Valsartan 40mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Valsartan

Disponível em:

Actavis UK Ltd

Código ATC:

C09CA03

DCI (Denominação Comum Internacional):

Valsartan

Dosagem:

40mg

Forma farmacêutica:

Tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02050502; GTIN: 5012617021830

Folheto informativo - Bula

VALSARTAN 40MG, 80MG AND 160MG
FILM-COATED TABLETS
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
WHAT 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 40MG FILM-COATED TABLETS 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 hours and 10 days.
•
TO TREAT SYMPTOMATIC HEART FAILURE IN ADULT PATIENTS.
Valsartan is used when a group of medicines called Angiotensin
Converting Enzym

Características técnicas

OBJECT 1
VALSARTAN 40 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 01-Mar-2016 | Accord-UK Ltd
1. Name of the medicinal product
Valsartan 40 mg Film-Coated Tablets
2. Qualitative and quantitative composition
One film-coated tablet contains 40 mg of valsartan
Excipients with known effect:
Each Valsartan 40 mg film-coated tablet contains 21.11 mg lactose
monohydrate and 0.126 mg lecithin
(contains soya oil)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Yellow, oval, biconvex, film-coated tablets, 9 x 4.5 mm, with a
scoreline on one side and marked with a
"V" on the other.
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 to10 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 mineralcorticoid receptor
antagonist 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 symptom