RIZENE TABLET

País: República de Sud-àfrica

Idioma: anglès

Font: South African Health Products Regulatory Authority (SAHPRA)

Disponible des:

Adcock Ingram Limited

Dosis:

See ingredients

formulario farmacéutico:

TABLET

Composición:

EACH TABLET CONTAINS EFAVIRENZ 600,0 mg EMTRICITABINE 200,0 mg TENOFOVIR DISOPROXIL FUMARATE 300,0 mg

Estat d'Autorització:

Registered

Data d'autorització:

2013-05-12

Informació per a l'usuari

Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
RIZENE 600 MG, 200 MG, 300 MG, FILM-COATED TABLETS
EFAVIRENZ, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING RIZENE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.
•
RIZENE 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 RIZENE is and what it is used for
2. What you need to know before you take RIZENE
3. How to take RIZENE
4. Possible side effects
5. How to store RIZENE
6. Contents of the pack and other information
1. WHAT RIZENE IS AND WHAT IT IS USED FOR
RIZENE contains three active substances that are used to treat human
immunodeficiency virus
(HIV)
infection:
efavirenz
is
a
non-
nucleoside
reverse
transcriptase
inhibitor
(NNRTI),
Page 2 of 12
emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
and tenofovir is a nucleotide
reverse transcriptase inhibitor (NRTI).
Each of these active substances, also known as antiretroviral
medicines, work by interfering
with an enzyme (reverse transcriptase) that is essential for the virus
to multiply.
RIZENE can be used alone as a complete regimen or in combination with
other anti-retroviral
medicines for the treatment of HIV-1 infection in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZENE
DO NOT TAKE RIZENE:
•
If you are hypersensitive (allergic) to efavirenz, emtricitabine
and/or tenofovir disoproxil
fumarate or any of the other ingredients of RIZENE (listed in section
6).
•
You had a liver disorder or liver failure attributed to treatment with
RIZENE.
•
If you have moderate to severe kidney failure.
•
If you are pregnant or breastfeeding.
•
If you have a heart condition, such as an abnormal electrical signal
called prolongation of
the QT interval that puts

Fitxa tècnica

Page 1 of 40
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
RIZENE, 600 mg, 200 mg, 300 mg, film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of RIZENE contains:
Efavirenz 600 mg
Emtricitabine 200 mg
Tenofovir disoproxil fumarate 300 mg
Sugar free.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
RIZENE is a pink coloured, capsule shaped, film-coated tablet debossed
with “H” on one side
and “128” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RIZENE is indicated for use alone as a complete regimen or in
combination with other anti-
Page 2 of 40
retroviral agents for the treatment of HIV-1 infection in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Take one RIZENE film-coated tablet daily on an empty stomach.
Dosing at bedtime may improve the tolerability of nervous system
symptoms.
PAEDIATRICS
RIZENE is not recommended for use by patients under the age of 18
years.
RENAL IMPAIRMENT
RIZENE is a fixed dose combination and should not be used by patients
that require dose
adjustment, such as those with moderate or severe renal impairment
resulting in a creatinine
clearance of less than 50 ml/min.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to efavirenz, emtricitabine, tenofovir disoproxil
fumarate or to any of the
components listed in section 6.1.
•
A history of previous liver injury/failure with efavirenz containing
antiretroviral treatment
(ART).
•
Pregnancy and lactation (see section 4.6).
•
Patients with moderate to severe renal impairment i.e. creatinine
clearance of less than 50
ml/min (see section 4.4 and 5.2).
•
RIZENE should not be used concurrently with the following medicinal
products due to
CYP3A4
competition:
terfenadine,
astemizole,
bepridil,
cisapride,
ergot
derivatives,
midazolam, pimozide or triazolam. Failure to observe this
contraindication can result in
reduced metabolism of these medicines and may result in serious and/or
life-threatening
Page 3