Valsartan Jubilant Tablet, film coated 80mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VALSARTAN

Available from:

Jubilant Pharmaceuticals nv Axxes Business Park, Guldensporenpark 22 – Block C, 9820 Merelbeke, Belgium

ATC code:

C09CA03

INN (International Name):

VALSARTAN 80 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

VALSARTAN 80 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2019-02-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALSARTAN JUBILANT 40 MG FILM-COATED TABLETS
VALSARTAN JUBILANT 80 MG FILM-COATED TABLETS
VALSARTAN JUBILANT 160 MG FILM-COATED TABLETS
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.
WHAT IS IN THIS LEAFLET
1.
What Valsartan Jubilant is and what it is used for
2.
What you need to know before you take Valsartan Jubilant
3.
How to take Valsartan Jubilant
4.
Possible side effects
5.
How to store Valsartan Jubilant
6.
Contents of the pack and other information
1.
WHAT VALSARTAN JUBILANT IS AND WHAT IT IS USED FOR
Valsartan Jubilant belongs to a class of medicines known as
angiotensin II receptor antagonist,
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 Jubilant works by
blocking the effect of angiotensin II. As a result, blood vessels
relax and blood pressure is lowered.
Valsartan Jubilant 40 mg 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
(

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valsartan Jubilant 40 mg film-coated tablets
Valsartan Jubilant 80 mg film-coated tablets
Valsartan Jubilant 160 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valsartan Jubilant 40 mg film-coated tablets
Each tablet contains 40 mg valsartan.
Excipient with known effect: Lactose anhydrous. Each tablet contains
51,3 mg lactose
anhydrous.
Valsartan Jubilant 80 mg film-coated tablets
Each tablet contains 80 mg valsartan.
Excipient with known effect: Lactose anhydrous. Each tablet contains
102,5 mg lactose
anhydrous.
Valsartan Jubilant 160 mg film-coated tablets
Each tablet contains 160 mg valsartan.
Excipient with known effect: Lactose anhydrous. Each tablet contains
205,0 mg lactose
anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Valsartan Jubilant 40 mg film-coated tablets
Yellow coloured, round, biconvex, film-coated tablets of 7.1 ± 0.2 mm
diameter, debossed
with “J” on one side and “40” on the other side of the tablet.
Valsartan Jubilant 80 mg film-coated tablets
Peach coloured, round, biconvex film-coated tablets of 8.7 ± 0.2 mm
diameter, scored on one
side and debossed with “80” on scored side and “J” on the
other side of the tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
Valsartan Jubilant 160 mg film-coated tablets
Yellow coloured, oval shaped, biconvex, film-coated tablets of 17.4 ±
0.2 mm length and of
6.9 ± 0.2 mm width, scored on one side and debossed with “160” on
scored side and “J” on
the other side of the tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
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4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Valsartan Jubilant 40 mg film-coated tablets _
Hypertension
Treatment of hypertension in children and adolescents 6 to 18 years of
age.
Recent myocardial infarction
Treatment of clinically stable