Ictastan 200mg/245mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

EMTRICITABINE ; TENOFOVIRDISOPROXILSUCCINAAT SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL

Available from:

Actavis Group PTC ehf

ATC code:

J05AR03

INN (International Name):

EMTRICITABINE ; TENOFOVIRDISOPROXILSUCCINAAT COMPOSITION corresponding to ; TENOFOVIRDISOPROXIL

Pharmaceutical form:

Filmomhulde tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Administration route:

Oraal gebruik

Therapeutic area:

Tenofovir Disoproxil And Emtricitabine

Product summary:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYVINYLALCOHOL (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);

Authorization date:

2016-05-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ICTASTAN 200MG/245MG, FILMOMHULDE TABLETTEN
Emtricitabine/tenofovir disoproxil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 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 Ictastan is and what it is used for
2.
What you need to know before you take Ictastan
3.
How to take Ictastan
4.
Possible side effects
5.
How to store Ictastan
6.
Contents of the pack and other information
1.
WHAT ICTASTAN IS AND WHAT IT IS USED FOR
ICTASTAN IS A TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV)
INFECTION IN ADULTS AGED 18
YEARS AND OVER.
ICTASTAN CONTAINS TWO ACTIVE SUBSTANCES, _emtricitabine _and
_tenofovir disoproxil succinate_. Both of
these active substances are _antiretroviral _medicines which are used
to treat HIV infection. Emtricitabine
is a _nucleoside reverse transcriptase inhibitor _and tenofovir is a
_nucleotide reverse transcriptase_
_inhibitor. _ However, both are generally known as NRTIs and they work
by interfering with the normal
working of an enzyme (reverse transcriptase) that is essential for the
virus to reproduce itself. Ictastan
should always be used combined with other medicines to treat HIV
infection. Ictastan can be
administered in place of emtricitabine and tenofovir disoproxil used
separately at the same doses.
THIS MEDICINE IS NOT A CURE FOR HIV INFECTION. While taking Ictastan
you may still develop infections
or other illnesses associated with HIV infection. You can still pass
on HIV when taking this medicine,
although the risk is lowered by effective antiretroviral therapy.
Discuss

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Ictastan 200mg/245mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of
tenofovir disoproxil
(equivalent to 300.6 mg of tenofovir disoproxil succinate).
Excipient with known effect:
Each tablet contains 96 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue coloured, capsule shaped film-coated tablets, plain on both
sides. The dimensions of the
tablets are 19.3 mm x 8.8 mm ± 5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
is a fixed dose combination of emtricitabine and
tenofovir disoproxil succinate. It is
indicated in antiretroviral combination therapy for the treatment of
HIV-1 infected adults aged 18 years
and over.
The
demonstration
of
the
benefit
of
the
combination
emtricitabine
and
tenofovir
disoproxil
in
antiretroviral therapy is based solely on studies performed in
treatment-naïve patients (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Adults: _The recommended dose of is one tablet, taken
orally, once daily. In order to
optimise the absorption of tenofovir, it is recommended that should be taken with
food. Even a light meal improves absorption of tenofovir from the
combination tablet (see section
5.2).
Where discontinuation of therapy with one of the components of
is indicated or where
dose modification is necessary, separate preparations of emtricitabine
and tenofovir disoproxil are
available. Please refer to the Summary of Product Characteristics for
these medicinal products.
If a patient misses a dose of within 12 hours of the
time it is usually taken, the patient
should take with food as soon as possible and resume
their normal dosing schedule.
If a patient misses a dose of by more than 1