Lopinavir/Ritonavir Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

lopinavir/ritonavir

Available from:

Mylan S.A.S.

ATC code:

J05AR10

INN (International Name):

lopinavir/ritonavir

Therapeutic group:

Antivirals for systemic use,

Therapeutic area:

HIV Infections

Therapeutic indications:

Lopinavir/ritonavir 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 to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

Product summary:

Revision: 9

Authorization status:

Authorised

Authorization date:

2016-01-14

Patient Information leaflet

67
B. PACKAGE LEAFLET
68
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPINAVIR/RITONAVIR MYLAN 200 MG/50 MG FILM-COATED TABLETS
lopinavir/ritonavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU OR YOUR CHILD.
-
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 or your child 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 Mylan is and what it is used for
2.
What you need to know before you or your child takes
Lopinavir/Ritonavir Mylan
3.
How to take Lopinavir/Ritonavir Mylan
4.
Possible side effects
5.
How to store Lopinavir/Ritonavir Mylan
6.
Contents of the pack and other information
1.
WHAT LOPINAVIR/RITONAVIR MYLAN IS AND WHAT IT IS USED FOR
-
Your doctor has prescribed lopinavir/ritonavir to help to control your
Human Immunodeficiency Virus
(HIV) infection. Lopinavir/ritonavir does this by slowing down the
spread of the infection in your
body.
-
Lopinavir/Ritonavir Mylan is not a cure for HIV infection or AIDS
-
Lopinavir/ritonavir 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 Mylan contains the active substances lopinavir and
ritonavir. Lopinavir/ritonavir
is an antiretroviral medicine. It belongs to a group of medicines
called protease inhibitors.
-
Lopinavir/ritonavir 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 OR YOUR CHILD TAKES
LOPINAVIR/RITONAVIR MYLAN
_ _
DO NOT TAKE LOPINAVIR/RITONAVIR MYLAN IF:
-
you are allergic to lopina

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets.
Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets
Each film-coated tablet contains 100 mg of lopinavir co-formulated
with 25 mg of ritonavir as a
pharmacokinetic enhancer.
Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets
Each film-coated tablet contains 200 mg of lopinavir co-formulated
with 50 mg of ritonavir as a
pharmacokinetic enhancer.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Lopinavir/Ritonavir Mylan 100 mg/25 mg film-coated tablets
Approx 15.0 mm x 8.0 mm, white, film coated, ovaloid, biconvex beveled
edge tablet debossed with 'MLR4'
on one side of the tablet and plain on the other side.
Lopinavir/Ritonavir Mylan 200 mg/50 mg film-coated tablets
Approx 18.8 mm x 10.0 mm, white, film coated, ovaloid, biconvex
beveled edge tablet debossed with
'MLR3' on one side of the tablet and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lopinavir/ritonavir 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 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 should be prescribed by physicians who are
experienced in the treatment of HIV
infection.
Lopinavir/ritonavir tablets must be swallowed whole and not chewed,
broken or crushed.
Posology
_Adults and adolescents _
The standard recommended dosage of lopinavir/ritonavir tablets is
400/100 mg (two 200/50 mg) tablets
twice daily taken with or without food. In adul