VIRAMUNE TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

NEVIRAPINE

Available from:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC code:

J05AG01

Pharmaceutical form:

TABLETS

Composition:

NEVIRAPINE 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BOEHRINGER INGELHEIM PHARMA KG

Therapeutic group:

NEVIRAPINE

Therapeutic area:

NEVIRAPINE

Therapeutic indications:

For use in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Authorization date:

2020-08-31

Patient Information leaflet

Proposed patient information leaflet
Viramune
April 2020
Tablets
Page 1 of 9
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
VIRAMUNE
®
TABLETS
Name and quantity of active ingredient:
Each Viramune tablet contains 200 mg nevirapine.
Inactive ingredients and allergens in this medicine: See section 2
'Important information about
some of this medicine’s ingredients' and section 6 'Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of HIV-1 (human immunodeficiency virus) infections
in combination with other
antiretroviral medicines.
THERAPEUTIC GROUP: antiretrovirals (anti-HIV - human immunodeficiency
virus).
The active ingredient, 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. By stopping the enzyme from working,
nevirapine helps control
HIV-1 infection.
IF VIRAMUNE HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
INFORMATION IN THIS
LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ "YOUR
CHILD" INSTEAD OF "YOU").
Proposed patient information leaflet
Viramune
April 2020
Tablets
Page 2 of 9
2.
BEFORE USING THIS MEDICINE
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING VIRAMUNE. DURING THE
FIRST 18 WEEKS
OF TREATMENT WITH VIRAMUNE IT IS VERY IMPORTANT THAT YOU AND YOUR
DOCTOR WATCH OUT
FOR SIGNS OF LIVER OR SKIN REACTIONS, BECAUSE THESE CAN BECOME SEVERE
AND EVEN LIFE
THREATENING. YOU ARE AT GREATER RISK OF SUCH REACTIONS

Summary of Product characteristics

Proposed prescribing information
Viramune
April 2020
Tablets
VIRAMUNE 200 MG TABLETS
NEVIRAPINE
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Viramune 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_ _
Each tablet contains 200 mg of nevirapine (as anhydrous).
_ _
Excipients
with known effect:
Each tablet contains 318 mg of lactose (as monohydrate).
Each tablet contains less than 1 mmol sodium (23 mg), that is to say
essentially ‘sodium-free’.
For the full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, oval, biconvex tablets. One side is embossed with the code
“54 193”, with a single bisect separating the
“54” and “193”. The opposite side is marked with the company
symbol. The score line is not intended for breaking
the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Viramune (nevirapine) is a non nucleoside reverse transcriptase
inhibitor of HIV-1. It is indicated for use in
combination with other antiretroviral agents for the treatment of
HIV-1 infection (see section 4.4). This indication
is based on analyses of changes in surrogate endpoints. At present,
there are no results from controlled clinical
trials evaluating the effect of Viramune in combination with other
antiretroviral agents on the clinical progression
of HIV-1 infection, such as the incidence of opportunistic infections
or survival.
Resistant virus emerges rapidly and uniformly when Viramune is
administered as monotherapy. Therefore,
Viramune should always be administered in combination with at least
one additional antiretroviral agent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Viramune should be administered by physicians who are experienced in
the treatment of HIV infection.
Posology
_Patients 16 years and older _
The recommended dose of Viramune is one 200 mg 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 200 mg tablet twice daily, in
combination with at least one additional