Ranexa 750mg Prolonged-Release Tablets

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

Ranolazine

Pieejams no:

A. MENARINI SINGAPORE PTE. LTD.

SNN (starptautisko nepatentēto nosaukumu):

Ranolazine

Vienības iepakojumā:

60tablet Tablets; 30tablet Tablets; 100tablet Tablets

Ražojis:

Menarini - Von Heyden GmbH

Lietošanas instrukcija

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
RANEXA PROLONGED RELEASE TABLETS
RANOLAZINE (375 MG , 500 MG, 750 MG)
1
WHAT IS IN THIS LEAFLET
1. What Ranexa is used for
2. How Ranexa works
3. Before you use Ranexa
4. How to use Ranexa
5. While you are using Ranexa
6. Side effects
7. Storage and Disposal of Ranexa
8. Product Description
9.Manufacturer
and
Product
Registration holder
10. Date of revision
1. WHAT RANEXA IS USED FOR
Ranexa
is
a
medicine
used
in
combination with other medicines to
treat stable angina pectoris, which is
a
chest pain or discomfort that you
feel
anywhere along the upper part
of your
body between your neck and
upper
abdomen, often brought on by
exercise
or
too
much
physical
activity.
You must talk to a doctor if you do
not
feel better or if you feel worse.
2. HOW RANEXA WORKS
The
mechanism
of
action
of
ranolazine
is
largely
unknown.
Ranolazine
may
have
some
antianginal
effects
by
inhibition of
the late sodium current in
heart cells.
3. BEFORE YOU USE RANEXA
_- When you must not use it _
•
if you are allergic to ranolazine or
any of the other ingredients of this
medicine listed in section 6 of this
leaflet.
•
if you have severe kidney problems
•
if you have moderate or severe liver
problems
if you are using certain medicines to
treat
bacterial
infections
(clarithromycin,
telithromycin),
fungal
infections
(itraconazole,
ketoconazole,
voriconazol,
posaconazol),
HIV
infection
(protease
inhibitors),
depression
(nefazodone)
or
heart
rhythm
disorders
(e.g.
quinidine,
dofetilide, or sotalol).
_- Before you start to use it _
Talk to your doctor before taking
Ranexa:
•
if
you
have
mild
or
moderate
kidney problems.
•
if you have mild liver problems.
•
if you have ever had an abnormal
electrocardiogram (ECG).
•
if you are elderly. (More than 75
years of age)
•
if you have low weight (60 kg or
less)
•
if you have heart failure (NYHA
Class III–IV).
Your doctor may decide to give you a
lower dose or take other precautions
if any of these apply to you.
_ _
_ _
_- Taking other

Produkta apraksts

RANEXA
®
Ranolazine
PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Ranexa 375 mg prolonged-release tablets
Ranexa 500 mg prolonged-release tablets
Ranexa 750 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ranexa 375 mg prolonged-release tablets:
Each tablet contains 375 mg of ranolazine.
Ranexa 500 mg prolonged-release tablets:
Each tablet contains 500 mg of ranolazine.
Ranexa 750 mg prolonged-release tablets:
Each tablet contains 750 mg of ranolazine.
Excipients (for 750mg only): Each tablet contains 0.04 mg azo
colouring agent
E102 and 12.0 mg lactose monohydrate
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Ranexa 375 mg prolonged-release tablets: Pale blue oval-shaped tablet
engraved
with 375 on one side.
Ranexa
500
mg
prolonged-release
tablets:
Light
orange
oval-shaped
tablet
engraved with 500 on one side.
Ranexa 750 mg prolonged-release tablets: Pale green oval-shaped tablet
engraved
with 750 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ranexa is indicated in adults as add-on therapy for the symptomatic
treatment of
patients with stable angina pectoris who are inadequately controlled
or intolerant
to
first-line
antianginal
therapies
(such
as
beta-blockers
and/or
calcium
antagonists).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Ranexa is available as 375 mg, 500 mg, and 750 mg prolonged-release
tablets.
Adults: The recommended initial dose of Ranexa is 375 mg twice daily.
After 2–4
weeks, the dose should be titrated to 500 mg twice daily and,
according to the
patient’s response, further titrated to a recommended maximum dose
of 750 mg
twice daily (see section 5.1).
If a patient experiences treatment-related adverse events (e.g.
dizziness, nausea, or
vomiting), down-titration of Ranexa to 500 mg or 375 mg twice daily
may be
required. If symptoms do not resolve after dose reduction, treatment
should be
discontinued.
Concomitant
treatment
with
CYP3A4
and
P-glycoprotein
(P-gp)
inhibitors:
Careful dose titration is recommended in