Lamivudine/Zidovudine Tablet, film coated 150mg/300mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LAMIVUDINE, ZIDOVUDINE

Available from:

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

ATC code:

J05AR01

INN (International Name):

LAMIVUDINE 150 mg ZIDOVUDINE 300 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LAMIVUDINE 150 mg ZIDOVUDINE 300 mg

Prescription type:

POM

Therapeutic area:

ANTIVIRALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2018-02-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMIVUDINE/ZIDOVUDINE 150 MG/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
is and what it is used for
2.
What you need to know before you take Lamivudine/Zidovudine
3.
How to take Lamivudine/Zidovudine
4.
Possible side effects
5.
How to store Lamivudine/Zidovudine
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE/ZIDOVUDINE IS AND WHAT IT IS USED FOR
LAMIVUDINE/ZIDOVUDINE IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY
VIRUS) INFECTION IN ADULTS AND
CHILDREN.
Lamivudine/Zidovudine
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
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
in the same way. Your doctor will monitor
the effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE
DO NOT TAKE LAMIVUDINE/ZIDOVUDINE:
-
if you are
ALLERGIC
to lamivudine or zidovudine or any of the other ingredients of this
medicine (listed
in section 6).
-
if y

Summary of Product characteristics

Page 1 of 18
1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine/Zidovudine 150 mg/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg lamivudine and 300 mg
zidovudine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, capsule shaped, biconvex, film-coated tablets,
debossed with ‘H’ on one side
and ‘L and 9’separated by a score line on other side.
Tablet length is approximately 17.5 mm and width is approximately 8.0
mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine/Zidovudine is indicated in antiretroviral combination
therapy for the treatment of
adults, adolescents and children with Human Immunodeficiency Virus
(HIV) infection (see section
4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Therapy should be initiated by a physician experienced in the
management of HIV infection.
_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 in these
patients. If gastrointestinal
intolerance occurs in patients weighing 21-30 kg, an alternative
dosing schedule with one-half
tablet taken thrice daily can be applied in attempt to improve
tolerability.
Page 2 of 18
Lamivudine/Zidovudine tablets should not be used for children weighing
less than 14 kg, since
d