Ranexa 375mg modified-release tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Ranolazine

Disponible desde:

A. Menarini Farmaceutica Internazionale SRL

Código ATC:

C01EB18

Designación común internacional (DCI):

Ranolazine

Dosis:

375mg

formulario farmacéutico:

Modified-release tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 02060300; GTIN: 5038227000317

Información para el usuario

1
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.
In addition to this leaflet, you will find a Patient Alert Card within
the box, which contains important
safety information that you need to know before you are given Ranexa
and during treatment with
Ranexa.
-
Keep this leaflet and the Patient Alert Card. You may need to read it
again.
-
Always show the Patient Alert Card to any doctor involved in your
treatment, including physicians
treating conditions other than angina pectoris.
-
Please make sure you have a list of all your other medicines with you
at any visit to a health care
professional.
-
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 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 IT 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.

Ficha técnica

OBJECT 1
RANEXA PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 16-Feb-2017 | A. Menarini
Farmaceutica Internazionale
SRL
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
Each tablet contains 375 mg of ranolazine.
Each tablet contains 500 mg of ranolazine.
Each tablet contains 750 mg of ranolazine.
< 750 mg tablet>
Excipients: 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
Prolonged-release tablet
Pale blue oval-shaped tablet engraved with 375 on one side.
Light orange oval-shaped tablet engraved with 500 on one side.
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
Patients should be given the Ranexa package leaflet and the Patient
Alert Card and instructed to present
their Patient Alert Card and medication list to their health care
professional at each visit.
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 C