Lopinavir / Ritonavir Tablet, film coated 200mg/50mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LOPINAVIR; RITONAVIR

Available from:

Accord Healthcare Limited

ATC code:

J05AR10

INN (International Name):

LOPINAVIR; RITONAVIR

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LOPINAVIR 200 mg; RITONAVIR 50 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Authorised

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPINAVIR /RITONAVIR 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.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please 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.
IN THIS LEAFLET:
1.
What Lopinavir/ Ritonavir tablets is and what it is used for
2.
What you need to know before you take Lopinavir/ Ritonavir tablets
3.
How Lopinavir/ Ritonavir tablets is used
4.
Possible side effects
5.
How to store Lopinavir/ Ritonavir tablets
6.
Contents of the pack and other information
1.
WHAT LOPINAVIR/ RITONAVIR TABLETS IS AND WHAT IT IS USED FOR
−
Your doctor has prescribed Lopinavir/ Ritonavir tabletsto help to
control your Human
Immunodeficiency Virus (HIV) infection. Lopinavir/ Ritonavir tablets
does this by slowing
down the spread of the infection in your body.
−
Lopinavir/ Ritonavir tablets is used by children 2 years of age or
older and adults who are
infected with HIV, the virus which causes AIDS. Lopinavir/ Ritonavir
tabletsshould not be
administered to children younger than 2 years of age unless
specifically directed by their
doctor.
−
Lopinavir/ Ritonavir tablets is an antiretroviral medicine. It belongs
to a group of medicines
called protease inhibitors.
−
Lopinavir/ Ritonavir tablets 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 TABLETS
DO NOT TAKE LOPINAVIR/ RITONAVIR
TABLETS:
−
if you are allergic (hypersensitive) to lopinavir, rit

Summary of Product characteristics

Page 1 of 41
1. NAME OF THE MEDICINAL PRODUCT
Lopinavir / Ritonavir 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 a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Lopinavir / Ritonavir 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 tablets 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 tablets 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 tablets 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
_Adult and adolescent use: _
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 adult patients, in
cases where once daily dosing is considered necessary for the
management of the patient, Lopinavir
/ Ritonavir 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
Page 2 of 41
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