Trizivir. 300 mg. / 150 mg. / 300 mg. 60 tablets 

WHAT IS AND WHAT IT IS USED TRIZIVIR?
Trizivir contains abacavir, lamivudine and zidovudine. They belong to the group of drugs known as anti-retroviral , nucleoside analogues also referred to as - reverse transcriptase inhibitors (NRTIs) and used for the treatment of infection with human immunodeficiency virus (HIV). These medicines may be administered separately as with other drugs for the combined treatment of infection by HIV, or together . The dose of each of the active substances of Trizivir is equivalent to the recommended dose for the self administration of each drug .
Trizivir is used for the treatment of infection by human immunodeficiency virus (HIV) in the elderly . Due to insufficient information currently not recommended for use in children and adolescents. Trizivir reduces the number of HIV- viruses , and maintain their low number . Moreover, the drug increases the number of CD4 cells. They are part of the white blood cells that play an important role in supporting a healthy immune system to fight infections. Response to treatment with Trizivir varies between patients. Your doctor will monitor you regularly to take account of the effects of your treatment.

2 . BEFORE YOU TAKE TRIZIVIR
You should not take Trizivir, if:
• if you have had an allergic reaction to Trizivir or any other medicine containing abacavir (Kivexa, Ziagen); to lamivudine or zidovudine, or any of the other ingredients of Trizivir.
• if you have liver disease .
• if you have severe kidney disease.
• If you have very low red blood cells (anemia ) or very low white blood cell count (neutropenia ) .
If you are unsure about any of the above contraindications , please consult your doctor.
Special warnings and precautions:
Hypersensitivity reaction ( serious allergic reaction) : About 5 in every 100 patients treated with abacavir, develop a hypersensitivity reaction .
The most common symptoms of this reaction are high temperature (fever ) and skin rash. Other frequently exhibited signs include: nausea , vomiting , diarrhea, abdominal pain and severe fatigue . Other symptoms : pain in the joints or muscles , swelling of the neck , shortness of breath, sore throat, cough, headache. Sometimes may appear inflamed mucosa of the eyes ( conjunctivitis) , formation of ulcers in the mouth or a fall in blood pressure .
These signs of an allergic reaction may occur at any time during treatment with Trizivir, usually appear within the first 6 weeks and worsen with continued therapy and may be life-threatening if treatment is continued.

DOCTOR IMMEDIATELY for advice on whether you should stop taking Trizivir. if:
1) you get a skin rash OR
2 ) to get one or more symptoms of at least TWO of the following groups:
- Fever ;
- Shortness of breath , sore throat or cough;
- Nausea , vomiting , diarrhea, or abdominal pain;
- Severe fatigue , pain or malaise .
If you have stopped taking Trizivir, due to a hypersensitivity reaction should never re-start therapy with Trizivir or any other medicine containing abacavir ( abacavir ), eg . Kivexa, Ziagen, as within hours you may experience a life-threatening drop in blood pressure or death.
If you have stopped taking Trizivir for any reason in particular - if you think you have side effects or any other disease , necessarily consult with your doctor before you start taking it again . Your doctor will decide if any of your symptoms may be related to a hypersensitivity reaction . If the doctor decides that it is possible such a link should never take Trizivir or any other medicine containing abacavir ( eg Kivexa, Ziagen) again. It is important to follow this advice of the physician.
In isolated cases, life-threatening hypersensitivity reactions occur when patients before discontinuation of Trizivir are reported only one symptom described in the medical safety card are resuming taking the drug .
In very rare cases of hypersensitivity reaction when resuming taking Trizivir from patients before termination had no symptoms of hypersensitivity.
If it turns out you are hypersensitive to Trizivir, return all unused medicine to your doctor or pharmacist for destruction mu._
Lactic acidosis: medicine of the Trizivir, ( nucleoside analogue reverse transcriptase inhibitors ) can cause a condition known as lactic acidosis , and an enlarged liver. Lactic acidosis, if it occurs, usually develops after a few months of treatment. Deep, rapid breathing, drowsiness, and non specific symptoms such as nausea , vomiting and stomach pain may indicate the development of lactic acidosis. This rare but serious side effect occurs more often in women , especially overweight. In the presence of liver disease also maybe you are at greater risk of developing this condition. While being treated with Trizivir, your doctor will monitor you closely for signs of lactic acidosis.
Redistribution of body fat : in patients taking combination antiretroviral therapy may be monitored Redistribution, accumulation or loss of body fat. Contact your doctor if you notice changes in body fat.
Liver disease / hepatitis : Tell your doctor if you have liver disease . Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal side effects on the liver. They may need to be monitored in liver function .
If you have hepatitis B infection , you should not stop treatment with Trizivir without the knowledge of your doctor as it may lead to recurrence of hepatitis. This recurrence may be more severe if you have serious liver disease.
Pancreatitis: in some patients treated with lamivudine and zidovudine, reported inflammation of the pancreas (pancreatitis ) . It is uncertain , however , whether this is due to the drug or is a manifestation of HIV infection. If your doctor finds no clinical signs , symptoms or changes in laboratory values that indicate pancreatitis should stop taking Trizivir immediately .
Anemia and neutropenia : zidovudine can reduce the number of red blood cells and can result in anemia . If this happens , the symptoms are fatigue and breathlessness . In rare cases, it can reduce the number of a certain type of white blood cells ( neutropenia) , which can we napravityu prone to infections . Your doctor will recommend periodic blood tests to check blood counts . These effects are usually reversible .

Immune Reactivation Syndrome : In some patients with advanced HIV infection ( AIDS) and a history of opportunistic infections soon after anti-HIV treatment may be signs and symptoms of inflammation from previous illnesses. It is believed that these symptoms are due to an improvement in the immune response of the organism and allow it to combat existing infections progressing without overt symptoms. If you notice any symptoms of infection, please inform your doctor immediately .

Other : Trizivir helps to control the state , but does not cure H1V infection. You should take it every day. Treatment should not be stopped without medical advice . However, if you suspect that you have symptoms of a hypersensitivity reaction ( see above ) , tell your doctor for advice on whether you should stop taking Trizivir.

Trizivir is not reduce the risk of transmission of H1V infection to others through sexual contact or blood contamination. You should continue to use appropriate precautions to prevent transmission of infection. Infections and related diseases H1V disease may continue to develop during treatment with Trizivir. It is therefore necessary to regularly consult with your doctor.

Taking Trizivir with other medications
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines , even those bought without a prescription.
Trizivir should not be taken in parallel with stavudine ( stavudine ), zalcitabine ( zalcitabine ), ribavirin ( ribavirin) , injections of ganciclovir ( gantsikpovir ) or foscarnet ( foscarnet ) .
Trizivir can interact with certain other drugs , which may enhance the severity of adverse (side) effects . Tell your doctor if you are taking any of these medicines ( ask your doctor if you are unsure ) .
• Phenytoin ( phenytoin ), sodium valproate ( sodium valproate ), phenobarbital ( phenobarbital ), oxazepam ( oxazepam ), lorazepam ( lorazepam ) .
• Acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever ), codeine ( codeine ), morphine ( morphine ), methadone ( methadone ), rifampicin ( rifampicin ), indomethacin ( indomethacin ), ketoprofen ( ketoprofen ) , naproxen ( naproxen ), cimetidine ( cimetidine ), clofibrate ( clofibrate ), isoprinosine ( isoprinosine ), probenecid ( probenecid ) .
• Pentamidine ( pentamidine ), pyrimethamine ( pyrimethamine ), co-trimoxazole ( co-trimoxazole ), dapsone ( dapsone ), atovaquone ( atovaquone ), amphotericin ( amphotericin ), flucytosine ( flucytosine ), interferon ( IFN ) .
• Vincristine ( vincristine ), vinblastine ( VLB ) and doxorubicin ( doxorubicin) . Alcohol increases the amount of abacavir in the blood.
Tell your doctor if you are taking oral products related to vitamin A , such as isotretinoin ( isotretinoin ) , as they may also increase the amount of abacavir in the blood.
As abacavir increases the rate of elimination of methadone ( metddon ) from the body , patients taking methadone, should be monitored for any signs of withdrawal and their methadone dose can be changed .

pregnancy
The use of Trizivir in pregnancy is not recommended. If you are pregnant or planning to become pregnant , you should tell your doctor to discuss the potential adverse effects and the benefits and risks of antiretroviral therapy for you and your child .
If you are taking Trizivir during pregnancy doctor may order regular visits to monitor the development of the child. You may have blood tests and other diagnostic tests.
Upon reception of nucleoside and nucleotide analogues from the mother during pregnancy from the reduced chance of being infected with HIV is greater than the risk of potential side effects .

breastfeeding
It is not recommended to breast-feed your baby while being treated with Trizivir. In addition, experts recommend that mothers infected with HIV, do not breast feed their infants under any circumstances in order to avoid transmission of HIV from mother to child . If you are breastfeeding , you should inform your doctor.

Effects on ability to drive and use machines
No studies on the effects of Trizivir on ability to drive and use machines. However, you should consider your health and possible side effects of Trizivir before driving or operating machinery.

3 . HOW TO TAKE TRIZIVIR?
Take Trizivir, as well as your doctor recommends and do your best not to miss any doses . If you are not sure how to take your medicine , ask your doctor .
The usual dose for adults of Trizivir is one tablet twice daily. Doses should be taken at intervals of about 12 hours. Swallow the tablets whole with water. Trizivir can be taken with or without food .
Your doctor may change the medication taken alone with lamivudine, zidovudine and abacavir, if it wants to reduce the dose of Trizivir, you take (eg if you have kidney problems ) .

If you take more than necessary Trizivir
If you accidentally take too large a dose of the drug should immediately inform your doctor or call an ambulance .

If you forget to take a dose of Trizivir
It is important to take the full daily dose of Trizivir, which is prescribed to ensure maximum benefit from the treatment. If you forget to take a dose , take it as soon as you remember and then continue to take doses exactly as specified time. Do not take a double dose to compensate the missed dose of the medication . It is important to take Trizivir regularly as irregular intake of the drug increases the risk of hypersensitivity reactions .

If you have stopped taking Trizivir
If you have stopped taking Trizivir for any reason, especially if you think you have side effects or any other disease , necessarily consult your doctor before you start taking it again . In some cases, your doctor may decide to start taking it again in a place where you can get immediate medical attention if necessary.

4 . POSSIBLE SIDE EFFECTS
Like all medicines, Trizivir can cause side effects, although not everybody gets them. For adverse drug reactions during treatment of HIV infection is difficult to assess whether they are due to Trizivir or any other medicines you are taking at the moment, or are the result of the disease . Therefore it is very important that you inform the physician of any changes in your health .
Hypersensitivity reaction (serious allergic reaction ) is roughly 5 out of every 100 patients treated with abacavir. More information about these events is included in the section " Special warnings " of this leaflet.
It is important to carefully read and understand the information about this serious reaction .
Trizivir contains abacavir , lamivudine and zidovudine. Adverse reactions listed below are reported with one or more of these drugs , and therefore may also occur by administration of Trizivir.

Very common side effects (reported in more than 10 100 patients), headache, nausea

Common side effects (reported in 1 to 10 of 100 patients)
- Anemia (low red blood cell count ) and neutropenia / leucopenia ( low white blood cells). If the formation of red blood cells is reduced you may have symptoms of tiredness or breathlessness . Reducing the number of white blood cells can reduce the resistance to infections . Increased levels of enzymes produced by the liver.
- Fatigue , fever, dizziness , malaise, a feeling of tiredness, sleepiness , sleep disorders , joint pain , muscle disorders , cough, symptoms of the nose ( irritation , runny nose ), loss of appetite, vomiting, stomach pain and cramps diarrhea .
- Abacavir hypersensitivity , skin rash ( without any other illness ) , hair loss .

Uncommon side effects (reported in 1 to 10 out of 1000 patients)
- A reduction in the number of platelets ( blood cells important for blood clotting) . If you have a low platelet count, it is possible to get easier bleeding . Shortness of breath, flatulence, pruritus.

Rare side effects (reported in less than 1 in 1000 patients), anxiety, depression, drowsiness , convulsions ( seizures) .
- Change in the taste , the color changes spotted on membranes of the mouth , indigestion , inflammation of the pancreas , liver disorders, such as enlargement of the liver , fat accumulation in the liver, jaundice and hepatitis , increasing the amount of the enzyme amylase.
- Frequent urination, breast enlargement in males , chest pain, which may suggest heart muscle disease called cardiomyopathy , numbness , tingling sensation or a feeling of weakness in the limbs, loss of muscle tissue staining of the nails and skin , sweating, chills , flu-like symptoms.

Very rare side effects (reported in less than 1 in 10,000 patients), serious skin reactions , severe anemia and neutropenia.

In some patients taking medicines of nucleoside analogues - reverse transcriptase inhibitors (NRTIs), have been reported cases of a condition known as lactic acidosis - an accumulation of lactic acid in the blood ( for more information see " Special warnings and precautions " ) .
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution . These may include loss of fat from legs, arms and face, increased fat in the abdomen and other internal organs , breast enlargement and fatty lumps on the back of the neck ( 'buffalo hump'). Not yet identified the cause of this condition and the long-term health effects . Combination antiretroviral therapy may also lead to elevation of lactic acid in the blood and of blood sugar in hyperlipidemia (increased blood fats ) and resistance to insulin .
If any of the side effects gets serious , or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.

5 . STORAGE TRIZIVIR FILM-COATED TABLETS
Trizivir Keep out of reach of children. Trizivir or store at temperatures exceeding 30 ° C.
Do not take the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . ADDITIONAL INFORMATION

What does Trizivir?
The active ingredients in each tablet Trizivir are 300 mg of abacavir ( abacavir sulfate ), 150 mg of lamivudine and 300 mg zidovudine.
The other ingredients in the tablet core are microcrystalline cellulose , sodium starch glycolate and magnesium stearate. The tablet coating contains hypromellose , titanium dioxide , polyethylene glycol, indigo carmine aluminum lake , iron oxide yellow.

Trizivir looks like and contents of the pack
The film-coated tablets are blue-green capsule-shaped and engraved ° GX LL1 " on one side. They are available in blister packs containing 60 tablets or bottles tamper children containing 60 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder : Glaxo Group Ltd