abacavir (as sulfate) and lamivudine
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ABACAVIR/LAMIVUDINE VIATRIS, WHICH CONTAINS ABACAVIR, MAY DEVELOP
A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING
IF TREATMENT WITH ABACAVIR/LAMIVUDINE VIATRIS IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY
FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE VIATRIS IF:
1) YOU GET A SKIN RASH OR
2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS:
FEVER
SHORTNESS OF BREATH, SORE THROAT OR COUGH
NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN
SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO ABACAVIR/LAMIVUDINE VIATRIS
TABLETS, NEVER TAKE ABACAVIR/LAMIVUDINE VIATRIS, OR ANY OTHER MEDICINAL PRODUCT CONTAINING
ABACAVIR AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR/LAMIVUDINE VIATRIS PACK, TO REMIND
YOU AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED
FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE
ABACAVIR/LAMIVUDINE VIATRIS.
What’s on this leaflet
Please learn this leaflet rigorously earlier than you begin ABACAVIR/LAMIVUDINE VIATRIS tablets.
This leaflet solutions some frequent questions on ABACAVIR/LAMIVUDINE VIATRIS tablets.
It doesn’t comprise all the accessible data.
It doesn’t take the place of speaking to your physician or pharmacist (also referred to as
a chemist).
All medicines have advantages and dangers. Your physician has weighed the anticipated advantages
of you taking ABACAVIR/LAMIVUDINE VIATRIS tablets towards the dangers this medication
may have for you.
In case you have any issues about taking this medication, ask your physician or pharmacist.
Maintain this leaflet with the tablets.
It’s possible you’ll have to learn it once more.
What ABACAVIR/ LAMIVUDINE VIATRIS tablets are used for
ABACAVIR/LAMIVUDINE VIATRIS tablets comprise abacavir and lamivudine which belong to
a bunch of medicines referred to as antiretrovirals.
These are additionally accessible as separate medicinal merchandise.
ABACAVIR/LAMIVUDINE VIATRIS tablets are used along with different antiretrovirals to
decelerate the development of human immunodeficiency virus (HIV) an infection, which may
result in Acquired Immune Deficiency Syndrome (AIDS) and different associated diseases (e.g.
AIDS-related Complicated or ARC).
ABACAVIR/LAMIVUDINE VIATRIS tablets don’t treatment AIDS or kill the HIV virus, however delays
additional harm to the immune system by stopping manufacturing of latest viruses.
You possibly can nonetheless cross on HIV when taking this medication, though the danger is lowered
by efficient antiretroviral remedy. You’ll nonetheless have the ability to cross on the HIV virus
by sexual exercise or by contamination with contaminated blood. You must nonetheless use correct
precautions to forestall this.
Whereas taking ABACAVIR/LAMIVUDINE VIATRIS tablets and/or some other remedy for HIV
illness, chances are you’ll proceed to develop different infections and different problems of HIV
an infection. You must maintain in common contact with the physician who’s taking care of
you.
ABACAVIR/LAMIVUDINE VIATRIS tablets aren’t addictive.
Earlier than you’re taking ABACAVIR/ LAMIVUDINE VIATRIS tablets
Don’t take if:
You could not take ABACAVIR/LAMIVUDINE VIATRIS tablets if:
you’ve ever had an allergic response to abacavir
you’re allergic to the lively ingredient lamivudine or any of the opposite substances
listed towards the tip of this leaflet.
you’ve a severe liver illness ABACAVIR/LAMIVUDINE VIATRIS will not be appropriate for
you.
Particular Warning
ABACAVIR/LAMIVUDINE VIATRIS incorporates abacavir. Abacavir could cause a severe allergic
response often called a hypersensitivity response, which may be life-threatening if therapy
with abacavir containing merchandise shouldn’t be stopped.
Analysis has discovered that individuals with a gene referred to as HLA-B (sort 5701) are extra seemingly
to have a hypersensitivity response to abacavir. Nonetheless, even if you happen to wouldn’t have
this gene sort it’s nonetheless attainable so that you can get this response. If you recognize you
have this gene sort, you should definitely inform your physician earlier than you’re taking abacavir.
The commonest signs of this response embody excessive temperature (fever) and a pores and skin
rash. Different most incessantly seen signs embody nausea, vomiting, diarrhoea or stomach
ache; extreme tiredness or physique aches or typically feeling in poor health; headache; shortness
of breath, sore throat or cough. When you develop any of those signs name your physician
IMMEDIATELY WHO WILL ADVISE YOU WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE
VIATRIS tablets. In case your physician shouldn’t be accessible you could urgently search different medical
recommendation (e.g. the Accident and Emergency unit of the closest hospital) earlier than taking
the subsequent dose.
Different signs might embody joint or muscle ache, swelling of the neck or itchy pores and skin.
Sometimes irritation of the attention (conjunctivitis), ulcers within the mouth, tingling
or numbness of the fingers or toes or low blood stress might happen. The signs of
this allergic response can happen at any time throughout therapy with ABACAVIR/LAMIVUDINE
VIATRIS tablets. Nonetheless they normally happen within the first six weeks of therapy, and
worsen with continued therapy.
In case you have had this severe response to ABACAVIR/LAMIVUDINE VIATRIS tablets, NEVER
take ABACAVIR/LAMIVUDINE VIATRIS or some other medicinal product containing abacavir
once more as inside hours chances are you’ll expertise a life-threatening decreasing of your blood
stress or demise.
Sometimes life threatening hypersensitivity reactions have occurred when ABACAVIR/LAMIVUDINE
VIATRIS tablets was restarted in sufferers who reported solely one of many signs on
the Alert Card earlier than stopping.
On very uncommon events, hypersensitivity has been reported when ABACAVIR/LAMIVUDINE
VIATRIS tablets had been restarted in sufferers who had no signs of hypersensitivity
earlier than stopping.
In case you have stopped taking ABACAVIR/LAMIVUDINE VIATRIS tablets for any motive it’s
essential that you simply contact your physician earlier than restarting. That is particularly so if
you assume you’re having side-effects from different medicines or have one other sickness.
Your physician will test whether or not any signs you had earlier than stopping could also be associated
to this hypersensitivity response. In case your physician thinks there’s a chance that
they had been associated, chances are you’ll be instructed by no means to take ABACAVIR/LAMIVUDINE VIATRIS tablets
once more. It’s important that you simply comply with this recommendation.
In case you are hypersensitive to ABACAVIR/LAMIVUDINE VIATRIS tablets it is best to return
all your unused ABACAVIR/LAMIVUDINE VIATRIS tablets to your physician or pharmacist
for correct disposal.
You could not take ABACAVIR/LAMIVUDINE VIATRIS tablets if:
you had a earlier allergic response to ABACAVIR/LAMIVUDINE VIATRIS tablets or different
abacavir containing merchandise
you’re pregnant, assume chances are you’ll be pregnant or are breastfeeding, except your physician
tells you to
the expiry date (EXP.) printed on the pack has handed
the packaging is torn or exhibits indicators of tampering.
You could inform your physician if:
you’re allergic to meals, dyes, preservatives or some other medicines
you’ve some other sickness
you’re taking some other medicines, together with medicines you purchase with no prescription
from a grocery store or well being meals store.
Abacavir or lamivudine in ABACAVIR/LAMIVUDINE VIATRIS tablets might work together with sure
different medicines. ABACAVIR/LAMIVUDINE VIATRIS tablets shouldn’t be taken with emtricitabine.
Some medicines might have an effect on how ABACAVIR/LAMIVUDINE VIATRIS works, or make it extra seemingly
that you will have unwanted effects. These medicines embody:
sorbitol-containing medicines (normally liquids) used commonly
trimethoprim-sulphamethoxazole (also referred to as co-trimoxazole), (an antibiotic used
to deal with PCP – Pneumocystis jiroveci pneumonia (also known as PCP) or toxoplasmosis).
Inform your physician or pharmacist in case you are taking any of those.
In case you are taking methadone, your physician might have to regulate your methadone dose, as
abacavir will increase the speed at which methadone leaves your physique. That is unlikely
to have an effect on most methadone customers.
How do I take ABACAVIR/ LAMIVUDINE VIATRIS tablets?
How a lot to take
Take ABACAVIR/LAMIVUDINE VIATRIS tablets as directed by your physician or pharmacist.
The conventional dose for adults and adolescents is one pill as soon as a day. Your physician might
prescribe a special dosage.
The best way to take them
ABACAVIR/LAMIVUDINE VIATRIS tablets ought to be swallowed entire with water. ABACAVIR/LAMIVUDINE
VIATRIS tablets wouldn’t have to be taken with meals.
How lengthy to take them for
As a result of your medication helps to regulate your situation, however doesn’t treatment it, you’ll
have to take the tablets on daily basis. Don’t cease taking ABACAVIR/LAMIVUDINE VIATRIS
tablets or change the dose with out first speaking to your physician.
What do I do if I take an excessive amount of? (Overdose)
When you assume you or anybody else might have taken too many ABACAVIR/LAMIVUDINE VIATRIS
tablets, instantly phone your physician or Poisons Info Centre (In Australia
phone 131126. In New Zealand phone 0800 POISON). Do that even when there are
no indicators of discomfort or poisoning. It’s possible you’ll want pressing medical consideration.
In case you are undecided what to do, contact your physician or pharmacist.
If you are taking ABACAVIR/ LAMIVUDINE VIATRIS tablets
Issues you could do
Inform your physician if, for any motive, you haven’t taken your medication precisely as directed.
In any other case, your physician might imagine that it was not efficient and alter your therapy
unnecessarily.
When you neglect to take them
It is very important take this medication as prescribed to make sure you get most profit.
When you neglect to take a dose, take it as quickly as you bear in mind, after which proceed as
earlier than.
Don’t take a couple of pill to make up for the doses you’ve missed.
In case you have stopped taking them
In case you have stopped taking ABACAVIR/LAMIVUDINE VIATRIS tablets for any motive, it
is essential that you simply contact your physician earlier than restarting. That is particularly so
if you happen to assume you’re having side-effects or have one other sickness. In some instances your
physician will ask you to restart ABACAVIR/LAMIVUDINE VIATRIS tablets the place medical care
may be readily accessed by your self or others.
Issues you could not do
Don’t give this medication to anybody else, even when their signs appear much like yours.
Don’t use ABACAVIR/LAMIVUDINE VIATRIS tablets to deal with some other complaints except
your physician tells you to.
In case you have hepatitis B an infection, you shouldn’t cease ABACAVIR/LAMIVUDINE VIATRIS
tablets with out directions out of your physician, as you will have a recurrence of your
hepatitis. This may occasionally happen resulting from you out of the blue stopping lamivudine.
Issues to watch out of
Watch out driving or working equipment till you understand how ABACAVIR/LAMIVUDINE VIATRIS
tablets have an effect on you.
No research on the results of ABACAVIR/LAMIVUDINE VIATRIS tablets on the flexibility to
drive and use machines have been carried out. Nonetheless, it is best to take note of
the state of your well being and the attainable unwanted effects of ABACAVIR/LAMIVUDINE VIATRIS
tablets earlier than contemplating driving or utilizing machines.
What are the side-effects?
Verify together with your physician as quickly as attainable if you happen to assume you’re experiencing any side-effects
or allergic reactions whereas taking ABACAVIR/LAMIVUDINE VIATRIS tablets, even when the
downside shouldn’t be listed on this leaflet.
Like all medicines, ABACAVIR/LAMIVUDINE VIATRIS tablets could cause some side-effects.
In the event that they happen, they’re probably to be minor and short-term. Nonetheless, some could also be
severe and might have medical consideration.
Hypersensitivity Response
ABACAVIR/LAMIVUDINE VIATRIS incorporates abacavir.
Abacavir could cause a severe allergic response often called a hypersensitivity response,
which may be life- threatening if therapy with abacavir containing merchandise shouldn’t be
stopped. That is described within the part “Particular warning” below “Earlier than you’re taking
ABACAVIR/LAMIVUDINE VIATRIS tablets”, of this leaflet.
It’s important that you simply learn and perceive the details about this severe response.
As ABACAVIR/LAMIVUDINE VIATRIS tablets incorporates each abacavir and lamivudine, the
unwanted effects reported for every of those have been mixed.
The commonest side-effects (may have an effect on at the very least one to 10 in each 100 folks)
are:
nausea, vomiting
diarrhoea
higher stomach ache
headache
excessive temperature
lethargy, fatigue, lack of urge for food
hair loss
joint and muscle ache
abacavir hypersensitivity
pores and skin rash (with out some other sickness).
Unusual side-effects (may have an effect on lower than one in each 100 folks) are:
will increase in enzymes produced by the liver
anaemia (low purple blood cell depend)
neutropenia (low white blood cell depend)
discount within the variety of platelets (blood cells essential for blood clotting).
If the manufacturing of purple blood cells is lowered, you will have signs of tiredness
or breathlessness.
A discount in your white blood cell depend could make you extra liable to an infection. If
you’ve a low platelet depend, chances are you’ll discover that you simply bruise extra simply.
Uncommon side-effects (may have an effect on lower than one in each 1,000 folks) are:
breakdown of muscle tissue, will increase of an enzyme referred to as amylase
irritation of the pancreas (pancreatitis).
Very uncommon side-effects (may have an effect on lower than one in each 10,000 folks) are:
severe pores and skin reactions
extreme anaemia.
Adjustments within the quantities of fatty substances and glucose within the blood have additionally been
reported. Inside the first few weeks of therapy with anti-HIV medicines, some folks,
notably these which have been HIV constructive for a while, might develop inflammatory
reactions (e.g. ache, redness, swelling, excessive temperature) which can resemble an an infection
and could also be extreme. It’s thought that these reactions are brought on by a restoration in
the physique’s means to battle infections, beforehand suppressed by HIV. When you turn into
involved about any new signs, or any adjustments in your well being after beginning HIV
therapy, please focus on together with your physician instantly.
In infants and infants uncovered to Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
throughout being pregnant or labour small short-term will increase in blood ranges of a substance
referred to as lactate have been noticed. Moreover there have been very uncommon reviews
of illnesses that have an effect on the nervous system resembling a delayed improvement and seizures.
Total, in kids whose moms took NRTIs throughout being pregnant, the profit from the
lowered likelihood of being contaminated with HIV is prone to be larger than the danger of
affected by unwanted effects.
Name your physician IMMEDIATELY if you happen to discover any of the next. The physician will inform
you whether or not it is best to cease taking ABACAVIR/LAMIVUDINE VIATRIS tablets and what you
ought to do:
Lactic Acidosis
Some folks taking ABACAVIR/LAMIVUDINE VIATRIS, or different medicines prefer it (NRTIs),
develop a situation referred to as lactic acidosis, along with an enlarged liver.
Lactic acidosis is brought on by a build-up of lactic acid within the physique. It’s uncommon; if
it occurs, it normally develops after just a few months of therapy. It may be life-threatening,
inflicting failure of inside organs.
Lactic acidosis is extra prone to develop in individuals who have liver illness, particularly
in girls.
Indicators of lactic acidosis embody:
deep, speedy, troublesome respiratory
drowsiness
numbness or weak point within the limbs
feeling sick (nausea), being sick (vomiting)
abdomen ache.
Allergic (anaphylactic) response
The signs of an allergic (anaphylactic) response which can happen quickly after beginning
ABACAVIR/LAMIVUDINE VIATRIS embody wheezing, swelling of the lips/mouth, issue
in respiratory, hayfever, lumpy rash (hives) or fainting.
Previous infections might flare up
Individuals with superior HIV an infection (AIDS) have weak immune methods, and are extra seemingly
to develop severe infections (opportunistic infections). When these folks begin
therapy, they could discover that previous, hidden infections flare up, inflicting indicators and signs
of irritation. These signs are in all probability brought on by the physique’s immune system changing into
stronger, in order that the physique begins to battle these infections.
Fats acquire and loss
Fats acquire and loss has been noticed with mixed antiretroviral remedy. A causal
relationship for this has not been established. Ought to any change in physique form be
seen, search medical recommendation.
This isn’t an entire checklist of all attainable side-effects. Others might happen in some
folks and there could also be some side-effects not but identified.
Don’t be alarmed by this checklist of attainable side-effects. It’s possible you’ll not expertise any
of them.
How do I retailer ABACAVIR/LAMIVUDINE VIATRIS tablets?
Maintain this medication the place kids can not attain it, resembling a locked cabinet.
Maintain ABACAVIR/LAMIVUDINE VIATRIS tablets in a cool, dry place the place it stays under
25°C.
Don’t retailer the tablets, or some other medication, in a toilet or close to a sink.
Don’t go away them within the automobile or on window sills.
Maintain your ABACAVIR/LAMIVUDINE VIATRIS tablets of their pack till you’re taking them.
In case your physician tells you to cease taking ABACAVIR/LAMIVUDINE VIATRIS tablets, or the
tablets have handed their expiry date, return any unused or expired medication to your
pharmacist.
Product description
What ABACAVIR/LAMIVUDINE VIATRIS tablets appear like
The tablets are white, film-coated, modified capsule formed, biconvex pill debossed
with AL12 on one aspect of the pill and M on the opposite aspect.
ABACAVIR/LAMIVUDINE VIATRIS tablets are equipped in blister packs containing 30 tablets.
Components
ABACAVIR/LAMIVUDINE VIATRIS tablets comprise 600 mg of abacavir because the sulfate salt
and 300 mg of lamivudine.
The tablets additionally comprise the next inactive substances:
microcrystalline cellulose
crospovidone
magnesium stearate
silicified microcrystalline cellulose
colloidal
anhydrous silica
talc
pill coating OPADRY II full movie coating system 13B58894 White (ARTG PI No:
13119) containing: hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.
ABACAVIR/LAMIVUDINE VIATRIS tablets comprise sorbates and sulfites.
Provider
ABACAVIR/LAMIVUDINE VIATRIS tablets are equipped by:
Alphapharm Pty Ltd buying and selling as Viatris
Stage 1, 30 The Bond
30-34 Hickson Highway
Millers Level NSW 2000
www.viatris.com.au
Telephone: 1800 274 276
Australian registration numbers:
ABACAVIR/LAMIVUDINE VIATRIS 600 mg/300 mg pill blister pack: AUST R 266516
The place to go for additional data
Pharmaceutical corporations aren’t ready to offer folks a person analysis
or medical recommendation. Your physician or pharmacist is the very best particular person to provide the particular person
recommendation you want. You may additionally have the ability to discover out extra details about your illness
from books, for instance in public libraries.
Counselling can also be accessible out of your native AIDS council.
This leaflet was ready in
July 2022.
ABACAVIR/LAMIVUDINE VIATRIS_cmiJul22/00
