Lamivudine/Zidovudine Mylan 150mg/300mg Film-coated tablet

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

ZIDOVUDINE, LAMIVUDINE

Dostupno od:

Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France

ATC koda:

J05AR01

INN (International ime):

ZIDOVUDINE, LAMIVUDINE

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

ZIDOVUDINE 300 milligram(s) ; LAMIVUDINE 150 milligram(s)

Tip recepta:

POM

Područje terapije:

ANTIVIRALS FOR SYSTEMIC USE

Status autorizacije:

Authorised

Datum autorizacije:

2013-01-18

Uputa o lijeku

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMIVUDINE/ZIDOVUDINE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Lamivudine/Zidovudine Mylan
3.
How to take Lamivudine/Zidovudine Mylan
4.
Possible side effects
5.
How to store Lamivudine/Zidovudine Mylan
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE/ZIDOVUDINE MYLAN IS AND WHAT IT IS USED FOR
Lamivudine/Zidovudine Mylan is used to treat HIV (human
immunodeficiency virus)
infection in adults and children.
Lamivudine/Zidovudine Mylan contains two active substances 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 Mylan does not completely cure HIV infection; it
reduces the amount
of HIV 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 cell that are
important in helping your body to
fight infection.
Not everyone responds to treatment with Lamivudine/Zidovudine Mylan in
the same way.
Your doctor will be monitoring the effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE MYLAN
DO NOT TAKE LAMIVUDINE/ZIDOVUDINE MYLAN:
•
If you are allergic to lamivudine or zidov

Svojstava lijeka

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine/Zidovudine Mylan 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 “M” on the left of
the scoreline and “103” on the right, on one side of the tablet,
and scored on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine/Zidovudine Mylan 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.
Posology
_ _
_Adults and adolescents weighing at least 30 kg_
The recommended dose of Lamivudine/Zidovudine Mylan is one tablet
twice daily.
_Children weighing between 21 kg and 30 kg_
The recommended oral dose of Lamivudine/Zidovudine Mylan 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 Mylan 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.
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Lamivudine/Zidovudine Mylan tablets should not be used for children
weighing less than 1