Telmisartan/Hydrochlorothiazide 80mg/12.5mg tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Hydrochlorothiazide; Telmisartan

متاح من:

Accord Healthcare Limited

ATC رمز:

C09DA; C09DA07

INN (الاسم الدولي):

Hydrochlorothiazide; Telmisartan

جرعة:

80 mg/12.5 milligram(s)

الشكل الصيدلاني:

Tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Angiotensin II antagonists and diuretics; telmisartan and diuretics

الوضع إذن:

Not marketed

تاريخ الترخيص:

2016-02-26

نشرة المعلومات

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

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide 80mg/12.5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Excipient(s) with known effect:
Each tablet contains 193.22 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 red, 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 red 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/12.5 mg hydrochlorothiazide) is indicated
in adults whose blood pressure is not adequately controlled on
telmisartan alone.
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/12.5 mg may be administered once
daily in patients whose blood
pressure is not adequately controlled by telmisartan 80 mg
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. Telmisartan/Hydrochlorothiazide is not
indicated in patients with severe hepatic
impairment. Thiazides should be used with caution in patients with
impaired hepatic function (see section 4.4).
Elderly
No dose adjustment is necessary.
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