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

Active substance(s): ABACAVIR HYDROCHLORIDE / LAMIVUDINE / ABACAVIR HYDROCHLORIDE / LAMIVUDINE / ABACAVIR HYDROCHLORIDE / LAMIVUDINE

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Package leaflet: Information for the user

• methadone, used as a heroin substitute. Abacavir
increases the rate at which methadone is removed
from the body. If you are taking 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.

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

• ribavirin, for treating hepatitis C. Abacavir may make
the combination of ribavirin and pegylated interferon
less effective at reducing levels of hepatitis C virus in
the body.
Tell your doctor if you are taking ribavirin.

(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.

Pregnancy
Abacavir/Lamivudine is not recommended for use
during pregnancy. Abacavir/lamivudine and similar
medicines may cause side effects in unborn babies. If you
have taken Abacavir/Lamivudine during your pregnancy,
your doctor may request regular blood tests and other
diagnostic tests to monitor the development of your child.
In children whose mothers took NRTIs during pregnancy,
the benefit from the protection against HIV outweighed
the risk of side effects.

IMPORTANT — Hypersensitivity reactions

If you are pregnant, if you become pregnant, or if you are
planning to become pregnant:
Talk to your doctor immediately about the risks
and benefits of taking Abacavir/Lamivudine, or
other medicines for treating HIV infection, during
your pregnancy.

Abacavir/Lamivudine 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.

Breast-feeding
Women who are HIV-positive must not breast-feed,
because HIV infection can be passed on to the baby
in breast milk. A small amount of the ingredients in
Abacavir/Lamivudine can also pass into your breast milk.

The Abacavir/Lamivudine pack includes an Alert
Card, to remind you and medical staff about abacavir
hypersensitivity. Keep this card with you at all times.

If you are breast-feeding, or thinking about breast-feeding:
Talk to your doctor immediately.

What is in this leaflet
1. What Abacavir/Lamivudine is and what it is used for
2. What you need to know before you take
Abacavir/Lamivudine
3. How to take Abacavir/Lamivudine
4. Possible side effects
5. How to store Abacavir/Lamivudine
6. Contents of the pack and other information

Driving and using machines
Abacavir/Lamivudine may cause side effects which could
affect your ability to drive or use machines.
Talk to your doctor about your ability to drive or operate
machines while taking Abacavir/Lamivudine.

Important information about some of the other
ingredients of Abacavir/Lamivudine

1. What Abacavir/Lamivudine is and what it
is used for

Abacavir/Lamivudine contains a colouring called sunset
yellow (E110), this may cause allergic reactions in
some people.

Abacavir/Lamivudine is used to treat HIV (human
immunodeficiency virus) infection in adults,
adolescents and in children weighing at least 25 kg.

3. How to take Abacavir/Lamivudine

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).
Abacavir/Lamivudine does not completely cure HIV
infection; it reduces the amount of virus in your body, and
keeps it at a low level. It also increases the CD4 cell count
in your blood. CD4 cells are a type of white blood cells that
are important in helping your body to fight infection.
Not everyone responds to treatment with
Abacavir/Lamivudine in the same way. Your doctor will
monitor the effectiveness of your treatment.

Do not take Abacavir/Lamivudine:
• if you are allergic (hypersensitive) to abacavir (or any
other medicine containing abacavir - (e.g. Trizivir,
Triumeq or Ziagen), 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.

Take special care with Abacavir/Lamivudine
Some people taking abacavir/lamivudine or other
combination treatments for HIV are more at risk of serious
side effects. You need to be aware of the extra risks:
• if you have ever had liver disease, including
hepatitis B or C (if you have hepatitis B infection, do not
stop Abacavir/Lamivudine without your doctor’s advice,
as your hepatitis may come back)
• if you are seriously overweight (especially if you are
a woman)
• if you are diabetic and using insulin
• if you have a kidney problem
Talk to your doctor if any of these apply to you before
using Abacavir/Lamivudine. You may need extra
check-ups, including blood tests, while you are taking
your medicine. See Section 4 for more information.

Abacavir hypersensitivity reactions
Even patients who do not have the HLA-B*5701 gene
may still develop a hypersensitivity reaction (a serious
allergic reaction).
Carefully read all the information about
hypersensitivity reactions in Section 4 of this leaflet.

Some people taking medicines for HIV infection develop
other conditions, which can be serious. You need to know
about important signs and 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.
Tell your doctor or pharmacist if you are taking any
other medicines, or if you have taken any recently,
including herbal medicines or other medicines you bought
without a prescription.

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
• 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.

Packing Site/Printer

Supplier Code TBC

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 intervals, you may be
more likely to have a hypersensitivity reaction.

If you have stopped taking Abacavir/Lamivudine
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 taking it again.
Your doctor will check whether your symptoms were
related to a hypersensitivity reaction. If the doctor thinks
they may have been related, you will be told never again
to take Abacavir/Lamivudine, or any other medicine
containing abacavir (e.g. Trizivir or Ziagen). It is
important that you follow this advice.
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.

Even patients who do not 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’.

Abacavir/Lamivudine contains abacavir (which is
also an active substance in medicines such as Trizivir,
Triumeq and Ziagen). 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?

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?

These include:

Lupin Ltd
(Verna - IN)

If you forget to take Abacavir/Lamivudine

Anyone taking Abacavir/Lamivudine could develop
a hypersensitivity reaction to abacavir, which
could be life threatening if they continue to take
Abacavir/Lamivudine.

Remember to tell your doctor or pharmacist if you
begin taking a new medicine while you are taking
Abacavir/Lamivudine.

MA No. N/A

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

Hypersensitivity reactions

Other medicines and Abacavir/Lamivudine

TrackWise PR No. 1079812

If you take more Abacavir/Lamivudine than
you should

When you are being treated for HIV, it can be hard to tell
whether a symptom is a side effect of Abacavir/Lamivudine
or other medicines you are taking, or an effect of the HIV
disease itself. So it is very important to talk to your doctor
about any changes in your health.

Look out for important symptoms

Superceded Affiliate Item Code 1011470

Stay in regular contact with your doctor

Like all medicines, this medicine can cause side effects,
although not everyone gets them.

It cannot be excluded that abacavir may increase the risk
of having a heart attack.
Tell your doctor if you have heart problems, if you smoke,
or have other illnesses that may increase your risk of heart
disease such as high blood pressure, or diabetes. Do not
stop taking Abacavir/Lamivudine unless your doctor
advises you to do so.

Affiliate Item Code 1079812

Swallow the tablets whole, with some water.
Abacavir/Lamivudine can be taken with or without food.

4. Possible side effects

Risk of heart attack

Component Type Leaflet

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

Abacavir/Lamivudine helps to control your condition.
You need to keep taking it every day to stop your illness
getting worse. You may still develop other infections and
illnesses linked to HIV infection.
Keep in touch with your doctor, and do not stop taking
Abacavir/Lamivudine without your doctor’s advice.

2. What you need to know before you take
Abacavir/Lamivudine

Description Abacavir / Lamivudine_600 mg / 300 mg_60 30 90

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you are
not sure.

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.

Date: 25 Jan 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 448048
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No.

170 x 660(30 x 60)
glue Layout

Barcode Info N/A

Non-Print
Colours

1

Time: 12:00
Page Count

1/2

Black
Glue
Area

Equate CMYK
with
Main Font
Dimensions

Myriad Pro
170 x 660 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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.

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 lifethreatening.

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.

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.

Contact your doctor immediately:

Your body shape may change
People taking combination therapy for HIV may find that
their body shape changes, because of changes in fat
distribution:
• Fat may be lost from the legs, arms or face.
• Extra fat may build up around the tummy (abdomen), or
on the breasts or internal organs.
• Fatty lumps (sometimes called buffalo hump) may
appear on the back of the neck.
It is not yet known what causes these changes, or whether
they have any long-term effects on your health. If you
notice changes in your body shape:
Tell your doctor.

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.

Lactic acidosis is a rare but serious side effect

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 (e.g. Trizivir,
Triumeq or Ziagen). If you do, within hours, your
blood pressure could fall dangerously low, which could
result in death.

Some people taking abacavir/lamivudine, or other
medicines like it (NRTIs), develop a condition called lactic
acidosis, together with an enlarged liver.
Lactic acidosis is caused by a build-up of lactic acid in the
body. It is rare; if it happens, it usually develops after a few
months of treatment. It can be life-threatening, causing
failure of internal organs.

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:

Lactic acidosis is more likely to develop in people who
have liver disease, or in obese (very overweight) people,
especially women.

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 (e.g. Trizivir, Triumeq or
Ziagen). It is important that you follow this advice.

Signs of lactic acidosis include:







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.

feeling sick (nausea), being sick (vomiting)
stomach pain
generally feeling unwell
loss of appetite, weight loss
deep, rapid, difficult breathing
numbness or weakness in the limbs

During your treatment, your doctor will monitor you for
signs of lactic acidosis. If you have any of the symptoms
listed above or any other symptoms that worry you:
See your doctor as soon as possible.

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.

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.

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. This card contains important safety
information, keep it with you at all times.

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.

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.

Other effects may show up in blood tests
Combination therapy for HIV can also cause:
• increased levels of lactic acid in the blood, which on rare
occasions can lead to lactic acidosis
• increased levels of sugar and fats (triglycerides and
cholesterol) in the blood
• resistance to insulin (so if you are diabetic, you may
have to change your insulin dose to control your blood
sugar).

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.

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)
• lactic acidosis (see the next section, ‘Other possible side
effects of combination therapy for HIV’)
• 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.

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 after EXP. The expiry date refers to the
last day of that month.
Store below 25°C.
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 in each Abacavir/Lamivudine filmcoated tablet are abacavir hydrochloride equivalent to
600 mg abacavir and 300 mg of lamivudine.

Very rare side effects
These may affect up to 1 in 10,000 people:
• 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).
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.

The other ingredients are microcrystalline cellulose,
crospovidone (Type A), povidone (K-30), iron oxide
yellow (E172) and magnesium stearate in the core of the
tablet. The tablet coating contains hypromellose HPMC
2910 -3mPas, hypromellose HPMC 2910 -6mPas, titanium
dioxide (E171), macrogol 400, polysorbate 80 and sunset
yellow aluminium lake (E110).

What Abacavir/Lamivudine looks like and
contents of the pack
Abacavir/Lamivudine are orange coloured, capsule
shaped, biconvex, 20.6 mm x 9.1 film-coated tablets,
engraved with“300” on one side and “600” on other side.
Abacavir/Lamivudine are supplied in blister packs
containing 30, 60 or 90 film-coated tablets, perforated unit
dose blister packs containing 30 x 1 film-coated tablets or
multi blister packs containing 60 or 90 film-coated tablets.
30 film-coated tablets in bottles containing an activated
carbon sachet or an activated carbon sachet and oxygen
absorber to control the moisture in the bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Other possible side effects of combination
therapy for HIV

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.

Combination therapy such as abacavir/lamivudine may
cause other conditions to develop during HIV treatment.

Manufacturer
Mylan S.A.S, 117 Allee des Parcs, 69 800 Saint Priest, France.

Symptoms of infection and inflammation

This leaflet was last revised in 02/2017.

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

Description Abacavir / Lamivudine_600 mg / 300 mg_60 30 90
Component Type Leaflet
Affiliate Item Code 1079812
Superceded Affiliate Item Code 1011470
TrackWise PR No. 1079812
MA No. N/A
Packing Site/Printer

Lupin Ltd
(Verna - IN)

Supplier Code TBC

1079812

Date: 25 Jan 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 448048
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No.

170 x 660(30 x 60)
glue Layout

Barcode Info N/A

Non-Print
Colours

1

Time: 12:00
Page Count

2/2

Black
Glue
Area

Equate CMYK
with
Main Font
Dimensions

Myriad Pro
170 x 660 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand Transcript

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.

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