Ranolazine Clonmel 500 mg prolonged-release tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ranolazine

Tersedia dari:

Clonmel Healthcare Ltd

Kode ATC:

C01EB18

INN (Nama Internasional):

Ranolazine

Bentuk farmasi:

Prolonged-release tablet

Area terapi:

ranolazine

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2022-07-29

Selebaran informasi

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RANOLAZINE CLONMEL 375 MG PROLONGED-RELEASE TABLETS
RANOLAZINE CLONMEL 500 MG PROLONGED-RELEASE TABLETS
RANOLAZINE CLONMEL 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 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 Clonmel is and what it is used for
2.
What you need to know before you take Ranolazine Clonmel
3.
How to take Ranolazine Clonmel
4.
Possible side effects
5.
How to store Ranolazine Clonmel
6.
Contents of the pack and other information
1.
WHAT RANOLAZINE CLONMEL IS AND WHAT IS USED FOR
Ranolazine Clonmel 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 CLONMEL
DO NOT TAKE RANOLAZINE CLONMEL
-
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

Karakteristik produk

Health Products Regulatory Authority
29 July 2022
CRN00CKLH
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranolazine Clonmel 500 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 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 16.5 mm x 8.0
mm, with "500" embossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ranolazine Clonmel 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 Clonmel is available as 375 mg, 500 mg, and 750 mg
prolonged-release tablets.
Adults: The recommended initial dose of Ranolazine Clonmel 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
Clonmel 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).