Valsartan 40mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Valsartan

Available from:

Milpharm Ltd

ATC code:

C09CA03

INN (International Name):

Valsartan

Dosage:

40mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502

Patient Information leaflet

Black
VALSARTAN
P15XXXXX
VALSARTAN
P15XXXXX
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 capsules belong 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 capsules work by blocking the effect of angiotensin II. As a
result, blood vessels relax and blood pressure is lowered.
Valsartan 40 mg capsules 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.
•
Valsartan can be used to treat symptomatic heart failure in adult
patients. Valsartan is used when a group of medicines called
Angiotensi

Summary of Product characteristics

OBJECT 1
VALSARTAN 40 MG CAPSULES
Summary of Product Characteristics Updated 07-Jun-2018 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Valsartan 40 mg capsules, hard
2. Qualitative and quantitative composition
Each hard capsule contains 40 mg of valsartan.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
Opaque light grey cap/Opaque light grey body, size '4' hard gelatin
capsules imprinted in black ink with 'I'
on cap and '70' on body, filled with white to off white granular
powder.
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 should be given
to a dose reduction.
Valsartan may be used in patients treated