Skip to Content

ABACAVIR/LAMIVUDINE 600 MG/300 MG FILM-COATED TABLETS

Active substance(s): ABACAVIR / LAMIVUDINE

View full screen / Print PDF » Download PDF ⇩
Transcript
TEVA UK Ref:

231-30-80095-A LEA ABACAVIR/LAMIVUDINE 600/300MG TAB 30 TUK
Version:

7

05 April 2016

Production pharmacode(s) will be added in the margin(s) (pink areas)

ABACAVIR/LAMIVUDINE
600 mg/300 mg
FILM-COATED TABLETS

methadone, you will be checked for any
withdrawal symptoms. Your methadone dose
may need to be changed.
Tell your doctor if you are taking methadone
• ribavirin, for treating hepatitis C. Abacavir may
PACKAGE LEAFLET: INFORMATION FOR THE USER
make the combination of ribavirin and pegylated
interferon less effective at reducing levels of
Read all of this leaflet carefully before you start
hepatitis C virus in the body.
taking this medicine because it contains important
Tell your doctor if you are taking ribavirin.
information for you.
• Keep this leaflet. You may need to read it again.
Pregnancy
• If you have any further questions, ask your
Abacavir/Lamivudine is NOT recommended for use
doctor or pharmacist.
during pregnancy. Abacavir/Lamivudine and
• This medicine has been prescribed for you only. similar medicines may cause side effects in unborn
Do not pass it on to others. It may harm them,
babies. If you become pregnant while you are
even if their signs of illness are the same as yours. taking Abacavir/Lamivudine, your baby may be
• If you get any side effects, talk to your doctor or given extra check-ups (including blood tests) to
pharmacist. This includes any possible side
make sure it is developing normally.
effects not listed in this leaflet. See section 4.
If you are pregnant, if you become pregnant, or if
IMPORTANT — Hypersensitivity reactions
you are planning to become pregnant:
Abacavir/Lamivudine contains abacavir. Some
Talk to your doctor immediately about the risks
people who take abacavir may develop a
and benefits of taking Abacavir/Lamivudine, or
hypersensitivity reaction (a serious allergic
other medicines for treating HIV infection, during
reaction), which can be life-threatening if they
your pregnancy.
continue to take abacavir containing products.
Breast-feeding
You must carefully read all the information under
‘Hypersensitivity reactions’ in the panel in Section 4. Women who are HIV-positive must NOT
The Abacavir/Lamivudine pack includes an ALERT breast-feed, because HIV infection can be passed
on to the baby in breast milk. A small amount of
CARD, to remind you and medical staff about
the ingredients in Abacavir/Lamivudine can also
abacavir hypersensitivity. Detach this card and
pass into your breast milk.
keep it with you at all times.
If you are breast-feeding, or thinking about
breast-feeding:
1. What Abacavir/Lamivudine is and what it is used Talk to your doctor immediately.
for
2. What you need to know before you take
Driving and using machines
Abacavir/Lamivudine
Abacavir/Lamivudine may cause side effects which
3. How to take Abacavir/Lamivudine
could affect your ability to drive or use machines.
Talk to your doctor about your ability to drive or
4. Possible side effects
operate machines while taking
5. How to store Abacavir/Lamivudine
Abacavir/Lamivudine.
6. Contents of the pack and other information
WHAT IS IN THIS LEAFLET

1 WHAT ABACAVIR/LAMIVUDINE IS
AND WHAT IT IS USED FOR

3 HOW TO TAKE

ABACAVIR/LAMIVUDINE

Abacavir/Lamivudine is used to treat HIV (human Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
immunodeficiency virus) infection in adults,
adolescents and in children weighing at least 25 kg. if you are not sure.
Abacavir/Lamivudine 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 inhibitors (NRTIs).

The recommended dose of Abacavir/Lamivudine
for adults, adolescents and children weighing 25 kg
or more is one tablet once a day.

Swallow the tablets whole, with some water.
Abacavir/Lamivudine can be taken with or without
Abacavir/Lamivudine does not completely cure HIV food.
infection; it reduces the amount of virus in your
Stay in regular contact with your doctor
body, and keeps it at a low level. It also increases
Abacavir/Lamivudine helps to control your
the CD4 cell count in your blood. CD4 cells are a
condition. You need to keep taking it every day to
type of white blood cells that are important in
stop your illness getting worse. You may still
helping your body to fight infection.
develop other infections and illnesses linked to HIV
infection.
Not everyone responds to treatment with
Abacavir/Lamivudine in the same way. Your doctor Keep in touch with your doctor, and do not stop
taking Abacavir/Lamivudine without your doctor’s
will monitor the effectiveness of your treatment.
advice.

2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ABACAVIR/LAMIVUDINE

Do NOT take Abacavir/Lamivudine
• if you are allergic to abacavir (or any other
medicine containing abacavir), lamivudine or
any of the other ingredients of this medicine
(listed in Section 6).
Carefully read all the information about
hypersensitivity reactions in Section 4.
• if you have severe liver disease.
Check with your doctor if you think any of these
apply to you. Do not take Abacavir/Lamivudine.

If you take more Abacavir/Lamivudine than
you should
If you accidentally take too much
Abacavir/Lamivudine, tell your doctor or your
pharmacist, or contact your nearest hospital
emergency department for further advice.

If you forget to take Abacavir/Lamivudine

If you forget to take a dose, take it as soon as you
remember. Then continue your treatment as
before. Do not take a double dose to make up for a
forgotten dose.

It is important to take Abacavir/Lamivudine
regularly, because if you take it at irregular
Warnings and precautions
Some people taking Abacavir/Lamivudine or other intervals, you may be more likely to have a
combination treatments for HIV are more at risk of hypersensitivity reaction.
serious side effects. You need to be aware of the
If you have stopped taking
extra risks:
Abacavir/Lamivudine
• if you have ever had liver disease, including
If you have stopped taking Abacavir/Lamivudine
hepatitis B or C (if you have hepatitis B infection, for any reason — especially because you think you
do not stop Abacavir/Lamivudine without your
are having side effects, or because you have other
doctor’s advice, as your hepatitis may come back) illness:
• if you are seriously overweight (especially if you talk to your doctor before you start taking it again.
are a woman)
Your doctor will check whether your symptoms
• if you have a kidney problem.
were related to a hypersensitivity reaction. If the
doctor thinks they may have been related, you will
Talk to your doctor if any of these apply to you
be told never again to take Abacavir/Lamivudine,
before using Abacavir/Lamivudine. You may need
or any other medicine containing abacavir. It is
extra check-ups, including blood tests, while you
important that you follow this advice.
are taking your medicine. See Section 4 for more
information.
If your doctor advises that you can start taking
Abacavir/Lamivudine again, you may be asked to
Abacavir hypersensitivity reactions
take your first doses in a place where you will have
Even patients who don’t have the HLA-B*5701
ready access to medical care if you need it.
gene may still develop a hypersensitivity reaction
(a serious allergic reaction).
4 POSSIBLE SIDE EFFECTS
Carefully read all the information about
hypersensitivity reactions in Section 4 of this leaflet.
During HIV therapy there may be an increase in
weight and in levels of blood lipids and glucose.
Risk of heart attack
This is partly linked to restored health and life
It cannot be excluded that abacavir may increase
style, and in the case of blood lipids sometimes to
the risk of having a heart attack.
Tell your doctor if you have heart problems, if you the HIV medicines themselves. Your doctor will test
for these changes.
smoke, or have other illnesses that may increase
your risk of heart disease such as high blood
Like all medicines, this medicine can cause side
pressure, or diabetes. Do not stop taking
effects, although not everybody gets them.
Abacavir/Lamivudine unless your doctor advises
you to do so.
When you are being treated for HIV, it can be hard
to tell whether a symptom is a side effect of
Look out for important symptoms
Abacavir/Lamivudine or other medicines you are
Some people taking medicines for HIV infection
taking, or an effect of the HIV disease itself. So it is
develop other conditions, which can be serious.
very important to talk to your doctor about any
You need to know about important signs and
changes in your health.
symptoms to look out for while you are taking
Abacavir/Lamivudine.
Read the information ‘Other possible side effects
of combination therapy for HIV’ in Section 4 of this
leaflet.
Protect other people
HIV infection is spread by sexual contact with
someone who has the infection, or by transfer of
infected blood (for example, by sharing injection
needles). You can still pass on HIV when taking this
medicine, although the risk is lowered by effective
antiretroviral therapy. Discuss with your doctor the
precautions needed to avoid infecting other people.

Other medicines and Abacavir/Lamivudine
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including herbal medicines or other
medicines you bought without a prescription.

Remember to tell your doctor or pharmacist if you
begin taking a new medicine while you are taking
Abacavir/Lamivudine.
These medicines should NOT be used with
Abacavir/Lamivudine:
• emtricitabine, to treat HIV infection
• other medicinal products containing lamivudine,
used to treat HIV infection or hepatitis B infection
• high doses of trimethoprim/sulfamethoxazole,
an antibiotic
• cladribine, used to treat hairy cell leukaemia.
Tell your doctor if you are being treated with any of
these.
Some medicines interact with Abacavir/Lamivudine
These include:
• phenytoin, for treating epilepsy
Tell your doctor if you are taking phenytoin. Your
doctor may need to monitor you while you are
taking Abacavir/Lamivudine
• methadone, used as a heroin substitute.
Abacavir increases the rate at which methadone
is removed from the body. If you are taking

Even patients who don’t have the HLA-B*5701
gene may still develop a hypersensitivity reaction
(a serious allergic reaction), described in this leaflet
in the panel headed ‘Hypersensitivity reactions’. It
is very important that you read and understand
the information about this serious reaction.
As well as the side effects listed below for
Abacavir/Lamivudine, other conditions can
develop during combination therapy for HIV.
It is important to read the information later in this
section under ‘Other possible side effects of
combination therapy for HIV’.
Hypersensitivity reactions
Abacavir/Lamivudine contains abacavir. Abacavir
can cause a serious allergic reaction known as a
hypersensitivity reaction. These hypersensitivity
reactions have been seen more frequently in
people taking medicines that contain abacavir.
Who gets these reactions?
Anyone taking Abacavir/Lamivudine could
develop a hypersensitivity reaction to abacavir,
which could be life-threatening if they continue
to take Abacavir/Lamivudine.
You are more likely to develop this reaction if
you have a gene called HLA-B*5701 (but you can
get a reaction even if you do not have this gene).
You should have been tested for this gene before
Abacavir/Lamivudine was prescribed for you.
If you know you have this gene, tell your doctor
before you take Abacavir/Lamivudine.
About 3 to 4 in every 100 patients treated with
abacavir in a clinical trial who did not have the
HLA-B*5701 gene developed a hypersensitivity
reaction.

What are the symptoms?
The most common symptoms are:
fever (high temperature) and skin rash.
Other common symptoms are:
nausea (feeling sick), vomiting (being sick),
diarrhoea, abdominal (stomach) pain, severe
tiredness.
Other symptoms include:
Pains in the joints or muscles, swelling of the
neck, shortness of breath, sore throat, cough,
occasional headaches, inflammation of the eye
(conjunctivitis), mouth ulcers, low blood
pressure, tingling or numbness of the hands or
feet.
If you continue to take Abacavir/Lamivudine, the
symptoms will get worse, and may be
life-threatening.
When do these reactions happen?
Hypersensitivity reactions can start at any time
during treatment with Abacavir/Lamivudine, but
are more likely during the first 6 weeks of
treatment.
Contact your doctor immediately:
1. if you get a skin rash, OR
2. if you get symptoms from at least 2 of the
following groups:
- fever
- shortness of breath, sore throat or cough
- nausea or vomiting, diarrhoea or abdominal
pain
- severe tiredness or achiness, or generally
feeling ill.
Your doctor may advise you to stop taking
Abacavir/Lamivudine.
If you have stopped taking Abacavir/Lamivudine
If you have stopped taking Abacavir/Lamivudine
because of a hypersensitivity reaction, you must
NEVER AGAIN take Abacavir/Lamivudine, or any
other medicine containing abacavir. If you do,
within hours, your blood pressure could fall
dangerously low, which could result in death.
If you have stopped taking Abacavir/Lamivudine
for any reason — especially because you think
you are having side effects, or because you have
other illness:
Talk to your doctor before you start again. Your
doctor will check whether your symptoms were
related to a hypersensitivity reaction. If the
doctor thinks they may have been, you will then
be told never again to take Abacavir/Lamivudine,
or any other medicine containing abacavir. It is
important that you follow this advice.
Occasionally hypersensitivity reactions have
developed in people who start taking abacavir
containing products again, but who had only one
symptom on the Alert Card before they stopped
taking it.
Very rarely patients who have taken medicines
containing abacavir in the past without any
symptoms of hypersensitivity have developed a
hypersensitivity reaction when they start taking
these medicines again.
If your doctor advises that you can start taking
Abacavir/Lamivudine again, you may be asked to
take your first doses in a place where you will
have ready access to medical care if you need it.
If you are hypersensitive to
Abacavir/Lamivudine, return all your unused
Abacavir/Lamivudine tablets for safe disposal.
Ask your doctor or pharmacist for advice.
The Abacavir/Lamivudine pack includes an Alert
Card, to remind you and medical staff about
hypersensitivity reactions. Detach this card and
keep it with you at all times.
Common side effects
These may affect up to 1 in 10 people:
• hypersensitivity reaction
• headache
• being sick (vomiting)
• feeling sick (nausea)
• diarrhoea
• stomach pains
• loss of appetite
• tiredness, lack of energy
• fever (high temperature)
• general feeling of being unwell
• difficulty in sleeping (insomnia)
• muscle pain and discomfort
• joint pain
• cough
• irritated or runny nose
• skin rash
• hair loss.
Uncommon side effects
These may affect up to 1 in 100 people and may
show up in blood tests:
• a low red blood cell count (anaemia) or low
white blood cell count (neutropenia)
• an increase in the level of liver enzymes
• a decrease in the number of cells involved in
blood clotting (thrombocytopenia).
Rare side effects
These may affect up to 1 in 1000 people:
• liver disorders, such as jaundice, enlarged liver
or fatty liver, inflammation (hepatitis)
• inflammation of the pancreas (pancreatitis)
• breakdown of muscle tissue.
Rare side effects that may show up in blood tests
are:
• increase in an enzyme called amylase.

Other possible side effects of combination therapy
for HIV
Combination therapy such as Abacavir/Lamivudine
may cause other conditions to develop during HIV
treatment.
Symptoms of infection and inflammation
Old infections may flare up
People with advanced HIV infection (AIDS) have
weak immune systems, and are more likely to
develop serious infections (opportunistic
infections). Such infections may have been “silent”
and not detected by the weak immune system
before treatment was started. After starting
treatment, the immune system becomes stronger,
and may attack the infections, which can cause
symptoms of infection or inflammation. Symptoms
usually include fever, plus some of the following:
• headache
• stomach ache
• difficulty breathing.
In rare cases, as the immune system becomes
stronger, it can also attack healthy body tissue
(autoimmune disorders). The symptoms of
autoimmune disorders may develop many months
after you start taking medicine to treat your HIV
infection. Symptoms may include:
• palpitations (rapid or irregular heartbeat) or
tremor
• hyperactivity (excessive restlessness and
movement)
• weakness beginning in the hands and feet and
moving up towards the trunk of the body.
If you get any symptoms of infection and
inflammation or if you notice any of the symptoms
above:
Tell your doctor immediately. Do not take other
medicines for the infection without your doctor’s
advice.
You may have problems with your bones
Some people taking combination therapy for HIV
develop a condition called osteonecrosis. With this
condition, parts of the bone tissue die because of
reduced blood supply to the bone. People may be
more likely to get this condition:
• if they have been taking combination therapy for
a long time
• if they are also taking anti-inflammatory
medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight.
Signs of osteonecrosis include:
• stiffness in the joints
• aches and pains (especially in the hip, knee or
shoulder)
• difficulty moving.
If you notice any of these symptoms:
tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

5 HOW TO STORE

ABACAVIR/LAMIVUDINE

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that
month.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6 CONTENTS OF THE PACK AND
OTHER INFORMATION

What Abacavir/Lamivudine contains
• The active substances are abacavir and
lamivudine.
Each film-coated tablet contains 600 mg of
abacavir and 300 mg of lamivudine.
• The other ingredients are:
- Tablet core: microcrystalline cellulose,
hydroxypropyl cellulose, sodium starch
glycolate (type A) and magnesium stearate.
- Film-coat: hypromellose, macrogol 4000,
titanium dioxide (E171), polysorbate 80, iron
oxide yellow (E172) and iron oxide red (E172).
What Abacavir/Lamivudine looks like and contents
of the pack
Abacavir/Lamivudine film-coated tablets are
orange, oblong, and biconvex with debossing 600
on one side and 300 on the other side with
dimension of ∼ 20.5 mm x 9 mm.
Abacavir/Lamivudine is available in pack sizes of
10, 30 and 90 film-coated tablets in blisters or 10x1,
30x1 and 90x1 film-coated tablets in perforated
unit-dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.),
Prilaz baruna Filipovica 25,
Zagreb, 10000, Croatia

This leaflet was last revised in 04/2016.
Very rare side effects
These may affect up to 1 in 10,000 people:
PL 00289/2001
• numbness, tingly feelings in the skin (pins and
needles)
• sensation of weakness in the limbs
• skin rash, which may form blisters and looks like
small targets (central dark spots surrounded by a
paler area, with a dark ring around the edge)
(erythema multiforme)
• a widespread rash with blisters and peeling skin,
particularly around the mouth, nose, eyes and
genitals (Stevens–Johnson syndrome), and a
more severe form causing skin peeling in more
than 30% of the body surface (toxic epidermal
necrolysis)
• lactic acidosis (excess lactic acid in the blood).
If you notice any of these symptoms contact a
doctor urgently.
Very rare side effects that may show up in blood
tests are:
• a failure of the bone marrow to produce new red
blood cells (pure red cell aplasia).
If you get side effects
Tell your doctor or pharmacist if any of the side
effects gets severe or troublesome, or if you notice
any side effects not listed in this leaflet.

80095-A

180 x 600

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide