Nevirapine Accord 400mg prolonged-release tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

NEVIRAPINE, ANHYDROUS

Available from:

Accord Healthcare Limited

ATC code:

J05AG01

INN (International Name):

NEVIRAPINE, ANHYDROUS

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

NEVIRAPINE, ANHYDROUS 400 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Authorised

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEVIRAPINE ACCORD 400 MG PROLONGED-RELEASE TABLETS
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
Accord is and what it is used for
2. What you need to know before you take Nevirapine Accord
3. How to take Nevirapine Accord 4. Possible side effects
5. How to store Nevirapine Accord
6. Contents of the pack and other information
1.
WHAT NEVIRAPINE ACCORD IS AND WHAT IT IS USED FOR
Nevirapine Accord 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 Accord
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 Accord 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 form.
2.
WHAT YOU

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Nevirapine Accord 400 mg prolonged-release tablets
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 Accord 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 Accord 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:
Page 2 of 30
Patients already on a regimen of nevirapin