Abacavir/Lamivudine Mylan Pharma 600 mg/300 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Abacavir sulfate; Lamivudine

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

J05AR; J05AR02

INN (International Name):

Abacavir sulfate; Lamivudine

Dosage:

600 mg/300 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2017-11-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABACAVIR/LAMIVUDINE MYLAN PHARMA
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 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 MYLAN PHARMA
CONTAINS ABACAVIR
. Some people who take abacavir (or any other
medicine containing 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 Mylan Pharma pack includes an
ALERT CARD
, to remind you and medical staff
about abacavir hypersensitivity.
REMOVE THIS CARD AND KEEP IT WITH YOU AT ALL TIMES
.
WHAT IS IN THIS LEAFLET
1.
What Abacavir/Lamivudine Mylan Pharma is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine Mylan Pharma
3.
How to take Abacavir/Lamivudine Mylan Pharma
4.
Possible side effects
5.
How to store Abacavir/Lamivudine Mylan Pharma
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE MYLAN PHARMA
IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY
VIRUS) INFECTION IN ADULTS,
ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG.
This medicine 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
transcr

Summary of Product characteristics

Health Products Regulatory Authority
13 February 2024
CRN00F44H
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine Mylan Pharma 600 mg/300 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains abacavir sulfate equivalent to 600 mg
of abacavir and 300 mg lamivudine.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White, oblong, biconvex, film-coated tablet (approximately 20.8 mm x
9.2 mm), debossed with ‘AL12’ on one side and ‘M’ on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Abacavir/lamivudine 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 is one tablet once daily.
_Children Under 25 kg_
Abacavir/Lamivudine Mylan Pharma 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 Mylan Pharma 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 pharmacokineti