Epivir

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

lamivudine

Available from:

ViiV Healthcare BV

ATC code:

J05AF05

INN (International Name):

lamivudine

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.,

Product summary:

Revision: 50

Authorization status:

Authorised

Authorization date:

1996-08-08

Patient Information leaflet

53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPIVIR 150 MG FILM-COATED TABLETS
_lamivudine _
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 doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Epivir is and what it is used for
2.
What you need to know before you take Epivir
3.
How to take Epivir
4.
Possible side effects
5.
How to store Epivir
6.
Contents of the pack and other information
1.
WHAT EPIVIR IS AND WHAT IT IS USED FOR
EPIVIR IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS AND CHILDREN.
The active ingredient in Epivir is lamivudine. Epivir is a type of
medicine known as an anti-retroviral.
It belongs to a group of medicines called
_nucleoside analogue reverse transcriptase inhibitors _
(
_NRTIs_
).
Epivir 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 Epivir in the same way. Your
doctor will monitor the
effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPIVIR
DO NOT TAKE EPIVIR:
•
if you are ALLERGIC
to
lamivudine or any of the other ingredients of this medicine (
_listed in Section _
_6_
)
_._
CHECK WITH YOUR DOCTOR
if you think this applies to you.
TAKE SPECIAL CARE WITH EPIVIR
Some people taking Epivir or other combination treatments for HIV are
more at risk of serious side
effects. You need

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Epivir 150 mg film-coated tablets
Epivir 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epivir 150 mg film-coated tablets
Each film-coated tablet contains 150 mg lamivudine.
Epivir 300 mg film-coated tablets
Each film-coated tablet contains 300 mg lamivudine
Excipient(s) with known effect:
Each 150 mg tablet contains 0.378 mg sodium.
Each 300 mg tablet contains 0.756 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Epivir 150 mg film-coated tablets
Film-coated tablet
White, diamond shaped scored tablets engraved with “GX CJ7” on
both faces.
Epivir 300 mg film-coated tablets
Film-coated tablet
Grey, diamond shaped and engraved with “GX EJ7” on one face
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epivir is indicated as part of antiretroviral combination therapy for
the treatment of Human
Immunodeficiency Virus (HIV) infected adults and children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The therapy should be initiated by a physician experienced in the
management of HIV infection.
Epivir may be administered with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing.
_ _
Epivir is also available as an oral solution for children over three
months of age and who weigh less
than 14 kg or for patients who are unable to swallow tablets (see
section 4.4).
Patients changing between lamivudine oral solution and lamivudine
tablets should follow the dosing
recommendations that are specific for the formulation (see section
5.2)
3
Alternatively, for patients who are unable to swallow tablets, the
tablet(s) 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, adolescents and children (weighing at least 25 kg): _
_ _
The recommended dose of Epivir is 300 mg daily. This may be
administered as either 150 mg twice
daily or 30