Abacavir/Lamivudine Rowex 600 mg/300 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lamivudine; Abacavir

Available from:

Rowex Ltd

INN (International Name):

Lamivudine; Abacavir

Dosage:

600 mg/300 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Authorization status:

Not marketed

Authorization date:

2016-09-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ABACAVIR/LAMIVUDINE ROWEX 600MG/300MG FILM-COATED TABLETS
abacavir/lamivudine
_ _
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.
IMPORTANT — HYPERSENSITIVITY REACTIONS
ABACAVIR/LAMIVUDINE ROWEX CONTAINS ABACAVIR
(which is also an active substance in
medicines such as
TRIZIVIR, TRIUMEQ
and
ZIAGEN
). Some people who take abacavir may
develop a
HYPERSENSITIVITY REACTION
(a serious allergic reaction), which can be life-
threatening if they continue to take abacavir containing products.
YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY
REACTIONS’ IN THE
PANEL IN SECTION 4
.
The Abacavir/Lamivudine Rowex pack includes an
ALERT CARD
, to remind you and medical
staff about abacavir hypersensitivity.
KEEP THIS CARD WITH YOU AT ALL TIMES.
WHAT IS IN THIS LEAFLET
1. What Abacavir/Lamivudine Rowex is and what it is used for
2. What you need to know before you take Abacavir/Lamivudine Rowex
3. How to take Abacavir/Lamivudine Rowex
4. Possible side effects
5.
How to store Abacavir/Lamivudine Rowex
6. Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE ROWEX IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE ROWEX IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY
VIRUS)
INFECTION IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25
KG
.
Abacavir/Lamivudine Rowex contains two active ingredients that are
used to treat HIV
infection: abacavir and lamivudine. These belong to a group of
anti-retroviral medicines
called
_nucleoside analogue reverse transcriptase in

Summary of Product characteristics

Health Products Regulatory Authority
04 December 2020
CRN009THV
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine Rowex 600 mg/300 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains abacavir hydrochloride equivalent to
600 mg abacavir and 300 mg lamivudine.
Excipient(s) with known effect
sunset yellow (E110) 1.4 mg per tablet
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Orange coloured, modified capsule shaped, biconvex, 20.6 mm x 9.1 mm
film-coated tablets, debossed with "300" on one side
and "600" on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Abacavir/Lamivudine Rowex is indicated in antiretroviral combination
therapy for the treatment of Human Immunodeficiency
Virus (HIV) infection in adults, adolescents and children weighing at
least 25 kg (see sections 4.4 and 5.1).
Before initiating treatment with abacavir, screening for carriage of
the HLA-B*5701 allele should be performed in any
HIV-infected patient, irrespective of racial origin (see section 4.4).
Abacavir should not be used in patients known to carry the
HLA-B*5701 allele.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be prescribed by a physician experienced in the
management of HIV infection.
Posology
_Adults, adolescents and children weighing at least 25 kg:_
The recommended dose of Abacavir/Lamivudine Rowex is one tablet once
daily.
_Children Under 25 kg_:
Abacavir/Lamivudine Rowex should not be administered to children who
weigh less than 25 kg because it is a fixed-dose tablet
that cannot be dose reduced.
Abacavir/Lamivudine Rowex is a fixed-dose tablet and should not be
prescribed for patients requiring dose adjustments.
Separate preparations of abacavir or lamivudine are available in cases
where discontinuation or dose adjustment of one of the
active substances is indicated. In these cases the physician should
refer to the individual product information for these
medicinal pr