TALIPHIO TABLET

Страна: Южна Африка

Език: английски

Източник: South African Health Products Regulatory Authority (SAHPRA)

Предлага се от:

Cipla Medpro (Pty) Ltd

дозиране:

200,0 mg, 25,0 mg & 25,0 mg

Лекарствена форма:

TABLET

Композиция:

EACH TABLET CONTAINS EMTRICITABINE 200,0 mg RILPIVIRINE HYDROCHLORIDE EQUIVALENT TO RILPIVIRINE 25,0 mg TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25,0 mg

Статус Оторизация:

Registered

Листовка

Cipla Medpro (Pty) Ltd.
Page 1 of 11
PATIENT INFORMATION LEAFLET FOR
TALIPHIO
SCHEDULING STATUS:
TALIPHIO 200/25/25 MG, FILM-COATED TABLETS
EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE AND TENOFOVIR ALAFENAMIDE
FUMARATE
CONTAINS SUGAR: 411,055 MG ANHYDROUS LACTOSE AND 129,450 MG LACTOSE
MONOHYDRATE.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TALIPHIO
•
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.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet (see section 4).
•
TALIPHIO 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 TALIPHIO is and what is used for
2.
What you need to know before you take TALIPHIO
3.
How to take TALIPHIO
4.
Possible side effects
S4
Cipla Medpro (Pty) Ltd.
Page 2 of 11
5.
How to store TALIPHIO
6.
Contents of the pack and other information.
1. WHAT TALIPHIO IS AND WHAT IT IS USED FOR
TALIPHIO is indicated in combination with other antiretroviral
medicines for the treatment of
adults infected with human immunodeficiency virus type 1 (HIV-1).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TALIPHIO
DO NOT TAKE TALIPHIO:
•
if you are hypersensitive (allergic) to emtricitabine, rilpivirine,
tenofovir alafenamide or
any of the other ingredients of TALIPHIO (listed in section 6)
•
in combination with carbamazepine, oxcarbazepine, phenobarbital,
phenytoin,
dexamethasone (except as a single dose treatment) rifabutin,
rifampicin, rifapentine, St.
John’s Wort, proton-pump inhibitors (PPIs) such as lansoprazole,
dexlansoprazole,
omeprazole, rabeprazole, pantoprazole and esomeprazole as
co-administration may
result in loss of therapeutic effect of TALIPHIO.
WARNINGS AND PRECAUTIONS
Special care should be taken with TALIPHIO:
•
if you have pain i

Данни за продукта

Cipla Medpro (Pty) Ltd.
Page 1 of 60
PROFESSIONAL INFORMATION
TALIPHIO
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
TALIPHIO (200/25/25 mg, film-coated tablets)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg emtricitabine, rilpivirine
hydrochloride equivalent to 25
mg rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg
tenofovir alafenamide.
Contains sugar: 411,055 mg anhydrous lactose and 129,450 mg lactose
monohydrate per
tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Pink coloured, capsule shaped biconvex film-coated tablets plain on
both sides.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
TALIPHIO is indicated in combination with other antiretroviral
medicines for the treatment of
adults infected with human immunodeficiency virus type 1 (HIV-1) (see
sections 4.2 and 5.1).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Cipla Medpro (Pty) Ltd.
Page 2 of 60
POSOLOGY
Adults, weighing at least 35 kg.
The recommended dose is one TALIPHIO tablet once a day with food.
SPECIAL POPULATIONS
_Elderly patients _
No dose adjustment of TALIPHIO is required in elderly patients.
_ _
_Paediatric population _
The safety and efficacy of TALIPHIO in children younger than 12 years
of age, or weighing <
35 kg, have not been established. No data is available.
_ _
_Renal impairment _
No dose adjustment of TALIPHIO is required in adults or adolescents
(aged at least 12 years
and of at least 35 kg body weight) with estimated creatinine clearance
(CrCl) ≥ 30 mL/min.
TALIPHIO should be discontinued in patients with estimated CrCl that
declines below 30
mL/min during treatment (see sections 4.4 and 5.2).
No dose adjustment of TALIPHIO is required in adults with end stage
renal disease (estimated
CrCl < 15 mL/min) on chronic haemodialysis; however, TALIPHIO should
generally be avoided
but may be used in these patients (see sections 4.4 and 5.2). On days
of haemodialysis,
TALIPHIO should be administered after completion of haemod