Ictastan 200 mg/245 mg film-coated tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Emtricitabine; Tenofovir disoproxil

Pieejams no:

Actavis Group PTC ehf

ATĶ kods:

J05AR; J05AR03

SNN (starptautisko nepatentēto nosaukumu):

Emtricitabine; Tenofovir disoproxil

Deva:

200/245 milligram(s)

Zāļu forma:

Film-coated tablet

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Antivirals for treatment of HIV infections, combinations; tenofovir disoproxil and emtricitabine

Autorizācija statuss:

Not marketed

Autorizācija datums:

2016-05-06

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Details
EMTRICITABINE TENOFOVIR 200MG & 245MG FILM-COATED TABLETS PIL - UK/IE
Black
BBBA1800
C. Grant
12/03/18
157 x 490
9pt
Remedica Ltd
12/03/18
01
Version 2
01.11.2017
_Continued over page_
_Continued top of next column_
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 N

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ictastan 200 mg/245 mg film-coated tablets
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
Ictastan 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
Posology
_Adults:_ The recommended dose of Ictastan is one tablet, taken
orally, once daily.
In order to optimise the absorption of
tenofovir, it is recommended that Ictastan 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
Ictastan 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 Ictastan within 12 hours of the time it
is usually taken, the patient should take Ictastan with
food as soon as possible and resume their normal dosing schedule. If a
patient misses a dose of Ictastan by more than
12 hours and it is almost time for their next dose, the patient should
not take the missed dose and simp