PRESSOLAT 10

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

NIFEDIPINE

Commercializzato da:

BAYER ISRAEL LTD

Codice ATC:

C08CA05

Forma farmaceutica:

TABLETS MODIFIED RELEASE

Composizione:

NIFEDIPINE 10 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

BAYER PHARMA AG, GERMANY

Gruppo terapeutico:

NIFEDIPINE

Area terapeutica:

NIFEDIPINE

Indicazioni terapeutiche:

Treatment of Hypertension.

Data dell'autorizzazione:

2014-04-30

Foglio illustrativo

לע העדוה
הרמחה
( עדימ
)תוחיטב
ל ןולעב
אפור
ןכדועמ(
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)
ךיראת :
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םושירה רפסמו תילגנאב רישכת םש
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25890
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5
7
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040
PRESSOLAT 10
םושירה לעב םש :
מ"עב לארשי רייאב
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ טסקט
יחכונ
שדח טסקט
Section 4.4 – Special
warnings and
precautions for use
In patients with mild, moderate
or severe impaired liver function,
careful monitoring and a dose
reduction may be necessary.
In patients with mild, moderate or
severe impaired liver function, careful
monitoring and a dose reduction may
be necessary. The pharmacokinetics
of nifedipine has not been investigated
in patients with severe hepatic
impairment (see section 4.2 and 5.2).
Therefore, nifedipine should be used
with caution in patients with severe
hepatic impairment.

Scheda tecnica

1/11
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH
AND ITS CONTENT WAS CHECKED AND
APPROVED BY IT IN FEBRUARY 2017.
1
NAME OF THE MEDICINAL PRODUCT
Pressolat 10
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 10 mg nifedipine.
Excipient with known effect: Lactose monohydrate.
For excipients see Section 6.1.
3
PHARMACEUTICAL FORM
Modified-release tablets.
Grey-pink, round, modified-release tablets marked with A10 on one side
and Bayer cross on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration _
Oral Use.
As a rule, tablets are swallowed whole with a little liquid, either
with or without food.
Pressolat should not be taken with grapefruit juice (see Section 4.5).
_Dosage regimen _
As far as possible the treatment must be tailored to the needs of the
individual according to the severity of the
disease and the patient's response.
Depending on the clinical picture in each case, the basic dose must be
introduced gradually.
Pressolat 10 mg is particularly suitable for dose titration. Dose
titration is particularly recommended for
hypertensives with severe cerebrovascular disease and for patients,
who because of low body weight or
multiple therapies with other antihypertensive drugs, are likely to
have an excessive reaction to nifedipine. In
addition, patients in whom side effects in response to the nifedipine
treatment make a finer dose adjustment
desirable should be individually stabilised with Pressolat 10 mg
.
2/11
Unless otherwise prescribed, the following dosage guidelines apply for
adults:

In hypertension:
1 Pressolat 10 mg tablet twice daily
(2 x 10 mg/day)
2 Pressolat 10 mg tablet twice daily
(2 x 20 mg/day)
If higher dosages are necessary, the dose can be increased in stages
up to maximum 60 mg daily.
Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may
result in the recommendation
to adapt the nifedipine dose or not to use nifedipin