TIVICAY 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DOLUTEGRAVIR AS SODIUM

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J05AX12

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DOLUTEGRAVIR AS SODIUM 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GLAXO WELLCOME SA, SPAIN

Therapeutic area:

DOLUTEGRAVIR

Therapeutic indications:

Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg

Authorization date:

2023-01-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physicians prescription only
TIVICAY 10 MG
TIVICAY 25 MG
TIVICAY 50 MG
FILM-COATED TABLETS
Each tablet contains:
Tivicay 10 mg: DOLUTEGRAVIR (AS SODIUM) 10 MG
Tivicay 25 mg: DOLUTEGRAVIR (AS SODIUM) 25 MG
Tivicay 50 mg: DOLUTEGRAVIR (AS SODIUM) 50 MG
For the list of inactive and allergenic ingredients in the
preparation, see section
2 -
Important information about some of the ingredients in this medicine
and
section 6 - Additional information.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or the pharmacist.
This medicine has been prescribed for you (or your child, if they are
the patient).
Do not pass it on to others. It may harm them, even if it seems to you
that their
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Tivicay is used as combination therapy (in combination with other
antiretroviral
medicines) to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION in
adults,
adolescents and children from the age of 6 years and weighing at least
14 kg.
Tivicay does not cure the HIV infection; it reduces the amount of
virus in your
body, and keeps it at a low level. As a result, it 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.
Not everyone responds to treatment with Tivicay in the same way. Your
physician will monitor the effectiveness of your treatment.
Tivicay treatment is always in combination with other antiretroviral
medicines
(
combination therapy
). To control the HIV infection, and to prevent the illness
from getting worse, you must continue taking all your medicines,
unless your
physician tells you otherwise.
THERAPEUTIC GROUP
Tivicay contains the active ingredient dolutegravir. This medicine
belongs to a
group of antiretroviral

Summary of Product characteristics

Page 1 of 35
1.
NAME OF THE MEDICINAL PRODUCT
Tivicay 10 mg film-coated tablets
Tivicay 25 mg film-coated tablets
Tivicay 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tivicay 10 mg film-coated tablets
Each film-coated tablet contains dolutegravir sodium equivalent to 10
mg dolutegravir.
Tivicay 25 mg film-coated tablets
Each film-coated tablet contains dolutegravir sodium equivalent to 25
mg dolutegravir.
Tivicay 50 mg film-coated tablets
Each film-coated tablet contains dolutegravir sodium equivalent to 50
mg dolutegravir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet (tablet).
Tivicay 10 mg film-coated tablets
White, round, biconvex tablets
approximately 6 mm in diameter debossed with ‘SV 572’ on
one side and ‘10’ on the other side.
Tivicay 25 mg film-coated tablets
Pale yellow, round, biconvex tablets approximately 7 mm in diameter
debossed with ‘SV
572’ on one side and ‘25’ on the other s
ide.
Tivicay 50 mg film-coated tablets
Yellow, round, biconvex tablets approximately 9 mm in diameter
debossed with ‘SV 572’ on
one side and ‘50’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Page 2 of 35
Tivicay is indicated in combination with other anti-retroviral
medicinal products for the
treatment of Human Immunodeficiency Virus (HIV) infected adults,
adolescents and children
of at least 6 years of age or older and weighing at least 14 kg.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Tivicay should be prescribed by physicians experienced in the
management of HIV infection.
_ _
Posology
_Adults _
_ _
_Patients infected with HIV-1 without documented or clinically
suspected resistance to the _
_integrase class _
The recommended dose of dolutegravir is 50 mg orally once daily.
Dolutegravir should be administered twice daily in this population
when co-administered with
some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or
rifampicin). Please refer
to section 4.5.
_Patients infected with HIV-1 w