Valsartan Rowa 160 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
13-04-2022
Summary of Product characteristics
(SPC)
13-04-2022
Active ingredient:
Valsartan
Available from:
Rowa Pharmaceuticals Limited
ATC code:
C09CA; C09CA03
INN (International Name):
Valsartan
Dosage:
160 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Angiotensin II antagonists, plain; valsartan
Authorization status:
Not marketed
Authorization date:
2011-04-21
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN ROWA 40 MG FILM-COATED TABLETS
VALSARTAN ROWA 80MG FILM-COATED TABLETS
VALSARTAN ROWA 160MG 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 symptoms are the same as yours.
If any of the side effects gets serious, 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 Rowa is and what it is used for
2.
What you need to know before you take Valsartan Rowa
3.
How to take Valsartan Rowa
4.
Possible side effects
5.
How to store Valsartan Rowa
6.
Contents of the pack and other information.
1.
WHAT VALSARTAN ROWA IS AND WHAT IT IS USED FOR
Valsartan Rowa belongs to a class of medicines known as angiotensin II
receptor antagonist, 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 Rowa works by
blocking the effect of
angiotensin II. As a result, blood vessels relax and blood pressure is
lowered.
VALSARTAN ROWA CAN BE USED FOR THREE DIFFERENT CONDITIONS:
TO TREAT HIGH BLOOD PRESSURE IN CHILDREN AND ADOLESCENTS 6 TO 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 h
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
12 April 2022
CRN00CG52
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Rowa 160 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 160 mg of valsartan.
EXCIPIENTS:
EXCIPIENTS WITH KNOWN EFFECT:
Each tablet contains
sorbitol 18.5 mg
lactose monohydrate 2.2 mg
sodium 0.64 mg (0.03 mmol)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Valsartan Rowa 160 mg film-coated tablets: cylindrical, coated, scored
on one side, ochre film-coated tablets.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adult patients and hypertension
in children and adolescents 6 to 18 years of age.
Recent myocardial infarction
Treatment of clinically stable adults 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
Hypertension
The recommended starting dose of Valsartan Rowa is 80 mg once daily.
The antihypertensive effect is substantially present
within 2 weeks, and maximal effects are attained within 4 weeks. In
some patients whose blood pressure is not adequately
controlled, the dose can be increased to 160 mg and to a maximum of
320 mg.
Valsartan Rowa may also be administered with other antihypertensive
agents (see sections 4.3, 4.4, 4.5 and 5.1). The addition of
a diuretic such as hydrochlorothiazide will decrease blood pressure
even further in these patients.
Recent myocardial infarction
In clinically stable patients, thera
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