LOPINAVIR/RITONAVIR SANDOZ

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LOPINAVIR (AMORPHOUS); RITONAVIR

Available from:

Rowex Ltd

ATC code:

J05A

INN (International Name):

LOPINAVIR (AMORPHOUS); RITONAVIR

Dosage:

200/50 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

DIRECT ACTING ANTIVIRALS

Authorization status:

Authorised

Authorization date:

2015-08-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPINAVIR/RITONAVIR SANDOZ 200 MG/50 MG FILM-COATED TABLETS
l
opinavir/ritonavir
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 Lopinavir/Ritonavir Sandoz is and what it is used for
2.
What you need to know before you take Lopinavir/Ritonavir Sandoz
3.
How to take Lopinavir/Ritonavir Sandoz
4.
Possible side effects
5.
How to store Lopinavir/Ritonavir Sandoz
6.
Contents of the pack and other information
1.
WHAT LOPINAVIR/RITONAVIR SANDOZ IS AND WHAT IT IS USED FOR
−
Your doctor has prescribed Lopinavir/Ritonavir Sandoz to help to
control your Human
Immunodeficiency Virus (HIV) infection. Lopinavir/Ritonavir Sandoz
does this by slowing down
the spread of the infection in your body.
−
Lopinavir/Ritonavir Sandoz is used by children 2 years of age or
older, adolescents and adults
who are infected with HIV, the virus which causes AIDS.
−
Lopinavir/Ritonavir Sandoz contains the active substances lopinavir
and ritonavir.
Lopinavir/Ritonavir Sandoz is an antiretroviral medicine. It belongs
to a group of medicines called
protease inhibitors.
−
Lopinavir/Ritonavir Sandoz is prescribed for use in combination with
other antiviral medicines.
Your doctor will discuss with you and determine which medicines are
best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPINAVIR/RITONAVIR SANDOZ
DO NOT TAKE LOPINAVIR/RITONAVIR SANDOZ:
−
if you are allergic to lopinavir, ritonavir or any of the other
ingredients of this medicine (listed in
section 6)
−
if you ha

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lopinavir/Ritonavir Sandoz 200/50mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of lopinavir and 50 mg of
ritonavir.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Yellow, oval, biconvex, film-coated tablets (19.00 x 10.20mm),
debossed with “H” on one side and “L3” on other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lopinavir/Ritonavir Sandoz is indicated in combination with other
antiretroviral medicinal products for the
treatment of human immunodeficiency virus (HIV-1) infected adults,
adolescents and children above the age of 2
years.
The choice of Lopinavir/Ritonavir Sandoz to treat protease inhibitor
experienced HIV-1 infected patients should be
based on individual viral resistance testing and treatment history of
patients (see sections 4.4 and 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lopinavir/Ritonavir Sandoz should be prescribed by physicians who are
experienced in the treatment of HIV
infection. Lopinavir/Ritonavir Sandoz film-coated tablets must be
swallowed whole and not chewed, broken or
crushed.
Posology
_Adults and adolescents_
The standard recommended dose of Lopinavir/Ritonavir Sandoz is 400/100
mg (two 200/50 mg) film-coated tablets
twice daily taken with or without food. In adult patients, in cases
where once daily dosing is considered necessary for
the management of the patient, Lopinavir/Ritonavir Sandoz may be
administered as 800/200 mg (four 200/50 mg) film-
coated tablets once daily with or without food. The use of a once
daily dosing should be limited to those adult patients
having only very few protease inhibitor (PI) associated mutations
(i.e. less than 3 PI mutations in line with clinical trial
results, see section 5.1 for the full description of the population)
and should take into account the risk of a lesser
sustainability of the virologic suppression (see section 5.1) and
higher risk of