Lamivudine/Zidovudine Aurobindo 150/300mg film-coated Tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

ZIDOVUDINE, LAMIVUDINE

Commercializzato da:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Codice ATC:

J05AR01

INN (Nome Internazionale):

ZIDOVUDINE 300 mg LAMIVUDINE 150 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

ZIDOVUDINE 300 mg LAMIVUDINE 150 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTIVIRALS FOR SYSTEMIC USE

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2013-02-20

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMIVUDINE/ZIDOVUDINE AUROBINDO 150/300 MG FILM-COATED TABLETS
lamivudine/zidovudine
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 Lamivudine/Zidovudine Aurobindo is and what it is used for
2.
What you need to know before you take Lamivudine/Zidovudine Aurobindo
3.
How to take Lamivudine/Zidovudine Aurobindo
4.
Possible side effects
5.
How to store Lamivudine/Zidovudine Aurobindo
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE/ZIDOVUDINE AUROBINDO IS AND WHAT IT IS USED FOR
LAMIVUDINE/ZIDOVUDINE AUROBINDO IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS)
INFECTION IN ADULTS AND CHILDREN.
Lamivudine/Zidovudine Aurobindo contains two active ingredients that
are used to treat HIV
infection: lamivudine and zidovudine. Both of these belong to a group
of anti-retroviral medicines
called _nucleoside analogue reverse transcriptase inhibitors_ (NRTIs).
Lamivudine/Zidovudine Aurobindo does not completely cure HIV
infection; it reduces the
amount of virus in your body, and keeps it at a low level. It also
increases the CD4 cell count in
your blood. CD4 cells are a type of white blood cells that are
important in helping your body to
fight infection.
Not everyone responds to treatment with Lamivudine/Zidovudine
Aurobindo in the same way.
Your doctor will monitor the effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE AUROBINDO
_ _
DO NOT TAKE LAMIVUDINE/ZIDOVUDINE AUROBINDO:

if you are allergic to l

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine/Zidovudine Aurobindo 150/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains lamivudine 150 mg and zidovudine 300
mg.
For
the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white modified capsule-shaped, biconvex film-coated
tablets with deep break line in
between ‘J’ and ’59 on one side and break line on other side.
The tablet can be divided into equal
doses. The size is 17.2 mm X 8.15 mm.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine/Zidovudine is indicated in antiretroviral combination
therapy for the treatment of
Human Immunodeficiency Virus (HIV) infection (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Lamivudine/Zidovudine may be administered with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing. For patients who are unable to swallow tablets, tablets may
be crushed and added to a
small amount of semi-solid food or liquid, all of which should be
consumed immediately (see
section 5.2).
_ _
_Adults and adolescents weighing at least 30 kg:_ the recommended dose
of
Lamivudine/Zidovudine is one tablet twice daily.
_ _
_Children weighing between 21 kg and 30 kg:_ the recommended oral dose
of
Lamivudine/Zidovudine is one-half tablet taken in the morning and one
whole tablet taken in the
evening.
_ _
_Children weighing from 14 kg to 21 kg:_ the recommended oral dose of
Lamivudine/Zidovudine is
one-half tablet taken twice daily.
The dosing regimen for paediatric patients weighing 14-30 kg is based
primarily on
pharmacokinetic modelling and supported by data from clinical studies
using the individual
components lamivudine and zidovudine. A pharmacokinetic overexposure
of zidovudine can
occur, therefore close safety monitoring is warranted