PACKAGE LEAFLET

Abacavir/Lamivudine/Zidovudine 300 mg/150 mg/300 mg Film-coated Tablets

abacavir/lamivudine/zidovudine

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.

What is in this leaflet

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

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

3.    How to take Abacavir/Lamivudine/Zidovudine

4.    Possible side effects

5.    How to store Abacavir/Lamivudine/Zidovudine

6.    Contents of the pack and other information

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

Abacavir/Lamivudine/Zidovudine is used to treat HIV (human immunodeficiency virus) infection in adults.

This medicine contains three active ingredients that are used to treat HIV infection: abacavir, lamivudine and zidovudine. All of these belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

This medicine helps to control your condition. This medicine does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. This helps your body to increase the CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in helping your body to fight infection.

Not everyone responds to treatment with this medicine in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take Abacavir/Lamivudine/Zidovudine:

•    if you are allergic (hypersensitive) to:

-    abacavir, or any other medicine containing    abacavir, for example

abacavir/lamivudine/zidovudine (which may be known as Trizivir), abacavir/lamivudine (which may be known as Kivexa) or abacavir (which may be known as Ziagen)

-    lamivudine

-    zidovudine

-    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 liver problems.

•    if you have severe kidney problems.

•    if you have a very low red blood cell count (anaemia) or a very low white blood cell count

(neutropenia).

Check with your doctor if you think any of these apply to you.

Warnings and precautions Hypersensitivity reactions

About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have a gene called HLA-B*5701 developed a hypersensitivity reaction (a serious allergic reaction).

However, patients who had the HLA-B*5701 gene were more likely to develop a hypersensitivity reaction than those who did not have the gene.

Your doctor should check if you have this gene before you start taking Abacavir/Lamivudine/Zidovudine. If you know you have this gene, tell your doctor before you take this medicine.

Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.

Some people taking this medicine 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 an enlarged or fatty liver, or hepatitis B or C (if you have hepatitis B infection, don’t stop taking this medicine without your doctor’s advice, as your hepatitis may come back)

•    if you are taking medicines that your doctor has told you can affect the liver, or if you drink more alcohol than recommended.

•    if you are seriously overweight (especially if you are a woman)

•    if you are diabetic (your doctor may need to adjust the amount of insulin or tablets you are taking), or you have been told you have, or are at risk of, raised blood sugar levels.

•    if you have problems with your bone marrow (the tissue within the bones that help produce blood cells).

Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you’re taking your medicine. See Section 4 for more information.

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, increased levels of fats (triglycerides and cholesterol) in the blood, or diabetes. Do not stop taking Abacavir/Lamivudine/Zidovudine unless your doctor advises you to do so.

Look out for important symptoms

Some people taking this medicine develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you are taking this medicine.

Read the information ‘Other possible side effects of Abacavir/Lamivudine/Zidovudine’ 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). This medicine will not stop you passing HIV infection on to other people. To protect other people from becoming infected with HIV:

•    Use a condom when you have oral or penetrative sex.

•    Avoid contact with other peoples’ blood — for example, don’t share needles.

Other medicines and Abacavir/Lamivudine/Zidovudine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines or 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/Zidovudine.

The following medicines should not be used with this medicine:

•    stavudine or emtricitabine, to treat HIV infection

•    other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B infection

•    ribavirin to treat viral infections

•    high doses of co-trimoxazole, an antibiotic.

•    cladribine, used to treat hairy cell leukaemia.

Tell your doctor if you are being treated with any of these.

Some medicines can make it more likely that you’ll have side effects, or make side effects worse These include:

•    sodium valproate, to treat epilepsy or a type of depression known as mania.

•    interferon or ganciclovir, to treat viral infections.

•    pyrimethamine, to treat malaria and other parasitic infections.

•    dapsone, to prevent pneumonia and treat skin infections.

•    fluconazole or flucytosine, to treat fungal infections such as candida.

•    pentamidine or atovaquone, to treat parasitic infections such as PCP.

•    amphotericin or co-trimoxazole, to treat fungal and bacterial infections.

•    probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective.

•    methadone, used as a heroin substitute.

•    vincristine, vinblastine or doxorubicin, to treat cancer.

Tell your doctor if you’re taking any of these.

Some medicines interact with this medicine

These include:

•    clarithromycin, an antibiotic. If you are taking clarithromycin, take your dose or after you take this medicine.

•    phenytoin, for treating epilepsy. Tell your doctor if you are taking phenytoin to monitor you while you are taking this medicine.

Methadone and Abacavir/Lamivudine/Zidovudine

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.

Pregnancy and breast-feeding

If you are pregnant, if you become pregnant, or if you are planning to become pregnant, talk to your doctor about the risks and benefits of taking this medicine during your pregnancy.

This medicine and similar medicines may cause side effects in unborn babies. If you become pregnant while you are taking this medicine, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.

Children whose mothers took medicines like this medicine (NRTIs) during pregnancy have a reduced risk of being infected with HIV. This benefit is greater than the risk of having side effects.

Women who are HIV-positive must not breast-feed because HIV infection can be passed on to the baby in breast milk.

If you are breast-feeding, or thinking about breast-feeding:

Talk to your doctor immediately.

Driving and using machines

This medicine can make you dizzy and have other side effects that make you less alert.

Do not drive or operate machines unless you are feeling well.

3. How to take Abacavir/Lamivudine/Zidovudine

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

Keep in touch with your doctor, and do not stop taking this medicine without your doctor’s advice.

How much to take

The recommended dose for adults is one tablet twice a day.

Take the tablets at regular times, leaving approximately 12 hours between each tablet.

Swallow the tablet whole, with some water. This medicine can be taken with or without food.

Use in children and adolescents

Children and adolescents under 18 years of age should not take Abacavir/Lamivudine/Zidovudine.

If you take more Abacavir/Lamivudine/Zidovudine than you should

If you accidentally take too much of this medicine, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Abacavir/Lamivudine/Zidovudine

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 this medicine regularly, because if you take it at irregular intervals it may not continue to work against the HIV infection, and you may be more likely to have a hypersensitivity reaction.

If you stop taking Abacavir/Lamivudine/Zidovudine

If you have stopped taking this medicine 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 to take this medicine again, or any other medicine containing abacavir (examples of these include abacavir/lamivudine/zidovudine (which may be known as Trizivir), abacavir/lamivudine (which may be known as Kivexa) or abacavir (which may be known as Ziagen). It is important that you follow this advice.

If your doctor advises that you can start taking this medicine 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 everybody gets them.

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

About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have a gene called HLA-B*5701 developed a hypersensitivity reaction (a serious allergic reaction). However, patients who had the HLA-B*5701 gene were more likely to develop a hypersensitivity reaction than those who did not have the gene, described in this leaflet under ‘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 this medicine, other conditions can develop during treatment.

It is important to read the information in this section of the leaflet under ‘Other possible side effects of this medicine’.

If you notice any of the following symptoms contact a doctor urgently:

•    Hypersensitivity (allergic) reactions. Please see the “Hypersensitivity reactions” box below for important information about these symptoms.

Rare side effects

These may affect up to 1 in 1,000 people:

•    inflammation of the pancreas (pancreatitis).

•    disease of the heart muscle causing tiredness, chest pains and a fast or irregular heartbeat

(cardiomyopathy).

•    liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis).

•    fits (convulsions).

•    breakdown of muscle tissue (rhabdomyolysis).

•    lactic acidosis (see the next section, ‘Other possible side effects of Abacavir/Lamivudine/Zidovudine ’).

A rare side effect that may show up in blood tests is:

•    a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

Very rare side effects

These may affect up to 1 in 10,000 people:

•    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).

A very rare side effect that may show up in blood tests is:

•    a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).

Not known (frequency cannot be estimated from the available data) side effects:

•    kidney, liver or respiratory (breathing) failure

-    nausea or vomiting, diarrhoea or abdominal pain

-    severe tiredness or achiness, or generally feeling ill.

Your doctor may advise you to stop taking this medicine.

Always carry your Alert Card while you are taking this medicine.

If you have stopped taking this medicine

If you have stopped taking this medicine or any other medicine containing abacavir (examples of these include abacavir/lamivudine/zidovudine (which may be known as Trizivir), abacavir (which may be known as Kivexa) or abacavir (which may be known as Ziagen)) because of a hypersensitivity reaction, you must NEVER USE THESE MEDICINES AGAIN. If you do, within hours, your blood pressure could fall dangerously low, which could result in death.

If you have stopped taking this medicine 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 this medicine, or any other medicine containing abacavir (Trizivir, Kivexa or Ziagen). It is important that you follow this advice.

If your doctor advises that you can start taking this medicine 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 this medicine, return all your unused tablets for safe disposal. Ask your doctor or pharmacist for advice._

Other side effects are:

Very common side effects

These may affect more than 1 in 10 people:

•    headache.

•    feeling sick (nausea).

Common side effects

These may affect up to 1 in 10 people:

•    being sick (vomiting).

•    diarrhoea.

•    stomach pains.

•    loss of appetite.

•    feeling dizzy.

•    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.

Common side effects that may show up in blood tests are:

•    a low red blood cell count (anaemia) or low white blood cell count (neutropenia, lymphopenia or leucopenia).

•    an increase in the level of liver enzymes.

•    an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow.

Uncommon side effects

These may affect up to 1 in 100 people:

•    feeling breathless.

•    wind (flatulence).

•    itching.

•    muscle weakness.

•    sensation of weakness in the limbs.

An uncommon side effect that may show up in blood tests is:

•    a decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia). This may be associated a reduction in bone marrow.

Rare side effects

These may affect up to 1 in 1000 people:

•    chest pain.

•    feeling depressed or anxious, not being able to concentrate, feeling drowsy.

•    indigestion, taste disturbance.

•    changes in the colour of your nails,    your skin, or the skin inside your mouth.

•    pinkish itchy swellings on the skin (known as hives or nettle rash).

•    a flu-like feeling — chills and sweating.

•    tingly feelings in the skin (pins and needles).

•    passing urine more often.

•    enlarged breasts in men.

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 in the arms and legs (peripheral neuropathy).

Not known (frequency cannot be estimated from the available data) side effects:

•    swelling or fluid retention

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 possible side effects not listed in this leaflet (also see ‘Reporting of side effects’ later in this leaflet).

Other possible side effects of Abacavir/Lamivudine/Zidovudine:

This medicine may cause other conditions to develop during HIV treatment.

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). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.

In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and

feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.

If you get any symptoms of infection while you are taking this medicine:

Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice. 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.

Lactic acidosis is a rare but serious side effect

Some people taking this medicine or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged or fatty 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.

Lactic acidosis is more likely to develop in people who have liver disease, are taking medicines that can affect the liver, or if you drink more alcohol than recommended, or in obese (very overweight) people, especially women.

Signs of lactic acidosis include:

•    deep, rapid, difficult breathing.

•    drowsiness, confusion.

•    general feeling of feeling unwell, loss of appetite, weight loss.

•    numbness or weakness in the limbs.

•    feeling sick (nausea), being sick (vomiting).

•    stomach pain.

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.

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:

Other effects may show up in blood tests

This medicine 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’re diabetic, your doctor may need to adjust the amount of insulin or tablets you are taking 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.

5. How to store Abacavir/Lamivudine/Zidovudine

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.

Blister packs: Do not store above 30°C.

Bottle: This medicinal product does not require any special storage conditions. Do not use this medicine after 60 days of first opening the bottle.

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/Zidovudine contains

-    The active substances are abacavir (as sulfate), lamivudine and zidovudine.

-    The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, sodium starch glycolate and magnesium stearate in the core of the tablet. The tablet coating contains hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminium lake (E132), iron oxide yellow (E172) and iron oxide red (E172).

What Abacavir/Lamivudine/Zidovudine looks like and contents of the pack

Abacavir/Lamivudine/Zidovudine film-coated tablets are light green, oval shaped, biconvex, film-coated tablets debossed with ‘ALZ1’ on one side and ‘M’ on other side.

Abacavir/Lamivudine/Zidovudine film-coated tablets are provided in blister packs containing 30, 50x1, 60, 60x1, 90 or 120 tablets; or in bottles containing 60 tablets.

Marketing Authorisation Holder

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

Manufacturers

Mylan Hungary Kft., H-2900, Komarom, Mylan utca 1, Hungary.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

This leaflet was last revised in 03/2014.

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