Valsartan Macleods 320 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VALSARTAN

Available from:

Macleods Pharma España, S.L.U. Avenida Diagonal, 468, 6°, puerta A, 08006, Barcelona, Spain

ATC code:

C09CA03

INN (International Name):

VALSARTAN 320 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VALSARTAN 320 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-01-26

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN MACLEODS 320 MG 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 Macleods is and what it is used for
2.
What you need to know before you take Valsartan Macleods
3.
How to take Valsartan Macleods
4.
Possible side effects
5.
How to store Valsartan Macleods
6.
Contents of the pack and other information
1.
WHAT VALSARTAN MACLEODS IS AND WHAT IT IS USED FOR
Valsartan Macleods 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. Valsartan works by blocking the effect of angiotensin II. As
a result, blood vessels relax and
blood pressure is lowered.
Valsartan Macleods 320 mg film-coated tablets
CAN BE USED
:
-
TO TREAT HIGH BLOOD PRESSURE IN ADULTS AND IN CHILDREN AND ADOLESCENTS
6 TO LESS THAN 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALSARTAN MACLEODS
DO NOT TAKE VALSARTAN MACLEODS
-
if you are allergic t

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Valsartan Macleods 40 mg film-coated tablets
Valsartan Macleods 80 mg film-coated tablets
Valsartan Macleods 160 mg film-coated tablets
Valsartan Macleods 320 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 40 mg of valsartan.
One film-coated tablet contains 80 mg of valsartan.
One film-coated tablet contains 160 mg of valsartan.
One film-coated tablet contains 320 mg of valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
40 mg:
Yellow, scored, oval shaped, biconvex, film-coated tablets debossed
with “L” and “12” on both sides
of the score on one side and plain on other side (approximate size:
9.5 x 5 mm).
The tablet can be divided into equal doses.
80 mg:
Light red, scored, oval shaped, biconvex, film-coated tablets debossed
with “L” and “13” on both
sides of the score on one side and plain on other side (approximate
size: 13 x 6.2 mm).
160 mg:
Brown, scored, oval shaped, biconvex, film-coated tablets debossed
with “L” and “14” on both sides
of the score on one side and plain on other side (approximate size:
16.5 x 7.7 mm).
320 mg:
Violet, scored, oval shaped, biconvex, film-coated tablets debossed
with “L15” on one side and plain
on other side (approximate size: 20.5 x 9.4 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension (only 40 mg)
Treatment of hypertension in children and adolescents 6 to less than
18 years of age.
Hypertension (only 80 mg, 160 mg and 320 mg)
Treatment of essential hypertension in adults, and hypertension in
children and adolescents 6 to less
than 18 years of age.
Recent myocardial infarction (only 40 mg, 80 mg and 160 mg)
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)
3
Heart failure (only 40 mg, 80 mg and 1