Vaspit 4 mg filmomhulde tabletten

Krajina: Holandsko

Jazyk: holandčina

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

Aktívna zložka:

PITAVASTATINE CALCIUM 4,18 mg/stuk SAMENSTELLING overeenkomend met ; PITAVASTATINE 4 mg/stuk

INN (Medzinárodný Name):

PITAVASTATINE CALCIUM 4,18 mg/stuk SAMENSTELLING overeenkomend met ; PITAVASTATINE 4 mg/stuk

Forma lieku:

Filmomhulde tablet

Zloženie:

ALUMINIUMMAGNESIUMMETASILICAAT, type 1A,B of C ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463a) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), ALUMINIUMMAGNESIUMMETASILICAAT, type 1A,B of C ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505)

Spôsob podávania:

Oraal gebruik

Dátum Autorizácia:

1900-01-01

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VASPIT 1 MG FILMOMHULDE TABLETTEN
VASPIT 2 MG FILMOMHULDE TABLETTEN
VASPIT 4 MG FILMOMHULDE TABLETTEN
pitavastatine
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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains a medicine called pitavastatin. This belongs
to a group of medicines called
‘statins’. Pitavastatin is used to correct the levels of fat
(lipid) in your blood and can be taken by
children from the age of 6 years, as well as by adults. An imbalance
of fats particularly cholesterol can
sometimes lead to a heart attack or stroke.
You have been given [Product name] because you have an imbalance of
fats and changing your diet
and making lifestyle changes have not been enough to correct this. You
should continue with your
cholesterol-lowering diet and lifestyle changes while you are taking
[Product name].
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]
-
if you are allergic to pitavastatin, any other statins or any of the
other ingredients of this medicine
(listed in section 6).
-
if you are pregnant or breast-feeding.
-
if you are a woman able to have children and you are not using a
reliable contraceptive method
(see ‘Pregnancy, breast-feeding and fertility

Súhrn charakteristických

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vaspit 1 mg filmomhulde tabletten
Vaspit 2 mg filmomhulde tabletten
Vaspit 4 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains pitavastatin calcium equivalent to 1
mg, 2 mg or 4 mg pitavastatin.
Excipient with known effect: lactose.
Each [Product name] 1 mg film-coated tablet contains 60.855 mg lactose
monohydrate.
Each [Product name] 2 mg film-coated tablet contains 121.71 mg lactose
monohydrate.
Each [Product name] 4 mg film-coated tablet contains 243.42 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
[Product name] 1 mg film-coated tablets: White round, concave, film
coated tablets, debossed with
‘10’ on one side and plain on the other side, with diameter
approximately 6mm.
[Product name] 2 mg film-coated tablets: Yellow round, concave, film
coated tablets, debossed with
‘20’ on one side and plain on the other side, with diameter
approximately 8mm.
[Product name] 4 mg film-coated tablets: White round, concave, film
coated tablets, debossed with
‘MC’ on one side and plain on the other side, with diameter
approximately 10.3mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product name] is indicated for the reduction of elevated total
cholesterol (TC) and LDL-C, in adults,
adolescents and children aged 6 years or older with primary
hypercholesterolaemia, including
heterozygous familial hypercholesterolaemia, and combined (mixed)
dyslipidaemia, when response to
diet and other non-pharmacological measures is inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients should be on a cholesterol lowering diet before treatment. It
is important that all patients
continue dietary control during treatment.
The usual starting dose is 1 mg once daily. Adjustment of dose should
be made at intervals of 4 weeks
or more. Doses should be individualized according to LDL-C levels, the
goal of therapy and patient