Valsartan Viatris 40 mg Film-coated Tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Valsartan

Sẵn có từ:

Viatris Limited

Mã ATC:

C09CA; C09CA03

INN (Tên quốc tế):

Valsartan

Dạng dược phẩm:

Film-coated tablet

Khu trị liệu:

Angiotensin II antagonists, plain; valsartan

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

2011-09-23

Tờ rơi thông tin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALSARTAN VIATRIS 40 MG FILM-COATED TABLETS
valsartan
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 Valsartan is and what it is used for
2.
What you need to know before you take Valsartan
3.
How to take Valsartan
4.
Possible side effects
5.
How to store Valsartan
6.
Contents of the pack and other information
1.
W
HAT VALSARTAN IS AND WHAT IT IS USED FOR
Valsartan belongs to a class of medicines known as angiotensin II
receptor antagonists, which help to
control high blood pressure. Angiotensin II is a substance in the body
that causes vessels to tighten,
thus causing your blood pressure to increase. Valsartan works by
blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is lowered.
Valsartan 40 mg film-coated tablets CAN BE USED FOR THREE DIFFERENT
CONDITIONS:
•
TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO LESS
THAN 18 YEARS OF AGE. High
blood pressure increases the workload on the heart and arteries. If
not treated it can
damage the blood vessels of the brain, heart, and kidneys, and may
result in a stroke, heart
failure, or kidney failure. High blood pressure increases the risk of
heart attacks. Lowering
your blood pressure to normal reduces the risk of developing these
disorders.
•
TO TREAT ADULT PATIENTS AFTER A RECENT HEART ATTACK (myocardial
infarction). ‘Recent’ here
means between 12 hours and 10 days.
•
TO TREAT SYMPTOMATIC HEART FAILURE IN ADULT PATIENTS. Valsartan is
used whe

Đặc tính sản phẩm

Health Products Regulatory Authority
07 February 2024
CRN00F07Q
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Viatris 40 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of valsartan.
Excipients with known effects
Each Valsartan 40 mg tablet contains 0.23 mg (0.01 mmol) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, oval-shaped, biconvex, film-coated tablets (9.2 x 3.7 mm)
debossed with ‘VN’ and ‘1’ on either side of the score line on
one side and ‘M’ on the other side. The tablet can be divided into
equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension in children and adolescents 6 to less than
18 years of age.
Recent myocardial infarction
Treatment of clinically stable adult patients with symptomatic heart
failure or asymptomatic left ventricular systolic dysfunction
after a recent (12 hours-10 days) myocardial infarction (see sections
4.4 and 5.1).
Heart failure
Treatment of adult patients with symptomatic heart failure when
ACE-inhibitors are not tolerated or in beta-blocker intolerant
patients as add-on therapy to ACE-inhibitors when mineralocorticoid
receptor antagonists cannot be used (see sections 4.2, 4.4,
4.5 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Recent myocardial infarction
In clinically stable patients, therapy may be initiated as early as 12
hours after a myocardial infarction.
After an initial dose of 20 mg twice daily, valsartan should be
titrated to 40 mg, 80 mg, and 160 mg twice daily over the next
few weeks. The starting dose is provided by the 40 mg divisible
tablet.
The target maximum dose is 160 mg twice daily. In general, it is
recommended that patients achieve a dose level of 80 mg
twice daily by two weeks after treatment initiation and that the
target maximum dose, 160 mg twice daily, be achieved by three
months, based on the patient's tolerabil