Mizetam 10 mg/10 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ATORVASTATINE CALCIUM 3-WATER SAMENSTELLING overeenkomend met ; ATORVASTATINE ; EZETIMIB

Beschikbaar vanaf:

Pharmaceutical Works Polpharma S.A. 19, Pelplinska Street 83-200 STAROGARD GDANSKI (POLEN)

ATC-code:

C10BA05

INN (Algemene Internationale Benaming):

ATORVASTATIN CALCIUM 3-WATER COMPOSITION equivalent to ; ATORVASTATIN ; EZETIMIB

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMCARBONAAT (E 170) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Atorvastatin and ezetimibe

Autorisatie datum:

2019-10-21

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIZETAM 10 MG/10 MG, TABLETTEN
MIZETAM 10 MG/20 MG, TABLETTEN
MIZETAM 10 MG/40 MG, TABLETTEN
MIZETAM 10 MG/80 MG, TABLETTEN
EZETIMIBE AND ATORVASTATIN
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 Mizetam is and what it is used for
2.
What you need to know before you take Mizetam
3.
How to take Mizetam
4.
Possible side effects
5.
How to store Mizetam
6.
Contents of the pack and other information
1.
WHAT MIZETAM IS AND WHAT IT IS USED FOR
Mizetam is a medicine to lower increased levels of cholesterol.
Mizetam contains ezetimibe and
atorvastatin.
Mizetam is used in adults to lower levels of total cholesterol,
“bad” cholesterol (LDL cholesterol), and
fatty substances called triglycerides in the blood. In addition,
Mizetam raises levels of “good”
cholesterol (HDL cholesterol).
Mizetam works to reduce your cholesterol in two ways. It reduces the
cholesterol absorbed in your
digestive tract, as well as the cholesterol your body makes by itself.
Cholesterol is one of several fatty substances found in the
bloodstream. Your total cholesterol is made
up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can
build up in the walls of your arteries
forming plaque. Eventually this plaque build-up can lead to a
narrowing of the arteries. This
narrowing can slow or block blood flow to vital organs such as the
heart and brain. This blocking of
blood flow can result in a heart attack or stroke.
HDL cholesterol i

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mizetam 10 mg/10 mg, tabletten
Mizetam 10 mg/20 mg, tabletten
Mizetam 10 mg/40 mg, tabletten
Mizetam 10 mg/80 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of
atorvastatin (as atorvastatin calcium
trihydrate).
Excipients with known effect
Each 10 mg/ 10 mg tablet contains 145 mg lactose.
Each 10 mg/ 20 mg tablet contains 170 mg lactose.
Each 10 mg/ 40 mg tablet contains 219 mg lactose.
Each 10 mg/ 80 mg tablet contains 317 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
10 mg/ 10 mg tablet: White to off white, capsule shaped tablets
(12.7mm x 5.1mm) on one side
debossed with“1”
10 mg/ 20 mg tablet: White to off white, capsule shaped tablets
(14.5mm x 6.8 mm) on one side
debossed with“2”
10 mg/ 40 mg tablet: White to off white, capsule shaped tablets
(16.4mm x 6.3 mm) on one side
debossed with“3”
10 mg/ 80 mg tablet: White to off white, capsule shaped tablets
(17.0mm x 8.0mm) on one side
debossed with“4”
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mizetam as an adjunct to diet is indicated as substitution therapy for
treatment of adults with primary
(heterozygous and homozygous familial and non-familal)
hypercholesterolaemia or mixed
hyperlipidaemia already controlled with atorvastatin and ezetimibe
given concurrently at the same
dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Mizetam is 1 tablet per day.
The maximum recommended dose of Mizetam is 10 mg/80 mg per day.
The patient should be on an appropriate lipid lowering diet and should
continue on this diet during
treatment with Mizetam.
2
Mizetam is not suitable for initial therapy. Treatment initiation or
dose adjustment if necessary should
only be done with the monocomponents and after setting the appropriate
doses the switch to the fixed
dose combination of the appropriate strength is possible.
_ _
_Elderly peop