Ranexa (previously Latixa)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

ranolazine

Διαθέσιμο από:

Menarini International Operations Luxembourg S.A. (MIOL)

Φαρμακολογική κατηγορία (ATC):

C01EB18

INN (Διεθνής Όνομα):

ranolazine

Θεραπευτική ομάδα:

Cardiac therapy

Θεραπευτική περιοχή:

Angina Pectoris

Θεραπευτικές ενδείξεις:

Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).,

Περίληψη προϊόντος:

Revision: 22

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2008-07-08

Φύλλο οδηγιών χρήσης

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RANEXA 375 MG PROLONGED-RELEASE TABLETS
RANEXA 500 MG PROLONGED-RELEASE TABLETS
RANEXA 750 MG PROLONGED-RELEASE TABLETS
ranolazine
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 illnes are the same as yours.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ranexa is and what it is used for
2.
What you need to know before you take Ranexa
3.
How to take Ranexa
4.
Possible side effects
5.
How to store Ranexa
6.
Contents of the pack and other information
1.
WHAT RANEXA IS AND WHAT IS USED FOR
Ranexa is a medicine used in combination with other medicines to treat
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 activity.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RANEXA
DO NOT TAKE RANEXA
-
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).
WARNING AND PRECAUTIONS
Talk to your doctor before taking Ranexa:
-
if you have mild or moderate kidney problems.
-
if you have

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ranexa 375 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 375 mg of ranolazine.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
Pale blue oval-shaped tablet engraved with 375 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 patients treated with moderate CYP3A4 inhibitors (e.g.
diltiazem, fluconazole,
erythromycin) or P-gp inhibitors (e.g. verapamil, ciclosporin) (see
sections 4.4 and 4.5).
Concomitant administration of potent CYP3A4 inhibitors is
contraindicated (see sections 4.3 and 4.5).
Renal impairment: Careful dose titration is recommended in patients
with mild to moderate renal
impairment (creatinine clearance 30–80 ml/min) (see sections 4.4,
4.8, and 5.2). Ranexa is
contraindicated in patients with severe renal impairment (creatinine
clearance
<
30 ml/min) (see
sections 4.3 and 5.2).
_ _
Hepatic impairment: Care