Telhyd 80 mg/12,5 mg tabletten

מדינה: הולנד

שפה: הולנדית

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

מרכיב פעיל:

HYDROCHLOORTHIAZIDE ; TELMISARTAN

זמין מ:

Apotex Europe BV

קוד ATC:

C09DA07

INN (שם בינלאומי):

HYDROCHLOROTHIAZIDE ; TELMISARTAN

טופס פרצבטיות:

Tablet

הרכב:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE ROOD (E 172) ; ISOMALT (E 953) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; MEGLUMINE ; POVIDON K 30 (E 1201),

מסלול נתינה (של תרופות):

Oraal gebruik

איזור תרפויטי:

Telmisartan And Diuretics

leaflet_short:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE ROOD (E 172); ISOMALT (E 953); KALIUMHYDROXIDE (E 525); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); MEGLUMINE; POVIDON K 30 (E 1201);

תאריך אישור:

2016-01-21

עלון מידע

TELHYD 40/12,5, 80/12,5, 80/25 MG, TABLETTEN – RVG 116678-79-80
MODULE 1.3
Product Information
Version: 2019-02-22
MODULE 1.3.1
Package Leaflet
Replaces: 2018-01-26b
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
TELHYD 40 MG/12,5 MG TABLETTEN
TELHYD 80 MG/12,5 MG TABLETTEN
TELHYD 80 MG/25 MG TABLETTEN
Telmisartan/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, 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 Telhyd is and what it is used for
2
What you need to know before you take Telhyd
3
How to take Telhyd
4
Possible side effects
5
How to store Telhyd
6
Contents of the pack and other information
1.
WHAT TELHYD IS AND WHAT IT IS USED FOR
Telhyd is a combination of two active substances, telmisartan and
hydrochlorothiazide in one tablet. Both of
these substances help to control high blood pressure.
-
Telmisartan belongs to a group of medicines called angiotensin II
receptor antagonists. Angiotensin-II is
a substance produced in your body which causes your blood vessels to
narrow thus increasing your blood
pressure. Telmisartan blocks the effect of angiotensin II so that the
blood vessels relax, and your blood
pressure is lowered.
-
Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics, which cause your urine
output to increase, leading to a lowering of your blood pressure.
High blood pressure, if not treated, can damage blood vessels in
several organs, which could lead sometimes
to heart attack, heart or kidney failure, stroke, or blindness. There
are usually no symptoms of high blood
pressure be

מאפייני מוצר

TELHYD 40 MG/12,5 MG / 80 MG/12,5 MG / 80 MG/25 MG, TABLETS - RVG
116678-79-80
MODULE 1.3
Product Information
Version: 2018-11-19
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-01-26d
1
1.
NAME OF THE MEDICINAL PRODUCT
Telhyd 40 mg/12,5 mg tabletten
Telhyd 80 mg/12,5 mg tabletten
Telhyd 80 mg/25 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Each tablet contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Excipients with known effect: 40 mg/12.5 mg: 135.25 mg Isomalt (E953)
Excipients with known effect: 80 mg/12.5 mg: 270.50 mg Isomalt (E953)
Excipients with known effect: 80 mg/25 mg: 270.50 mg Isomalt (E953)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
40 mg/12.5 mg:
White and red coloured, two layered, modified capsule shaped, biconvex
uncoated tablets, 14.1 x 6.9 mm
with “APO” engraved on one side and “40/12.5” on the other
side. White layer may contain red specks and
red layer may contain white specks
80 mg/12.5 mg:
White and red coloured, two layered, modified capsule shaped, biconvex
uncoated tablets, 16.3 x 8.0 mm
with “APO” engraved on one side and “80/12.5” on the other
side. White layer may contain red specks and
red layer may contain white specks.
80 mg/25 mg:
White and yellow coloured, two layered, modified capsule-shaped,
biconvex uncoated tablets, 16.3 x 8.0 mm
with “APO” engraved on one side and “80/25” on the other side.
White layer may contain yellow specks and
yellow layer may contain white specks.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
TELHYD 40 MG/12,5 MG / 80 MG/12,5 MG / 80 MG/25 MG, TABLETS - RVG
116678-79-80
MODULE 1.3
Product Information
Version: 2018-11-19
MODULE 1.3.1
Summary of Product Characteristics
Replaces: 2018-01-26d
2
Telhyd 40 mg/12.5 mg and Telhyd 80 mg/12.5 mg
Telhyd fixed dose combination (40 mg