KIVEXA 600 MG/300 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Kivexa 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

Kivexa contains abacavir(which is also the active substance in medicines such as Trizivir,Triumeqand Ziagen). Some people who take abacavir may develop a hypersensitivity reaction(a severe allergic reaction), which can be life-threatening if they continue to take medicines containing abacavir.

You must read the information on “Hypersensitivity reactions” in section 4 of this leaflet carefully.

Ask your doctorif you think any of these situations apply to you. Do not take Kivexa.

Be especially careful with Kivexa

Some people who take Kivexa or other combination treatments for HIV have a higher risk of serious side effects. You need to know that there is a higher risk:

• 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, do not stop taking Kivexa without your doctor's advice, as it may get worse)
• if you are significantly overweight(especially if you are a woman)
• if you have kidney problems.

Ask your doctor before starting Kivexa if youhave any of these conditions.You may need to have extra checks, including blood tests, while taking this medicine. For more information, see section 4.

Hypersensitivity reactions to abacavir

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

Read the information on “Hypersensitivity reactions” in section 4 of this leaflet carefully.

Risk of cardiovascular events

It cannot be excluded that abacavir increases the risk of having a heart attack or stroke.

Tell your doctorif you have heart problems, if you smoke, or if you have other diseases that may increase your risk of heart disease, 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 who take medicines for HIV infection develop other conditions that can be serious. You need to know what important signs and symptoms to look out for while you are taking Kivexa.

Read the information on “Other possible side effects of combination therapy for HIV” in section 4 of this leaflet.

Other medicines and Kivexa

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,including those obtained without a prescription.

Remember to tell your doctor or pharmacist if you start taking any new medicines while you are taking Kivexa.

The following medicines must not be used with Kivexa:

• emtricitabine, to treat HIV infection
• other medicines that contain lamivudine, used to treat HIV infectionor hepatitis B
• high doses of co-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic
• cladribine, used to treat hairy cell leukaemia.

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

Some medicines interact with Kivexa

These include:

• phenytoin, used to treat epilepsy.

Tell your doctorif you are taking phenytoin. Your doctor may need to monitor you while you are 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 need to be checked for signs of methadone withdrawal. You may need to have your methadone dose changed.

Tellyour doctorif you are taking methadone.

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

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

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

Pregnancy

Kivexa is not recommended during pregnancy. Kivexa and similar medicines may harm your unborn baby. If you have taken Kivexa during your pregnancy, your doctor may request that you have regular blood tests and other checks on your baby.

Breast-feeding

It is recommended that HIV-infected women do not breast-feedbecause HIV can be passed to the baby through breast milk. A small amount of the ingredients of Kivexa can also pass into breast milk.

If you are breast-feeding or thinking of breast-feeding, consult your doctor as soon as possible.

Driving and using machines

Kivexa can cause side effects that may affect your ability to drive or use machines.

Consult your doctorabout your ability to drive or use machines while taking Kivexa

Important information about some of the ingredients of Kivexa

Kivexa contains a colour called orange yellow (E110), which may cause allergic reactions in some people.

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

3. How to take Kivexa

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

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.

Keep in regular contact with your doctor

Kivexa helps to control your condition. You need to take it every day to control your HIV infection. You may still develop other infections and illnesses associated with HIV.

Stay in touch with your doctor and do not stop taking Kivexawithout talking to your doctor first.

If you take more Kivexa than youshould

If you accidentally take more Kivexa than you should, tell your doctor or pharmacist, or contact the nearest hospital emergency department for more 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 normal treatment schedule.

Do not take a double dose to make up for a forgotten dose.

It is important to take Kivexa regularly, as irregular intake of Kivexa can increase the risk of a hypersensitivity reaction.

If you have stopped taking Kivexa

If for any reason you have stopped taking Kivexa — especially because you think you have had side effects or because of another illness:

Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor thinks that they may have been related, you should never take Kivexa or any other medicine containing abacavir (e.g.Trizivir, Triumeqor Ziagen) again.It is important that you follow this advice.

If your doctor advises you to restart treatment with Kivexa, they may ask you to take the first doses in a place where you can easily get medical help if you need it.

4. Possible Adverse Effects

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

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

When you are undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of Kivexa or other medications you are taking, or if it is due to an effect of the disease caused by HIV. Therefore, it is very important that you inform your doctor about any change in your health.

Even patients who do not present the HLA-B*5701 gene can develop a hypersensitivity reaction(a severe allergic reaction), described in this prospectus in the section called “Hypersensitivity Reactions”.

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

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

It is important that you read the information under the heading “Other Possible Adverse Effects of Combined HIV Treatment”.

Hypersensitivity Reactions

Kivexacontains abacavir(an active ingredient also present in Trizivir, Triumeq, and Ziagen).

Abacavir can produce a severe allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medications containing abacavir.

Who suffers from these reactions?

Anyone taking Kivexa could develop a hypersensitivity reaction to abacavir, which could put their life at risk if they continue taking Kivexa.

You are more likely to develop this reaction if you have a gene called HLA-B*5701(but you can suffer from this reaction even if you do not have this gene). Before starting treatment with Kivexa, you should have undergone a test to detect this gene. If you know you have this gene, tell your doctor before taking Kivexa.

About 3 to 4 out of every 100 patients treated with abacavir in a clinical trial who did not present the HLA-B*5701 gene developed a hypersensitivity reaction.

What are the symptoms?

The most frequent symptoms are:

• fever (high temperature) and skin rash.

Other frequently observed signs are:

• nausea (discomfort), vomiting, diarrhea, abdominal pain (stomach), and excessive fatigue.

Other symptoms may include:

• joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasional headache, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, and numbness or tingling of the hands or feet.

When do these reactions occur?

Hypersensitivity reactions can appear at any time during treatment with Kivexa, but they are more likely to occur in the first 6 weeks of treatment.

Contact your doctor immediately:

1if you have a skin rash OR

2if you have symptoms included in at least 2 of the following groups:

• fever
• difficulty breathing, sore throat, or cough
• nausea or vomiting, diarrhea, or abdominal pain
• excessive fatigue or general discomfort.

Your doctor may advise you to stop taking Kivexa.

While taking Kivexa, always carry the Patient Information Card with you.

If you have stopped taking Kivexa

If you have stopped taking Kivexa due to a hypersensitivity reaction, NEVER TAKE Kivexa OR ANY OTHER MEDICATION CONTAINING ABACAVIR (e.g., Trizivir, Triumeq, or Ziagen) AGAIN. If you do, within hours, you may experience a drop in blood pressure that can be life-threatening or cause death.

If, for any reason, you have interrupted treatment with Kivexa — especially because you think you have adverse effects or due to another illness:

Consult your doctor before restarting treatment. Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a relationship, they will indicatethatyou should never take Kivexa or any other medication containing abacavir (e.g., Trizivir, Triumeq, or Ziagen) again. It is important that you follow this warning.

Occasionally, hypersensitivity reactions have developed in people who restart abacavir after having had only one symptom of those included in the Patient Information Card before stopping it.

Very rarely, reactions have developed in people who restart treatment with abacavir but did not have any symptoms of hypersensitivity before stopping it.

If your doctor advises you to restart treatment with Kivexa, they may ask you to take the first doses in a place where you have easy access to medical assistance if needed.

If you are hypersensitive to Kivexa, you must return all unused Kivexa tablets to be safely disposed of. Consult your doctor or pharmacist.

The Kivexa packaging includes a Patient Information Cardto remind you and healthcare personnel about hypersensitivity reactions. Separate the card from the packaging and always carry it with you.

Frequent Adverse Effects

May affect up to 1 in 10people:

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

Uncommon Adverse Effects

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

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

Rare Adverse Effects

May affect up to 1 in 1,000people:

• liver disorders, such as jaundice, liver enlargement, or fatty liver, inflammation (hepatitis)
• pancreas inflammation (pancreatitis)
• muscle tissue rupture.

Rare adverse effects that may appear in blood tests are:

• increase in an enzyme called amylase.

Very Rare Adverse Effects

May affect up to 1 in 10,000people:

• numbness, tingling sensation in the skin (pins and needles)
• weakness sensation in the limbs
• skin rash that can form blisters resembling small targets (dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling over 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 adverse 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 suffer from adverse effects

Tell your doctor or pharmacistif you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus.

Other Possible Adverse Effects of Combined HIV Treatment

Combined treatments, such as Kivexa, can 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 severe infections (opportunistic infections). Such infections may have been "latent" and not detected by the weakened immune system before starting treatment. After starting treatment, the immune system becomes stronger, so it begins to fight these infections, which can cause symptoms of infection or inflammation. The symptoms generally include fever, in addition to some of the following:

• headache
• stomach pain
• difficulty breathing.

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

• palpitations (rapid or irregular heartbeats) or tremors
• hyperactivity (excessive restlessness and movement)
• weakness starting in the hands and feet and ascending towards the body trunk.

If you observe any symptom of infectionand inflammation or if you notice any of the above symptoms:

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

You may have bone problems

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

• if they have been taking combined treatment for a long time
• if they also take anti-inflammatory medications called corticosteroids
• if they drink alcohol
• if their immune system is severely 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:

Tell your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Kivexa

Keep this medication out of sight and reach of children.

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

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Kivexa Composition

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

The other ingredients 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).

Kivexa Appearance and Package Contents

The tablets are orange, film-coated, capsule-shaped, and engraved on one side with GS FC2. They are available in blister packs containing 30 tablets and multi-packs containing 90 (3x30) tablets.

Marketing Authorization Holder

ViiV Healthcare BV

Van Asch van Wijckstraat 55H

3811 LP Amersfoort

Netherlands.

Manufacturer

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:

Date of the Last Revision of this Prospectus:

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