3TC
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
07-03-2023
Summary of Product characteristics
(SPC)
14-07-2023
Active ingredient:
Lamivudine 150mg;
Available from:
GlaxoSmithKline NZ Limited
INN (International Name):
Lamivudine 150 mg
Dosage:
150 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Lamivudine 150mg Excipient: Magnesium stearate Microcrystalline cellulose Opadry white YS-1-7706-G Sodium starch glycolate
Units in package:
Bottle, plastic, HDPE, White, 60 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Mylan Laboratories Limited
Therapeutic indications:
3TC in combination with other anti-retroviral agents is indicated for the treatment of HIV infected adults and children.
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, HDPE, White - 60 tablets - 60 months from date of manufacture stored at or below 30°C
Authorization date:
1995-08-04
Patient Information leaflet
1
3TC
_Lamivudine tablets 150 mg, 300 mg and oral solution 10 mg/mL _
_ _
___________________________________________________________________________________________________
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking 3TC tablets
or oral solution.
This leaflet answers some common
questions about 3TC. It does not
contain all of the available
information.
It does not take the place of talking
to your doctor or pharmacist.
WHAT 3TC IS USED FOR
3TC contains the active ingredient
lamivudine, which belongs to a
group of medicines called
antiretrovirals.
Please note that the active ingredient
in 3TC, lamivudine, is also available
as a combination medicine,
Combivir, containing another
antiretroviral medicine called
zidovudine.
3TC is used, in combination with
other antiretrovirals, for the
treatment of HIV infected adults and
children.
3TC does not cure AIDS or HIV
infection, but slows down
production of human
immunodeficiency virus. In this way
it stops ongoing damage to the
body’s immune system, which
fights infection.
While taking 3TC and/or any other
therapy for HIV disease, you may
continue to develop further
infections and other complications
of HIV disease. You should keep in
regular contact with your doctor.
The long term risks and benefits of
taking 3TC are not known.
Your doctor may have prescribed
3TC for another reason. Ask your
doctor if you have any questions
about why 3TC has been prescribed
for you.
3TC is not addictive.
BEFORE YOU TAKE 3TC
_WHEN YOU MUST NOT TAKE _
_IT _
Do not take 3TC tablets or oral
solution if you have ever had an
allergic (hypersensitivity)
reaction to lamivudine.
Do not take 3TC tablets or oral
solution if you have ever had an
allergic reaction to any of the
other ingredients in 3TC listed
at the end of this leaflet.
Do not take 3TC tablets or oral
solution if you are pregnant,
trying to become pregnant or
breastfeeding, unless your
doctor says you should.
Your doctor may discuss with you
th
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Summary of Product characteristics
1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
3TC lamivudine 150 mg and 300 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3TC film-coated tablet contains 150 mg or 300 mg lamivudine.
For the full list of excipients, see section 6.1 List of excipients
3. PHARMACEUTICAL FORM
Film-coated tablets.
3TC 150 mg tablets are white, diamond shaped scored tablets and
engraved with the
code “GX CJ7” on both faces.
3TC 300 mg tablets are grey, diamond-shaped, engraved ‘GX EJ7’ on
the upper
tablet face.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
3TC in combination with other anti-retroviral agents is indicated for
the treatment of
HIV infected adults and children.
4.2
DOSE AND METHOD OF ADMINISTRATION
3TC therapy should be initiated by a physician experienced in the
management of
HIV infection.
Dose
_Adults, adolescents and children weighing at least 25 kg _
The recommended dose of 3TC is 300 mg daily. This may be administered
as either
150 mg twice daily or 300 mg once daily.
Patients changing between lamivudine oral solution and lamivudine
tablets should
follow the dosing recommendations that are specific for the
formulation (see section
5.2 pharmacokinetic properties).
Special populations
_Elderly _
2
No specific data are available, however special care is advised in
this age group due
to age associated changes such as the decrease in renal function and
alteration of
haematological parameters.
_Renal impairment _
Lamivudine plasma concentrations (AUC) are increased in patients with
moderate to
severe renal impairment due to decreased clearance (see section 5.2
Pharmacokinetic properties). The dosage should therefore be reduced
for patients
with a creatinine clearance of <50 mL/minute as shown in the table
below.
There are no data available on the use of lamivudine in children with
renal
impairment.
The same percentage reduction in the adult dose is recommended for
paediatric
patients with renal impairment.
DOSING RECOMMENDATIONS: ADULTS, ADOLESCENTS AND CHILDREN WEIGHING AT
LEAST
25 KG:
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