Tivicay

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

dolutegravir

Available from:

ViiV Healthcare BV

ATC code:

J05AX12

INN (International Name):

dolutegravir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

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.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 4 weeks of age or older and weighing at least 3 kg.

Product summary:

Revision: 34

Authorization status:

Authorised

Authorization date:

2014-01-16

Patient Information leaflet

81
B. PACKAGE LEAFLET
82
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TIVICAY 10 MG FILM-COATED TABLETS
TIVICAY 25 MG FILM-COATED TABLETS
TIVICAY 50 MG FILM-COATED TABLETS
dolutegravir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU (OR YOUR CHILD, IF THEY
ARE THE PATIENT) START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you (or your child, if they are
the patient) only. Do not pass it
on to others. It may harm them, even if their signs of illness are the
same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tivicay is and what it is used for
2.
What you need to know before you take Tivicay
3.
How to take Tivicay
4.
Possible side effects
5.
How to store Tivicay
6.
Contents of the pack and other information
1.
WHAT TIVICAY IS AND WHAT IT IS USED FOR
Tivicay contains the active ingredient dolutegravir. Dolutegravir
belongs to a group of anti-retroviral
medicines called
_integrase inhibitors (INIs)_
.
Tivicay is used to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
in adults, adolescents and children
of at least 6 years of age or older, and who weigh at least 14 kg.
Tivicay does not cure HIV infection; it reduces the amount of virus in
your body, and keeps it at a low level.
As a result of that, 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
doctor will monitor the effectiveness
of your treatment.
Tivicay is always used in combination with other anti-retroviral
medicines (
_combination therapy_
).
To control your HIV infection, and to stop your illness from getting
worse, you must keep taking all your
medicines, un

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 side.
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
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.
3
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 in