

Krajina: Holandsko

Jazyk: holandčina

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

Aktívna zložka:

FOSINOPRIL NATRIUM ; HYDROCHLOORTHIAZIDE

Dostupné z:

Teva Pharma B.V. Swensweg 5 2031 GA HAARLEM

ATC kód:

C09BA09

INN (Medzinárodný Name):

FOSINOPRIL SODIUM ; HYDROCHLOROTHIAZIDE

Forma lieku:

Tablet

Zloženie:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 0-WATER ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON (E 1201),

Spôsob podávania:

Oraal gebruik

Terapeutické oblasti:

Fosinopril And Diuretics

Prehľad produktov:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 0-WATER; NATRIUMLAURILSULFAAT (E 487); POVIDON (E 1201);

Dátum Autorizácia:

2005-07-14

Príbalový leták

Fosinopril/HCT, tablets, NL/H/0780/001, 04.11.2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSINOPRILNATRIUM/HYDROCHLOORTHIAZIDE 20/12,5 TEVA, TABLETTEN 20/12,5
MG
fosinopril sodium 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 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 Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA is and what it
is used for
2.
What you need to know before you take Fosinopril
Sodium/Hydrochlorothiazide 20/12.5 TEVA
3.
How to take Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA
4.
Possible side effects
5.
How to store Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA
6.
Contents of the pack and other information
1.
WHAT FOSINOPRIL SODIUM/HYDROCHLOROTHIAZIDE 20/12.5 TEVA IS AND WHAT IT
IS USED FOR
•
Fosinopril Sodium/Hydrochlorothiazide 20/12.5 TEVA contains two active
ingredients: fosinopril
sodium and hydrochlorothiazide.
•
Fosinopril sodium belongs to the group of medicines called
antihypertensives (which are used to
lower blood pressure) and is an angiotensin converting enzyme
inhibitors (ACE-inhibitors).
•
Hydrochlorothiazide belongs to a group of drugs called diuretics
(“water tablets”) and is an
antihypertensive (lowers blood pressure)
•
Fosinopril sodium/hydrochlorothiazide is used as a treatment for high
blood pressure when
treatment with fosinopril on its own has proven ineffective. It may
also be used to replace separate
tablets containing 20 mg of fosinopril and 12.5 mg of
hydrochlorothiazide.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSINOPRIL
SODIUM/HYDROCHLOROTHIAZ

Súhrn charakteristických

Fosinopril/HCT, tablets, NL/H/0780/001, 015.08.2022
rvg 31564 EU SPC IB-046 met NL info-clean 2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Fosinoprilnatrium/Hydrochloorthiazide 20/12,5 Teva, tabletten 20/12,5
mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of fosinopril sodium and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect:
Each tablet contains 210.7 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Mottled peach, capsule shaped tablet, scored on one side and debossed
with "9" on one side of score,
and "3" on the other side of the score, debossed with "7344" on the
other side of tablet.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fosinopril Sodium/Hydrochlorothiazide 20/12.5 Teva is indicated for
the treatment of essential
hypertension in patients who have inadequately responded to treatment
with fosinopril as
monotherapy.
This fixed dose may also replace the combination of 20 mg fosinopril
and 12.5 mg
hydrochlorothiazide in patients who have been stabilised on the
individual active substances given in
the same proportions as separate medications.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This fixed dose combination is not suitable for initial therapy.
Individual dose titration with the monocomponents is recommended. If
clinically appropriate, a direct
change from monotherapy to combination therapy may be considered.
Posology
ADULTS
The usual dose is one tablet of fosinopril sodium/hydrochlorothiazide
20/12.5 Teva once daily.
SPECIAL POPULATIONS
_Patients with hepatic impairment _
Adjustment of the usual dose is not necessary.
Fosinopril/HCT, tablets, NL/H/0780/001, 015.08.2022
rvg 31564 EU SPC IB-046 met NL info-clean 2
_Patients with renal impairment _
In patients with renal impairment (creatinine clearance > 30 ml/min
and < 80 ml/min) dose
adjustment should be carried out with special care and individual dose
titration with the
monocomponents is recommen