Lamivudine Mylan 150mg

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 150 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 150 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 150 mg film-coated tablet contains 150 mg of lamivudine.
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 tablet,
debossed with “M105” on
one side and a functional scoreline on the other.
The tablet can be divided into equal doses.
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).
Page 2 of 16
_Children (weighing less than 25 kg) _
Dosing according to weight bands is recommended for lamivudine
tablets.
_Children weighing ≥20 kg to <25 kg_
The recommended dose is 225 mg daily. This may be administered as
either 75 mg (one-half
of a 150 mg tablet) taken in the morning and 150 mg (one whole 150 mg
tablet) taken in the
evening, or 225 mg (one and a half 150 mg tablets) taken once daily.
_Children weighing 14 to <20 kg _
The recommended dose is 150 mg daily. This may be administered as 75
mg (one-half of a
150 mg tablet) taken twice daily, or 150 mg (one whole 150 mg tablet)
taken once daily.
_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 dail