Ranolazine Krka 500 mg prolonged release tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ranolazine

Beschikbaar vanaf:

KRKA, d.d., Novo mesto

ATC-code:

C01EB18

INN (Algemene Internationale Benaming):

Ranolazine

farmaceutische vorm:

Prolonged-release tablet

Therapeutisch gebied:

ranolazine

Autorisatie-status:

Marketed

Autorisatie datum:

2023-03-31

Bijsluiter

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RANOLAZINE KRKA 375 MG PROLONGED-RELEASE TABLETS
RANOLAZINE KRKA 500 MG PROLONGED-RELEASE TABLETS
RANOLAZINE KRKA 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ranolazine Krka is and what it is used for
2.
What you need to know before you take Ranolazine Krka
3.
How to take Ranolazine Krka
4.
Possible side effects
5.
How to store Ranolazine Krka
6.
Contents of the pack and other information
1.
WHAT RANOLAZINE KRKA IS AND WHAT IT IS USED FOR
Ranolazine Krka 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 KRKA
DO NOT TAKE RANOLAZINE KRKA
-
if you are allergic to ranolazine or any of the other ingredients of
this medicine (listed in section
6).
-
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).
WARNINGS AND PRECAUTIONS
Talk to

Productkenmerken

Health Products Regulatory Authority
01 December 2023
CRN00DVH9
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranolazine Krka 500 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 500 mg ranolazine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Pale brownish yellow, oval, biconvex film-coated tablets marked with
500 on one side of the tablet. Tablet dimensions:
approximately 17 × 8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ranolazine Krka 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 Krka is available as 375 mg, 500 mg, and 750 mg
prolonged-release tablets.
Adults: The recommended initial dose of Ranolazine Krka 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
Krka 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