Abacavir/Lamivudine Clonmel 600mg/300mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Abacavir; Lamivudine

Available from:

Clonmel Healthcare Ltd

ATC code:

J05AR; J05AR02

INN (International Name):

Abacavir; Lamivudine

Dosage:

600/300 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Antivirals for treatment of HIV infections, combinations; lamivudine and abacavir

Authorization status:

Not marketed

Authorization date:

2016-05-06

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ABACAVIR/LAMIVUDINE CLONMEL 600 MG/300 MG 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
_ _
IMPORTANT — HYPERSENSITIVITY REACTIONS
ABACAVIR/LAMIVUDINE CLONMEL CONTAINS ABACAVIR (which is also an active
substance in
other related medicines). 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 Clonmel pack includes an ALERT CARD, to remind
you and medical
staff about abacavir hypersensitivity. DETACH THIS CARD AND KEEP IT
WITH YOU AT ALL TIMES._ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Abacavir/Lamivudine Clonmel is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine Clonmel
3.
How to take Abacavir/Lamivudine Clonmel
4.
Possible side effects
5.
How to store Abacavir/Lamivudine Clonmel
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE CLONMEL IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE CLONMEL IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS)
INFECTION IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25
KG.
Abacavir/Lamivudine Clonmel contains two active ingredients that are
used to treat HIV
infection: abacavir and lamivudine. These belong to a group of
anti-retroviral medicines
called

Summary of Product characteristics

Health Products Regulatory Authority
11 October 2019
CRN008TMC
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine Clonmel 600mg/300mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg abacavir and 300 mg lamivudine
Excipient with known effect:
Sunset Yellow FCF Aluminium Lake (E110) 1.86 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Orange, film-coated, modified capsule shaped tablets. The dimensions
of the tablets are 19.4 mm x 10.4 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Abacavir/Lamivudine Clonmel 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 Clonmel is one tablet once
daily.
_Children Under 25 kg:_
Abacavir/Lamivudine Clonmel 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 Clonmel 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 products.
_Special Populations_
_Elderly:_
No pharma