TIVICAY DISPERSIBLE TABLET 5 MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Dolutegravir Sodium eqv Dolutegravir

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

J05AX12

Pharmaceutical form:

TABLET, FOR SUSPENSION

Composition:

Dolutegravir Sodium eqv Dolutegravir 5.00 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)

Authorization status:

ACTIVE

Authorization date:

2022-05-30

Patient Information leaflet

NOTE: The Patient Information Leaflet will not be in the commerical
pack. It will be available on the company
website.
PATIENT INFORMATION LEAFLET
TIVICAY 5 MG DISPERSIBLE TABLETS
DOLUTEGRAVIR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Keep this leaflet. You may need to read it again. If you have any
questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you personally. Don’t pass it
on to other people - it may
harm them even if their symptoms seem to be the same as yours.
IN THIS LEAFLET
1.
WHAT TIVICAY IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE TIVICAY
3.
HOW TO TAKE TIVICAY
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TIVICAY
6.
FURTHER INFORMATION
7.
STEP-BY-STEP INSTRUCTIONS
1. WHAT TIVICAY IS AND WHAT IT IS USED FOR
TIVICAY IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS AND IN
CHILDREN AGED AT LEAST 4 WEEKS, WHO WEIGH AT LEAST 3 KG.
The active ingredient in TIVICAY is dolutegravir. TIVICAY is a type of
medicine known as an
anti-retroviral. It belongs to a group of medicines called _integrase
inhibitors_ (INIs).
TIVICAY does not cure HIV infection; it reduces the amount of virus in
your body, and keeps it at
a low level. TIVICAY also increases the CD4 cell count in your blood.
CD4 cells are a type of
white blood cells that are important in helping your body to fight
infection.
TIVICAY is used, in combination with other anti-retroviral medicines
(_combination therapy_), to
treat HIV infection in adults and children. To control your HIV
infection, and to stop your illness
from getting worse, you must keep taking all your medicines, unless
your doctor tells you to stop
taking any.
NOTE: The Patient Information Leaflet will not be in the commerical
pack. It will be available on the company
website.
2. BEFORE YOU TAKE TIVICAY
DON’T TAKE TIVICAY

if YOU (OR YOUR CHILD, IF THEY ARE THE PATIENT) ARE ALLERGIC
_(HYPERSENSITIVE)_ TO DOLUTEGRAVIR or
to any of the other ingredients of TIVICAY (listed in Section 6).

if you (or your

Summary of Product characteristics

TIVICAY
DOLUTEGRAVIR
QUALITATIVE AND QUANTITATIVE COMPOSITION
White, round, biconvex tablets debossed with ‘SV H7S’ on one side
and ‘5’ on the other side.
Each tablet contains 5 mg of dolutegravir (as dolutegravir sodium).
CLINICAL INFORMATION
INDICATIONS
Treatment of human immunodeficiency virus (HIV) infection in
combination with other
antiretroviral agents in adults and children aged at least 4 weeks of
age or older and weighing at
least 3 kg.
DOSAGE AND ADMINISTRATION
Pharmaceutical form:
Dispersible tablets.
POSOLOGY
_TIVICAY_ therapy should be initiated by a physician experienced in
the management of HIV
infection.
_TIVICAY_ is available as dispersible tablets for patients aged at
least 4 weeks and weighing at least 3
kg, or for patients in whom film-coated tablets are not appropriate.
_TIVICAY_ is available as film-
coated tablets for patients aged at least 6 years and weighing at
least 14 kg. The bioavailability of
dispersible tablets and film-coated tablets is not comparable,
therefore they must not be used as
direct replacements (_see_ _Pharmacokinetics_). For example, the
recommended adult dose for
dispersible tablets is 30 mg versus 50 mg for film-coated tablets.
Patients changing between
dispersible and film-coated tablets should follow the dosing
recommendations that are specific for
the formulation.
_TIVICAY_ can be taken with or without food.
The dispersible tablets may be swallowed whole with drinking water or
dispersed in drinking water.
When dispersed, the amount of water will depend on the number of
tablets prescribed. The tablet(s)
should be fully dispersed before swallowing (_see Instructions for
Use_). Do not chew, cut or crush
the tablets.
METHOD OF ADMINISTRATION
ADULTS
PATIENTS INFECTED WITH HIV-1 WITHOUT RESISTANCE TO THE INTEGRASE CLASS
The recommended dose of dolutegravir dispersible tablets is 30 mg once
daily.
PATIENTS INFECTED WITH HIV-1 WITH RESISTANCE TO THE INTEGRASE CLASS
(DOCUMENTED OR CLINICALLY
SUSPECTED)
The recommended dose of dolutegravir dispersible tablets is 30