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drug-medicine : combivir

 

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Medicine: combivir

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.

  • 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. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What Combivir is and what it is used for
  • 2. Before you take Combivir
  • 3. How to take Combivir
  • 4. Possible side effects
  • 5. How to store Combivir
  • 6. Further information

1. WHAT COMBIVIR IS AND WHAT IT IS USED FOR

Combivir belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection.

Combivir is used in antiretroviral combination therapy for the treatment of HIV infection in adults and adolescents over 12 years of age. Combivir reduces the amount of HIV virus in your body, and keeps it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cell, that play an important role in maintaining a healthy immune system to help fight infection. Combivir has been shown to significantly reduce the risk of disease progression. Response to treatment with Combivir varies between patients. Your doctor will be monitoring the effectiveness of your treatment.

2. BEFORE YOU TAKE COMBIVIR

Do not take Combivir

  • If you are hypersensitive (allergic) to lamivudine or zidovudine or any of the other ingredients of Combivir tablets.
  • If you have very low red blood cell count (severe anaemia) or very low white blood cell count (neutropenia).

If you are not sure please ask your doctor.

Take special care with Combivir

Combivir is not recommended for use in children under 12 years of age, as a liquid form allowing for dose reduction is not available for Combivir.

Discuss the use of Combivir with your doctor if you have kidney or liver disease to ensure the doses of the active substances in Combivir are suitable for you.

It is important that your doctor knows about all your symptoms even if you think they are not related to HIV infection. Your doctor may decide to prescribe lamivudine or zidovudine as separate medicines instead of Combivir.

Anaemia (low red blood cell count) and neutropenia/leucopenia (low white blood cell count) may occur within 4-6 weeks due to treatment with zidovudine, one of the active substances in Combivir. If severe, your physician may stop treatment with Combivir. This has occurred more commonly in patients with advanced HIV disease and with higher doses of zidovudine than the dose in Combivir. Regular blood tests will be arranged to check whether there is a problem. This adverse reaction is infrequent in patients with early HIV disease and blood tests may be performed less frequently.

The class of medicines to which Combivir belongs (NRTIs) can cause a condition called lactic acidosis, together with 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, might indicate the development of lactic acidosis. This rare, but serious side effect occurs more often in women, particularly if very overweight. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with Combivir, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.

If you have a chronic hepatitis B infection, you should not stop your treatment without instructions from your doctor, as you may have a recurrence of your hepatitis. This recurrence may be more severe if you have serious liver disease.

 

You will need to take Combivir every day. This medicine helps to control your condition and delay disease progression, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor. Do not stop taking your medicine without first talking to your doctor.

Treatment with Combivir has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer. You should continue to use appropriate precautions to prevent this.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines

It is important that you tell your doctor about all the medicines you are taking including those you have bought yourself. These may affect the action of Combivir, or Combivir may affect their action. Combivir should not be taken with zalcitabine, high doses of co-trimoxazole, or injections of ganciclovir or foscarnet, as lamivudine, one of the active substances in Combivir may interact with these. Combivir should also not be taken with ribavirin or stavudine, as zidovudine the other active substance in Combivir may reduce the action of these medicinal products.

Zidovudine, may also interact with the following medicines and may make any side effects worse: Phenytoin, probenecid, rifampicin, atovaquone, valproic acid, methadone, acetyl salicylic acid, codeine, morphine, indomethacin, ketoprofen, naproxen, oxazepam, lorazepam, cimetidine, clofibrate, dapsone, isoprinosine, pentamidine, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin.

Pregnancy and breast-feeding

If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.

If you have taken Combivir during your pregnancy, your doctor may request regular visits to monitor the development of your child. Such visits may include blood tests and other diagnostic tests.

In children whose mothers took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.

If you are breast-feeding please inform your doctor before taking any medicines. Combivir is not recommended if you are breast-feeding. It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.

3. HOW TO TAKE COMBIVIR

Always take Combivir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Combivir for adults and adolescents from over 12 years of age is one tablet twice a day. Each dose of Combivir should be taken approximately 12 hours apart. Swallow Combivir tablets whole with water or another drink. They can be taken with or without food.

If your doctor wishes to reduce your dose of Combivir, for example if you have kidney problems, then your medicine may be changed to lamivudine and zidovudine taken as separate medicines, which are available as tablets or liquid.

If you take more Combivir than you should

Accidentally taking too much Combivir is unlikely to cause any serious problems. However, you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Combivir

If you forget to take a dose of Combivir, take it as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Combivir can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Combivir, by other medicines you are taking at the same time or by the HIV disease. For this reason it is very important that you inform your doctor about any changes in your health. Do not be alarmed by this list of possible side effects, you may not experience them.

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 (belly), and other internal organs, breast enlargement and fatty lumps on the back of the neck ('buffalo hump'). The cause and long-term health effects of these conditions are not known at this time.

Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

The most commonly reported (greater than 1 in every 100 patients treated) side effects that may occur are headache, nausea, vomiting, stomach pain, diarrhoea, fever, rash (red, raised or itchy), increase in certain liver enzymes, joint pain, muscle pain and other muscle disorders, dizziness, cough, nasal symptoms, tiredness, difficulty sleeping, hair loss, anaemia (low red blood cell count) and neutropenia (low white blood cell count). If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness and a reduction in your white blood cell count can make you more prone to infection.

Uncommon (between 1 in 1000 and 1 in 100 patients treated) side effects that may occur are flatulence, breathlessness, general aches and pains and reduction in platelets (blood cells important for blood clotting). If you have a low platelet count you may notice that you bruise more easily.

There are rare reports (between 1 in 10,000 and 1 in 1000 patients treated) of patchy colour changes inside the mouth, heartburn, chest pain (possibly indicating a heart muscle disease called cardiomyopathy), breakdown of muscle tissue, liver disorders such as enlarged liver, fatty liver, inflammation of the liver (hepatitis), inflammation of the pancreas, nail and skin colour changes, sweating, flu-like feeling, drowsiness, passing urine more frequently, breast enlargement in male patients, chest pain, chills, loss of appetite, taste changes, tingling in the limbs, seizures, inability to concentrate, depression and feeling anxious, increase of lactic acid in the body known as lactic acidosis (see Take special care with Combivir).

While many of the side effects that have been reported occur with both lamivudine and zidovudine when given as separate medicines, some are more likely to occur with one of the medicines only. Your doctor may decide that you need to stop taking Combivir and take lamivudine and zidovudine separately. This will allow your doctor to vary the dose or stop one of the active substances if it is considered that this will help manage any side effects.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE COMBIVIR

Keep out of the reach and sight of children.

Do not use Combivir after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

Do not store above 30°C.

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. FURTHER INFORMATION

What Combivir contains

  • The active substances are lamivudine 150 mg and zidovudine 300 mg.
  • The other ingredients are:
    • tablet core; microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate, colloidal silicon dioxide.
    • tablet film-coat; hypromellose, titanium dioxide, macrogol 400 and polysorbate 80.

 

 

Medicamentweb.com, the website for Patient Information Leaflets, is dedicated to share information about pharmaceutical products with the general public, and is particularly interested in making PILs available online. Of course, this information cannot replace the advice of your GP, doctor or pharmacist. If you should be worried in any way about your health, we urge you to see a doctor.

 

 

 

 

 

 

 

 

 

 

 

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