Lopinavir /Ritonavir Accord 200 mg/50 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LOPINAVIR, RITONAVIR

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

J05AR10

INN (International Name):

LOPINAVIR 200 mg RITONAVIR 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LOPINAVIR 200 mg RITONAVIR 50 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2017-01-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPINAVIR /RITONAVIR ACCORD 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.
IN THIS LEAFLET:
1.
What Lopinavir /Ritonavir Accord is and what it is used for
2.
What you need to know before you take or your child takes Lopinavir
/Ritonavir Accord
3.
How Lopinavir /Ritonavir Accord is used
4.
Possible side effects
5.
How to store Lopinavir /Ritonavir Accord
6.
Contents of the pack and other information
1.
WHAT LOPINAVIR /RITONAVIR ACCORD IS AND WHAT IT IS USED FOR
−
Your doctor has prescribed Lopinavir /Ritonavir Accord to help to
control your Human
Immunodeficiency Virus (HIV) infection. Lopinavir /Ritonavir Accord
does this by slowing down
the spread of the infection in your body.
-
Lopinavir /Ritonavir Accord is not a cure for HIV infection or AIDS
−
Lopinavir /Ritonavir Accord 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 Accord contains the active substances lopinavir
and ritonavir. Lopinavir
/Ritonavir Accord is an antiretroviral medicine. It belongs to a group
of medicines called protease
inhibitors.
−
Lopinavir /Ritonavir Accord 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 OR YOUR CHILD TAKES LOPINAVIR
/RITONAVIR ACCORD
DO NOT TAKE LOPINAVIR /RITONAVI

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Lopinavir /Ritonavir Accord 200 mg/50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
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 Accord tablets are yellow, oval, biconvex,
film-coated tablets, with a dimension
of approx. 19.0 mm in length and 10.2 mm in width, debossed with
“H” on one side and “L3” on other
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lopinavir /Ritonavir Accord 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 Accord 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 Accord should be prescribed by physicians who are
experienced in the
treatment of HIV infection.
Lopinavir /Ritonavir Accord tablets must be swallowed whole and not
chewed, broken or
crushed.
Posology
_Adult and adolescents: _
the standard recommended dosage of Lopinavir /Ritonavir Accord tablets
is
400/100 mg (two 200/50 mg) 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
Accord tablets may be administered as 800/200 mg (four 200/50 mg
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