Lamivudine/Zidovudine Hetero Europe 150 mg/300 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LAMIVUDINE 0-WATER ; ZIDOVUDINE

Beschikbaar vanaf:

Hetero Europe S.L. Viladecans Business Park, Edificio Brasil, Catalunya 83-85 08840 VILADECANS (SPANJE)

ATC-code:

J05AR01

INN (Algemene Internationale Benaming):

LAMIVUDINE 0-WATER ; ZIDOVUDINE

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Zidovudine And Lamivudine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-08-06

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMIVUDINE/ZIDOVUDINE HETERO EUROPE 150 MG/300 MG, FILMOMHULDE
TABLETTEN
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 of the side effects, talk to your doctoror pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lamivudine/Zidovudine Hetero Europe is and what it is used for
2.
What you need to know before you take Lamivudine/Zidovudine Hetero
Europe:
3.
How to take Lamivudine/Zidovudine Hetero Europe:
4.
Possible side effects
5.
How to store Lamivudine/Zidovudine Hetero Europe:
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE/ZIDOVUDINE HETERO EUROPE IS AND WHAT IT IS USED FOR
LAMIVUDINE/ZIDOVUDINE HETERO EUROPE IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS)
INFECTION IN ADULTS AND CHILDREN.
Lamivudine/Zidovudine Hetero Europe 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 Hetero Europe 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 Hetero
Europe in the same way. Your
doctor will monitor the effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE HETERO
EUROPE
DO

Productkenmerken

1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine/Zidovudine Hetero Europe 150 mg/300 mg, filmomhulde
tabletten
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, scored, capsule shaped, biconvex, film-coated
scored tablets, debossed with ‘H’ on one
side and ‘L and 9’ separated by a score line on other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine/Zidovudine Hetero Europe 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 Hetero Europe 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 Hetero
Europe is one tablet twice daily.
_Children weighing between 21 kg and 30 kg: _the recommended oral dose
of Lamivudine/Zidovudine
Hetero Europe 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 Hetero
Europe 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 wa