Livalo Film-coated Tablets 2mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Pitavastatin Calcium (as Hydrate)

Available from:

DKSH MALAYSIA SDN. BHD.

INN (International Name):

Pitavastatin Calcium (as Hydrate)

Units in package:

30 Tablets

Manufactured by:

Kowa Company, Ltd, Nagoya Factory

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
LIVALO FILM-COATED TABLETS 2MG
LIVALO FILM-COATED TABLETS 4MG
_ _
Pitavastatin Calcium (as hydrate) (2.0 mg or 4.0mg of pitavastatin
calcium)
1
WHAT IS IN THIS LEAFLET
1. What LIVALO is used for
2. How LIVALO works
3. Before you use LIVALO
4. How to use LIVALO
5. While you are using it
6. Side effects
7. Storage and Disposal of LIVALO
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT LIVALO IS USED FOR
LIVALO contains a medicine called
pitavastatin. This belongs to a group
of medicines called ‘statins’.
LIVALO 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 LIVALO
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
LIVALO.
HOW LIVALO WORKS
LIVALO inhibits synthesis of
cholesterol in the liver by its
inhibitory effect on HMG-CoA
reductase, and consequently lowers
plasma cholesterol.
LIVALO is usually used in the
treatment of primary hyperlipidemia
including familial
hypercholesterolaemia or mixed
dyslipidemia.
BEFORE YOU USE LIVALO
_- When you must not use it _
Do not take LIVALO:
-
if you are allergic (hypersensitive)
to pitavastatin, any other statin or
the other ingredients of LIVALO
(listed in ‘8. Product Description’).
-
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’).
-
if you currently have liver
problems.
-
if you take ciclosporin – used after
an organ transplant.
-
if you have repeated or unexplained
muscle aches or pains.
If you are not sure, talk to your doctor
or pharmacist before takin

Summary of Product characteristics

200.0
表
天
296.3
色
調
ジキスミ
トラップ
（
）
角度
tdw31
APP.TB
品
名 リバロ添付文書MYS
制作日
MC
2022.10.3
C
本コード
0582-0966-20
校
作業者印 AC
仮コード

初校
永
森
KOWA COMPANY, LTD.
LIVALO FILM-COATED TABLETS 2MG/ LIVALO FILM-COATED TABLETS 4MG
1. NAME OF THE MEDICINAL PRODUCT
2mg: LIVALO Film-coated Tablets 2mg.
4mg: LIVALO Film-coated Tablets 4mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.0mg (for LIVALO Tablets 2mg) or
4.0mg (for LIVALO Tablets 4mg) of
pitavastatin calcium (as hydrate).
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
2mg: Slightly light-colored yellow-red, scored film-coated tablets
embossed “Kowa 202” on one face and
scored on the reverse. The tablet can be divided into equal halves.
4mg: Light yellow, scored film-coated tablets embossed “Kowa 203”
on one face and scored on the reverse.
The tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
LIVALO 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 1mg or
2mg 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 response. The maximum daily dose is
4mg.
Elderly
No dose adjustment necessary in patients older than 70 years (see
section 5.1 and section 5.2).
Paediatric population
Children and adolescents aged 6 years and over:
LIVALO use in children should only be carried