Nevirapine Dr. Reddy's 400 mg, tablet met verlengde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

NEVIRAPINE 0-WATER

Beschikbaar vanaf:

Dr. Reddy's Laboratories (UK) Ltd.

ATC-code:

J05AG01

INN (Algemene Internationale Benaming):

NEVIRAPINE 0-WATER

farmaceutische vorm:

Tablet met verlengde afgifte

Samenstelling:

HYPROMELLOSE (Release controlling polymer)(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 (Release controlling polymer)(E 464); HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b);

Autorisatie datum:

2018-02-23

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEVIRAPINE DR. REDDY'S 400 MG, TABLET 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 [Invented name] is and what it is used for
2. What you need to know before you take [Invented name]
3. How to take [Invented name]
4. Possible side effects
5. How to store [Invented name]
6. Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] 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, [Invented name] 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.
[Invented name] prolonged-release tablets should only be used after a
two-week treatment with another type
of nevirapine medicine (immediate-release tablets or suspension),
unless you are currently on these
medicines and are switching to the prolonged-release

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nevirapine Dr. Reddy's 400 mg, tablet 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).
[Invented name] 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 should be used (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
[Invented name] 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 combination
with at least two additional antiretroviral agents.
Patients currently on a nevirapine immediate-release twice daily
regimen:
2
Patients already on a regimen of