JASUPA TABLET

Maa: Etelä-Afrikka

Kieli: englanti

Lähde: South African Health Products Regulatory Authority (SAHPRA)

Saatavilla:

GlaxoSmithKline South Africa (Pty) Limited

Annos:

Not Indicated

Lääkemuoto:

TABLET

Koostumus:

None

Valtuutuksen tilan:

Registered

Pakkausseloste

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
JASUPA FILM-COATED TABLETS
DOLUTEGRAVIR 50 MG/RILPIVIRINE 25 MG
Contains sugar (as lactose monohydrate 55,15 mg/tablet and D-mannitol
203,14 mg/tablet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING JASUPA:
•
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.
•
JASUPA 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 JASUPA is and what it is used for
2. What you need to know before you take JASUPA
3. How to take JASUPA
4. Possible side effects
5. How to store JASUPA
6. Contents of the pack and other information.
1.
WHAT JASUPA IS AND WHAT IT IS USED FOR:
JASUPA contains two active ingredients that are used to treat HIV
infection: dolutegravir plus
rilpivirine.
Dolutegravir belongs to a group of anti-retroviral medicines called
_integrase inhibitors _
(INIs). Rilpivirine belongs to a group of anti-retroviral medicines
called _non-nucleoside analogue _
_reverse transcriptase inhibitors (NNRTIs)_.
Page 2 of 11
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE JASUPA:
DO NOT TAKE JASUPA:
•
if you are hypersensitive (allergic) to dolutegravir or rilpivirine or
to any of the other
ingredients of JASUPA (listed in section 6)
•
if you are taking any of the following medicines:
-
dofetilide
or
pilsicainide
(to
treat
heart
conditions)
carbamazepine,
oxcarbazepine,
phenobarbitone or phenytoin (also known as anticonvulsants used to
treat epilepsy and
prevent seizures)
-
fampridine (also known as dalfampridine; used in multiple sclerosis)
-
rifampicin or rifapentine (to treat some bacterial infections such as
tuberculosis)
-
omeprazole, esomeprazole, lansoprazole, pantoprazole or rabeprazole
(proton pump
inhibitors that are medicines to prevent and treat stomach ulcers,
heartburn, or acid reflux
disease)
-
de

Valmisteyhteenveto

Approved PI
Page 1 of 40
JASUPA
FILM-COATED TABLETS
SCHEDULING STATUS:
S4
1.
NAME OF MEDICINE:
JASUPA
(Dolutegravir 50 mg/Rilpivirine Hydrochloride 25 mg)
Film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains 50 mg of dolutegravir (as
dolutegravir sodium) and 25 mg
of rilpivirine (as rilpivirine hydrochloride).
Contains sugar (as lactose monohydrate 55,15 mg/tablet and D- mannitol
203,14 mg/tablet).
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
Film-coated tablets.
Pink, film-coated, oval, biconvex tablets debossed with ‘SV J3T’
on one side.
4.
CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
JASUPA is indicated for the treatment of human immunodeficiency
virus-1 (HIV-1) infection in
adults who are virologically suppressed (HIV-1 RNA
Approved PI
Page 2 of 40
< 50 copies/ml), for at least 6 months on a stable protease inhibitor
(PI), integrase strand
transfer inhibitor (INSTI) or non-nucleoside reverse transcriptase
inhibitor (NRTI) plus
nucleoside reverse transcriptase inhibitor (NRTI) based regimens,
without known or suspected
resistance to either antiretroviral component.
Co-administration with any other NNRTI medicines is not recommended
(see section 4.5).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
Therapy should be initiated by a medical practitioner experienced in
the management of HIV
infection.
If the patient misses a dose of JASUPA, the patient should take it
with a meal as soon as
they remember, if it is more than 12 hours until the next dose. If the
next dose is due within
12 hours, the patient should skip the missed dose and resume the usual
dosing schedule.
Separate preparations of dolutegravir and rilpivirine should be used,
where dose adjustment
or discontinuation of one of the individual components is indicated
(see section 4.5).
In these cases, the medical practitioner should refer to the
individual professional information.
_ADULTS:_ The recommended dose of JASUPA in adults is one tablet once
daily, taken orally
with a meal