Telmisartan/Hydrochlorothiazide 80mg/25mg tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Hydrochlorothiazide; Telmisartan

Beszerezhető a:

Accord Healthcare Limited

ATC-kód:

C09DA; C09DA07

INN (nemzetközi neve):

Hydrochlorothiazide; Telmisartan

Adagolás:

80 mg/25 milligram(s)

Gyógyszerészeti forma:

Tablet

Recept típusa:

Product subject to prescription which may be renewed (B)

Terápiás terület:

Angiotensin II antagonists and diuretics; telmisartan and diuretics

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2016-02-26

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Telmisartan/Hydrochlorothiazide
40 mg/12.5 mg tablets
Telmisartan/Hydrochlorothiazide
80 mg/12.5 mg tablets
Telmisartan/Hydrochlorothiazide
80 mg/25 mg tablets
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 Telmisartan/Hydrochlorothiazide is and
what it is used for
2. What you need to know before you take
Telmisartan/Hydrochlorothiazide
3. How to take Telmisartan/Hydrochlorothiazide
4. Possible side effects
5. How to store Telmisartan/Hydrochlorothiazide
6. Contents of the pack and other information 1.
WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE
IS AND WHAT IT IS USED FOR
Telmisartan/Hydrochlorothiazide 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. Th

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide 80mg/25mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Excipient(s) with known effect:
Each tablet contains 180.72 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off white on one side and yellow, possibly mottled, on other
side, biconvex, bilayer, oblong shaped, uncoated
tablets, approximately 16.2 mm in length and 7.9 mm in width, debossed
with “T2” on yellow side and plain on other
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan/Hydrochlorothiazide fixed dose combination (80 mg
telmisartan/25 mg hydrochlorothiazide) is indicated in
adults whose blood pressure is not adequately controlled on
Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg (80 mg
telmisartan/12.5 mg hydrochlorothiazide) or adults who have been
previously stabilised on telmisartan and
hydrochlorothiazide given separately.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Telmisartan/Hydrochlorothiazide should be taken in patients whose
blood pressure is not adequately controlled by
telmisartan alone. Individual dose titration with each of the two
components is recommended before changing to the
fixed dose combination. When clinically appropriate, direct change
from monotherapy to the fixed combination may be
considered.
Telmisartan/Hydrochlorothiazide 80 mg/25 mg may be administered once
daily in patients whose blood pressure
is not adequately controlled by Telmisartan/Hydrochlorothiazide 80
mg/12.5 mg or in patients who have been
previously stabilised on telmisartan and hydrochlorothiazide given
separately.
Renal impairment
Periodic monitoring of renal function is advised (see section 4.4).
Hepatic impairment
In patients with mild to moderate hepatic impairment the posology
should not exceed Telmisartan/Hydrochlorothiazide
40 mg/12.5 mg once daily.