Lamivudine Mylan 300mg

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

LAMIVUDINE

Dostupno od:

Generics UK Limited

ATC koda:

J05AF05

INN (International ime):

LAMIVUDINE

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

LAMIVUDINE 300 mg

Tip recepta:

POM

Područje terapije:

ANTIVIRALS FOR SYSTEMIC USE

Status autorizacije:

Authorised

Datum autorizacije:

2013-04-29

Uputa o lijeku

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMIVUDINE 150 MG FILM-COATED TABLETS
LAMIVUDINE 300 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 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 is and what it is used for
2.
What you need to know before you take Lamivudine
3.
How to take Lamivudine
4.
Possible side effects
5.
How to store Lamivudine
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE IS AND WHAT IT IS USED FOR
Lamivudine is used to treat HIV (human immunodeficiency virus)
infection in adults and children.
Lamivudine belongs to a group of antiviral medicines, also known as
antiretrovirals, called
nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Lamivudine 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 CD4 cell count in your
blood. CD4 cells are a type of
white blood cell that are important in maintaining a healthy immune
system to help fight infection.
Response to treatment with lamivudine varies between patients. Your
doctor will be monitoring the
effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE
DO NOT TAKE LAMIVUDINE:

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.
Page 2 of 7
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lamivudine:

if you are currently being treated for HIV wit

Svojstava lijeka

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lamivudine Mylan 300 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 300 mg film-coated tablet contains 300 mg of lamivudine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white colored, oval shaped, biconvex film-coated tablet,
debossed with “M300”
on one side and plain on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine Mylan 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.
Posology
_Adults, adolescents and children (weighing at least 25 kg)_
The recommended dose of Lamivudine Mylan is 300 mg daily. This may be
administered as
either 150 mg twice daily or 300 mg once daily (see section 4.4).
The 300 mg tablet is only suitable for the once a day regimen.
Page 2 of 16
_Children (weighing less than 25 kg) _
_Children from three months of age _
As an accurate dosage cannot be achieved with the 300 mg non-scored
tablet formulation in
this patient population, it is recommended that the Lamivudine Mylan
150 mg scored tablet
formulation is used and the corresponding recommended dosage
instructions are followed.
_Children less than three months of age_
The limited data available are insufficient to propose specific dosage
recommendations (see
section 5.2).
Patients changing from the twice daily dosing regimen to the once
daily dosing regimen
should take the recommended once daily dose (as described above)
approximately 12 hours
after the last twice daily dose, and then continue to take the
recommended once daily dose
(as described above) approximately every 24 hours. When changing back
to a twice daily
regimen, patients should take the recommended twice daily dose
approximately 24 hours
after the last onc