DIOVAN 80 MG FILM-COATED TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

VALSARTAN

Available from:

NOVARTIS ISRAEL LTD

ATC code:

C09CA03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

VALSARTAN 80 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SIEGFRIED BARBERA, S.L., SPAIN

Therapeutic group:

VALSARTAN

Therapeutic area:

VALSARTAN

Therapeutic indications:

For treatment of hypertension. Diovan is indicated for the treatment of heart failure (NYHA class II-IV) in patients who are intolerant of angiotensin converting enzyme inhibitors. In a controlled clinical trial Diovan signicantly reduced hospitalisations for heart failure. There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an ACE inhibitor. Diovan is indicated to improve survival following myocardial infarction in clinically stable patients with signs symptoms or radiological evidence of left ventricular failure and /or with left ventricular systolic dysfunction.

Authorization date:

2023-03-31

Patient Information leaflet

؟ءاودلا لامعتسإ ةيفيك )3
.بيبطلا تاميلعت بسح رضحتسملا لامعتسإ
ً
امئاد بجي
صوصخب
ً
اقثاو نكت مل اذإ يلديصلا نم وأ بيبطلا
نم حاضيتسلإا كيلع
.رضحتسملاب جلاعلا ةقيرطو ةيئاودلا
ةعرجلا
ةيئاودلا ةعرجلا .طقف بيبطلا لبق نم
ناددحي جلاعلا ةقيرطو ةيئاودلا ةعرجلا
.ءاودلا فص
ُ
و هلجأ نم بابطتسلإاب ةقلعتم
ةيدايتعلإا
.قوف امو ةنس 65 رامعأب ىضرم ىدل ناڤويد
لامعتسإ ناكملإاب
.ةنس 18 رمع نود نيقهارملاو لافطلأا
،عضرلل صصخم ريغ ءاودلا اذه
.اهب ىصوملا ةيئاودلا ةعرجلا زواجت زوجي
لا
مهنم ريثكلا .ةلكشملا تاملاعب عفترملا
مدلا طغض ىضرم ظحلاي لا ةداع
ىتح كبيبط ىدل تارايزلا ىلع ةبظاوملا
مهملا نم اذل .ديج لكشب نورعشي
.ديج لكشب ترعش ولو
:لوانتلا ةقيرط
قحس صوصخب تامولعم رفوتت لا .ماعط نودب
وأ عم ناڤويد لوانت ناكملإاب
لوانت بجي .ءاملا نم سأك عم ناڤويد علب
بجي .يلطملا صرقلا غضم وأ
دنبلا نعمتب أرقإ ءاجرلا رطشلا
تاميلعتل .موي لك نم تقولا سفن يف ناڤويد
."ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك"
ربكأ ةيئاود ةعرج أطخلاب تلوانت اذإ
ةيعضول لقتنإو كبيبط ىلإ
ً
لااح هجوت ءامغإ وأ/و ديدش راودب رعشت
تنك اذإ
،ءاودلا نم أطخلاب لفط علب اذإ وأ ةطرفم
ةيئاود ةعرج تلوانت اذإ .ءاقلتسلإا
.ءاودلا ةبلع كعم رضحأو ىفشتسملا يف
ئراوطلا ةفرغل وأ بيبطلا ىلإ
ً
لااح هجوت
ناڤويد لوانت تيسن �

Summary of Product characteristics

1
DIO API SEP23 V1.3
1. NAME OF THE MDICINAL PRODUCT
DIOVAN
®
40 mg film-coated tablets
DIOVAN
®
80 mg film-coated tablets
DIOVAN
®
160 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg of valsartan.
Each film-coated tablet contains 80 mg of valsartan.
Each film-coated tablet contains 160 mg of valsartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Diovan
®
40 mg Film-coated tablet: Yellow, ovaloid film-coated tablet with
bevelled
edges, slightly covex, scored on one side; with debossing “D” on
one side of the
score and “O” on the other side of the score and “NVR” on the
reverse side of the
tablet. The tablet can be divided into equal doses.
Diovan
®
80 mg Film-coated tablet: Pale red, round film-coated tablet with
bevelled
edges, scored on one side with debossing “D” on one side of the
score and “V” on
the other side of the score and “NVR” on the reverse side of the
tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
Diovan
®
160 mg Film-coated tablet: Grey-orange, ovaloid film-coated tablet
slightly
convex, scored on one side with debossing “DX” on one side of the
score "DX" on the
other side of the score and “NVR” on the reverse side of the
tablet.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
There is no information regarding chewing or crushing of the tablets.
4
.
CLINICAL PARTICULARS
Page 2 of 21
DIO SPI SEP23 V1.3
4.1
Therapeutic indications
Hypertension (Diovan 80 mg and 160 mg)
For treatment of hypertension.
Heart failure (Diovan 40 mg, 80 mg and 160 mg)
Diovan is indicated for the treatment of heart failure (NYHA class
II-IV) in patients
who are intolerant of angiotensin converting enzyme inhibitors. In a
controlled clinical
trial, Diovan significantly reduced hospitalizations for heart
failure. There is no
evidence that Diovan provides added benefits when it is us