Kivexa 600 mg/300 mg film-coated tablets

Don?t take Kivexa:

• if you?re allergic(hypersensitive) to abacavir (or any other medicine containing abacavir ? (e.g. Trizivir or Ziagen), lamivudine or any of the other ingredients of Kivexa (listed in Section 6)Carefully read the all information about hypersensitivity reactions in Section 4.
• if youhave severe liver disease
• if youhave severe kidney disease
• 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. Don?t take Kivexa

Take special care with Kivexa

Some people taking Kivexa 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, don?t stop Kivexa without your doctor?s advice, as your hepatitis may come back)
• if you?re seriously overweight (especially if you?re a woman) 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.

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). 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. Don?t stop taking Kivexa 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?re taking Kivexa. 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). Kivexa 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.
• Don?t risk blood transfer ? for example, don?t share needles.

Other medicines and Kivexa
Tell your doctor or pharmacist if you?re taking any other medicines, or if you?ve taken any recently, 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?re taking Kivexa.

These medicines should not be used with Kivexa:

• 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. Tell your doctor if you?re 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:

• co-trimoxazole, to treat bacterial infectionsTell your doctor if you?re taking this.

Some medicines interact with Kivexa

These include:

• phenytoin, for treating epilepsy. Tell your doctor if you?re taking phenytoin. Your doctor may need to monitor you while you?re taking Kivexa.
• 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?re taking methadone.

Pregnancy
Kivexa is not recommended for use during pregnancy. Kivexa and similar medicines may cause side effects in unborn babies. If you become pregnant while you?re taking Kivexa, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.

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

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

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

Driving and using machines
Don?t drive or operate machines unless you?re feeling well.

Important information about some of the other ingredients of Kivexa tablets
Kivexa contains a colouring called sunset yellow (E110), this may cause allergic reactions in some people.

Always take Kivexa exactly as your doctor has told you to. Check with your doctor or pharmacist if you?re not sure.

Swallow the tablets whole, with some water. Kivexa can be taken with or without food.

Stay in regular contact with your doctor

Kivexa 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 don?t stop taking Kivexa without your doctor?s advice.

How much to take
The usual dose of Kivexa for adults is one tablet once a day.

If you take too much Kivexa

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

If you forget to take Kivexa

If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Don?t take a double dose to make up for a missed dose.

It is important to take Kivexa regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.

If you have stopped taking Kivexa

If you have stopped taking Kivexa 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 Kivexa, 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 Kivexa 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.

Like all medicines, Kivexa can cause side effects, but not everyone gets them.

When you?re being treated for HIV, it can be hard to tell whether a symptom is a side effect of Kivexa 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.

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), 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 Kivexa, 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

Kivexa contains abacavir (which is also an active ingredient in medicines such as Trizivir and Ziagen).

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).

Who gets these reactions?

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

You are more likely to develop such a reaction if a gene called HLA-B*5701 (but you can get a reaction even if you don?t have this gene). You should have been tested for this gene before Kivexa was prescribed for you. If you know you have this gene, tell your doctor before you take Kivexa.

What are the symptoms?
The most common symptoms are:
fever (high temperature) and skin rash.
Other common symptoms are:
n ausea (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, headache occasionally, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure.

If you continue to take Kivexa, the symptoms will get worse, andmay be life-threatening.

When do these reactions happen?

Hypersensitivity reactions can start at any time during treatment with Kivexa, but are more likely during the first 6 weeks of treatment.

Occasionally, reactions have developed in people who start taking abacavir again, and had only one symptom on the Alert Card before they stopped taking it.

Very rarely, reactions have developed in people who start taking abacavir again, but who had no symptoms before they stopped taking it.

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 Kivexa.

Always carry your Alert Card while you are taking Kivexa.
If you have stopped taking Kivexa

If you have stopped taking Kivexa because of a hypersensitivity reaction, you must NEVER AGAIN take Kivexa, or any other medicine containing abacavir (e.g. Trizivir or Ziagen). If you do, within hours, your blood pressure could fall dangerously low, which could result in death.

If you have stopped taking Kivexa 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 Kivexa, 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 Kivexa 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 Kivexa, return all your unused Kivexa tablets for safe disposal. Ask your doctor or pharmacist for advice.

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)
• 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

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.

Other possible side effects of combination therapy for HIV

Combination therapy such as Kivexa 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.
If you get any symptoms of infection while you?re taking Kivexa:
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 Kivexa, 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.

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

Signs of lactic acidosis include:

• deep, rapid, difficult breathing
• drowsiness
• 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: Tell your doctor.

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?re diabetic, you may have to change your insulin dose to control your blood sugar).

Keep Kivexa out of the reach and sight of children.

Do not take Kivexa after the expiry date shown on the carton.

Do not store above 30°C.

If you have any unwanted Kivexa tablets, don?t dispose of them in your waste water or your household rubbish. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Kivexa contains

The active substances in each Kivexa film-coated tablet are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.

The other ingredients are microcrystalline cellulose, sodium starch glycollate and magnesium stearate in the core of the tablet. The tablet coating contains Opadry Orange YS-1-13065-A containing hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80 and sunset yellow aluminium lake (E110).

What Kivexa looks like and contents of the pack

Kivexa film-coated tablets are engraved with ?GS FC2? on one side. They are orange and capsule-shaped and are provided in bottles or blister packs containing 30 tablets and blister packs containing 90(3 x 30) tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Manufacturer: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.

Or

Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien ViiV Healthcare sprlbvba TélTel 32 02 656 25 11 LuxembourgLuxemburg ViiV Healthcare sprlbvba BelgiqueBelgien TélTel 32 02 656 25 11

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

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Lietuva

GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com

This leaflet was approved in {MM/YYYY}