Ranolazine STADA Arzneimittel AG 500 mg, tabletten met verlengde afgifte

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

RANOLAZINE 500 mg/stuk

INN (Algemene Internationale Benaming):

RANOLAZINE 500 mg/stuk

farmaceutische vorm:

Tablet met verlengde afgifte

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMHYDROXIDE (E 524) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

2022-07-21

Bijsluiter

1
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
RANOLAZINE STADA ARZNEIMITTEL AG 375 MG, TABLETTEN MET VERLENGDE
AFGIFTE
RANOLAZINE STADA ARZNEIMITTEL AG 500 MG, TABLETTEN MET VERLENGDE
AFGIFTE
RANOLAZINE STADA ARZNEIMITTEL AG 750 MG, TABLETTEN MET VERLENGDE
AFGIFTE
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 [product name] is and what it is used for
2.
What you need to know before you take [product name]
3.
How to take [product name]
4.
Possible side effects
5.
How to store [product name]
6.
Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IS USED FOR
[product name] 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 [PRODUCT NAME] DO NOT TAKE
[PRODUCT NAME]
-
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
so

Productkenmerken

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Ranolazine STADA Arzneimittel AG 375 mg, tabletten met verlengde
afgifte
Ranolazine STADA Arzneimittel AG 500 mg, tabletten met verlengde
afgifte
Ranolazine STADA Arzneimittel AG 750 mg, tabletten met verlengde
afgifte
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.
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.
White, oblong, convex, film-coated tablet of dimensions 16.5 mm x 8.0
mm, with “500“ embossed on
one side.
White, oblong, convex, film-coated tablet of dimensions 19 mm x 9.2
mm, with “750“ embossed on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product name] 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
[product name] is available as 375 mg, 500 mg, and 750 mg
prolonged-release tablets.
Adults: The recommended initial dose of [product name] 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 [product name] 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.