COMBIVIR (lamivudine 150mg and zidovudine 300mg) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamivudine, Quantity: 150 mg; zidovudine, Quantity: 300 mg

Available from:

ViiV Healthcare Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 4000

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Combivir is indicated for use alone or in combination with other antiretroviral therapies in the treatment of HIV infection.

Product summary:

Visual Identification: White to off-white film-coated, capsule-shaped, scored tablet engraved with "GXFC3" on both tablet face. Each tablet contains lamivudine 150 mg and zidovudine 300 mg; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-01-23

Patient Information leaflet

COMBIVIR
_lamivudine 150 mg and zidovudine 300 mg tablets_
AUSTRALIA AND NEW ZEALAND CONSUMER
MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Combivir
tablets.
This leaflet answers some common
questions about Combivir. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Combivir
tablets against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT COMBIVIR TABLETS
ARE USED FOR
Combivir contains both lamivudine
and zidovudine which belong to a
group of medicines called
antiretrovirals.
Please note that these medicines are
also available separately: lamivudine
alone is 3TC, (tablets and oral
solution) and zidovudine alone is
Retrovir(capsules and syrup).
Combivir is used, alone or with other
antiretrovirals, to slow down the
progression of human
immunodeficiency virus (HIV)
infection, which can lead to Acquired
Immune Deficiency Syndrome
(AIDS) and other related illnesses
(e.g. AIDS-related Complex or
ARC).
Combivir does not cure AIDS or HIV
infection, but slows production of
human immunodeficiency virus. In
this way it stops ongoing damage to
the body's immune system, which
fights infection.
You can still pass on HIV when
taking this medicine, although the
risk is lowered by effective
antiretroviral therapy. Discuss with
your doctor the precautions needed to
avoid infecting other people.
While taking Combivir and/or any
other therapy for HIV disease, you
may continue to develop other
infections and other complications of
HIV infection. You should keep in
regular contact with your doctor.
The long-term risks and benefits of
taking Combivir are not known.
Your doctor may have prescribed
Combivir for another reason. Ask
your doctor if you have any questions
about

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
COMBIVIR (LAMIVUDINE AND ZIDOVUDINE)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Lamivudine and zidovudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMBIVIR Tablets are a fixed combination product containing lamivudine
150 mg and
zidovudine 300 mg in each tablet. Product information for 3TC (tablets
and oral solution) and
RETROVIR (capsules and syrup) contain additional information specific
for lamivudine and
zidovudine, respectively.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
COMBIVIR tablets are available as both scored and unscored tablets.
COMBIVIR unscored tablets are white to off-white capsule-shaped
film-coated tablets,
engraved with “GXFC3” on one tablet face.
COMBIVIR scored tablets are white to off-white capsule-shaped
film-coated tablets,
engraved with “GXFC3” on both tablet faces.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COMBIVIR is indicated for use alone or in combination with other
antiretroviral therapies in
the treatment of HIV infection.
4.2
DOSE AND METHOD OF ADMINISTRATION
COMBIVIR may be administered with or without food. Food reduces the C
max
and extends
the T
max
of lamivudine but the amount of drug absorbed is not reduced. The
clinical
significance of this is not known (see Section 5.2 PHARMACOKINETIC
PROPERTIES).
For situations where discontinuation of therapy with one of the active
constituents of
COMBIVIR, or dose reduction is necessary, separate preparations of
lamivudine (3TC
tablets and oral solution) and zidovudine (RETROVIR Capsules and
Syrup) are available.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing. For patients who are unable to swallow tablets, the
tablet(s) may be crushed and
100% of the crushed tablet could be added to a small amount of
semi-solid food or liquid, all
of which should be consumed immediately (see Section 5.2
PHARMACOKINETIC
PROPERTIES).
2
The dosing regimens for paediatric patients weighing 14-30 kg is