KIVEXA. 600 mg. / 300 mg. 30 tablets

IMPORTANT - Hypersensitivity
Kivexa contains abacavir ( which is also the active ingredient in medicines such as Trizivir and Ziagen). Some patients taking abacavir may develop a hypersensitivity reaction ( serious allergic reaction) , which can be life threatening if they continue to take abacavir . You should carefully read all the information in " Hypersensitivity " panel of point 4.
In Kivexa pack an Alert card to remind you and medical staff about abacavir hypersensitivity. Detach this card and keep it with you.

What is in this leaflet
1. What Kivexa and what it is used?
2 . What you should know before taking Kivexa?
3 . How to take Kivexa?
4 . Possible side effects
5 . How to store Kivexa?
6 . Package Contents and more information
1. What Kivexa and what it is used?
Kivexa is used for the treatment of HIV (human immunodeficiency virus ) infection in adults.
Kivexa contains two active substances which are used for the treatment of HIV infection : abacavir and lamivudine. They belong to the class of antiretroviral drugs called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Kivexa not a cure for HIV infection , it reduces the amount of virus in your body and keeps it at a low level. It also increases the number of CD4 cells in your blood. CD4 cells are a type of white blood cells that are important in helping the body to fight infection .
Not everyone responds to treatment with Kivexa in the same manner . Your doctor will monitor the effectiveness of treatment.

2 . What you should know before taking Kivexa?
Do not take Kivexa:
• if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir - (eg Trizivir 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.
• if you have severe liver disease
• if you have severe kidney disease
• if you have a very low red blood cell count (anemia) or very low white blood cell count (neutropenia ) .
Tell your doctor if you think any of the above applies to you . Do not take Kivexa.

Take special care with Kivexa
For some people taking Kivexa or other combination treatments for HIV, the risk of serious side effects is increased . You need to know the additional risk factors:
• if you have ever had liver disease , including hepatitis B or C ( if you have hepatitis C, do not stop taking Kivexa, without first checking with your doctor , as your hepatitis may occur again)
• if you are severely overweight (especially if you're a woman )
Talk to your doctor before using Kivexa, if you believe that any of the above statements apply to you. You may need extra check-ups , including blood tests while taking the drug. See Section 4 for more information .

Hypersensitivity
During a clinical trial, about 3 to 4 in every 100 patients treated with abacavir not have a gene called HLA-B * 5701 developed a hypersensitivity reaction ( serious allergic reaction).
Read all information about hypersensitivity reactions in Section 4 of this leaflet.

Risk of heart attack
Can not be excluded that abacavir is associated with an increased risk of heart attack. Tell your doctor if you have heart problems, if you smoke or have a medical condition that increases the risk of heart disease such as high blood pressure or diabetes. Do not stop taking your medicine unless your doctor advises you to do so.

Watch out for important symptoms
Some people taking medicines for HIV infection develop other conditions, which can be serious . You need to know the important signs and symptoms to look out for their appearance while 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 is infected or by infected blood (for example, using the same injection needles) . Kivexa can not stop the transmission of infection to others . To protect other people from becoming infected with HIV:
• Use a condom when you have oral sex or intercourse with penetration.
• Do not expose to risk blood transfer - for example , do not share needles. Other medicines and Kivexa
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines , including herbal medicines or other medicines you bought without a prescription.
Be sure to tell your doctor or pharmacist if you begin taking a new medicine while you are being treated with Kivexa.

The following drugs should not be administered concurrently with Kivexa:
• Emtricitabine for the treatment of HIV infection
• other medicinal products containing lamivudine , that are used to treat HIV infection or infection with hepatitis B virus
• high doses of antibiotic co-trimoxazole .
• cladribine used for the treatment of hairy cell leukemia .
Tell your doctor if you are taking any of the above drugs.
Some medicines may increase the risk of side effects or make side effects worse .

These include :
• co-trimoxazole for the treatment of bacterial infections Tell your doctor if you are taking this medicine.

Some medicines interact with Kivexa
These include :
• phenytoin, which are used for the treatment of epilepsy .
Tell your doctor if you are taking phenytoin. You may need your doctor to monitor you while taking Kivexa.
• methadone, which is used as a substitute for heroin. Abacavir increases the rate at which methadone is removed from the body. If you are taking methadone will be monitored for symptoms of withdrawal . You have to change your methadone dose you are taking.
Tell your doctor if you are taking methadone.
pregnancy
Kivexa is not recommended for use during pregnancy. Kivexa -like medicines may cause side effects in unborn babies. If you become pregnant while taking Kivexa, your baby may be subjected to additional tests and examinations ( including blood tests) to make sure it is developing normally .
If you are pregnant , become pregnant or plan to become pregnant:
Immediately discuss with your doctor the risks and benefits of taking Kivexa or other medicines to treat HIV infection during your pregnancy.

breastfeeding
HIV- positive women should not breastfeed because HIV can be passed to the baby in breast milk .
If you are breastfeeding or plan to breastfeed :
Immediately consult your doctor.

Driving and using machines
Do not drive or operate machinery unless you are feeling well .

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

3 . How to take Kivexa?
Always take this medicine exactly as your doctor tells you . If you are not sure , ask your doctor or pharmacist.
Swallow the tablets whole with water. Kivexa can be taken with or without food. Stay in touch with your doctor
Kivexa helps to control your condition . You should continue to take the medicine every day to prevent your illness worse. May still develop infections or other illnesses associated with HIV infection.
Keep in touch with your doctor and stop taking Kivexa without consulting a doctor .

How much to take ?
The usual dose of Kivexa for adults is one tablet once daily. If you take more Kivexa than
If you accidentally take more dose Kivexa, tell your doctor or 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. Do not take a double dose to make up for a missed dose.
It is important to take Kivexa regularly as irregular intake of the drug increases the likelihood of developing a hypersensitivity reaction .

If you stop taking Kivexa
If you stop taking Kivexa for any reason - especially if you think you have side effects or for other illness:
Consult your doctor before you start taking it again . Your doctor will check whether your symptoms are related to a hypersensitivity reaction and if they decide that they will tell you never to take Kivexa
or any other medicine containing abacavir ( as Trizivir or Ziagen).
It is important to follow this advice .
If your doctor advises you to start taking Kivexa, you may need to take your first dose in a place where you can get immediate medical help if you need it .

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
In the treatment of HIV infection can not always determine whether a symptom is a side effect associated with the use of Kivexa or other medicines you are taking at the same time or is a manifestation of HIV disease. Therefore it is very important that you inform your doctor about any changes in your health .
During a clinical trial, approximately 3 to 4 out of every 100 patients treated with abacavir, who did not have a gene called HLA-B * 5701 developed a hypersensitivity reaction ( serious allergic reaction) , which is described in the " reactions hypersensitivity " of this leaflet. 's very important that you read and understand the information about this serious reaction .
In addition , side effects from taking Kivexa, listed below , in a combination therapy for HIV can develop , and other conditions .
It is important to read the information in " Other possible side effects of combination therapy for HIV" in this leaflet.

Hypersensitivity
Kivexa contains abacavir (the active ingredient in the drug Trizivir and Ziagen).
During a clinical trial, about 3 to 4 in every 100 patients treated with abacavir not have a gene called HLA-B * 5701 developed a hypersensitivity reaction ( serious allergic reaction).

Who gets these reactions ?
Anyone taking Kivexa, can develop a hypersensitivity reaction to abacavir, which can be life threatening if they continue taking Kivexa.
More likely to develop this reaction is greater if you have a gene called HLA-B * 5701 (but you can get a reaction not have this gene ) . Before you start taking Kivexa, you should be tested for this gene . If you know you have this gene, tell your doctor before you start taking Kivexa.

What are the symptoms ?
The most common symptoms are:
• fever (high temperature) and skin rash.

Other common symptoms are:
• nausea , vomiting , diarrhea, abdominal (stomach ) pain, severe fatigue.
Other symptoms include :
• pain in the joints or muscles , swelling of the neck , shortness of breath , sore throat , cough, headache.
• sometimes , inflammation of the eyes ( conjunctivitis) , mouth ulcers , low blood pressure .
If you continue to take Kivexa, symptoms will get worse and can become life-threatening.

When these reactions ?
Hypersensitivity reactions may occur at any time while taking Kivexa, but mostly during the first 6 weeks of treatment.
Sometimes reactions can occur in people who start taking abacavir again, before they stopped taking had only one symptom on the Alert Card .
Very rare effects may develop in people who start taking abacavir again, before they stopped taking it did not have any symptom.

Immediately contact your doctor :
1 if you get a skin rash OR
2 if you get symptoms from at least two of the following groups:
- fever
- Shortness of breath, sore throat or cough
- Nausea or vomiting, diarrhea or abdominal pain
- Severe tiredness or achiness or generally feeling unwell . Your doctor may advise you to stop taking Kivexa.
Wear Alert Card with you at all while taking Kivexa.

If you stop taking Kivexa
If you have stopped taking Kivexa due to a hypersensitivity reaction , NEVER AGAIN should start treatment with Kivexa, or any other medicine containing abacavir (eg Trizivir or Ziagen), as within hours you may experience a life-threatening drop in blood your pressure that can lead to death .
If you have stopped taking Kivexa for any reason - especially if you are having side effects or other illness:
Consult with your doctor before you start taking it again .
It will assess whether your symptoms were related to a hypersensitivity reaction and if it finds such a relationship will tell you never to take Kivexa or any other medicine containing abacavir ( Trizivir or as Ziagen). It is important to follow this advice .
If your doctor decides to start taking Kivexa, he may tell you to do it in a place where you can get immediate medical attention if necessary.
If it turns out you are hypersensitive to Kivexa, return all unused medication for safe disposal. Seek advice your doctor or pharmacist.

Common side effects
These may occur in up to 1 in 10 patients:
• hypersensitivity reaction
• headache
• vomiting
• nausea
• diarrhea
• stomach 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
• irritated or runny nose
• skin rash
• hair loss.

Uncommon side effects
These may affect up to 1 in 100 patients and occur in blood tests :
• low red blood cells ( anemia) or low white blood cells ( neutropenia)
• increases in liver enzymes
• reducing the number of cells involved in the clotting of blood ( thrombocytopenia) . Rare side effects

These may affect up to 1 in 1000 patients:
• liver problems such as jaundice , enlarged liver , increased fat in the 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 the level of an enzyme called amylase

Very rare side effects
These may affect up to 1 in 10 000 patients:
• numbness of the skin ( needles)
• a feeling of weakness in the limbs
• skin rash, which may have 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 blistering and peeling of the skin , particularly around the mouth, nose, eyes and genitals ( Syndrome Stevens-Johnson), and a more severe form of this rash , peeling in more than 30% of the skin of body ( toxic epidermal necrolysis) .
Immediately contact your doctor if you notice any of these symptoms.
Very common side effects, which can be observed in the blood tests are:
• failure of the bone marrow to produce new red blood cells ( pure red blood cell ) .
If you get side effects
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice other effects not listed in this leaflet .
Other possible side effects of combination therapy for HIV
Combination therapy including a Kivexa, may lead to the development of other diseases in the treatment of HIV.

Old infections may reappear
People with advanced HIV infection ( AIDS ) have weakened immune systems and are more likely to develop serious infections Opportunistic infections) is greater . When you begin treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are most likely due to the strengthening of the immune system so that the body starts to fight infections.
Furthermore opportunistic infections after taking drugs to treat HIV infection , may develop autoimmune disorders ( a condition that develops when the immune system attacks healthy tissues of the body). Autoimmune disorders can develop many months after initiation of treatment. If you notice any signs of infection or other symptoms such as muscle weakness, a weakness that starts from the hands and feet and goes to the body , palpitations, tremors, increased activity , please inform your doctor immediately to seek appropriate treatment.
If you experience symptoms of infection while taking Kivexa:
Tell your doctor immediately . Do not take other medicines for the infection without your doctor has advised you to do so.
Your body shape may change
People taking combination therapy for HIV, may notice changes in body shape due to changes in fat distribution :
• Loss of fat from the legs, arms or face.
• Extra fat accumulation in the abdomen , breasts or internal organs .
• On the back of the neck may occur Fatty lumps (sometimes called " buffalo hump " ) .
Not yet known what causes these changes , and whether they have 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 patients taking Kivexa or other medicines like it (a nucleoside analogue reverse transcriptase inhibitors ) , develop a condition called lactic acidosis, together with an enlarged liver.
Lactic acidosis is caused by a buildup of lactic acid in the body. It is rare , and if , it usually develops after a few months of treatment. Lactic acidosis can be life-threatening , causing failure of internal organs .
Lactic acidosis is more likely to develop in people with liver disease , or who are severely overweight , particularly in women .

Signs of lactic acidosis include :
• deep, rapid , difficult breathing
• drowsiness
• numbness or weakness in the limbs
• nausea , vomiting
• stomach pain .
During treatment, your doctor will monitor you for signs of lactic acidosis. If any of the above symptoms or any other symptoms that worry you:
As soon as possible consult your doctor. You may have bone problems
Some people taking combination therapy for HIV develop a condition called osteonecrosis . In this condition of the bone tissue die because of reduced blood supply to the bone. The probability of patients developing this condition is greater than :
• if they were of a combination therapy for an extended period of time
• if they are also taking anti-inflammatory medicines called corticosteroids
• If you consume alcohol
• if their immune systems are very weak
• if you are overweight .

Signs of osteonecrosis include :
• stiffness
• pain ( especially in the hip , knee or shoulder)
• difficulty in movement.
If you notice any of these symptoms :
Tell your doctor.
Other effects may show up in blood tests
Combination therapy for HIV can cause:
• increased levels of lactic acid in the blood, which in rare cases can lead to lactic acidosis.
• increased levels of sugar and fat (triglycerides and cholesterol ) in the blood
• resistance to insulin ( so if you are diabetic , you may need dosage adjustments of insulin needed to control your blood sugar).

5 . How to store Kivexa?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton.
Do not store above 30 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Package Contents and more information
What does Kivexa?
The active ingredients in each tablet Kivexa 600 mg of abacavir (as sulfate) and 300 mg lamivudine.
The other ingredients in the tablet core are microcrystalline cellulose , sodium starch glycolate and magnesium stearate. The tablet coating contains Opadry Orange YS- 1-13065 -A, containing hypromellose , titanium dioxide (E171), macrogol 400 , polysorbate 80 and sunset yellow aluminum lake ( E110) .

Kivexa looks like and contents of the pack ?
Kivexa tablets are engraved with 'GS FC2' on one side. The tablets are orange , capsule-shaped and are available in blister packs or bottles containing 30 tablets in blister packs of 90 ( 3 x 30) tablets.