Label: Information for the User

Kivexa 600 mg/300 mg Film-Coated Tablets

abacavir/lamivudine

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonly for you, and you should notgive it to other people, even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

IMPORTANT — Hypersensitivity Reactions

Kivexa contains abacavir(which is also the active ingredient in medicines such asTrizivir,TriumeqandZiagen). Some people who take abacavir may develop ahypersensitivity reaction(severe allergic reaction), which can be life-threatening if abacavir-containing medicines are continued.

You must carefully read the information about “Hypersensitivity Reactions” in section 4 of this label.

The Kivexa packaging includes aMedication Information Cardto remind you and healthcare professionals of your hypersensitivity to abacavir.You must remove this card and carry it with you at all times..

1.What Kivexa is and for what it is used

2.What you need to knowbefore starting to take Kivexa

3.How to take Kivexa

4.Possible adverse effects

5.Storage of Kivexa

6.Contents of the package and additional information

Kivexa is used in the treatment of infection caused by the HIV (human immunodeficiency virus) in adults, adolescents, and children who weigh at least 25 kg.

Kivexa contains two active ingredients used for the treatment of infection caused by HIV: abacavir and lamivudine. Both belong to a group of antiretroviral medications callednucleoside reverse transcriptase inhibitors (NRTIs).

Kivexa does not completely cure HIV infection; it reduces the amount of virus in the body and keeps it at a low level. It also increases the number of CD4 cells in the blood. CD4 cellsare a type of white blood cell that plays an important role in helping your body fight infection.

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

Do not take Kivexa

• if you areallergic(hypersensitive)to abacavir (or to any other medicine that contains abacavir — e.g.Trizivir,TriumeqorZiagen), lamivudine or to any of the other components ofthis medicine(includingthose listed in section 6).

Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.

Consult your doctorif you think you are affected by any of these circumstances.Do not take Kivexa.

Be especially careful with Kivexa

Some people taking Kivexa or other combined HIV treatments have a higher risk of severe side effects. You need to know that there is a higher risk:

• if you havemoderate or severe liver disease
• if you have ever hadliver disease, including hepatitis B or C (if you have hepatitis B do not stop taking Kivexa without your doctor's advice, as it may worsen)
• if you havesignificant overweight(especially if you are a woman)
• if you have anykidney problems.

Consult your doctor before starting to take Kivexa ifyou suffer from any of these circumstances.You may need additional tests, including blood tests, while taking this medicine.For more information see section 4.

Abacavir hypersensitivity reactions

Even patients who do not have the HLA-B*5701 gene can develop ahypersensitivity reaction(a severe allergic reaction).

Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.

Risk of cardiovascular events

It cannot be ruled out that abacavir may increase the risk of cardiovascular events.

Inform your doctorif you have cardiovascular problems, smoke or suffer from diseases that may increase your risk of cardiovascular diseases such as high blood pressure or diabetes. Do not stop taking Kivexa unless your doctor advises you to.

Be aware of important symptoms

Some people taking HIV medicines develop other disorders, which can be serious. You need to know what signs and symptoms to look out for while taking Kivexa.

Read the information about “Other possible side effects of combined HIV treatment” in section 4 of this leaflet.

Other medicines and Kivexa

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine,including medicines based on plants and those acquired without a prescription.

Remember to inform your doctor or pharmacist if you start taking a new medicine while taking Kivexa.

Do not use the following medicines with Kivexa:

• emtricitabine, to treatHIV infection
• other medicines that contain lamivudine, used to treatHIV infectionorhepatitis B
• high doses ofco-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic
• cladribine, used to treatleukaemia.

Inform your doctorif you are being treated with any of these medicines.

Some medicines interact with Kivexa

These include:

• phenytoin, to treatepilepsy.

Inform your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are taking Kivexa.

• methadone, used as asubstitute for heroin. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will need to be monitored for signs of withdrawal. You may need your methadone dose to be adjusted.

Inform your doctorif you are taking methadone.

• medicines (usually liquids) that containsorbitol and other polyols(such as xylitol, mannitol, lactitol or maltitol), if taken regularly.

Inform your doctor or pharmacistif you are being treated with any of these.

• riociguat, to treathigh blood pressure in the blood vessels(pulmonary arteries) that carry blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase the levels of riociguat in your blood.

Pregnancy

Do not use Kivexa during pregnancy. Kivexa and similar medicines may cause adverse effects in babies during pregnancy.If you have been takingKivexaduring your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your baby. In babies whose mothers took INTIs during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects.

Breastfeeding

Do not recommendthat women with HIV breastfeed, as the infection can be transmitted to the baby through breast milk. A small amount of the components of Kivexa may also pass into breast milk.

If you are breastfeeding or plan to breastfeed,you should consult your doctor as soon as possible.

Driving and operating machinery

Kivexa may cause side effects that can affect your ability to drive or operate machinery.

Consult your doctorabout your ability to drive or operate machinery while taking Kivexa

Important information about some of the components of Kivexa

Kivexa contains a colourant called Sunset Yellow FCF (E110), which may cause allergic reactions in some people.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Kivexa for adults, adolescents, and children weighing at least 25 kg or more, is one tablet once a day.

Swallow the tablets whole with a little water. Kivexa can be taken with or without food.

Maintain regular contact with your doctor

Kivexa helps control your condition. You will need to take it every day to prevent your condition from worsening. You may continue to develop other infections and diseases associated with HIV infection.

Remain in contact with your doctor and do not stop taking Kivexawithout first speaking with your doctor.

If you take more Kivexa than youshould

If you accidentally take more Kivexa than you should, inform your doctor or pharmacist, or contact the nearest hospital emergency service for further information.

If you forget to take Kivexa

If you forget to take a dose, take it as soon as you remember and then continue with your regular treatment.

Do not take a double dose to compensate for missed doses.

It is essential to take Kivexa regularly, as irregular intake of Kivexa may increase the risk of experiencing a hypersensitivity reaction.

If you have interrupted treatment with Kivexa

If for any reason, you have stopped taking Kivexa — especially because you think it has side effects or due to another illness:

Consult your doctor before resuming treatment. Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers it may have been related,they will instruct you thatyou should never take Kivexa again or any other medication that contains abacavir (e.g. Trizivir, Triumeqor Ziagen).It is essential that you follow this warning.

If your doctor advises you to resume treatment with Kivexa, you can ask them to take the first doses in a place where you have easy access to medical assistance if necessary.

During treatment for HIV, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to recovery of health and lifestyle, and in the case of lipids in the blood, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

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

When you are being treated for HIV, it can be difficult to distinguish whether a symptom is a side effect of Kivexa or of other medicines you are taking, or is due to an effect of the disease caused by HIV itself.Therefore, it is very important that you inform your doctor about any change in your health.

Even patients who do not have the HLA-B*5701 gene can develop ahypersensitivity reaction(a severe allergic reaction), described in this leaflet in the box called “Hypersensitivity reactions”.

It is very important that you read and understand the information about this serious reaction.

In addition to the side effects listed below for Kivexa, other disorders may develop during combined HIV treatment.

It is important that you read the information under the heading “Other possible side effects of combined HIV treatment”.

If you have stopped taking Kivexa because of a hypersensitivity reaction,NEVER TAKE KIVEXA OR ANY OTHER MEDICINE CONTAINING ABACAVIR (e.g. Trizivir, Triumeq or Ziagen) AGAIN.If you do, within hours, you may experience a drop in blood pressure that can put your life at risk or cause death.

Occasionally, hypersensitivity reactions have developed in people who have taken abacavir again after having had only one symptom of those included in the Patient Information Leaflet before they stopped taking it.

Common side effects

May affectup to 1 in 10people:

• hypersensitivity reaction
• headache
• vomiting
• feeling unwell (nausea)
• diarrhea
• abdominal pain
• loss of appetite
• tiredness, lack of energy
• fever (high temperature)
• general feeling of being unwell
• difficulty sleeping (insomnia)
• muscle pain and discomfort
• joint pain
• cough
• stuffy or runny nose
• skin rash
• hair loss.

Rare side effects

May affectup to 1 in 100people and may be reflected in blood tests:

• low red blood cell count(anemia)or low white blood cell count(neutropenia)
• an increase in enzymes produced by the liver
• a decrease in the number of cells involved in blood clotting (thrombocytopenia).

Very rare side effects

May affectup to 1 in 1,000people:

• liver damage, such as jaundice, liver enlargement or fatty liver, inflammation (hepatitis)
• pancreatitis (inflammation of the pancreas)
• muscle rupture.

The very rare side effects that may appear in blood tests are:

• an increase in an enzyme calledamylase.

Very rare side effects

May affectup to 1 in 10,000people:

• tingling, numbness in the skin (pins and needles)
• weakness in the limbs
• skin rash, which may form blisters that look like small darts (a central dark spot surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form that causes peeling of the skin on 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.

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

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

If you experience side effects

Inform your doctor or pharmacistif you consider that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet.

Other possible side effects of combined HIV treatment

Combined treatments, such as Kivexa, may cause other disorders to develop during HIV treatment.

Symptoms of infection and inflammation

Exacerbation of old infections

People with advanced HIV infection (AIDS)have a weakened immune system and are more likely to develop serious infections (opportunistic infections). Such infections may have been “latent” and not detected by the weakened immune system before treatment began. After treatment began, the immune system becomes stronger, and it starts to fight these infections, which can cause symptoms of infection or inflammation. The symptoms usually includefever, as well as some of the following:

• headache
• abdominal pain
• difficulty breathing.

In rare cases, as the immune system becomes stronger, it may also attack healthy tissues (autoimmune disorders). The symptoms of autoimmune disorders may appear many months after starting to take medicines to treat HIV infection. The symptoms may include:

• palpitations (rapid or irregular heartbeats) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness that starts in the hands and feet and ascends to the trunk of the body.

If you notice any symptoms of infectione inflammation or if you notice any of the above symptoms:

• Inform your doctor immediately. Do not take any other medicine for the infection without your doctor's advice.

You may have problems with your bones

Some patients receiving combined HIV treatment develop a bone disease calledosteonecrosis. With this disease, part of the bone tissue dies due to a reduction in blood supply to the bone. People are more likely to develop this disease:

• if they have been taking a combined treatment for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune system is very weakened
• if they are overweight.

The signs of osteonecrosis include:

• stiffness in the joints
• pain and discomfort (especially in the hip, knee or shoulder)
• difficulty moving.

If you notice any of these symptoms:

Inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, evenif it is apossibleside effect not mentioned in this leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging..The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe packaging and the medication that you no longerneed.By doing so, you will help protect the environment.

Composition of Kivexa

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

The other components are microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate in the tablet core. The coating contains Opadry Orange YS-1-13065-A, which in turn contains hypromellose (E464), titanium dioxide, macrogol 400, polysorbate 80, and yellow-orange FCF (E110).

Appearance of Kivexa and contents of the package

The tablets are orange, film-coated, capsule-shaped, and engraved on one side with GS FC2. They are presented in blisters containing 30 tablets and multi-packs in blisters containing 90 (3 x 30) tablets.

Marketing Authorization Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H

3811 LP Amersfoort

Netherlands.

Responsible for manufacturing

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu.