Nevirapine Hetero 400 mg, tabletten met verlengde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NEVIRAPINE 0-WATER

Beschikbaar vanaf:

Hetero Europe S.L.

ATC-code:

J05AG01

INN (Algemene Internationale Benaming):

NEVIRAPINE 0-WATER

farmaceutische vorm:

Tablet met verlengde afgifte

Samenstelling:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Nevirapine

Product samenvatting:

Hulpstoffen: HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b);

Autorisatie datum:

2018-03-06

Bijsluiter

Nevirapine Hetero 400 mg, tabletten met verlengde afgifte –
NL/H/3536/001/DC
NL pl
NL/p/001/18/2
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEVIRAPINE HETERO 400 MG, TABLETTEN MET VERLENGDE AFGIFTE
nevirapine
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 Nevirapine Hetero is and what it is used for
2. What you need to know before you take Nevirapine Hetero
3. How to take Nevirapine Hetero
4. Possible side effects
5. How to store Nevirapine Hetero
6. Contents of the pack and other information
1.
WHAT NEVIRAPINE HETERO IS AND WHAT IT IS USED FOR
Nevirapine Hetero belongs to a group of medicines called
antiretrovirals, used in the treatment of Human
Immunodeficiency Virus (HIV-1) infection.
The active substance of your medicine is called nevirapine. Nevirapine
belongs to a class of anti-HIV
medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). Reverse transcriptase is an
enzyme that HIV needs in order to multiply. Nevirapine stops reverse
transcriptase from working. By
stopping reverse transcriptase from working, Nevirapine Hetero helps
control HIV-1 infection.
Nevirapine is indicated for the treatment of HIV-1 infected adults,
adolescents and children three years and
above and able to swallow tablets. You must take nevirapine together
with other antiretroviral medicines.
Your doctor will recommend the best medicines for you.
Nevirapine Hetero prolonged-release tablets should only be used after
a two-week treatment with another
type of nevirapine medicine (immediate-releas

Productkenmerken

Nevirapine Hetero 400 mg, tabletten met verlengde afgifte–
NL/H/3536/001/DC
NL SmPC
NL/s/005/18/1
1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
Nevirapine Hetero 400 mg, tabletten met verlengde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 400 mg of nevirapine (as
anhydrous).
Excipient with known effect: each prolonged-release tablet contains
375 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
White to off-white oval shaped, approx. 9.3 x 19.2 mm, biconvex
tablets debossed with ‘H’ on one side and
‘N1’ on other side. The prolonged release tablet should not be
divided.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nevirapine is indicated in combination with other anti-retroviral
medicinal products for the treatment of
HIV-1 infected adults, adolescents, and children three years and above
and able to swallow tablets (see
section 4.2).
Nevirapine Hetero 400 mg prolonged-release tablets are not suitable
for the 14-day lead-in phase for patients
starting nevirapine.
Other nevirapine formulations, such as immediate-release tablets or
oral suspension, may be checked for
their availability and used accordingly (see section 4.2).
Most of the experience with nevirapine is in combination with
nucleoside reverse transcriptase inhibitors
(NRTIs). The choice of a subsequent therapy after nevirapine should be
based on clinical experience and
resistance testing (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Nevirapine Hetero 400 mg should be administered by physicians who are
experienced in the treatment of
HIV infection.
Posology
_Adults _
The recommended dose of nevirapine for patients initiating nevirapine
therapy is one 200 mg immediate-
release tablet daily for the first 14 days (this lead-in period should
be used because it has been found to
lessen the frequency of rash), followed by one 400 mg
prolonged-release tablet once daily, in combinati