Valsartan 160mg capsules

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Valsartan

थमां उपलब्ध:

Dexcel-Pharma Ltd

ए.टी.सी कोड:

C09CA03

INN (इंटरनेशनल नाम):

Valsartan

डोज़:

160mg

फार्मास्यूटिकल फॉर्म:

Capsule

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 02050502; GTIN: 5033847001539

सूचना पत्रक

PACKAGE LEAFLET:
INFORMATION FOR THE USER
DIOVAN
® 160MG CAPSULES
(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.
The name of your medicine is Diovan 160mg capsules
but it will be referred to as Diovan throughout this
leaflet. Please note that this leaflet also contains
information about other strengths such as Diovan
40mg capsules and Diovan 80mg capsules.
WHAT IS IN THIS LEAFLET:
1. What Diovan is and what it is used for
2. What you need to know before you take Diovan
3. How to take Diovan
4. Possible side effects
5. How to store Diovan
6. Contents of the pack and other information
1. WHAT DIOVAN IS AND WHAT IT IS USED
FOR
Diovan contains the active substance: valsartan and
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.
Diovan works by blocking the effect of angiotensin II.
As a result, blood vessels relax and blood pressure is
lowered.
Diovan 40, 80 and 160mg Capsules CAN BE USED

TO TREAT PEOPLE AFTER A RECENT HEART ATTACK
(myocardial infarction). ‘Recent’ here means
between 12 hours and 10 days.

TO TREAT SYMPTOMATIC HEART FAILURE.
Diovan is used when a group of medicines called
Angiotensin Converting Enzyme (ACE) inhibitors (a
medication to treat heart failure) cannot be used or
it may be used in addition to ACE inhibitors when
beta blockers (another medication to treat heart
failure) cannot be used.

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Valsartan 160 mg Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 160 mg valsartan.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
Appearance:
Dark grey cap and flesh opaque body, marked CG GOG in white ink on the
cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension
Recent myocardial infarction
Treatment of clinically stable 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 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
dose
of
Valsartan
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 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, 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 b