Ranolazine 375 mg Prolonged-release tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ranolazine

Available from:

Elc Group s.r.o.

ATC code:

C01EB18

INN (International Name):

Ranolazine

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

ranolazine

Authorization status:

Not marketed

Authorization date:

2022-07-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RANOLAZINE 375 MG PROLONGED-RELEASE TABLET
RANOLAZINE 500 MG PROLONGED-RELEASE TABLET
RANOLAZINE 750 MG PROLONGED-RELEASE TABLET
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 illness 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 Ranolazine is and what it is used for
2.
What you need to know before you take Ranolazine
3.
How to take Ranolazine
4.
Possible side effects
5.
How to store Ranolazine
6.
Contents of the pack and other information
1.
WHAT RANOLAZINE IS AND WHAT IS USED FOR
Ranolazine 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 RANOLAZINE
DO NOT TAKE RANOLAZINE
-
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 Ranolazine:
-
if you have mild or moderate kidney p

Summary of Product characteristics

Health Products Regulatory Authority
12 March 2024
CRN00F0GM
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranolazine 375 mg Prolonged-release tablet
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.
White, oblong, convex, film-coated tablet of dimensions 15 mm x 7.2
mm, with "375" embossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ranolazine 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
Ranolazine is available as 375 mg, 500 mg, and 750 mg
prolonged-release tablets.
Adults: The recommended initial dose of Ranolazine 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 Ranolazine 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). Ranolazine
is contraindicated in patients