Pravasor 40 mg omhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

PRAVASTATINE NATRIUM 40 mg/stuk SAMENSTELLING overeenkomend met ; PRAVASTATINE 38 mg/stuk

Beschikbaar vanaf:

Laboratoires S.M.B. S.A. Rue de la Pastorale 26-28 1080 BRUSSEL (BELGIË)

ATC-code:

C10AA03

INN (Algemene Internationale Benaming):

PRAVASTATINE NATRIUM 40 mg/stuk SAMENSTELLING overeenkomend met ; PRAVASTATINE 38 mg/stuk

farmaceutische vorm:

Omhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Pravastatin

Autorisatie datum:

2019-12-16

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAVASOR 40 MG OMHULDE TABLETTEN
Pravastatinenatrium
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 Pravasor is and what it is used for
2.
What you need to know before you take Pravasor
3.
How to takePravasor
4.
Possible side effects
5.
How to store Pravasor
6.
Contents of the pack and other information
1.
WHAT PRAVASOR IS AND WHAT IT IS USED FOR
Pravastatin, the active substance of Pravasor, belongs to a group of
medicines called statins (or HMG-
CoA reductase inhibitors). It prevents the production of cholesterol
by the liver and consequently
reduces the levels of cholesterol and other fats (triglycerides) in
your body. When there are excessive
levels of cholesterol in the blood, the cholesterol accumulates on the
walls of blood vessels and blocks
them.
This condition is called hardening of the arteries or atherosclerosis
and it may lead to:
▪
chest pain (angina pectoris), when a blood vessel in the heart is
partially blocked,
▪
a heart attack (myocardial infarction), when a blood vessel in the
heart is completely blocked,
▪
a stroke (cerebrovascular accident), when a blood vessel in the brain
is completely blocked.
This medicine is used in 3 situations:
In the treatment of high levels of cholesterol and fats in the blood
Pravasor is used to lower high levels of "bad" cholesterol and to
raise the levels of "good" cholesterol
in the blood when changes to diet and exercise have failed to
adequately do this.
In the prevention of heart and blood ves

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pravasor 40 mg omhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 40 mg of pravastatin sodium.
Excipient(s) with known effect
Each tablet contains 18 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet
Green oblong coated tablet (length 13,9 mm)
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hypercholesterolemia _
Treatment of primary hypercholesterolemia or mixed dyslipidaemia, as
an adjunct to diet, when
response to diet and other non-pharmacological treatments (e.g.
exercise, weight reduction) is
inadequate.
_Primary prevention _
Reduction of cardiovascular mortality and morbidity in patients with
moderate or severe
hypercholesterolemia and at high risk of a first cardiovascular event,
as an adjunct to diet (see section
5.1).
_Secondary prevention _
Reduction of cardiovascular mortality and morbidity in patients with a
history of myocardial infarction
or unstable angina pectoris and with either normal or increased
cholesterol levels, as an adjunct to
correction of other risk factors (see section 5.1).
_Post transplantation _
Reduction of post transplantation hyperlipidaemia in patients
receiving immunosuppressive therapy
following solid organ transplantation. (see sections 4.2, 4.5 and
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to initiating Pravastatin Sodium Tablets, secondary causes of
hypercholesterolemia should be
excluded and patients should be placed on a standard lipid-lowering
diet which should be continued
during treatment.
Posology
_Hypercholesterolemia _
The recommended dose range is 10-40 mg once daily. The therapeutic
response is seen within a week
and the full effect of a given dose occurs within four weeks,
therefore periodic lipid determinations
should be performed and the dosage adjusted accordingly. The maximum
daily dose is 40 mg.
_Cardiovascular prevention _
In all preventive mo