ADCO-LAMIVUDINE TABLETS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

each tablet CONTAINS LAMIVUDINE 150,0 MG

Authorization status:

Registered

Authorization date:

2007-02-02

Patient Information leaflet

Page 1 of 10
PATIENT INFORMATION LEAFLET FOR ADCO-LAMIVUDINE TABLETS
SCHEDULING STATUS
S4
ADCO-LAMIVUDINE TABLETS, 150 MG, FILM-COATED TABLETS
LAMIVUDINE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
ADCO-LAMIVUDINE TABLETS
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
ADCO-LAMIVUDINE TABLETS has been prescribed for you personally and you
should not
share your medicine with other people. It may harm them, even if their
symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1.
What ADCO-LAMIVUDINE TABLETS is and what it is used for
2.
What you need to know before you take ADCO-LAMIVUDINE TABLETS
3.
How to take ADCO-LAMIVUDINE TABLETS
4.
Possible side effects
5.
How to store ADCO-LAMIVUDINE TABLETS
6.
Contents of the pack and other information
1. WHAT ADCO-LAMIVUDINE TABLETS IS AND WHAT IT IS USED FOR
Page 2 of 10
Lamivudine is an anti-virus medicine used in the treatment of the
infection caused by the Human
Immunodeficiency Virus (HIV). HIV grows and multiplies through DNA
chain formation.
Lamivudine helps control HIV infection by inhibiting or interfering
with the reverse transcriptase
enzyme that HIV needs to multiply. This helps keep HIV from
reproducing.
ADCO-LAMIVUDINE TABLETS is used in combination with other antiviral
medicines in the
treatment of HIV infection in adults and children. It has been shown
to work particularly well in
combination with zidovudine-containing medicines.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCO-LAMIVUDINE TABLETS
ADCO-LAMIVUDINE TABLETS is not a cure for HIV infection or AIDS.
People taking ADCO-
LAMIVUDINE TABLETS may still develop infections or other illnesses
associated with HIV
disease and AIDS. It is therefore important that you remain under the
supervision of your doctor
while taking ADCO-LAMIVUDINE TABLETS. ADCO-LAMIVUDINE TABLETS does not
reduce
the risk of passing HIV to others through sexual contact or blood
contamination. Y

Summary of Product characteristics

Page 1 of 16
PROFESSIONAL INFORMATION FOR ADCO-LAMIVUDINE TABLETS
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
ADCO-LAMIVUDINE TABLETS, 150 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains: 150 mg lamivudine.
Sugar free
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
A white film-coated, oval, biconvex tablet with a breakline on one
side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADCO-LAMIVUDINE TABLETS is indicated as part of antiretroviral
combination therapy for
the treatment of HIV infected adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS MORE THAN 12 YEARS OF AGE:
Page 2 of 16
The recommended dose of ADCO-LAMIVUDINE TABLETS is 300 mg daily. This
may be
administered as either 300 mg once daily or 150 mg twice daily.
The professional information for zidovudine must be consulted for
information on its dosage
and administration.
For patients with low body weights (less than 50 kg), the recommended
oral dose of ADCO-
LAMIVUDINE TABLETS is 2 mg/kg twice daily.
CHILDREN ≥ 3 MONTHS TO 12 YEARS OF AGE:
The recommended dose is 4 mg/kg twice daily up to a maximum of 300 mg
daily.
CHILDREN < 3 MONTHS OF AGE:
There are limited data to propose specific dosage recommendations (see
section 5.2).
ADCO-LAMIVUDINE TABLETS can be taken with or without food.
RENAL AND HEPATIC IMPAIRMENT:
Renal
impairment,
whether
disease-
or
age-related,
affects
lamivudine
elimination.
For
recommended dosage regimens in patients with a creatinine clearance
below 50 ml/min see
table below.
ADULTS AND ADOLESCENTS > 12 YEARS OF AGE:
CREATININE CLEARANCE (ML/MIN)
RECOMMENDED DOSE OF ADCO-LAMIVUDINE TABLETS
≥ 50
150 mg twice daily
30 – 49
150 mg once daily
15 – 29
150 mg first dose, then 100 mg once daily
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5 – 14
150 mg first dose, then 50 mg once daily
< 5
50 mg first dose, then 25 mg once daily
CHILDREN > 3 MONTHS TO 12 YEARS:
CREATININE CLEARANCE (ML/MIN)
RECOMMENDED DOSE OF ADCO-LAMIVU