ALUVIA 100/25 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbvie (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS LOPINAVIR 100,0 mg RITONAVIR 25,0 mg

Authorization status:

Registered

Authorization date:

2010-04-06

Patient Information leaflet

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PATIENT INFORMATION LEAFLET SCHEDULING STATUS:
ALUVIA 100/25
™ FILM-COATED TABLETS
(Lopinavir 100 mg / Ritonavir 25 mg)
“
Sugar free”
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ALUVIA
100/25

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

ALUVIA 100/25 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 Aluvia 100/25 is and what it is used for
2.
What you need to know before you or your child take Aluvia 100/25
3.
How to take Aluvia 100/25
4.
Possible side effects
5.
How to store Aluvia 100/25
6.
Contents of the pack and other information
1.
WHAT ALUVIA 100/25 IS AND WHAT IT IS USED FOR
ALUVIA 100/25 film-coated tablets contain 100 mg of lopinavir and 25
mg of ritonavir
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ALUVIA 100/25 is an inhibitor of the human immunodeficiency virus
(HIV) protease enzyme.
It helps control HIV infection by inhibiting or interfering with the
protease enzyme that HIV
needs to multiply.
ALUVIA 100/25 is used by adults and children with a body surface area
of 1.3 m
2
or greater
who are infected with HIV, the virus which causes AIDS. Your doctor
has prescribed
ALUVIA 100/25 to help control your HIV infection.
ALUVIA 100/25 is prescribed for use in combination with other
antiviral medicines. Your
doctor will determine which medicines are best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALUVIA 100/25
DO NOT TAKE ALUVIA 100/25:

If you are allergic (hypersensitive)
to lopinavir, ritonavir or to any of the other ingredients
of Aluvia 100/25 (listed in section 6).

If you have severe liver problems.

If you are currently taking any of the following medicines:
-
Alfuzosin (used in men to treat symptoms of enlarged prostate)
-
Apalutamide (used for prostate cancer)
-
Astemizole (used to treat allergy symptoms – this medicine may be
available withou

Summary of Product characteristics

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PROPOSED PROFESSIONAL INFORMATION
SCHEDULING STATUS
Schedule 4
1. NAME OF THE MEDICINE
ALUVIA 100/25 FILM-COATED TABLET
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ALUVIA 100/25 film-coated tablet contains 100 mg of lopinavir and
25 mg of ritonavir.
“Sugar free“
_“FOR FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 _
3
PHARMACEUTICAL FORM
pink film-coated tablets embossed with the Abbott logo “
” and the Code “AC”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALUVIA 100/25 film-coated tablet is indicated in combination with
other antiretroviral
medicines for the treatment of HIV-infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ALUVIA 100/25 tablets may be taken with or without food. ALUVIA 100/25
tablets should
be swallowed whole and not chewed, broken or crushed.
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ALUVIA 100/25 should be initiated by medical practitioners who are
experienced in the
treatment of HIV infection.
POSOLOGY
The recommended oral dose of ALUVIA 100/25 film-coated tablets are as
follows:
_ADULTS _

ALUVIA 100/25 film-coated tablets 400/100 mg (given as two, 200/50 mg
tablets) twice
daily with or without food.

ALUVIA 100/25 FILM-coated tablets 800/200 mg (given as four, 200/50 mg
tablets) once
daily with or without food – in patients with less than three
lopinavir-associated
mutations. There are insufficient data to support the use of once
daily administration of
ALUVIA 100/25 IN adult patients with three or more
lopinavir-associated mutations.
ALUVIA 100/25 should not be administered once daily in combination
with carbamazepine,
phenobarbital or phenytoin.
_PAEDIATRIC PATIENTS _
ALUVIA 100/25 should not be administered once daily in paediatric
patients. The adult dose
of ALUVIA 100/25 film-coated tablets (two 200/50 mg tablets twice
daily) may be used in
children with a Body Surface Area (BSA)* greater than 1,3 m
2
. ALUVIA 100/25 film-coated
tablets once daily have not been evaluated in paediatric patients.
* Body surface area can be calculated with the following equation:
_ _
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