SONKE EFAVIRENZ 200 CAPSULES

Země: Jihoafrická republika

Jazyk: angličtina

Zdroj: South African Health Products Regulatory Authority (SAHPRA)

Dostupné s:

Sonke Pharmaceuticals (Pty) Ltd

Dávkování:

See ingredients

Léková forma:

CAPSULES

Složení:

EACH CAPSULE CONTAINS EFAVIRENZ 200,0 mg

Stav Autorizace:

Registered

Datum autorizace:

2007-05-10

Informace pro uživatele

Sonke Pharmaceuticals (Pty) Ltd
Sonke Efavirenz 200 capsules and Sonke Efavirenz 600 film-coated
tablets
Page 1 of 12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
SONKE EFAVIRENZ 200 CAPSULES
SONKE EFAVIRENZ 600 FILM-COATED TABLETS EFAVIRENZ CONTAINS SUGAR:
SONKE EFAVIRENZ 200: LACTOSE MONOHYDRATE 62,50 MG.
SONKE EFAVIRENZ 600: LACTOSE MONOHYDRATE 237,60 MG.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING SONKE
EFAVIRENZ
•
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.
•
SONKE EFAVIRENZ 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 SONKE EFAVIRENZ is and what it is used for
2. What you need to know before you take SONKE EFAVIRENZ
3. How to take SONKE EFAVIRENZ
4. Possible side effects
5. How to store SONKE EFAVIRENZ
6. Contents of the pack and other information
1. WHAT SONKE EFAVIRENZ IS AND WHAT IT IS USED FOR
SONKE EFAVIRENZ is used in combination with other medicines
(antiretrovirals) for the treatment of HIV
infection in adults, adolescents and children weighing 13 kg and
above, and/or 3 years and above.
Sonke Pharmaceuticals (Pty) Ltd
Sonke Efavirenz 200 capsules and Sonke Efavirenz 600 film-coated
tablets
Page 2 of 12
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SONKE EFAVIRENZ
DO NOT TAKE SONKE EFAVIRENZ
•
If you are hypersensitive (allergic) to efavirenz or any of the other
ingredients of SONKE EFAVIRENZ
(listed in section 6).
•
If you are pregnant or planning to become pregnant or are
breastfeeding.
•
If you had a liver disorder or liver failure attributed to treatment
with SONKE EFAVIRENZ.
•
If you are taking any of the following medicines:
-
Ergot derivatives such as ergotamine tablets – used for treatment of
migraine.
-
Terfenadine or astemizole – used for treatment of allergies.
-
Cisapride – used for trea

Charakteristika produktu

Sonke Pharmaceuticals (Pty) Ltd
Sonke Efavirenz 200 capsules and Sonke Efavirenz 600 film-coated
tablets
Page 1 of 44
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S4
1. NAME OF THE MEDICINE
SONKE EFAVIRENZ 200 Capsules
SONKE EFAVIRENZ 600 Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SONKE EFAVIRENZ 200:
Each capsule contains efavirenz 200 mg.
Contains sugar: Lactose monohydrate 62,50 mg.
SONKE EFAVIRENZ 600:
Each film-coated tablet contains efavirenz 600 mg.
Contains sugar: Lactose monohydrate 237,60 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
CAPSULE
SONKE EFAVIRENZ 200: White/white, opaque, hard gelatine, self-locked
capsules of size 0 elongated, imprinted
twice with RD38 in black ink on cap and body and containing a white to
pale yellow free flowing granular powder.
FILM-COATED TABLET
SONKE EFAVIRENZ 600: Peach coloured, capsule shaped, biconvex, film-.
coated tablets, debossed with RC68 on
one side and plain on other side with intact coating
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SONKE EFAVIRENZ 200 CAPSULES are indicated in combination with other
antiretroviral medicines for the
Sonke Pharmaceuticals (Pty) Ltd
Sonke Efavirenz 200 capsules and Sonke Efavirenz 600 film-coated
tablets
Page 2 of 44
treatment of HIV-1 infected adults, adolescents and children, greater
than 3 years of age and 13 kg weight.
SONKE EFAVIRENZ 600 TABLETS are indicated in combination with other
antiretroviral medicines for the treatment
of HIV-1 infected adults, adolescents and children weighing greater
than or equal to 40 kg.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults: _
The recommended dosage of SONKE EFAVIRENZ in combination with a
protease inhibitor and/or nucleoside
analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally,
once daily.
In order to improve the tolerability of nervous system side effects,
bedtime dosing is recommended during the first
two to four weeks of therapy and in patients who continue to
experience these symptoms (see sec