Lazela 500 mg, tabletten met verlengde afgifte

Страна: Нідерланди

мова: голландська

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

Активний інгредієнт:

RANOLAZINE 500 mg/stuk

ІПН (Міжнародна Ім'я):

RANOLAZINE 500 mg/stuk

Фармацевтична форма:

Tablet met verlengde afgifte

Склад:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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), 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)

Адміністрація маршрут:

Oraal gebruik

Дата Авторизація:

1900-01-01

інформаційний буклет

1
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
LAZELA 375 MG, TABLETTEN MET VERLENGDE AFGIFTE
LAZELA 500 MG, TABLETTEN MET VERLENGDE AFGIFTE LAZELA 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 Lazela is and what it is used for
2.
What you need to know before you take Lazela
3.
How to take Lazela
4.
Possible side effects
5.
How to store Lazela
6.
Contents of the pack and other information
1.
WHAT LAZELA IS AND WHAT IS USED FOR
Lazela 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 LAZELA
DO NOT TAKE LAZELA
-
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 Lazela:
-
if you have mild or moderate kidney problems.
-
if you have mild l

Характеристики продукта

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Lazela 375 mg, tabletten met verlengde afgifte
Lazela 500 mg, tabletten met verlengde afgifte
Lazela 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
Lazela 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
Lazela is available as 375 mg, 500 mg, and 750 mg prolonged-release
tablets.
Adults: The recommended initial dose of Lazela 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 Lazela 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