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

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

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Abacavir/Lamivudine
P15XXXXX

Abacavir/Lamivudine
P15XXXXX


Package leaflet: Information for the user

Abacavir/Lamivudine 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 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.
The Abacavir/Lamivudine pack includes an Alert Card, to remind you
and medical staff about abacavir hypersensitivity. Take out this card
and keep it with you at all times.
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
1. What Abacavir/Lamivudine 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.
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.
2. What you need to know before you take Abacavir/Lamivudine
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. Check with your doctor
if you think this applies to you. Do not take Abacavir/ Lamivudine
Warnings and precautions
Talk to your doctor or pharmacist before taking 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 moderate or severe liver disease
• 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 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 don’t 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.
Risk of heart attack
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.
Look out for important symptoms
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.
Other medicines and Abacavir/Lamivudine
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
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.

Black



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.
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.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
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.
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.
If you are breast-feeding, or thinking about breast-feeding:
Talk to your doctor immediately.
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 tablets
Abacavir/Lamivudine contains a colouring called sunset yellow (E110),
this may cause allergic reactions in some people.
3. How to take Abacavir/Lamivudine
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
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 food.
Stay in regular contact with your doctor
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.
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 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, Triumeq 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.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everyone gets them.
During HIV therapy there may be an increase in weight and in levels of
blood lipids and glucose. This is partly linked to restored health and life
style, and in the case of blood lipids sometimes to the HIV medicines
themselves. Your doctor will test for these changes.
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.
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 (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?
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 HLAB*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.
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
(e.g. Trizivir, Triumeq or Ziagen). 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 (e.g. Trizivir, Triumeq or Ziagen). 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. Take out 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.
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).
• lactic acidosis (excess lactic acid in the blood)

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 or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via Yellow Card Scheme Website:
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 take this medicine after the expiry date, which is stated on the
label, carton and blister after EXP. The expiry date refers to the last
date of that month.
Blister pack: Store below 30ºC.
HDPE: This medicinal product does not require any special storage
conditions.
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 to protect the environment.
6. Contents of the pack and other information
What Abacavir/Lamivudine contains
The active substances are Abacavir/Lamivudine
Each film-coated tablet contains 600mg of abacavir
(as sulfate) and 300mg lamivudine.
The other ingredients are:
Tablet core: Cellulose, microcrystalline, sodium starch glycolate (Type
A), magnesium stearate Tablet coat: hypromellose 2910 (3cp),
hypromellose 2910(6cp), titanium Dioxide, polysorbate 80, Macrogol
400, FD&C Yellow No.6 Aluminum lake (E110).
What Abacavir/Lamivudine looks like and contents of the pack
Film-coated tablet
Orange coloured, modified capsule shaped, film-coated tablets,
debossed with ‘H’ on one side and ‘27’ on the other side. The size is
20.7 mm X 9.2 mm.
Abacavir/Lamivudine film-coated tablets are available in blister packs
and white opaque HDPE container closed with white opaque
polypropylene closure.
Pack sizes:
Blister packs: 30, 50, 60, 90 film-coated tablets
HDPE packs: 30, 100 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
Hf26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 08/2016.

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.

Symptoms of infection and inflammation
Old infections may flare up

P15XXXXX

Other possible side effects of combination therapy for HIV
Combination therapy such as Abacavir/Lamivudine may cause other
conditions to develop during HIV treatment.

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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