VIRAMUNE ORAL SUSPENSION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

NEVIRAPINE ANHYDROUS (AS HEMIHYDRATE)

Available from:

BOEHRINGER INGELHEIM ISRAEL LTD.

ATC code:

J05AG01

Pharmaceutical form:

SUSPENSION

Composition:

NEVIRAPINE ANHYDROUS (AS HEMIHYDRATE) 50 MG / 5 ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

WEST-WARD COLUMBUS INC., USA

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
Viramune
April 2020
Suspension
Page 1 of 11
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
VIRAMUNE
®
SUSPENSION
Name and quantity of active ingredient:
Every 5 ml of Viramune suspension contain 50 mg nevirapine (as
nevirapine anhydrous
hemihydrate).
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
Viramune
April 2020
Suspension
Page 2 of 11
2.
BEFORE USING THIS MEDICINE
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE. 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 THREAT

Summary of Product characteristics

Viramune
Prescribing Information
Suspension
April 2020
Page 1 of 27
VIRAMUNE 50MG/5ML ORAL SUSPENSION
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Viramune 50 mg/5 ml oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral suspension contains 10 mg of nevirapine (as
hemihydrate).
Each bottle contains 2.4 g of nevirapine (as hemihydrate) in 240 ml of
Viramune oral
suspension.
Excipients with known effect
:
Each ml of oral suspension contains 150 mg sucrose, 162 mg
sorbitol, 1.8 mg of methyl
paraben and 0.24 mg of propyl paraben.
This medicine contains less than 1 mmol sodium (23 mg) per dosage
unit, that is to say
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
White to off-white homogenous suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use in combination with other antiretroviral agents for the
treatment of HIV-1 infection.
Viramune is indicated in combination with other anti-retroviral
medicinal products for the
treatment of HIV-1 infected adults, adolescents, and children of any
age (see section 4.2).
Most of the experience with Viramune is in combination with nucleoside
reverse transcriptase
inhibitors (NRTIs). The choice of a subsequent therapy after Viramune
should be based on
clinical experience and resistance testing (see section 5.1).
Viramune
Prescribing Information
Suspension
April 2020
Page 2 of 27
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 for Viramune is 20 ml (200 mg) oral suspension
once 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 20 ml (200 mg) oral suspension twice
daily, in combination
with at least two additional antiretroviral agents.
Viramune is also available as a 200 mg tablet for patients 16 years
and older, or for olde