Valsartan 40mg capsules, hard
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
valsartan
Available from:
Milpharm Limited
ATC code:
C09AA03
INN (International Name):
valsartan
Dosage:
40mg
Pharmaceutical form:
Capsule, hard
Administration route:
Oral use
Units in package:
28, 30 and 500 capsules, hard
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
APL Swift Services (Malta) Limited
Therapeutic group:
Angiotensin II Antagonists, plain
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 Heart failure Treatment of symptomatic heart failure in adult patients when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used, or as add-on therapy to ACE inhibitors when beta blockers cannot be used
Authorization status:
Authorised
Authorization date:
2015-09-14
Patient Information leaflet
VALSARTAN 40 MG CAPSULES, HARD
VALSARTAN 80 MG CAPSULES, HARD
VALSARTAN 160 MG CAPSULES, HARD
Valsartan
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
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
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.
•
TO TREAT SYMPTOMATIC HEART FA
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
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 symptomatic heart failure in adult patients when
Angiotensin
Converting Enzyme (ACE) inhibitors cannot be used, or as add-on
therapy to ACE
inhibitors when beta blockers cannot be used (see sections
4.4 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 ren
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