Valsartan Rowa 40 mg film-coated tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Valsartan

Disponibbli minn:

Rowa Pharmaceuticals Limited

Kodiċi ATC:

C09CA; C09CA03

INN (Isem Internazzjonali):

Valsartan

Dożaġġ:

40 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Angiotensin II antagonists, plain; valsartan

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2011-04-21

Fuljett ta 'informazzjoni

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

Karatteristiċi tal-prodott

Health Products Regulatory Authority
12 April 2022
CRN00CG52
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valsartan Rowa 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 40 mg of valsartan
EXCIPIENTS:
EXCIPIENTS WITH KNOWN EFFECT:
sorbitol 4.6 mg
lactose monohydrate 0.5 mg
sodium 0.16 mg (0.01 mmol)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Valsartan Rowa 40 mg film-coated tablets: cylindrical, coated, scored
on one side, yellow film-coated tablets.
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 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 tolerability. If symptomatic
hypotension or renal dysfunction occur, consideration