Telmisartan 40 mg Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Telmisartan

Tersedia dari:

Accord Healthcare Ireland Ltd.

Kode ATC:

C09CA; C09CA07

INN (Nama Internasional):

Telmisartan

Dosis:

40 milligram(s)

Bentuk farmasi:

Tablet

Area terapi:

Angiotensin II antagonists, plain; telmisartan

Status otorisasi:

Marketed

Tanggal Otorisasi:

2019-08-02

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN 20MG, 40MG AND 80MG TABLETS
telmisartan
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.
-
The full name of this medicine is Telmisartan 20mg, 40mg and 80mg
Tablets but within this
leaflet it will be referred to as Telmisartan.
WHAT IS IN THIS LEAFLET
:
1.
What Telmisartan is and what it is used for
2.
What you need to know before you take Telmisartan
3.
How to take Telmisartan
4.
Possible side effects
5.
How to store Telmisartan
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN IS AND WHAT IT IS USED FOR
Telmisartan contains the active substance telmisartan which belongs to
a class of medicines known as
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.
Telmisartan tablets are used to treat essential hypertension (high
blood pressure) in adults.
‘Essential’ means that the high blood pressure is not caused by
any other condition.
High blood pressure, if not treated, can damage blood vessels in
several organs which could lead
sometimes to heart attacks, heart or kidney failure, strokes or
blindness. There are usually no
symptoms of high blood pressure before damage occurs. Thus it is
important to regularly measure
blood pressure to verify if it is within the normal range.
Telmisartan is also used to
reduce cardiovascular ev

Karakteristik produk

Health Products Regulatory Authority
19 December 2022
CRN00D7T1
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan 40 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg telmisartan
Excipients with known effect:
Telmisartan 40 mg tablets:
Each tablet contains 1.52 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
40 mg tablets: 5.9 x 12.0 mm, white to off-white, oval, biconvex,
uncoated tablets with breakline, debossed with 'KO' on either
side of breakline and '2' on other side of breakline and plain on
other side. The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults.
Cardiovascular prevention
Reduction of cardiovascular morbidity in adults with:
- manifest atherothrombotic cardiovascular disease (history of
coronary heart disease, stroke, or peripheral arterial disease) or
- type 2 diabetes mellitus with documented target organ damage.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Treatment of essential hypertension_
The usually effective dose is 40 mg once daily. Some patients may
already benefit at a daily dose of 20 mg. In cases where the
target blood pressure is not achieved, the dose of telmisartan can be
increased to a maximum of 80 mg once daily.
Alternatively, telmisartan may be used in combination with
thiazidetype diuretics such as hydrochlorothiazide which has been
shown to have an additive blood pressure lowering effect with
telmisartan. When considering raising the dose, it must be
borne in mind that the maximum antihypertensive effect is generally
attained four to eight weeks after the start of treatment
(see section 5.1).
_Cardiovascular prevention_
The recommended dose is 80 mg once daily. It is not known whether
doses lower than 80 mg of telmisartan are effective in
reducing cardiovascular morbidity.
When initiating telmisartan therapy for the reduction of
cardiovascular morbidi